The Swedish biotechnology
innovation system
VINNOVA Innovation in Focus VF 2001:2
TITEL (svensk):
Det svenska biotekniska innovationssystemet
TITLE (english):
The Swedish biotechnology innovation system
FÖRFATTARE/AUTHOR:
Anna Sandström, Anna Backlund, Helena Häggblad,
Nils Markusson, Lennart Norgren, and Li Westerlund
SERIE/SERIES:
VINNOVA Innovation i fokus VF 2001:2
ISBN 91-89588-06-1
ISSN 1650-3147
PUBLICERINGSDATUM/DATE PUBLISHED:
2001/03
UTGIVARE/PUBLISHER: VINNOVA – Verket för
innovationssystem/The Swedish Agency for Innovation
Systems, Stockholm
VINNOVA DIARIENR/RECORD NO:
NUTEK 1A2-98-3913
REFERAT (syfte, metod, resultat):
Denna studie beskriver det svenska innovationssystemet för bioteknik. Studien är avsedd att ge underlag för att
utforma offentliga åtgärder som främjar tillväxt inom området bioteknik, genom att identifiera drivkrafter och
hinder för innovation och tillväxt. Studien utgår från ett innovationssystemsperspektiv, och bygger på statistik,
arbetsseminarier, intervjuer, en enkät samt en genomgång av aktuell litteratur.
Den mest odiskutabla slutsatsen är betydelsen av en stark forskningsbas, eftersom den är en förutsättning för
innovation och tillväxt i forskningsintensiva teknikbaserade företag som bioteknikföretagen. Ett fortsatt offentligt
åtagande att investera i bioteknikrelaterade ämnesområden är därför ytterst viktigt.
ABSTRACT (aim, method, results):
The present study describes the Swedish biotechnology innovation system. The aim is to identify forces and
obstacles that enhance or impede innovation and growth. This is intended to facilitate the identification of public
measures that will promote growth in the Swedish biotechnology innovation system. The study applies an
innovations systems perspective, and is based on statistics, workshop results, interviews, a questionnaire survey,
and literature.
The most indisputable conclusion is the importance of a strong science base, since it is a prerequisite for
innovations and growth in research-intensive, technology-based enterprises such as biotechnology companies. A
continued public commitment to investments in scientific fields relevant to biotechnology is thus of most
importance.
Cover-picture (upper):
GMO-rape for the Canadian market, Svalöf Weibull AB.
Photographer: Staffan Erlandsson.
Cover-picture (lower):
The Principle of Pyrosequencing Technology. Illustration courtesy of Pyrosequencing AB. (Pyrosequencing
technology is based on an enzyme cascade system that generates light when a nucleotide is incorporated onto a
DNA template).
I VINNOVAs – Verket för innovationssystem - publikationsserier redovisar forskare, utredare och analytiker sina projekt. Publiceringen
innebär inte att VINNOVA tar ställning till framförda åsikter, slutsatser och resultat.
De flesta VINNOVA-publikationer finns att läsa eller ladda ner via www.vinnova.se.
VINNOVA – The Swedish Agency for Innovation Systems - publications are published at www.vinnova.se
The Swedish biotechnology innovation system
Preface
Innovation plays a pivotal role in creating economic growth and a competitive
society. Public measures that are meant to stimulate innovativeness and growth
should take into account the specific conditions that apply to different innovation
systems. Analysis of different innovation systems makes it possible to understand
what conditions underlie, enhance, or impede innovation and growth and how
these conditions differ from system to system. This leads to a firmer basis for
measures by which the present innovation system may be stimulated to bring
about better competitiveness and increased growth.
In the present study the Swedish biotechnology innovation system is described.
The aim is to identify forces that enhance or impede innovation and growth in
order to facilitate the identification of public measures that will promote growth in
the Swedish biotechnology innovation system. The work was carried out during
the period November 1998 - November 2000. The study is based on statistics,
workshop results, interviews, a questionnaire survey, and literature. The statistics
include data on Swedish scientific publication patterns, Swedish patenting in the
US patent system, the turnover, number of employees, and educational level in
identified companies, public funding of research, and also some data on public
financing of start-ups and on the investments that venture capital companies have
made in Swedish biotechnology. Large parts of the contents of the present report
have previously been published in Swedish1. The present version, however,
includes a more elaborate analysis of the geographic distribution of the biotech
industry, updated data on the development of the industry, and the results of a
questionnaire sent to the managing directors of identified companies.
This report has been produced as part of a project, which was jointly financed
by NUTEK2 and the European Union. The report was authored by Anna
Backlund, Helena Häggblad, Nils Markusson, Lennart Norgren, and Anna
Sandström, who was also project leader. Section 6.2 was authored by Li
Westerlund, Stockholm University.
Göran Marklund
VINNOVA, Division of Innovation Systems Studies
1
Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer och
tillväxt. NUTEK, Working Paper May 2000.
2 The Division of Innovation Systems Studies was formerly a part of NUTEK, Swedish National
Board for Industrial and Technical Development.
CONTENT
SAMMANFATTNING ..................................................................................................... I
SUMMARY....................................................................................................................VII
1
INTRODUCTION ..................................................................................................1
2
METHODOLOGY .................................................................................................3
2.1
2.2
2.3
2.4
2.5
2.6
3
SWEDISH PAPERS IN SCIENCE CITATION INDEX ..................................................................3
SWEDISH PATENTS IN THE US PATENT SYSTEM ..................................................................6
INTERVIEWS AND LITERATURE ..........................................................................................9
BIOTECHNOLOGY COMPANIES ............................................................................................9
QUESTIONNAIRE TO IDENTIFIED BIOTECH COMPANIES .....................................................10
WORKSHOP ......................................................................................................................11
EARLY DEVELOPMENT OF THE SWEDISH BIOTECH INDUSTRY.....12
3.1
3.2
3.3
3.4
3.5
3.6
3.7
4
THE PHARMACEUTICAL INDUSTRY ...................................................................................12
FOOD AND PACKAGING INDUSTRIES .................................................................................16
PLANT IMPROVEMENT AND BIOLOGICAL PLANT PROTECTION ..........................................17
SOIL, WATER, AND WASTE TREATMENT TECHNOLOGY .....................................................17
CHEMICAL INDUSTRY .......................................................................................................18
PULP & PAPER ..................................................................................................................18
LITERATURE ON THE DEVELOPMENT OF THE BIOTECH INDUSTRY INTERNATIONALLY ......19
THE SWEDISH BIOTECH INDUSTRY TODAY ...........................................23
4.1
4.2
4.3
4.4
4.5
4.6
4.7
4.8
4.9
4.10
4.11
4.12
5
INTRODUCTION ................................................................................................................23
DRUG DISCOVERY AND DRUG DEVELOPMENT ..................................................................26
DIAGNOSTICS AND MEDICAL TECHNOLOGY......................................................................31
BIOTECH SUPPLIES: NEW TECHNIQUES, PROCESSES AND EQUIPMENT ...............................32
PRODUCTION OF BIOLOGICAL MOLECULES, MICRO-ORGANISMS OR CELLS .......................34
FOOD AND FEED ...............................................................................................................34
AGROBIOTECHNOLOGY ....................................................................................................38
ENVIRONMENTAL BIOTECHNOLOGY .................................................................................40
REGIONAL DISTRIBUTION OF COMPANIES .........................................................................40
GEOGRAPHIC COLLABORATION PATTERN .........................................................................44
COMPANIES’ OPINIONS CONCERNING DRIVING FORCES, OBSTACLES, AND WHAT SHOULD
BE DONE TO PROMOTE GROWTH .......................................................................................45
BIOTECH INDUSTRY ORGANISATIONS ...............................................................................51
SWEDISH RESEARCH IN LIFE SCIENCE FIELDS ....................................53
5.1
5.2
5.3
5.4
5.5
5.6
6
SWEDEN – A LARGE PRODUCER OF LIFE SCIENCE ARTICLES..............................................53
WHAT ABOUT THE QUALITY OF THE ARTICLES? ...............................................................54
THE SWEDISH SCIENCE SYSTEM .......................................................................................56
INTERNATIONAL COLLABORATION IN LIFE SCIENCE RESEARCH ........................................64
SUMMARY CONCERNING SCIENTIFIC PUBLICATIONS.........................................................65
WHAT CONCLUSIONS CAN BE DRAWN FROM THE PUBLICATION STATISTICS? ...................67
PATENTING IN BIOTECHNOLOGY AND BIOTECHNOLOGYRELATED FIELDS .............................................................................................68
6.1
6.2
6.3
6.4
6.5
6.6
6.7
INTRODUCTION ................................................................................................................68
REGULATION - PATENTS FOR BIOTECHNOLOGICAL INVENTIONS.......................................69
SWEDISH PATENTING IN THE US PATENT SYSTEM ............................................................78
THE DYNAMICS OF SWEDISH PATENTING .........................................................................80
WHO OWNS THE PATENTS?...............................................................................................82
IS SWEDEN GIVING AWAY SWEDISH INVENTIONS? ...........................................................82
WHAT CONCLUSIONS CAN BE DRAWN FROM THE PATENTING STATISTICS?.......................84
7
FINANCING OF BIOTECH RESEARCH AND ENTERPRISES .................85
7.1
7.2
7.3
7.4
7.5
8
GENERAL UNIVERSITY FUNDS ..........................................................................................85
PARTICIPATION IN THE EU 4TH FRAMEWORK PROGRAMME ..............................................85
PUBLIC RESEARCH COUNCILS AND FOUNDATIONS, NUTEK AND FOA............................86
FINANCING OF BIOTECHNOLOGY RESEARCH IN FIGURES ..................................................89
FINANCING OF INNOVATIONS AND THE FORMATION OF NEW COMPANIES .........................91
PROMOTING GROWTH WITHIN SWEDISH BIOTECH: INITIATIVES,
PLAYERS, AND GOVERNMENT AGENCIES...............................................95
8.1
8.2
8.3
9
INITIATIVES PROMOTING ENTERPRISE ..............................................................................95
INDUSTRIAL RESEARCH INSTITUTES .................................................................................97
PUBLIC ORGANISATIONS IMPORTANT TO THE INNOVATION SYSTEM ...............................100
CONCLUSIONS.................................................................................................102
9.1
9.2
9.3
9.4
9.5
9.6
THE BIOTECH INDUSTRY .................................................................................................103
THE IMPORTANCE OF AN ENVIRONMENT WITH A GOOD INNOVATIVE CLIMATE ...............106
RESEARCH AND EDUCATION...........................................................................................107
THE IMPORTANCE OF RESEARCH ON THE INNOVATION PROCESSES .................................108
TECHNOLOGY TRANSFER AND KNOWLEDGE EXCHANGE ................................................110
CONCLUDING REMARKS .................................................................................................112
10
APPENDIX .........................................................................................................113
A.
THE BIOTECH INDUSTRY IN 1999..............................................................113
B.
SCIENTIFIC PUBLICATIONS .......................................................................127
C.
PATENTING ......................................................................................................134
D.
FINANCING .......................................................................................................144
E.
QUESTIONNAIRE ............................................................................................147
F.
INTERVIEWS ....................................................................................................150
Sammanfattning
Denna studie beskriver det svenska innovationssystemet för bioteknik. Studien
är avsedd att ge underlag för att utforma offentliga åtgärder som främjar tillväxt
inom området bioteknik, genom att identifiera drivkrafter och hinder för
innovation och tillväxt.
Studien bygger på statistik, arbetsseminarier, intervjuer, en enkät samt en
genomgång av aktuell litteratur. De statistiska uppgifterna avser en bred
uppsättning indikatorer:
•
•
•
•
•
•
•
svensk vetenskaplig publicering
svensk patentering i USA3
ekonomiska uppgifter om de företag som identifierats
uppgifter om personalens utbildning i dessa företag
offentlig forskningsfinansiering
offentligt stöd till nystartade företag
riskkapitalinvesteringar i svenska bioteknikföretag
Utgångspunkter
Ett innovationssystem kan avgränsas från flera olika utgångspunkter, beroende
på analysens syfte: Teknologiska system fokuserar på kunskapskällor och vägar
för kunskapsspridning. Industriella system avgränsas av flödena i
förädlingskedjan. Regionala innovationssystem fokuserar på kluster baserade på
lokala arbetsmarknader för kompetent personal, nära tillgång till specialiserade
leverantörer etc. Vi använder en teknologibaserad definition som fokuserar på
aktörer inom kunskapsområdet bioteknik:
"Aktörer som utvecklar, producerar, analyserar eller använder biologiska
system på en mikro, cellulär eller molekylär nivå, samt offentliga och privata
institutioner som påverkar deras agerande."
Genom att komplettera det teknologiska perspektivet med en analys av de
förädlingskedjor företagen ingår i kan vi identifiera flera delsystem inom
kunskapsområdet bioteknik (se nästa avsnitt). Vi har funnit att en
teknologibaserad definition bör kombineras med en "sektoriell" uppdelning när vi
formulerar policyrekommendationer. Vissa rekommendationer blir generella för
hela det teknologiska systemet medan andra blir specifika för enskilda delsystem.
Inom vissa sektorer spelar de studerade företagen t ex i första hand en roll som
kunskapsförmedlare mellan universitetsforskning och andra företag, medan de
inom andra sektorer säljer egna produkter på marknaden. Drivkrafter och hinder
för tillväxt, liksom företagens dynamik, ser därmed olika ut inom olika sektorer.
Analyser och slutsatser fokuserar på små och medelstora företag med upp till
500 anställda.
USA utgör den största marknaden för produkter inom detta område. Vi antar att företagen i stor
utsträckning väljer att täcka kommersiellt intressanta patent i USA, vilket gör det till en god bas för
internationella jämförelser.
3
i
Den biotekniska industrin
Enligt Ernst & Young hade Sverige 1999 den fjärde största bioteknikindustrin i
Europa, efter Storbritannien, Tyskland och Frankrike. I vår studie har vi
identifierat ca 145 forsknings- och kunskapsintensiva små och medelstora företag
(med anställd personal 1999, och verksamhet inom de områden som täcks av vår
avgränsning). Företagen delades in i följande kategorier:
•
•
•
•
•
•
Läkemedel och medicin (läkemedelsutveckling, diagnostik etc.)
Agrobioteknik (genmodifierade växter, biologiskt växtskydd etc.)
Miljöbioteknik (marksanering, vattenrening, avfallshantering)
Bioteknisk utrustning och tjänster (tjänster, processer, utrustning och
mätinstrument för bioteknisk användning)
Kost-hälsa produkter (i huvudsak probiotika)
Bioproduktion (biomolekyler eller mikroorganismer)
De studerade företagen (med mindre än 500 anställda) hade ca 3000 anställda
under 1999, en ökning med ca 30 procent sedan 1997. Alla delområden hade ökat
antalet anställda från 1997 till 1999. Personalen är högutbildad, med 10 - 20
procent forskarutbildade. Som drivkrafter för denna positiva utveckling nämns:
•
•
•
•
•
•
•
Kvalitén på universitetens forskning, och goda samarbetsmöjligheter med
denna
Den internationella kunskapsexplosionen inom området
En växande världsmarknad
Tillgången på riskkapital
Utvecklingen till idag har skapat ett antal framgångsrika företag som tjänar
som goda exempel och förebilder
Astras och Pharmacias närvaro
En ökad entreprenörsanda
De nya bioteknikföretagen fungerar ofta som länkar mellan akademisk
forskning och etablerade företag, för att introducera och sprida ny teknik. De
tillhandahåller teknikplattformar, kunskap, tjänster och produktembryon till större
företag, t ex internationella läkemedelskoncerner eller stora svenska
livsmedelproducenter. "Produkterna" kan vara läkemedelskandidater eller
mikroorganismer med goda hälsoegenskaper som kan användas i kost-hälsa
produkter, men de kan också vara en förmåga att upprätthålla starka nätverk med
universitetsforskning, som ger möjlighet att identifiera frontlinjeforskning med
kommersiell potential. Detta gäller till exempel för företag som identifierar och
utvecklar nya läkemedel, eller företag som utvecklar kost-hälsa produkter. Inom
andra områden är det vanligare att företagen på egen hand utvecklar produkter
ända till marknaden. Detta gäller speciellt inom bioteknisk utrustning och
insatsvaror, miljöbioteknik, bioproduktion och agrobioteknik.
Forskningsbasen
Utvecklingen i det biotekniska innovationssystemet är i stor utsträckning
beroende av forskningsresultat från högskolan. En analys av svenska
forskargruppers publiceringsmönster i relevanta biovetenskapliga tidskrifter kan
därför identifiera aktörer i systemet, samarbetsmönster, och hur väl svensk
forskning står sig i internationell jämförelse.
ii
Universitetsforskare dominerar publiceringen, med 95 procent av alla artiklar.
Karolinska Institutet svarar för 36 procent, medan universiteten i Lund, Göteborg
och Uppsala bidrar med 13 - 18 procent vardera. Som en jämförelse svarar
företagen tillsammans för 7 procent av publiceringen, och av detta kommer tre
fjärdedelar från Astra och Pharmacia4
Samarbetsmönstren stärker bilden av ett starkt samarbete mellan
bioteknikföretagen och universitetsforskning, då 65 procent av företagens artiklar
var samförfattade med universitetsgrupper. Antalet företag som medverkar i
vetenskaplig publicering ökar, men antalet artiklar med ursprung i företag
minskar, liksom antalet artiklar samförfattade med svenska forskargrupper. Detta
beror främst på förändringar hos Astra och Pharmacia, som har minskat både sin
totala vetenskapliga publicering och antalet artiklar i samverkan med svenska
forskargrupper inom de studerade ämnesområdena.
Det finns inga entydiga tendenser vad gäller det totala antalet svenska artiklar
inom bioteknikrelaterade ämnen, eller kvaliteten hos dessa, i internationell
jämförelse, utvecklingen ser olika ut inom olika delområden. Fler förändringar går
ändå i negativ än i positiv riktning, vad gäller kvalitet mätt som antalet citeringar.
I förhållande till folkmängden är den svenska publikationsvolymen störst i världen
inom neurovetenskap och immunologi, och nummer två (efter Schweiz) inom
molekylärbiologi och genetik, mikrobiologi, biokemi och biofysik, samt cell- och
utvecklingsbiologi. Inom bioteknik och tillämpad mikrobiologi ligger den svenska
publikationsvolymen på tredje plats, efter Schweiz och Danmark.
Patentering
En analys av svensk patentering i USA inom bioteknik åren 1984-1998 gav
inte lika imponerande resultat. Totalt för alla teknikområden svarar svenska
uppfinnare för en procent av patenten, vilket ger oss en fjärdeplats i världen
relaterat till folkmängd. Inom bioteknik var motsvarande andel 0,5 - 1 procent. De
svenska volymandelarna av patenteringen var högre inom de näraliggande
områdena läkemedel, medicinsk elektronik och medicinsk utrustning.
Patentstatistiken understryker också Pharmacias och Astras starka dominans.
Av 784 patent inom bioteknik eller bioteknikrelaterade områden med svensk
anknytning under åren 1986-1997, så innehades 30 procent av något av dessa
båda företag. Nästan 10 procent av patenten hade utländsk uppfinnare men svensk
innehavare, något som kan ses som en indikation på Sveriges förmåga att
“importera“ innovationer. Svenska företag tycks även tillvarata svenska
uppfinningar, eftersom ungefär samma andel patent hade svenska uppfinnare som
svenska innehavare (65 procent). En kombination av patentstatistik och
publiceringsdata visar att ungefär en tredjedel av de företag som patenterat också
publicerad minst en vetenskaplig artikel inom ett bioteknikrelaterat område, och
en fjärdedel hade samförfattat artiklar med forskare vid ett svenskt universitet
eller offentliga forskningsinstitut.
Bioteknikindustrins lokalisering och internationella kontakter
4
Numera Astra Zeneca och Pharmacia Corporation
iii
Bioteknikföretagen återfinns främst i storstadsområden, samt i
universitetsstäder med omfattande medicinsk forskning. Ungefär lika många
företag är lokaliserade till Lund/Malmö-regionen som till Stockholmsområdet.
Därefter följer Uppsala och Göteborg, med ungefär hälften så många företag
vardera. Den minsta regionen med åtminstone tio bioteknikföretag är Umeå. Om
vi enbart studerar företag med mindre än 200 anställda, så svarar Stockholm och
Lund/Malmö vardera för ca 30 procent av antalet sysselsatta i dessa företag, följda
av Uppsala med 18 procent, Göteborg med 7 procent och Umeå med 4 procent.
Det går inte att avgränsa ett “svenskt“ innovationssystem inom bioteknik.
Företag, forskningsinstitut, universitet och andra aktörer är alla i stor utsträckning
engagerade i internationella nätverk och samarbetsprojekt. Nästan en tredjedel av
alla svenska vetenskapliga artiklar inom området var samförfattade med utländska
forskare. På samma sätt hade nästan en tredjedel av patenten upphovsmän från
flera länder. Det är även vanligt att patentägaren och uppfinnaren har olika
nationalitet. Vår enkät till företagsledare i de bioteknikföretag vi identifierat
understryker detta: Så många som 64 procent av dessa företag uppgav att de
samverkade med utländska forskargrupper i sin forskning och produktutveckling.
Motsvarande andel för samverkan med andra företag i utlandet, och/eller uppdrag
till dessa, i sin forskning och produktutveckling var också hög, 49 procent.
AstraZeneca och Pharmacia Corporation
Astras och Pharmacia har fungerat som motorer i det biotekniska
innovationssystemet, inte bara för företag inom läkemedelsutveckling och
diagnostik, utan också inom t ex bioteknisk utrustning och tjänster. Genom
samarbete med svenska forskargrupper har de både bidragit med finansiering och
givit forskarna ett ökat medvetande om industriella problem. De har också utgjort
en rekryteringskälla för kompetent personal till nya bioteknikföretag: Flera av
dessa är också avknoppningar från Astra eller Pharmacia.
Näringspolitiska slutsatser, och aktörernas åsikter
Drivkrafter och hinder för tillväxt ser olika ut för olika innovationssystem, och
det är viktigt att politiken anpassas till dessa skilda förutsättningar. Både forskare
och företagsledare betonar att den nya kunskap som skapas inom funktionell
genomik och proteomik är den viktigaste drivkraften för innovation inom
läkemedelsindustrin i framtiden. Därför behövs fortsatta satsningar på forskning
och utbildning inom dessa områden.
Stöd till patientnära, klinisk forskning är också viktigt, även i fortsättningen.
Traditionell läkemedelsutveckling och klinisk forskning är nödvändiga
komplement till forskning inom molekylär medicin. Om resultaten från
biomedicinsk forskning ska komma till användning så måste de testas och
dokumenteras i kliniska prövningar. En god kapacitet för klinisk forskning stöder
på detta sätt även utvecklingen av biomedicinska företag i Sverige.
För utveckling av kost-hälsa produkter krävs ökad tvärvetenskaplig forskning
som kombinerar kunskap inom näringsfysiologi, medicin och
livsmedelsproduktion. Tvärvetenskaplig forskning är överhuvudtaget viktig för att
kommersialisera den växande kunskapen inom biovetenskap. Kopplingar mellan
biologi - kemi - medicin å ena sidan, och teknisk kunskap inom t ex IT och
iv
elektronik bör prioriteras. Både forskare och entreprenörer anser att sådana
investeringar bör fokuseras på redan framgångsrika forskningsmiljöer. Särskilda
insatser bör göras för att attrahera framstående utländska forskare till Sverige, och
för att undvika att vi förlorar de bästa svenska forskarna till utlandet.
Vikten av fungerande nätverk till forskning med hög kvalitet betonas också i
svaren på den enkät som sänts ut till företagen. Fortsatta och ökade investeringar i
utbildning och forskning inom områden relaterade till bioteknikindustrin är
således nödvändiga för en fortsatt positiv utveckling. Exakt vilka områden som
bör prioriteras framgår dock inte lika klart. Tillgången på kvalificerad personal i
framtiden uppfattas som ett problem av många, på grund av det låga intresset för
teknik och naturvetenskap bland barn och ungdomar.
Forskare med intresse av att kommersialisera sina idéer liksom entreprenörer i
nystartade företag betonar behovet av bättre fungerande kunskapsutbyte mellan
universitet och näringsliv. De insatser som görs fokuserar på rätt frågor, såsom
patentering, affärsplanutveckling, tidig finansiering, regelverk etc., men
stödsystemet innehåller alltför många aktörer med underkritiska resurser och brist
på samordning. En del företagsledare nämner också behov av bättre
kontaktfunktioner vid högskolan för att hjälpa företagen få kontakt med rätt
forskare och ge överblick över aktuell forskning vid högskolan.
Man bör lägga mindre vikt vid att få forskare att själva starta företag. I stället
bör man fokusera på att föra samman forskare med personer med
industrierfarenhet, som kan hjälpa till att starta företag. Forskaren kan då välja att
stanna vid universitetet och samarbeta med det nya företaget, eller att gå över till
företaget. Ett annat alternativ är att hjälpa forskaren skriva avtal med ett
existerande företag. Företagsinkubatorer nära goda forskningsmiljöer anses också
stimulera tillväxten av nya företag.
Man efterlyser mer flexibla former för stöd till samverkan mellan företag och
forskargrupper, utan för mycket formella krav vad gäller antal deltagare,
projektets utformning och längd etc. Stödet skulle t ex kunna avse att
vetenskapligt dokumentera, verifiera och testa teknikplattformar. Samverkan med
ett företag får inte utgöra en belastning när man söker offentliga forskningsanslag.
Ett förbättrat kunskaps- och kompetensutbyte mellan forskning och företag är
viktigt inte bara för att kommersialisera enskilda resultat. En ökad
personalrörlighet skulle främja detta utbyte, och öka kunskapen vid universiteten
om industriella problem och arbetsformer. Det stela akademiska
meriteringssystemet nämns som ett hinder, speciellt vid medicinsk och
naturvetenskaplig fakultet. Om en forskare har lämnat universitetet för industrin
är det mycket svårt att senare återvända med viktiga nya erfarenheter.
Bristen på kunskapsutbyte med biovetenskaplig forskning är speciellt tydlig
inom områden där företagen idag använder bioteknik i begränsad utsträckning:
Papper & massa liksom livsmedelsindustrin. Vissa företag inom dessa områden
behöver också öka sitt medvetande om den nya bioteknikens potential.
Tillgången på riskkapital har ökat starkt i Sverige under de senaste åren, men
det är fortfarande svårt att finansiera tidiga utvecklingsfaser. En ökad offentlig
v
finansiering i dessa faser nämns ofta som ett sätt att stimulera tillväxten inom
bioteknik i Sverige.
Företag som utvecklar kost-hälsa produkter efterlyser tydligare regler för
marknadsföring av sådana produkter. Varorna har hamnat i en gråzon mellan
livsmedelslagstiftningen och läkemedelslagstiftningen, och det är svårt för
konsumenten att finna produkter med dokumenterad effekt.
Flera aktörer efterlyser en ökad kunskap i samhället om vad bioteknik är, och
om fördelarna med att använda bioteknik jämfört med traditionella metoder.
Många av företagens representanter inom alla delområden nämner det svenska
skattesystemet som ett hinder, speciellt skatter på optioner, inkomstskatten och
arbetsgivaravgiften. Några nämner problemet att svenska uppfinningar
exploateras utomlands i stället för i Sverige. Detta anses bero på bättre tillgång på
riskkapital i t ex USA, bättre kunskap om områdets utvecklingspotential (både
inom media, hos politiker och hos allmänheten) och ett allmänt bättre
affärsklimat.
Några pekar också på att stödet till mindre och medelstora samt till nystartade
företag är bättre utvecklat även i andra länder i Europa. Ökad såddfinansiering,
ökat stöd till samverkan med universitetsforskning, liksom bättre och mer
samordnat stöd till småföretag och nya företag nämns ofta. Svårigheten är som
alltid att dra gränsen mellan marknaden och offentliga åtgärder. Det är dock
tydligt att de företagsledare som besvarat enkäten tror att ökat stöd till småföretag
och nystartade företag, ökade incitament för att investera i bioteknikindustrin och
att stimulera entreprenörskap skulle ge en ännu bättre tillväxt i den svenska
bioteknikindustrin.
vi
Summary
The present study describes the Swedish biotechnology innovation system. The
aim is to identify forces and obstacles that enhance or impede innovation and
growth. This is intended to facilitate the identification of public measures that will
promote growth in the Swedish biotechnology innovation system. The study is
based on statistics, workshop results, interviews, a questionnaire survey, and
literature. The statistics include data on Swedish scientific publication patterns,
Swedish patenting in the US patent system, the economy of identified companies
and the education of personnel in these companies, public funding of research,
and also some data on public financing of start-ups and the investments that
venture capital companies have made in Swedish biotechnology.
Approach
An innovation system can be defined from several different perspectives. There
are technological innovation systems, supply-chain innovation systems, regional
innovation systems, and so on. The basis of our definition of the biotechnology
innovation system is technological and encompasses those organisations that are
active in the biotechnological domain:
“The players that develop, produce, analyse, or use biological systems on a
micro-, cellular, or molecular level and the public and private institutions that
affect their behaviour”.
Supplementing the technological perspective with the supply-chain perspective
makes it possible to subdivide the biotechnological innovation system into subsystems (see the next passage below). It has become clear that the above
technology-based definition should preferably be complemented with a sectoral
division of sub-systems in order to make it possible to draw policy conclusions.
The policy conclusions in a few cases apply to the whole technological innovation
system, but there are also some that are specific to individual sub-systems. The
roles of the companies in different sub-systems differ since they have different
lines of business, products, and clients. This is, for instance, the case as regards
the varying extent to which the companies in the different sub-systems are
intermediary firms or take their products to the market themselves. Therefore the
dynamics of the sub-systems and the forces that enhance or impede their growth
differ. Such differences are also found within specific sub-systems, e.g. in one that
includes both big multinational corporations and very small companies. The
analysis and policy conclusions in this study focus on micro-, small, and mediumsized companies with up to 500 employees.
The biotech industry
According to Ernst & Young, Sweden in 1999 had the fourth largest
biotechnology industry in Europe after Great Britain, Germany, and France. In the
present study about 145 research and knowledge intensive micro-, small, and
medium-sized enterprises (SMEs) were identified (with employees in 1999 and
with activities according to our chosen definition). The companies were
categorised into the following sub-systems:
vii
•
•
•
•
•
•
Pharmaceuticals and medicine (drug discovery and development,
diagnostics, etc)
Agrobiotechnology (plant improvement, biological plant protection, etc)
Environmental biotechnology (soil, water, and waste treatment)
Biotech supplies (services, processes, equipment and instruments for
biotechnological use)
Functional food and feed (mainly probiotics)
Bioproduction (biomolecular or micro-organism production)
The SMEs (<500 employees) had about 3 000 employees in 1999, which is a
30 per cent increase since 1997. The companies in all the sub-systems increased
their number of employees between 1997 and 1999. The employees in these
companies had a high level of education, and 10-20 per cent of them had a
doctor’s degree. The driving forces behind the positive development of the
biotech industry were, for example:
•
•
•
•
•
•
•
•
The quality of Swedish academic research
The collaboration between academic research and industry
The international knowledge explosion in the area
An increasing global market
Availability of venture capital
The industrial development leading to successful companies serving as good
examples
The presence of the large companies Astra and Pharmacia
A stronger entrepreneurial spirit.
Biotechnology companies are often important intermediaries between
academia and industry for the purpose of pushing and diffusing technology. They
are suppliers of technology platforms, knowledge, services, and product embryos
to larger companies, such as international pharmaceutical companies or large
Swedish companies in the food sector. The products they sell can for example be
drug candidates or micro-organisms which have a beneficial influence on health
and therefore can be used in functional food. They also transfer knowledge from
academia to their customers through strong networks with academia. These
networks have the purpose of identifying frontline research that is suitable for
commercialisation. Products can also be the licensing of patented results. In some
sub-systems it is common for companies to develop products and take them to the
market themselves. This applies especially to the sub-systems Biotech supplies,
Environmental biotechnology, Bioproduction, and Agrobiotechnology.
The science base
The development and dynamics of the biotechnology innovation system are
heavily dependent on academic research results. Therefore a bibliometric
approach can be used to identify players and collaboration patterns and to
compare the performance of Swedish researchers with that of international
researchers. An analysis of Swedish publication patterns in relevant
biotechnology-related journal categories 1986-1997, including an international
comparison of the publication volumes1984-1998, was therefore made.
The dominance of the universities was clear from the data; in fact academic
researchers contributed to 95 per cent of the publications investigated. Karolinska
viii
Institutet contributed to 36 per cent of the total number of publications, while the
universities of Lund, Gothenburg, and Uppsala contributed to 13-18 per cent each.
By comparison, companies contributed to 7 per cent of the publications, and of
this share Astra and Pharmacia (presently AstraZeneca and Pharmacia
Corporation) authored 75 per cent. The collaboration pattern shows that
biotechnology companies were strongly dependent on university research, 65 per
cent of their publications being co-authored with university groups. Also, 93 per
cent of the managing directors responding to the questionnaire claimed that their
companies collaborate with academic research groups. The number of companies
involved in publishing scientific papers was increasing, but the total number of
articles by companies was decreasing, and so was the number of co-authorship
articles together with Swedish public research organisations. This was largely due
to changes in the publication pattern shown by the two pharmaceutical companies
Astra and Pharmacia. They displayed a general decrease in their publication
volumes and also in their number of co-authorship articles together with Swedish
public research organisations.
By international comparison there were no obvious trends regarding the
Swedish publication volumes or the quality of the publications in biotechnologyrelated science in general. The changes found differed between the various
scientific fields. More changes,however, were negative than positive, when
quality was measured by citation levels. In relation to population the Swedish
publication volumes were largest in the world in Neuroscience and Immunology,
second after Switzerland in Molecular biology and genetics, Microbiology,
Biochemistry and biophysics, and Cell and developmental biology, and third after
Switzerland and Denmark in Biotechnology and applied microbiology.
Patenting
The analysis of Swedish patenting in biotechnology in the US patent system
during 1984-1998 gave less impressive results. In all fields combined, the
Swedish inventors’ share of the total patenting volume amounted to one per cent,
which corresponds to a fourth place in the world in relation to population. The
share of biotechnology was 0.5-1 per cent. The patenting volumes were larger for
pharmaceuticals, medical electronics, and medical equipment, which are related
fields. The patenting statistics also revealed the strong dominance of Pharmacia
and Astra in this field. Of the identified 784 patents in biotechnology and
biotechnology-related fields with a Swedish player in 1986-1997, 30 per cent
were assigned to one of these two companies. Almost 10 per cent of the patents
had foreign inventors but a Swedish assignee. This can be taken as a sign of the
Swedish ability to ”import” innovations. Swedish companies also seem to be good
at keeping Swedish inventions, since approximately the same share of the patents
had Swedish inventors as had Swedish assignees (65 per cent). When the patent
statistics were combined with publication data, it turned out that about one third of
the companies found in the patenting statistics had published at least one
biotechnology-related scientific paper and one fourth had co-authored papers with
a public research organisation.
ix
Geographic distribution of the biotech industry and international links
Geographically, biotechnology companies are mostly found in metropolitan
areas and in cities with large universities conducting a great deal of medical
research. About the same number of companies are located in the Lund/Malmö
area as in the Stockholm area. Then follow the Uppsala and Gothenburg areas,
each of them with about half that number of companies. The smallest area with
more than ten biotechnology companies is the Umeå region. If only micro- and
small-sized companies are included (<200 employees), about 30 per cent of the
total number of employees in the biotech industry in 1999 were found in each of
the Stockholm and Lund/Malmö regions. Then followed Uppsala with 18 per
cent, Gothenburg with 7 per cent, and Umeå with 4 per cent.
It is difficult to find an all-Swedish innovation system in biotechnology.
Companies, research institutes, universities, and other players are extensively
involved in international networks and international collaboration. In our
publishing statistics almost a third of all the Swedish publications investigated
were co-authored with scientists from other countries. Similarly, almost a third of
the patents had co-inventors from more than one country. It is also often the case
that the assignee is from another country than the inventor. The questionnaire sent
to the managing directors of the identified biotech companies underlines this; as
many as 64 per cent of these companies claimed that they collaborated with
foreign academic groups in their research and development activities. The
corresponding share for collaboration with and/or outsourcing to other companies
abroad was also high, 49 per cent.
AstraZeneca and Pharmacia Corporation
The presence of Astra and Pharmacia has stimulated the growth of the Swedish
biotech industry not only in the pharmaceutical and medical sub-systems but also,
for example, in the biotech supplies sub-system. The two companies have
collaborated with Swedish university groups and in doing so provided financing
and given academia an increased awareness of industrial problems. They have
been a source of recruitment of capable personnel for new companies; in fact
some of the new companies are spin-offs from Astra or Pharmacia.
Policy implications and opinions of players in the system
As mentioned above, the forces that enhance or impede innovations and growth
and therefore lead to policy conclusions differ between the various sub-systems. It
is often claimed by scientists and industrialists that the major driving force behind
future innovations in the pharmaceutical industry is the new knowledge that is
produced in genomics, functional genomics, and proteomics research. There is
therefore a need for continued public commitment to education and research in
these and related fields. It is important to point out that public investments in
clinical research are also very important. Clinical research and traditional
development of drugs and therapies are essential complements to research in
molecular medicine. If the biomedical research is to be applied, it has to be tested
and documented in clinical trial procedures. Therefore high-capacity clinical
research will have a positive influence on the development of the drug discovery
and drug developing companies that use biotechnological tools. In the area of
functional food the needed increased research is in multidisciplinary fields
x
combining nutritional, medical, and food technology knowledge. There is also an
increased demand for multidisciplinary research to stimulate the
commercialisation of the incredibly fast-growing knowledge accumulated in life
science. Especially the combining of technical sciences such as information
technology, engineering, electronics, on the one hand, and natural and life science
fields such as biotechnology, biology, chemistry and medicine, on the other,
should be a priority. It is also often claimed both by academic researchers and
entrepreneurs that investments would be most effective, if the already successful
environments at the major universities were stimulated. Efforts should also be
made to attract foreign frontline scientists and to avoid losing the best Swedish
academics to other countries by providing better terms for them in Sweden than
today.
The importance of high quality research and collaboration with academia is
also evident from the companies’ answers to the questionnaire sent out. Continued
and increased investments in education and research in fields relevant to the
biotech industry are thus needed for a lasting positive development of the area. It
is, however, less clear what particular fields should be prioritised. Concern
regarding continued access to qualified personnel is evident among the
respondents. This concern is due to the lack of interest that many young people
today have in higher education in science and technology.
Academic researchers with a commercial idea and entrepreneurs in start-up
companies often point to better functioning technology transfer and knowledge
exchange between industry and academia as very important for the growth of
Swedish biotechnology. It is often claimed, though, that too many initiatives, with
too small resources and with insufficient co-ordination, are taken by various
players. However, these initiatives focus on the right issues, like help with
patenting, business plans for start-ups, early-stage financing, rules and
regulations, etc. Among other things mentioned by them were the need of better
functioning liaison offices at the universities who could help companies to get into
contact with relevant scientists and to find easily accessible information about the
research performed at the universities. It was suggested that there should perhaps
be less emphasis on turning academics into entrepreneurs. More efforts should
perhaps instead be made to contact people with the right industrial experience
who could assist in forming a new company to exploit an innovation. The inventor
could opt to stay at the university and collaborate with the new company or leave
academia for a position in the company. Alternatively, he/she could be helped to
draw up an agreement with an established company for commercialisation of the
innovation. Company incubators in environments close to academic centres were
also said to stimulate growth. Moreover, more flexible programmes in support of
collaborative projects between companies and university groups were requested.
The new programmes should have less restrictions regarding the number of
participants, project length, etc. The investments could, for instance, be aimed at
scientific documention, verification, and testing of technological platforms.
Finally, the prospects of getting public research grants should not be hampered, if
a university group collaborated with a company and received financing from it.
Beside efforts to commercialise research, there should be more initiatives and
channels for exchange of knowledge and expertise between academia and
industry. Greater mobility of people would increase this exchange and also
xi
enhance the academic awareness of industrial problems and industrial project
management. An obstacle to this is the rigid academic qualification system,
especially at medical and natural science faculties. Once a scientist has left
academic research for industry, it is often very difficult for him/her to return. A
lack of knowledge exchange between life science scientists and companies is
particularly apparent in sectors that today use biotechnology in innovative ways
only to a little extent, like the pulp and paper industry or the food sector.
Moreover, some companies in these sectors need an increased awareness of the
value of getting acquainted with new technologies to invest in.
Much more venture capital is available in Sweden today than only a few years
ago. There is, however, a lack of capital for the very early phases in a company’s
development. An increase in public financing of very early company development
is often mentioned as a tool that would stimulate growth and the
commercialisation of biotechnological innovations in Sweden.
A request from developers of biotechnological functional food products is that
there should be clearer marketing rules for the use of scientific evidence of
product effects. Such evidence is not allowed in marketing under the present
regulations.
Several players in the biotechnology innovation system have also mentioned
the need for an increased awareness in the whole of society of what biotechnology
is and the advantages of using biotechnology compared to traditional techniques.
In answering the questionnaire many company representatives in all subsystems referred to the Swedish tax legislation as a problem hampering
development. The taxes most often mentioned were the tax on stock options, the
income tax, and the employment tax. A few respondents brought up the problem
that many Swedish inventions have been, and will be, developed abroad instead of
in Sweden. This was said to be due to the relatively better conditions in, for
instance, the USA concerning availability of venture capital, a greater awareness
of the potential of the area (especially in media, among politicians and also the
general public) and a generally better business climate for this type of companies.
Some respondents also pointed out that the support system for SMEs and start-up
companies is better in other European countries. Increased seed financing,
increased support for collaboration with academia and also better functioning and
better co-ordinated support for start-ups and SMEs were requests often made. The
problem here, as always, is to strike a balance between a free market and
intervention by public authorities. It is, however, clear that the respondents to the
questionnaire believed that expanding the support system for SMEs and start-up
companies, increasing the incentives for investing in the biotech industry, and
stimulating entrepreneurship would promote the growth of the industry.
xii
1
Introduction
The aim of the present study is to identify forces that enhance or impede
innovation and growth. This is intended to facilitate the identification of public
measures that will promote growth in the Swedish biotechnology innovation
system. Biotechnology has been mainly a target of policy concern and less of
government intervention. The Swedish Council for Planning and Co-ordination of
Research (FRN) has studied Swedish research policy as expressed in the
Government’s research bills. They found that biotechnology was mentioned in
questions regarding:
•
The science base (”the need for basic research”).
•
Sweden’s industrial competitiveness.
•
Risks and ethical problems.
In the Government’s research bill 1996/97:5 on research and society, the
following was written (in translation) about biotechnology under the heading
Growing Areas of Technology: Biotechnology has great potential for
development. Sweden should strive for a position at the forefront of
biotechnology research and development. The connection between research and
product development is clear in the area of biotechnology. Co-operation with
universities or small, specialised development firms is often necessary for
biotechnology firms. Access to high-quality research is vital to advanced
biotechnology firms. It is important that current R&D efforts in the area are
sustained and that NUTEK continues to stimulate them and also develops its own
role in relation to other funding bodies in the area of biotechnology.
Biotechnology was also prioritised in the preceding research bill 1992/93:170
on research for knowledge and progress. The Government wrote the following
proposal (in translation): … there should be a concentration of efforts regarding
new generic technologies. Prioritised areas are information technology, materials
science, and biotechnology.
Bioscience and biotechnology, information technology and information
science, and materials science and materials technology were priorities in the area
of science and technology in the Government’s research bill 2000:01/3 on
reserach and renewal. The bill argued that bioscience and biotechnology are
strategic areas since (in translation): ...the modern, emergent, industrial
applications of biosciences can, used in the right way, contribute to a development
towards a long-term sustainable society and better quality of life. The fast
development of knowledge was thought to prove important for many sectors of
society and lead to new industrial applications in many areas.
In order to correctly describe and understand the biotechnology innovation
system and achieve the aim of this study, a large amount of different data and
information was collected. The present study is therefore based on statistics,
workshop results, interviews, a questionnaire survey, and literature. Interviews
were performed with scientists, entrepreneurs and policy makers in the area of
biotechnology. A workshop was arranged in November 1999 on what the
1
Government and other public authorities should do to stimulate Swedish
biotechnology, and a questionnaire was sent out to all identified biotechnology
companies in June 2000. The statistics include data on Swedish scientific
publication patterns, Swedish patenting in the US patent system, the economy of
identified companies and the education of personnel in these companies, public
funding of research, and also some data on public financing of start-ups and the
investments venture capital companies have made in Swedish biotechnology.
By the biotechnology innovation system we mean:
The players that develop, produce, analyse, or use biological systems on a micro-,
cellular, or molecular level and the public and private institutions that affect their
behaviour.
The definition thus includes both classical and modern biotechnology, but the
focus is on modern biotechnology and innovative use of classical biotechnology.
The definition is in accordance with present definitions internationally used.
Whether the players within the system constitute a well functioning innovation
system depends on how well they are interconnected. The most important players
are research groups at the universities and the biotech industry. The definition
means that the companies involved can be found in different business sectors and
that it is often only a fraction of a company that is involved in biotechnology
activities. The figure below shows some sectors in which to a varying extent
biotechnology activities can be expected.
Sectors in which biotechnology activities can be expected
Agriculture
Pharmaceuticals
Food
Biotechnology
Forestry/
Pulp & Paper
2
Environment
Chemistry
2
Methodology
In this chapter we will describe the data that has been used, how we have used
it and why we have chosen to include specific data. In the project we have tried to
identify as many as possible of the companies and others that are engaged in
biotechnology or biotechnology-related fields, but our focus is on companies that
supply innovation services and/or are knowledge-intensive (have in-house R&D)
and that use modern or classical biotechnology in an innovative way. The tools
that we have used are described below.
2.1
Swedish papers in Science Citation Index
In order to determine knowledge flows and knowledge production in
biotechnology-related fields studies of scientific publication patterns have been
performed. Since biotechnology is a research-intensive field, it has been
considered relevant to use scientific publications in biotechnology-related subject
fields for the analysis. It has, however, been necessary to take into account that
much knowledge production results from research and development within
business enterprises and is for obvious reasons never published. The aim of these
enterprises is to develop new products, processes or services, and therefore the
innovation process is not made public until a product is placed on the market or a
patent application has been filed. However, when it comes to collaboration
between public research organisations and industry, bibliometry is very useful
since there are strong incentives in academia for publishing scientific results. If
companies collaborate with academic groups, it is accordingly more likely that the
results get published. Both academic positions and, to some extent, research
grants are assigned on the basis of the volume and content of the scientists’
production. The comparison of publication volumes between different subject
fields also needs to be analysed with some precaution, since the amount of work
needed for a publication and the difficulty of getting published varies between
different scientific subject fields.
A description of the publication pattern of different organisations gives
important information about what organisations are most prominent in different
scientific subject fields and also information about relations between those
involved. The publication pattern of business enterprises is interesting since they
largely develop new innovations in collaboration with public research
organisations, and many public efforts are directed towards increasing the
knowledge exchange between the two types of organisation. The data gives
insight into the dynamics of the collaboration, and this might indicate the success
of the efforts made. It is also often claimed that the Swedish biotechnology
innovation system is vulnerable because of its dependence on the two large
pharmaceutical companies Astra and Pharmacia. By studying their collaboration
pattern, as manifested in scientific publications, some indications may be found as
to whether their network strategies have changed from national to international
collaboration and from outsourcing research to increasing in-house capabilities. It
may also give some insight into how great their dependence on Swedish
collaboration is. The extent and the dynamics of international collaboration within
the area will also be analysed.
3
Bibliometry is used to describe the Swedish biotechnology innovation system at
three levels:
•
•
•
The publication volume of the science base, including the public research
organisations and their internal collaboration;
Business enterprises and their collaboration with public research organisations;
International links in biotechnology; the importance of international collaboration
and the national performance in international comparison.
The first level is the largest category in terms of publication volume and
includes the public research organisations and the inter-relationships between
these organisations.At the second level firms and industrial research institutes are
identified and their collaboration pattern with public research organisations
analysed. At the third level the role and the significance of international
collaboration are investigated by analysing the articles that are co-published with
foreign scientists. The information on links between organisations and different
countries is of great importance when studying the role of different players, both
Swedish and non-Swedish, in the national economy and how they may or may not
be dependent on each other.
Data collection
For the international comparison of Swedish publication volumes and relative
impact factors in life science fields relevant to biotechnology, the National
Science Indicators on Diskette (NSIOD) from the Institute for Scientific
Information (ISI) was used. The relative impact is the number of citations
received per paper divided by the number of citations received per paper for the
whole world.
For all other analysis, a bibliometric dataset was constructed by downloading
all papers with the word ”Sweden” in the address field from the CD-ROMeditions of Science Citation Index (SCI). SCI includes the most important ten to
fifteen per cent of all scientific journals in medicine, natural sciences and
engineering, but is sometimes claimed to cover life science somewhat better than
engineering. All the Swedish addresses were standardised according to main
organisation. The dataset covers the period 1986-1997, and during that period
Swedish authors published 135 000 papers. The CD-ROM for a certain year does
not contain the complete publication volume of that year, since the articles
published towards the end of the year appear in the next year’s CD-ROM edition.
Therefore the analysis of the publication volume in 1997 is underestimated by
about 10% and corresponding lower figures for 1997 may be found in the tables
and diagrams. Articles published in 1985 but found on the 1986 CD-ROM were
excluded from the analysis.
For identification of articles relevant to biotechnology, the journal subject
categories as defined by ISI were used5. The life science journal subject categories
listed in the table below were considered to be biotechnology-related on the basis
5
See Journal performance indicators on diskette (JPIOD).
4
of the previously mentioned definition of the biotechnology innovation system
that we are using.
ISI’s journal categories in SCI selected as biotechnology-related
CQ
DA
DB
DR
DX
MB
NI
QE
QU
RU
ZE
Biochemistry & Molecular biology
Biophysics
Biotechnology & Applied microbiology
Cell biology
Chemistry, medical
Mathematical methods, biology & medicine
Immunology
Materials science, biomaterials
Microbiology
Neuroscience
Virology
All in all, we identified 28 418 Swedish papers published in journals covered
by SCI and classified with the selected codes in 1986-1997. Only journals listed in
Journal Performance Indicators on Diskette (JPIOD,) produced by ISI, were
included, which means that the journals must have received at least 100 citations
during 1981-1996. The journal coverage of SCI can be said to encircle basic
research quite well. However, its set of journals includes some journals with a
rather low impact factor, i.e. they are infrequently cited. Of the papers, 218 were
excluded since the journals they were published in had no listed impact factor.In
order to reduce the number of marginal journals in terms of impact, we also
limited our analysis to journals that had reached an impact factor of at least 5. The
impact factors were taken from JPIOD. These impact factors are based on the
mean number of citations a journal has received for its articles in 1981-1996. This
led to a total number of 25 045 articles, i.e. 12% of the articles were not included
in the following analysis due to there being no impact factor listed or an impact
factor less than five. The rationale for applying these criteria is that the SCI
coverage is quite good when it comes to influential core journals, whereas the
coverage of less significant journals is more arbitrary. The method, however, has
the drawback that journals focusing on narrow fields run the risk of not being
included, due to an impact factor of <5, even though they may be of good quality.
Therefore the articles in excluded journals with an impact factor of less than five
were screened for information about firms and firm collaborations.However, no
additional firms or firm collaborations were found that had not been identified in
the already analysed dataset..
The distribution of the 25 045 articles with an impact factor over 5 in the
selected journal categories and the mean impact factor, from JPIOD, for the
journals are shown in Table B1 in Appendix B. The subject field with the largest
publication volume is Biochemistry & Molecular biology with more than 38% of
the publications, and then follow Immunology and Neuroscience with 22% each.
The number of publications in the journal categories Biochemistry & Molecular
biology, Biomaterials, and Cell-biology distinctly increased during the nineties
compared to the eighties. None of the selected journal categories show a clear
decrease in publication volume. The mean impact factors increased slightly during
the nineties compared to the eighties (Table B1). Of the identified journals which
5
have an impact factor over five and in which Swedish authors publish, the thirteen
journals with more than 300 Sweden-related articles, 1986-1997, represent 26% of
the total Swedish publication volume in biotechnology-related science (Table B2).
All Swedish addresses to the authors of the articles were standardised
according to main organisation in order to produce data on the organisational
level. The results for university hospitals and universities are displayed together,
since they are in practice inseparable when it comes to research activities. In
Table B3, the organisations identified are merged into groups in order to show
production distributed by sector. The term “public research organisation”, which
often appears in the pages that follow, includes universities, university colleges,
university hospitals and public research institutes (e.g. the Swedish Institute for
Infectious Disease Control, SMI). As expected, the major part of the articles are
authored by university researchers, and as many as 95% of all articles include at
least one author from a university or a university hospital. Authors in firms have
on average contributed seven percent of the articles in biotechnology-related life
science fields and,here there was a decrease during the nineties compared to the
eighties.
The proportions of the total publication volumes that the Swedish organisations
with more than 500 articles published in 1986-1997 within the selected
biotechnology-related sciences are presented in Table B4. As is seen, the first nine
organisations are public research organisations, but the two large pharmaceutical
companies Pharmacia and Astra hold the 10th and 11th positions.
2.2
Swedish patents in the US patent system
Patents are often used in studies of national innovativeness in different fields.
Since a patent is necessary for an invention to be protected, it is a good indicator
of innovativeness. We have chosen to study the amount of patenting in the US
patent system since the biotechnology market is global and most biotech
inventions need to be protected on the large US market.
All in all, 11 900 patents issued during 1986-1997 and having a Swedish
assignee and/or inventor were found. The patents in the USPTO server6 were
downloaded as screen dumps, i.e. text versions of the front pages of issued patents
were retrieved. These front pages were then converted into field-delimited
records. A selection of USPTO classification codes of biotechnology-related
fields yielded 915 patents:
6
The www-server of the US Patent Office (http://patents.uspto.gov/access/search-adv.html) was
used to retrieve Swedish patents.
6
The USPTO patent classes selected as including Biotechnology
or Biotechnology-related patents
Code
424
426
435
436
514
530
800
930
935
US patent class
Drug, Bio-Affecting and Body Treating Compositions
Food or Edible Material: Processes, Compositions, and Products
Chemistry: Molecular Biology and Microbiology
Chemistry: Analytical and Immunological Testing
Drug, Bio-Affecting and Body Treating Compositions
Chemistry: Natural Resins or Derivatives; Peptides or Proteins; Lignins or
Reaction Products Thereof
Multicellular Living Organisms and Unmodified Parts Thereof
Peptide or Protein Sequence
Genetic Engineering: Recombinant DNA Technology, Hybrid or Fused Cell
Technology, and Related Manipulations of Nucleic Acids
The 915 patents also included patents that were clearly not relevant, mainly
stemming from the ”Food or Edible Material: Processes, Compositions, and
Products” patent class. The patents therefore had to be analysed one by one, and a
new classification system was developed for this study (Appendix C, Table C1).
The classification system was developed on the basis of the actual patents found.
A first distribution was made between Biotechnology and Biotechnology-related
patents. The distinction between the two was based on the definition of
biotechnology mentioned in the introduction. This means, for instance, that
Pharmaceuticals appear under both headings since a distinction can be made
between biopharmaceuticals and pharmaceuticals based on organic chemical
synthesis. The same argument holds for the other classes and sub-classes under
the two headings, e.g. Laboratory equipment appears under the heading
Biotechnology if the equipment is specified for biomolecular analysis and
production.
After applying the above classification, 784 patents between 1986-1997 with a
Swedish inventor and/or assignee remained. The distribution of these into the
patent classes described in Table C1 is shown in the table below.
7
Distribution of the 784 patents in biotechnology or biotechnology-related
fields with a Swedish inventor and/or assignee
BIOTECHNOLOGY
Class
Sub-class
Agriculture
Agricultural technique
Animal food
Process
Food technique
Functional food
Wood or pulp treatment
Bioprocess
Food
Forestry
Biotech supplies &
processes
Biosensor
No. of
issued
patents
7
4
11
3
3
8
6
BIOTECHNOLOGY Total
49
9
74
1
8
43
1
102
329
BIOTECHNOLOGY-RELATED
New or improved chemicals or processes
Environmental technique
Food technique
Functional food
Quality control
Forestry
Wood or pulp treatment
Laboratory technique
Laboratory equipment
Medical Technique
Nutrient solution and plasma replacement
Contrast agent
Tissue treatment
Wound treatment
Other
Pharmaceuticals
Diagnostics
Drug delivery systems
Drugs and their preparation
BIOTECHNOLOGY-RELATED Total
42
9
3
7
5
3
15
10
28
10
12
8
4
73
226
455
Medical Technique
Pharmaceuticals
Genomics and functional genomics
Laboratory equipment
Process
Transgenic animal
Tissue treatment
Diagnostics
Drug delivery systems
Drugs and their preparation
Chemistry
Environment
Food
The data shows that a majority of the patents are within the field of
pharmaceuticals, which was an expected result. The relatively large number of
patents in the area “New or improved chemicals or processes” can also be partly
related to the pharmaceutical industry. The table, under the heading
Biotechnology as well as under the heading Biotechnology-related, shows that the
number of patents issued in environmental, forestry, food and agricultural
techniques is relatively small. There is also a relatively large number of patents in
the class Biotech supplies & processes.
Two parties that can be identified in the patenting statistics are the assignee and
the inventor. The assignee is usually one or more firms (can also be a private
person) and the inventor is one or more private persons. There is always at least
8
one inventor for each patent, whereas an assignee is not always entered. When a
patent is assigned, the assignee becomes the owner of the patent and has the same
rights as the original patentee had. Patents may be owned jointly by two or more
persons, as in the case of a patent granted to joint inventors or in the case of
assignment of a partial interest in a patent. Joint owners of a patent may make,
use, sell, and import the invention for their own profit, provided they do not
infringe on someone else’s patent rights. They may do all this without regard to
the other owners. Owners may sell their interest or any part of it, or grant licenses
to others, without regard to the other joint owners, unless all the joint owners have
made a contract governing their relation to each other. The patenting statistics are
analysed further in Chapter 6, and tables displaying the patenting statistics from
the USPTO database are found in Appendix C.
2.3
Interviews and Literature
Interviews were performed with people working on technology transfer,
financing of research or innovations, entrepreneurs, scientists, etc. (Appendix F).
The international literature on players in the field of biotechnology, their
strategies and innovation processes, is vast, and an attempt to screen the literature
for a background and an understanding of the conditions under which these
players exist has been made7. The literature on Swedish biotechnology is, as may
be expected, mainly limited to pharmaceuticals and biomedicine, due to the
dominance of these areas, whereas written material on other areas is scarce.
2.4
Biotechnology companies
Identification and categorisation
Biotechnology is a field undergoing continuous and rapid development. The
technology is very close to the science base and many of the new small, dedicated
biotechnology companies are university spin-offs. Many other Swedish
biotechnology companies share the origin of being spin-offs from either of the
two large pharmaceutical companies Astra and Pharmacia. The speed at which
new enterprises appear, are bought, merge, change names, etc. makes it difficult
to identify new enterprises and complicated to follow the development of ”old”
ones.
Very different sources were used to identify companies 8. A database listing
some 1 500 companies was constructed, and a selection of biotechnology
companies fitting our definition was performed, which reduced the number of
companies significantly. A first categorisation was made on the basis of
descriptions of their fields of activity found on the Internet, literature (newspapers
etc.), and personal contacts with experts or the companies themselves. The
companies were divided into the following categories: Pharmaceuticals and
medicine (drug development, diagnostics etc); Agrobiotechnology (genetically
modified plants, biological plant protection); Environmental biotechnology (soil,
7
Anna Backlund, Sara Modig and Cecilia Sjöberg, Biotechnology and Pharmaceuticals – a
literature study, NUTEK, Working paper August 1998
8
Bioprint, publishing and consulting AB; SIK, The Swedish institute for Food and Biotechnology;
Swedepark (the umbrella organisation for Swedish science and technology parks) and also
personal contacts and the Internet.
9
waste, and water treatment); Biotech supplies (processes, equipment and
instruments for biotechnological use); Functional food (mainly probiotics) and
Bioproduction (biomolecular or micro-organism production). The companies were
then asked in a questionnaire (Appendix E) to correct any mistakes in the
categorisation and description of their businesses and also whether companies
they knew of were missing in a working paper sent out together with the
questionnaire in June 2000.
Educational data on personnel
A NUTEK and Statistics Sweden database of all individuals pertaining to the
Swedish work-force aged 16 or more was used. The database is based on Statistics
Sweden's register data and contains, for instance, information about individuals'
education levels and profiles and information about enterprises and establishments
where they are employed. It can, for example, be used to find the number of
employees at different work places and also profiles of their education. The data
may only be presented in such a way that an individual company cannot be
identified. As could be expected, the database showed that the educational level of
the companies studied was very high. In all categories of the biotech industry the
proportion of employees with a PhD was 10-20 percent.
Economic data (turnover, number of employees, etc.)
A database from the Swedish company Svenska Market Management AB was
used to obtain economic data on the companies. The data is based on the annual
reports that companies submit to the Swedish Patent and Registration Office. Data
from the last three available years was extracted, which can mean either that the
last year was the whole year 1999 or the split financial year 1998/99, depending
on how the individual companies organised the data they submitted to the
Swedish Patent and Registration Office.
2.5
Questionnaire to identified biotech companies
A questionnaire (Appendix E) was sent in June 2000 to the managing directors
of the 139 companies identified as having activities according to the chosen
definition of biotechnology and having employees in 1998. Together with the
questionnaire a report on the Swedish biotechnology innovation system was sent
out. The report among other things included a description of the biotech industry
and the individual companies and their fields of activity. In August 2000 the
companies that had not responded were contacted by telephone. The analysis of
the questionnaire started on October 1st and the response rate was then 62 percent.
Of the respondents answering the question regarding their field of activity, 67
percent endorsed the categorisation used in the report sent out. The description of
the companies was in the present report in most cases changed in accordance with
the answers found in the questionnaire. In a few cases the old classification was
kept since the description that the companies entered in the questionnaire was
considered to fit the classification used in the report. The results concerning this
are found in Appendix A. Results and analysis of the other questions are found in
Section 4.10.
10
2.6
Workshop
A workshop was held in November 1999 with 28 participants from industry,
ministries, government agencies and academia. The aims of the workshop were:
(1) to identify what knowledge, information and services are used and will be
required in the innovation process of the biotech industry in Sweden, and (2) to
discuss the present and future role of the government and government agencies.
The overall goal was broken down into the following questions:
•
•
•
•
•
What actors, firms included, are sources of ideas for innovation today? What
actors provide knowledge and competence?
What ”types” of knowledge and competence are needed today?
What actors, firms included, will be sources of ideas for innovation in the
future? What actors will provide knowledge and competence?
What ”types” of knowledge and competence will be of importance in order to
maintain and improve the competitiveness of the Swedish biotechnology
innovation system?
How can public actors achieve greater competence in the technological
infrastructure?
The results of the workshop are mainly given in Chapter 9, CONCLUSIONS.
11
3
Early development of the Swedish biotech industry
There are mainly two different types of companies that use classical or modern
biotechnology. On the one hand, the mature companies in traditional areas, such
as the food sector, pharmaceuticals, or the pulp and paper industry, have gradually
become more innovative users of biotechnology. On the other hand, modern
biotech companies often have the mature companies as purchasers of their
products or services. This chapter will give an account of how the use of
biotechnology has developed in these two types of companies. The focus of the
rest of the study, however, is on the modern knowledge and research intensive
biotech industry.
3.1
The pharmaceutical industry9
The Swedish pharmaceutical industry was born in the first decades of the
twentieth century. Most companies, as in many other countries, were founded as
spin-offs from pharmacies. The companies produced standardised medical
substances for local markets. Drugs were rarely discovered and developed in
Swedish pharmaceutical companies at that time. Neither was there a strong
chemical industry, and very little relevant research was performed in Sweden. All
but a few products were based on foreign knowledge.
This follower strategy prevailed in Sweden for a relatively long period. In the
1940s and 1950s a series of dramatically effective drugs were introduced on the
market - by foreign firms. Not until the early sixties did Swedish companies
respond by stepping up their R&D expenditure, which by the end of the 1970s
reached international levels. The R&D was performed in close co-operation with
academic researchers and with the strong Swedish health-care sector, where
clinical studies could be performed. The instrument industry was another
important partner in this R&D.
In the 1980s the effects of the R&D spending began to show in increasing
sales. The average growth rate of sales in the 1980s was about 16 per cent, as
opposed to 6 to 8 per cent in the preceding decades. Around 1980 Sweden became
a net exporter of medicines. The growth rate increased further to around 27 per
cent in the early nineties, and the pharmaceutical industry is today one of
Sweden’s two main high-tech export industries, the other being
telecommunications.
The eighties also saw a strong restructuring of the Swedish pharmaceutical
industry. At the end of the 1970s there were seven major companies (Astra, Kabi,
Pharmacia, Ferring, Leo, Ferrosan and ACO) but soon after only three remained:
Astra, Pharmacia and Ferring.
9
Is partly based on the chapter: ”The Development of Beta Blockers at Astra-Hässle and the
technological System of the Swedish Pharmaceutical Industry” by Rickard Stankiewicz in the
book Technological Systems and Industrial Dynamics, ed. Bo Carlsson, 1997
12
Leo and Ferring
Leo produced hormones extracted from urine and human organs and also
synthesised drugs for treatment of cancer where a cytotoxic was coupled to a
hormone10. Leo was later bought by Pharmacia. Ferring also based its business on
the production of hormones. The company was founded in Malmö in 1950 and
developed a patented method to extract peptides from pig pituitary glands. In the
sixties Ferring started to produce the peptide hormones vasopressin and oxytocin
synthetically on an industrial scale. With this an international action programme
started, which during the eighties and nineties resulted in about 30 companies all
over the world and with more than 2,000 employees globally. The group today
has its main office in Holland, while its marketing and product development is
concentrated in Copenhagen. The production is still located in Malmö, where the
Swedish marketing branch, Ferring Läkemedel AB, is situated. Since the
company lacks R&D in Sweden, it will not be mentioned in the coming chapters.
Pharmacia and Kabi
Pharmacia in the forties developed dextrane by means of fermentation.
Dextrane can be used as a complement to blood transfusions during surgery, and
crosslinked dextrane (Sephadex) can also be used for separation of biomolecules.
One application of Pharmacia’s expertise in bioseparation was the extraction of
Hyaluronic acid from cockscombs.
Pharmacia has grown both organically and through take-overs and mergers. In
1990 Pharmacia was bought by Procordia and merged with Kabi under the name
Kabi Pharmacia. In 1993 the Italian company Farmitalia Carlo Erba was bought
and the name was changed to Pharmacia. About 20 companies in Europe and the
USA were taken over and Pharmacia became one of the twenty largest
pharmaceutical companies in the world. During the nineties the restructuring
continued and Pharmacia has now merged with the US companies Upjohn (1995)
and Monsanto (2000) and formed Pharmacia Corporation.
The earliest commercial use of modern biotechnology, such as production of
recombinant proteins, etc., came during the eighties. Pharmacia’s interest arose
when Kabi and KabiGen, which produced growth hormones, were incorporated
into the company. State-owned Kabi and KabiGen, the latter of which was a spinoff from Kabi in 1978 for exploitation of the new gene technology, were the first
modern biotech companies in Sweden11. Kabi had experience in the area of
fermentation and bioseparation for production of substances such as penicillin and
streptokinase. Kabi (KabiVitrum) in 1978 signed an agreement with the American
company Genentech about production of the growth hormone that Kabi had
earlier extracted from pituitary glands. Genentech had already managed to
produce the human protein somatostatine using recombinant DNA technology.
Kabi licensed the technology from Genentech and thus got access not only to
knowledge about this technology but also to the genetically modified bacteria that
Genentech had developed and was using in its production. Growth hormone was
10
Lennart Norgren, ”Kunskapsöverföring från universitet till företag, En studie av
universitetsforskningens betydelse för de svenska läkemedelsföretagens produktlanseringar 19451984”, Dissertation at the Department of Ekonomic History, Uppsala University, 1989.
11
Maureen McKelvey, Evolutionary Innovation, early industrial uses of genetic engineering,
Linköping University, 1994
13
successfully produced by Genentech in the USA in 1979 and at Kabi in Sweden in
1980. In 1985 a growth-hormone based drug produced by Genentech was
approved by the FDA (Food and Drug Administration) in the USA. A
corresponding drug developed by Kabi was approved by the Swedish Medical
Products Agency. In 1991 this growth-hormone drug accounted för 55% of the
market outside the USA and generated revenues amounting to 243 million dollars.
In the same year Genentech’s earnings from its drug amounted to 157 million
dollars on the US market.
Astra
Astra was founded in 1913 and initiated its own research and development in
the area of new drugs in 1931. The company started to export pharmaceuticals as
early as 1934. During the forties the production of penicillin began and Astra was
introduced on the Stockholm stock exchange in 1955. In 1982 an agreement about
collaboration in the US with Merck & Co was signed and in 1996 the Astra
product Losec became the most sold drug in the world. Astra merged with British
Zeneca in 1999 to form AstraZeneca.
Astra began using modern biotechnological tools in its R&D activities
somewhat later than Pharmacia. The antiviral project that Medivir later took over
was launched in 1968, but recombinant DNA technology was not used until the
late eighties. Apart from Astra and Pharmacia, mainly new small companies with
close ties to academic research made use of modern biotechnology.
Symbicom, KaroBio, Skandigen, Medivir and others
Symbicom, KaroBio, Skandigen and Medivir, founded during the eighties,
were companies that early used biotechnological tools applied to the biomedical
field. Symbicom was a spin-off from the University of Umeå. The strategy was to
conduct research within molecular medicine through collaboration between
scientists with a background in either chemistry or molecular biology. When Astra
bought Symbicom in 1993, it took over the company’s patent portfolio. Included
in the portfolio was, for instance, the vaccine against borrelia, which today
generates good revenues for AstraZeneca. The activities that had been performed
at Symbicom were transferred to Mölndal (Hässle) outside Gothenburg.
KaroBio and Medivir were started by, among others, personnel from Astra.
KaroBio was based on research performed at Karolinska Institutet, and Medivir
took over the antiviral project that the personnel from Astra were involved in. In
the project comprehensive collaboration with scientists at different Swedish
universities had been established, and Medivir extended this strategy with
university collaboration even further. The success of Medivir is largely due to its
extensive network connections with academic groups. Symbicom also built its
activity on extensive network connections with scientists at different Swedish
universities, and KaroBio still has comprehensive collaboration with Karolinska
Institutet.
Skandigen AB, established in 1983, initiated a large number of biomedical
research projects during the eighties and exploited their results. The basis of the
projects was the notion that the production of drugs based on human (or animal)
14
raw material, such as blood plasma, should preferably be abandoned due to the
risk of transferring viruses. This was also one of Kabi’s motives for introducing
the use of recombinant DNA technique into its production of growth hormone.
Another motive was the anticipation that drugs produced using biotechnology
would be cheaper than drugs produced by extraction from human or animal raw
material. In the former case the cost of treatment could be reduced, and this would
have a great influence on the cost-effectiveness of medical care. Skandigen
wanted to act as a bridge between academic science and the pharmaceutical
industry by investing in early development projects that would later be transferred
to the pharmaceutical industry for commercialisation. The normal time for a
project of this kind to be ready for commercialisation was about 15 years. For this
reason Skandigen on twelve different occasions up to 1998 raised money through
new issues of shares and convertibles amounting to a total of SEK 345 million.
Due to the lack of profitability for Skandigen’s projects in their early stages, its
activities were gradually transferred to subsidiary companies such as Fermentech
Medical Ltd in Scotland. The company has now changed its name to Skanditek
Industriförvaltning AB and is mainly an industrial management company within
electronics, information and communication technology. It also performs contract
production in the areas of telecommunications and medical technology.
During the nineties many new biotech companies have appeared. They are
mainly engaged in drug development, biomedicine and diagnostics. The majority
of them are spin-offs either from large pharmaceutical companies or from
universities. There are also examples of companies that were established when
state-owned businesses were being restructured. For example, SBL Vaccin is
based on research previously performed by the National Bacteriological
Laboratory (SBL). In 1993, SBL was closed down and instead the private
company SBL Vaccin and the state-owned Swedish Institute for Infectious
Disease Control (SMI) were established.
Sockerbolaget and Pharmacia collaborated on the development of dextrane,
which was later transferred to a new company. Companies like Isosep (previously
Biocarb), Biophausia (previously Medisan) and Pharmalink all have activities
related to that research.
Pharmacia's activities in the area of bioseparation were transferred to a
subsidiary called Pharmacia Biotech. Since 1997 British Nycomed Amersham
(55%) and Pharmacia Corporation (45%) have been the owners of this company
under its new name Amersham Pharmacia Biotech. The company now has plans
to be introduced on the NASDAQ stock exchange and Pharmacia Corporation is
intending to reduce its share of the company. Today Amersham Pharmacia
Biotech is a world leader in the field of biotech supplies and instruments.
Early obstacles to growth
An early obstacle to the start-up firms in the eighties and nineties was the lack
of long-term venture capital. For example, Symbicom at an early stage had to sell
25 percent of the company to Astra. This reduced its independence, and the entire
company was later sold to Astra. There was also a lack of examples of successful
companies that could inspire potential entrepreneurs. It is only in the last few
15
years that some biotech companies are beginning to show profits. Within
academia a change in attitude has also taken place and more academic scientists
today have a positive view on collaboration with industry and also on becoming
entrepreneurs themselves. The earlier sceptical view within academia, the lack of
venture capital and also the lack of good examples are all possible explanations
why not more companies were previously started or had a successful development
within this area.
3.2
Food and packaging industries
The food industry in Sweden has its roots in the agricultural sector. Until the
second half of the nineteenth century food processing was mainly performed on
farms or in private households. Mills, dairies and slaughterhouses were among the
first industrial food companies. The food industry made great progress after the
Second World War. Economies of scale, developments in packaging and
distribution and also changed patterns of consumption were driving forces
favouring continued industrialisation12.
The major part of the Swedish food production has been heavily regulated
since the late nineteenth century. A consequence of this is that Sweden has
developed almost no large food companies operating on international markets. In
the 1990s the sector was deregulated, partly as a consequence of the entry into the
European single market. The deregulation has fuelled the ongoing
internationalisation of the food industry. The farmers’ organisations today own
about 45 % of the food industry, and large multinational companies operating on
international markets own about 20 %. The dairy industry is one of the most hightech food industries. It has developed in close co-operation with a number of
strong equipment manufacturers.
The food industry has not used modern biotechnology to a great extent 13. It is
said that two positive words associated with food products are ‘traditional’ and
‘natural’ These words are, however, not usually associated with modern
biotechnology. Biotechnology applications are therefore mainly limited to
classical biotechnology such as fermentation and the addition of lactic acid
bacteria. It is mainly within the field of functional food that innovative use of
biotechnology is being developed. By functional food we mean food products that
have a positive influence on health and that have a documented, specific
physiological effect. The dairy industry has, for instance, developed products with
specific stems of bacteria that have a documented positive effect on the
gastrointestinal system.
Some circumstances that could explain the lack of innovative use of classical
and modern biotechnology in the food sector are that there is a lack of ability to
access the new technology, that the price of the technology has not been
considered competitive compared to traditional technology and that the potential
of functional food has not been appreciated. Also, the food sector produces pricesensitive consumer products that do not have large margins and therefore cannot
bear high R&D costs. During the eighties and nineties a few new small companies
have appeared in the area of functional food. Most of these are spin-offs from
12
13
Source: ”Från konservbruk till evigt röd tomat” Temanr 3, 1988, Teknik & Kultur.
Source: ”Bioteknikanvändning i svensk livsmedelsindustri”, NUTEK R:1998:24
16
universities and have the food sector as purchasers of their products and services.
The research that lies behind their innovations is often multidisciplinary,
combining nutritional, medical, and microbiological research with food
technology competence.
The Swedish food packaging industry, and particularly the company Tetra Pak,
has developed strongly since the 1950s. This development is based on paper
packaging innovations, which today dominate the world market for liquid
foodstuffs. The biotechnology-related R&D of TetraPak is mainly concerned with
hindering unwanted appearance of micro-organisms in food products through
aseptic packaging.
3.3
Plant improvement and biological plant protection
Svalöf Weibull AB14 is the dominating Swedish company in the field of plant
improvement. The company was created in 1993 as a result of a merger between
two firms in the sector (Svalöf and Weibull), both founded in the second half of
the nineteenth century. Another Swedish plant improvement company was
Hilleshög, whose focus was to improve sugar-beets. It is now part of the Swiss
company Novartis under the name Novartis Seeds.
Svalöf Weibull and Novartis Seeds use biotechnology in their R&D activities.
The applications of these companies and Amylogene (owned by German BASF
and The Swedish Farmers’ Association) for permission to grow genetically
modified plants on a trial basis were accepted by the Swedish Board of
Agriculture during the nineties. Amylogene was founded in 1987 by the
companies Svalöf Weibull and Lyckeby Stärkelse with the aim of using gene
technology to develop potatoes only containing amylopectine starch. A few small
companies using micro-organisms for biological plant protection appeared during
the eighties and nineties.
3.4
Soil, water, and waste treatment technology
In the 1980s soil remediation began to be performed in Sweden. Its main
predecessor were US oil companies. A number of small firms are now active in
this field. Some companies were founded as subsidiaries of foreign soil
remediation firms and others emanate from the construction industry as a new part
of their activities. The Swedish market is now expanding, mainly financed by
public funds and by oil companies. The most common way in which these
companies use biotechnology is by adding micro-organisms of the same kind that
are normally found in the humus layer of the soil.
The handling of wastewater started with public dams for household water in
the early nineteen hundreds. In the 1960s many more elaborate public facilities
were built, and in the 1990s many industries built their own wastewater treatment
facilities. Biologic treatment reached a breakthrough in the same period.
There has been a strong development of laboratory testing within
environmental technology and other fields. For instance different kinds of
14
40 % owned by German BASF
17
biosensors and tests using molecular biology have been developed. A few
companies focusing on environmental laboratory testing have emerged.
3.5
Chemical industry
Sweden has a small chemical industry except in the area of pharmaceuticals.
Before the Second World War the Swedish industry held a strong position in
explosives and matches. The explosives industry still contributes to Swedish
defence. Large volume production of inorganic chemicals is one of the most
extensive and oldest sectors of the chemical industry. Sulphuric acid was the
largest product from the point of view of volume from the early nineteenth
century until around 1990. The production decreased mainly due to a restructuring
of the European fertiliser industry. In the 1950s and 1960s the petrochemical
industry emerged and established a centre on the west coast. During the whole
postwar period plastics have undergone the strongest development and today
represent the largest product group. Other main product groups are paints and
detergents15.
Most industries use chemical products. The main Swedish customers are the
pulp and paper, iron and metal ware, construction materials, and food industries.
Environmental issues have been a strong driving force behind changes in the
chemical industry. Environmental and energy taxes have contributed to the slower
growth of the chemical industry in Sweden. During the 1990s increasing attention
has been directed to the environmental effects of chemical components in other
products.
An early use of biotechnology in the chemical industry were fermentation
processes to produce chemicals such as acetone, butanol, and glycerol. Examples
of chemical companies that may have some biotechnological activities today are
Akzo Nobel (head office in the Netherlands), Arizona Chemical, which produces
products based on pine oil, and BIM Kemi, which as a minor business markets
micro-organisms for reduction of hydrogen sulphide16.
3.6
Pulp & paper
The pulp and paper industry of Sweden emerged in the nineteenth century.
Although its roots can be found in older paper manufacture, dating back as far as
the sixteenth century, and though it depended on existing structures in wood and
steel production, the pulp and paper industry was largely a new structure based on
technology developed abroad. The chemical pulp making processes were
introduced into Sweden in the 1870s and made large expansion possible. The
volume produced began to rise steeply around the turn of the century. In this
period R&D made its way into the industry and a central theme of the time was
quality control17.
15
Sveriges industri, Industriförbundet, 1992
Source: The homepage of the Association of Swedish Chemical Industries(Kemikontoret) with
business descriptions for the member companies, www.chemind.se
17
Sven Rydberg, ”Papper i perspektiv – svensk skogsindustri under 100 år”, The Forest industry in
collaboration with Gidlunds förlag, 1990
16
18
The interwar period featured mergers in the industry resulting in fewer
companies and larger utilities and Sweden entered into a period of relative
specialisation in bulk production. The increased and broadened R&D efforts made
it possible to establish a co-operative research institute in 1942. The R&D
focussed on issues applying to product improvement rather than basic research, a
direction of efforts that has since been maintained. Machine manufacturers today
largely contribute to the high-tech content of pulp and paper production.
Continuous production instead of batch production and a strong increase in the
demand of the packaging industry facilitated the growth of production in the
postwar period. Sweden was a major exporter especially of pulp. In the seventies
slower growth in the main markets, increased competition and possibly a slower
technological development meant tougher conditions for the industry. Paper
became the main export product rather than pulp, partly due to the fact that
recycled paper became an increasingly important raw material for paper
production. In the prosperous late eighties the continued and strengthened merger
trend resulted in world-standard sized companies, and the industry came to be
strongly concentrated. Today it is dominated by fewer companies such as SCA,
Modo and Stora Enso.
In 199818 no Swedish pulp and paper company was a large user of enzymatic
bleaching in its processes in spite of the fact that Korsnäs AB was performing
full-scale trials as early as 1990. The reason was that the method that was
developed and patented was considered too expensive. In both Finland and
Canada, however, enzymatic bleaching is used today (50 and 10 per cent of the
plants in Finland and Canada, respectively, use enzymatic bleaching).
At the present time the use of biotechnology in the industry is mainly limited to
the treatment of the wastewater used in the production. During the nineties
research collaboration occurred between the industry and universities concerning
enzymatic treatment of wood fibre, mapping of genomes for different types of
trees and development of genetically modified trees with better qualities.
3.7
Literature on the development of the biotech industry
internationally19
Contemporary biotechnology is often described as a science-based industry
that emerged in the USA in the 1970s in academic spin-off firms, typically in
partnership with venture capital providers. Factors that stimulated the
development of the industry in the USA were the links between the
biotechnological firms and academia, the presence of experienced venture capital
providers, the financing offered by large companies, and the government spending
on health-care research. Another stimulating factor was the presence of clusters of
firms and star scientists.
In Europe, the biotechnology industry developed more slowly. The reason has
sometimes been said to be a lack of venture capital and entrepreneurship in
academia. European companies accessed knowledge through the establishment of
laboratories in the USA or through the acquisition of American biotechnology
18
19
Laestadius, ”Biotechnology-A Neglected Paradigm Shift in Forest Industry?”, KTH, 1998
References are found at the end of this section
19
firms. This was a result of attempts made by the companies to find the best
research in areas where Europe was weak and not a systematic transfer of research
from Europe to the USA. The number of partnerships increased during the 1980s
and 1990s. There were several motivations for seeking partners. The companies
were facing global competition, and there seems to have been a shift in focus in
the biotechnology industry from R&D to manufacturing and marketing, which
may have required new assets and regulatory expertise.
Sources of innovation and innovation services.
The development of biotechnology has involved a network of alliances
between universities, new biotechnology firms and large pharmaceutical and
chemical companies. The step from academic research to industrial applications is
relatively short and there are no major technical differences between industrial
and academic laboratories. Production mainly involves laboratory work and
marketing; the manufacturing phase is thus very short [1, 2, 3]. The process from
inventions made in universities to innovation in industry is often straightforward.
According to Kenney (1986), Stanley Cohen at Stanford University and Herbert
Boyer at the University of California made the most important biotechnological
invention, when they developed the recombinant DNA technique [4].
The relationship between small biotechnology firms and large pharmaceutical
companies has been described in numerous articles. The role of the former has
changed over time. Senker and Sharp [3] identified three phases. In the first phase
during the 1970s and early 1980s, the contract research phase, the small
biotechnology firms performed research to receive financing from the
pharmaceutical companies, which thus got access to leading edge research. When
these companies started to build their own in-house competence in the late 1980s,
the small firms became sources of skill and recruitment, and many take-overs took
place. In the present phase, the biotechnology firms are sources of new products
and licenses. They are also important intermediates between academia and
industry for pushing and diffusing technology. However, they are dependent on
large companies as they lack the distribution facilities, marketing skills and capital
needed to launch a new drug [3]. The small firms have technology that the large
companies want to secure. What the small firms want is to retain their
technological knowledge internally at the same time as they are willing to sell
marketing rights or deliver products. [4].
Nevertheless, the pharmaceutical companies seem to maintain an active core of
R&D to be able to monitor and absorb external knowledge. In a number of articles
it is argued that it may be difficult to organise research in a creative way in a large
company and that flexible and informal organisations are important for
innovations to occur. This flexibility and informality may be more easily obtained
in small firms.
Sweden is one of the most health-care intensive countries in the world. The
large resources and the emphasis on hospitals (with large technical equipment and
specialist competence) rather than small clinics have stimulated innovation.
Furthermore, the health-care system and academia are strongly linked together.
Academic hospitals accounted for roughly 40 per cent of the biomedical research
performed in 1995. They help to target industrial research and participate actively
20
in the development of new therapies. Swedish doctors also receive significant
research training during their education. Nevertheless, these elements do not mean
that success automatically follows. According to Stankiewicz (1997) the firms
must be able to recognise, assimilate and exploit the relevant technological
opportunities [5]. The build-up of biomedical research in Sweden was the result of
a desire to strengthen the health-care system, not a policy to promote industrial
innovation. Academia was dominant, and Stankiewicz argues that the innovative
capabilities thus were embedded in an environment indifferent to
commercialisation.
The absence of a governmental industrial and technology policy for
pharmaceuticals is the consequence of several factors [5]. Firstly, a seemingly
well working system did not motivate policy initiatives. Secondly,
pharmaceuticals were regarded as belonging to the health-care sector and not to
the industrial sector. Thirdly, in the 1960s and 1970s, technology policy was
geared towards support of small and medium-sized enterprises (SMEs) with
limited R&D resources. Finally, the tools of R&D policy, such as support for cooperative applied research, did not quite fit an industry with strong dependence on
basic research and intense product orientation.
Thus, the firms had to integrate the resources of the technological system
themselves. Not all companies were engaged in intense collaboration with
academia. In the 1950s and 1960s, such co-operation generally decreased. This is
to some extent explained by the diminished importance of corporate financing of
academia but also by the cultural gap that began to divide academia and industry,
as the latter built up large internal resources. Some companies did not follow this
trend, e.g. Hässle. In the 1980s, industry-academia alliances were viewed as
important again [5].
In an article on the Swedish pharmaceutical and biotechnological so-called
competence block, it is argued that the competence to make the right decisions
varies between large and small firms [2]. The top leadership in these industries
seldom includes persons with experience from the management of explorative
R&D. Thus, large resources may be allocated for non-innovative purposes. In
small firms, a larger share of the employees, with their various backgrounds,
influence the decisions. The competence of venture capital providers is also
important. The conclusion of the article is that an optimal organisation for
exploiting the competence base is to have many small firms and many venture
capital providers and thus combine two successful approaches.
References to section 3.7
[1] Arora, A. And Gambardella, A. (1994) Evaluating technological information
and utilizing it: scientific knowledge, technological capability and external
linkages in biotechnology. J. Econ. Behav. Organisation 24, pp. 91-114.
[2] Eliasson, G. and Eliasson, Å. (1997). The pharmaceutical and
biotechnological competence block and the development of Losec. In
Technological systems and Industrial Dynamics (Carlsson, B., ed.) pp. 139-168.
21
[3] Senker, J. and Sharp, M. (1997) Organisational Learning in Co-operative
Alliances: Some studies in Biotechnology. Technology Analysis & Strategic
Management 9(1), pp. 35-51.
[4] Kenney, M. (1986) Schumpeterian innovation and entrepreneurs in
capitalism: the case of the U.S. biotechnology industry. Research Policy 15, pp.
21-31.
[5] Stankiewicz, R. (1997). The development of Beta Blockers at Astra-Hässle
and the Technological System of the Swedish Pharmaceutical Industry. In
Technological systems and Industrial Dynamics (Carlsson, B., ed.), pp. 93-138.
22
4
The Swedish biotech industry today
In this chapter the Swedish knowledge and research intensive biotech industry
of today will be described. The companies that mainly use modern biotechnology
in Sweden are those in the pharmaceutical industry. Besides companies engaged
in drug discovery, drug development and diagnostics, plant improvement and
bioproduction companies also use modern biotechnology. In the field of
biological plant protection, environmental technology and functional food, the use
of naturally occurring micro-organisms with desired characteristics concerning
function and toxicity is prevalent. The food industry mainly uses classical
biotechnology. The pulp and paper industry has R&D activities within modern
biotechnology, mostly in collaboration with university groups. The applications of
biotechnology mainly concern the treatment of water used in processes and wood
protection against fungi.
4.1
Introduction
Industrial structure
In the table below the knowledge and research intensive biotech industry of
Sweden is described. The table shows the number of companies, divided into
classes according to the number of employees in each subarea in 1999. The
different classes span from A (1-9 employees) to F (>500 employees). The large
pulp and paper, and food companies are not included. An estimation of the
occurrence, extent and importance of biotechnology in those companies is
difficult and will not be attempted.
The companies that will be described in the following sections are mainly the
micro, small and medium-sized companies. These companies produce goods,
services, and knowledge in different niche areas, often as subcontractors or in
collaboration with large Swedish and international companies and corporations.
Sweden has a comparatively large number of new research-based start-ups within
life science20. In the tables of Appendix A, the names of the companies and their
fields of activity are listed. Grey-marked companies do not fit the chosen
definition of biotechnology companies.
The companies included in the table below correspond to the ones found in the
Tables A3-13, Appendix A (except for the grey-marked ones). These are
biotechnology companies according to our definition. The large companies
AstraZeneca, Pharmacia Corporation, and Amersham Pharmacia Biotech AB are
also included. The majority of the companies are very small and 49 per cent had
less than 5 employees in 1999.Only approximately 12 per cent had more than 50
employees. The total number of identified micro, small and medium-sized
companies was 141 in 1999. The number of their employees was 3 000, which
corresponds to an increase of 30 per cent since 1997 (Table A1, Appendix A). The
rate at which new businesses are set up and established companies change their
name, merge or vary their line of business, make it difficult to survey the situation
and the development.
20
Ernst & Young, 1999
23
Number of biotechnology companies divided into classes according to
the number of employees in each subarea in 1999
Category / Class*
Agrobiotechnology
Bioproduction
Biotech supplies
Environmental biotechnology
Functional food and feed
Pharmaceuticals and medicine
Diagnostics
Drug delivery
Drug discovery and development
Medical technology
Total no. of companies
Per cent (%)
Micro
Small
A
B
C
4 (4)
2
8 (8)
7
1
19(17)
4
7 (6)
1
3 (3)
4
40(33)
28
6
8 (5)
11
2
3 (3)
2
1
26(23)
12
1
3 (2)
3
2
81(71)
46
7
56.2(49.3) 31.9 4.9
D
Medium
E
2
Large
F
1
1
1
3
2
1
2
2
5
3.5
2
1.4
3
2.1
Total
8
17
25
8
7
79
21
7
43
8
144
* Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99;
D: 100-199; E: 200-499; F: >500.
The majority of the companies are found in the areas of drug discovery and
development, diagnostics, biotech supplies, and bioproduction. The level of
education of the employees in these companies is high. The average proportion of
employees with a doctor’s degree lies between ten and twenty per cent for all the
different categories of companies. The largest proportion is found in companies
working at discovering and developing new drugs.
Among the categories, the companies engaged in drug discovery and
development had the largest increase in the number of employees. This number
increased by 82 per cent between 1997 and 1999 (Table A1 in Appendix A). All
the categories increased their number of employees during the period, with the
exception of agrobiotechnology, whose number was constant. The companies in
the categories biotech supplies and medical technology increased their number of
employees by about 50 per cent. The majority of the companies had a negative
operating income during 1999 (the largest proportion of companies with negative
results occurred in the categories drug discovery and development and medical
technology), whereas the turnover of the companies generally increased.
Geographically, the companies are mostly located in the metropolitan areas,
mainly in cities with large universities: Stockholm, Uppsala, Lund/Malmö,
Gothenburg, and Umeå.
The following sections provide some information about companies in the
different subareas as regards their growth potential, innovation processes,
economy21, and the eductional level of their personnel22. First, however, a general
description of driving forces, potentials, and innovation processes will be given.
21
Source: A database from the Swedish company Svenska Market Management AB was used to
obtain data on the economy of the companies and their number of employees. The data is based on
the Annual Reports that companies submit to the Swedish Patent and Registration Office. Data
from the last three available years was extracted, which can mean either that the last year was the
whole year 1999 or the split financial year 1998/99, depending on how the individual companies
organised the data they submitted to the Swedish Patent and Registration Office.
22
Source: A NUTEK and Statistics Sweden database of all individuals pertaining to the Swedish
work-force, aged 16 or more, was used. The database is based on Statistics Sweden's register data
24
Driving forces and potentials
Our knowledge of life’s basic building stones, the genes, is at present,
increasing dramatically. Shortly the complete human genome will be mapped23, as
the genomes of other organisms already have been, and more are to follow. This
forms the basis of a long and elaborate effort to find the genetic and molecular
mechanisms behind the biological life processes, which in turn can give us an
opportunity to understand, influence and take advantage of the great variety of
nature. This knowledge will be an important driving force behind societal and
industrial development in the foreseeable future. Today it is difficult to grasp the
future possibilities offered by the industrial applications of life science. These
applications, however, seem to have great potential for contributing to the
development towards a sustainable society and for increasing our life quality and
well-being.
The increased knowledge that, for instance, the genome mapping projects
generate and the fast technical development in electronics, IT etc., have great
potential for stimulating the growth of the commercialisation of life science
research. This includes the knowledge and research intensive biotech companies
that lead the development, often in close collaboration with scientists at the
universities. It also includes the subcontractors, production facilities, and
collaborative partners of these enterprises. The potential for growth is also large
for the consumers of the knowledge and expertise that is accumulated and the
services and products that are being developed. These consumers can, for
instance, be found in Swedish staple industries, such as pulp and paper, food,
agriculture, and chemicals, and also in the field of environmental technology. At
the same time there is an increased demand for co-ordinated efforts to make the
necessary investments in infrastructure, such as the management of large
databases and expensive equipment and the creation of innovative
multidisciplinary environments at the universities. As a sign of the potential of
this area, 20-25 per cent of the companies found on the so-called O-list at the
Stockholm stock exchange are engaged in life science fields.
The large growth potential that the knowledge and research intensive biotech
companies have will thus be shared by others if their technology can be
transferred to businesses that today only use modern or classical biotechnology in
innovative ways to a small extent. Below, some areas, which can benefit from the
new technology, are described.
•
The health care sector can benefit from new drugs, faster and better
diagnostic tools, individually based treatment with better efficiency and less
side effects, gene therapy and the use of new bio- and biocompatible
materials.
•
Sustainable development. By using nature’s own solutions it is possible to
achieve more effective processes, new biodegradable materials with tailor-
and contains, for example, information about individuals' education levels and profiles and
information about enterprises and establishments where they are employed.
23
As early as April 2000 the American company Celera said that the complete human genome had
been sequenced and that what was left was only a matter of sorting the data.
25
made characteristics and to increase and improve the use of biological
processes in waste treatment.
•
Food with increased nutritional value, better quality and the possibility of
positively affecting our quality of life can be developed, and so can new
refinement processes and better tools for quality control in the food sector.
•
The wood, pulp, paper, and chemical industries can increase their use of
enzymes and bacteria in order to develop new products and processes. They
can also increase their use of new biological raw materials.
•
Agriculture and forestry can become more efficient and more
environmentally sound through biological plant protection instead of
chemicals, better quality control and plant improvement.
•
New materials from biological raw materials. This category of products can
find applications in many manufacturing businesses, such as the car industry,
if the research is developed by, for instance, intermediary companies
generating commerciable products or ideas for products.
Much of the driving force can be found in multidisciplinary efforts including
various fields of research and technology for solving life science issues.
Innovation processes
The interviews performed and the workshop arranged indicate that the
innovation processes in this kind of knowledge and research intensive companies
can be divided into two phases: the exploratory research phase and the product
development phase. The exploratory research phase is often characterised by close
collaboration with university groups. The companies identify ideas for new
products or services from clients, academic researchers or company personnel.
Moreover, in this phase technology platforms, patents, and product embryos are
generated. Only a few of these ideas are often developed into finished products or
services since their development depends on whether they fit the company’s
present strategy, product portfolio, or clients. The product development phase, on
the other hand, is to a greater extent characterised by commissions and
outsourcing, if the complete process cannot be kept in-house.
Even within the narrow group of biotech companies the innovation processes
exhibit great variation depending on the products and services produced and on
the type of clients the companies have. For some of the identified categories of
companies different innovation processes are described in the following sections.
4.2
Drug discovery and drug development
Today there are very few companies that develop new drugs without using
biotechnological tools. For this reason we have included in Appendix A, Table
A3, all companies that have been identified as developing new drugs and whose
research and development is located in Sweden Some non-Swedish companies
with R&D facilities in Sweden are thus also included.Considerably fewer
companies, however, have the development of biopharmaceuticals, i.e. drugs
26
based on large biological molecules such as proteins, as their goal. Instead the
large biological molecules are targets for the drugs that are developed. These
drugs are often small molecules produced by organic chemical synthesis.
The large pharmaceutical companies
The Swedish pharmaceutical industry, including AstraZeneca and Pharmacia
Corporation, has grown tremendously, in the order of 400-600 per cent, during the
last two decades24. In 1996 the turnover was SEK 120 billion and 75 000 people
were employed globally. A clear driving force behind the growth of the industry
has been the fruitful collaboration between the companies and the universities,
which has led to internationally successful products. Today AstraZeneca and
Pharmacia Corporation dominate the area in Sweden. Both of them work globally,
in all their fields of activity, including sales and marketing, production, and R&D.
The drug discovery and drug development companies are an essential part of
the biotechnological innovation system and Astra and Pharmacia and their
present-day successors AstraZeneca and Pharmacia Corporation have played a
very important role for this group of companies. They have collaborated with
Swedish university groups and in doing so provided financing and given academia
an increased awareness of industrial problems, they have been collaborative
partners and purchasers of the products and services that the intermediary
companies have developed and they have also been a source of recruitment of
capable personnel. Many of these companies are spin-offs from one of the two
large pharmaceutical companies. In many of the newly started companies
previous employees at Astra and Pharmacia are found in leading positions. They
contribute experience and expertise from the pharmaceutical industry in areas
such as project management, business development and R&D. In this context it is
worth noting that restructuring and changed priorities within Astra and Pharmacia
have often led to project spin-offs. Such changes, then, can have a positive effect,
if other companies are able to continue the projects and take advantage of the
human resource that is represented by people who are trying to find other
employment in the biotech industry.
The new companies are either spin-offs from the large pharmaceutical
companies or from the universities, and often these two sources in combination.
The demand of the pharmaceutical industry for products, services, or expertise is
global, and AstraZeneca and Pharmacia Corporation can just as easily turn to
foreign intermediary companies and university groups as to Swedish organisations
for collaboration. The probability that they will collaborate with a Swedish
organisation, however, increases with geographic proximity. That these two
companies continue to have substantial R&D activities in Sweden is thus very
important both for the start-up of new intermediary companies and for giving
them a reason to stay in Sweden. At the same time the market for the intermediary
biotech companies is also global and they turn to the international pharmaceutical
industry for collaboration and for sale of their products and services.
The recent initiative by Pharmacia Corporation to create a separate, researchbased biotechnology enterprise and also the transfer of certain Pharmacia clinical
24
Source: Den biomedicinska industrin i Sverige, NUTEK B:1998:8
27
development resources to an external clinical research organisation (CRO) are in
the context of the location of future R&D activities of Pharmacia very
interesting25. Under the plan, Pharmacia will establish a new biotech company as
an independent, entrepreneurial business together with outside investors.
Pharmacia will make a substantial investment in the new venture. The new
company is expected to consist primarily of Pharmacia’s Sweden-based metabolic
diseases research group with its focus on diabetes and obesity, its related
biopharmaceutical development unit and the company’s Plasma business. The
initiative to start a new biotech company will involve many of the R&D personnel
in Sweden, and the question is how successful the new company will be in the
long run at attracting investments for the expensive activities and the many
personnel. As many as 800 personnel are said to be affected by the plans. The
income, apart from external investments from, for instance, Pharmacia
Corporation, will initially mainly stem from Pharmacia's Plasma business, which
provides a range of products derived from blood plasma for use in treating
haemophilia and in immunology and intensive-care settings. The Plasma business
recorded global sales of $80 million in 1999. Other sources of income will be the
same as for other intermediary biotech companies, for example collaboration
projects with large pharmaceutical companies, licensing and the sale of services
and developed drug candidates. Responsibility for developing the full potential of
these resources will be assumed by a Sweden-based management.
AstraZeneca is also restructuring its business activities by forming a new
company, Syngenta. The agrochemical business of AstraZeneca will be carried on
in Syngenta and AstraZeneca will thus instead focus on pharmaceuticals. The
fears that Astra’s Swedish research base would be scaled down drastically
following its 1999 merger with Zeneca have not materialised according to the
head of AstraZeneca’s R&D. Instead about 40 per cent of AstraZeneca’s research
is today conducted in Sweden26. Three of AstraZeneca’s research sites are located
in Sweden, two in the UK and two in the USA. The cost of land in the hightechnology clusters of the USA, the expensiveness of recruiting and retaining top
US scientists and also the high costs of clinical trials (claimed to be three times as
expensive in the USA as in Europe) are reasons for keeping R&D units in Europe.
AstraZeneca, however, is also heavily investing in the USA with for instance a
new research facility in Boston.
In 1999 AstraZeneca and Pharmacia Corporation had 8 547 and 5 114
employees, respectively, in Sweden. This corresponds to an increase of 17 per
cent and a decrease of 2.5 per cent, respectively, since 1997. Because of the
merger between Pharmacia & Upjohn and Monsanto in 2000, some of the
economic data has not been found for 1999. AstraZeneca’s turnover was SEK 25
687 million in 1999, which is an increase of 48 per cent since 1997, and the
operating income increased by 90 per cent to SEK 3 885 million in 1999.
25
26
Press release Pharmacia Corporation 30 June 2000
Source: Financial Times, Oct 18, 2000
28
The companies that discover and develop drugs and drug delivery
systems
In Table A3, Appendix A, the companies that discover and develop drugs are
listed. It can be seen in the table at the beginning of this chapter, that 40 per cent
of the companies that discover and develop drugs had more than 10 employees in
1999, but only 1.2 per cent had more than 50 employees. The educational level of
the employees in these companies is high. Of the employees in 25 out of 38
identified SMEs in 1998 (i.e. excluding AstraZeneca and Pharmacia & Upjohn)
about 20 per cent had a PhD. Only six companies had no employees with a PhD.
The share of personnel with a post upper secondary school education was 30 per
cent27. Since 1997 the number of employees has increased by 82 per cent and the
turnover by 40 per cent (Tables A1 and A2, Appendix A). In 1999 the operating
income was negative for 32 of the companies, which means that many of them are
still not profitable. About 35 per cent of the companies had a negative breeding
value to employee ratio in 1999, which is the highest value of all the categories in
the study.
Interesting start-up companies
Many new companies appeared in the late nineties, and many of the existing
companies are increasing their business activities. This is the case for companies
such as Medivir in Stockholm and A Carlsson Research in Gothenburg. In
Stockholm there are, for instance, the two start-up companies Accuro
Immunology (cancer treatment) and the Swedish-American company Biostratum
(connective tissue research), both of which are spin-offs from Karolinska
Institutet. Another new company is Arexis (functional genomics). Arexis is based
on research at SLU and Karolinska Institutet and focuses on mutations linked to
metabolic diseases.
Innovation processes in drug development
The most important source of ideas for innovations in drug discovery and drug
development is often said to be university and clinical research. The companies
develop drug candidates or knowledge of certain diseases or certain biological
areas in close collaboration with research groups at universities and university
hospitals. They often have an established network with academic groups, which
can sometimes be regarded as their extended R&D units. They often collaborate
with university groups or clinical scientists throughout the complete innovation
process.
These companies have to rely on a functioning knowledge and technology
market, where their income is derived from collaboration agreements with the
pharmaceutical industry, from licensing out their patents, or from selling drug
candidates. The market is global. Only a few of these companies today take their
drug candidates through all the phases of the clinical trials required on to the
market. This is often due to a lack of resources for the expensive clinical trials
procedure and a lack of resources to build a marketing and sales organisation.
Some companies take their products through phase one and two of the clinical
27
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
29
trials, which leads to greater profits if the product shows positive results. Many of
the companies are aiming to take their products further in the future before selling
or licensing out.
That there are good prerequisites for this kind of business idea is due to the fact
that the large pharmaceutical companies are growing and are thus becoming less
flexible. It may be difficult to organise research in a creative way in a large
company and flexible and informal organisations are important for innovations to
occur. This flexibility and informality may be more easily obtained in small firms.
It is difficult for the large pharmaceutical companies to have an insight into the
latest university research and the ability to commercialise it. They therefore seem
to increasingly rely on intermediary biotech companies to provide them with ideas
and to play an important role in their innovation processes. The large
pharmaceutical companies are also increasingly focusing on a few disease areas,
leaving room for new companies to find a narrow yet lucrative niche.
Nevertheless, the large pharmaceutical companies seem to maintain an active core
of R&D to be able to monitor and absorb external knowledge.
Bank analysts and stock brokers as well as venture capitalists, however, have
thus far had difficulties in appreciating the value of these intermediary companies.
At the same time, these companies are in need of long-term financing since future
earnings may be far away in the future (see Section 7.5). In this context it is
important to mention that the largest knowledge and technology market today
exists in the USA. Some of the intermediary companies have therefore, through
mergers or take-overs of American biotech companies, established a presence
there or are in other ways trying to establish important international networks.
In the future, major driving forces behind growth in this area are the genomemapping projects and the research into molecular medicine. Improved techniques
for producing biological molecules and for finding new drug targets by genome
mapping and research into functional genomics and proteomics increases the
growth potential and the potential for starting new businesses in the
pharmaceutical area. The use of recombinant DNA techniques, new and improved
techniques for bioseparation, and the development of equipment for biomolecular
analysis and DNA sequencing are likely to grow as a result of the increasing
knowledge. Thus, development and growth of the research-intensive drug
discovery and drug development companies will lead to growth in a number of
other areas. It is important to point out that investments in clinical research is also
very important. Clinical research and traditional development of drugs and
therapies are essential complements to research into molecular medicine. If the
biomedical research is to be applied, it also has to be tested and documented in
clinical trial procedures. Therefore high-capacity clinical research will also have a
positive influence on the development of the drug discovery and drug developing
companies in Sweden.
In Table A4, Appendix A, the companies in the area of drug delivery are listed.
The drug delivery companies are conducting research on how the active
substances of medicines can be made to reach their target molecules in the body
and how a satisfactory uptake of these substances, which are often difficult to
dissolve, can be ensured. The number of employees in the category of drug
delivery increased from 158 in 1997 to 213 in 1999 (a 35 % increase). The
30
turnover in 1999 was SEK 236 million, corresponding to an increase of 24 per
cent in two years. Only 2 of the 7 companies had a negative operating income in
1999 and all the companies had a positive breeding value to employee ratio.
4.3
Diagnostics and medical technology
The companies
In the tables of Appendix A, a number of company categories included are not
biotechnology companies according to our definition (for example, companies in
the area of biocompatible materials, consulting agencies in the areas of clinical
trials, clinical analysis and clinical research). The companies, however, are very
interesting in this context since they have fields of activity very close to the
chosen definition or are important to the innovation system. The diagnostics and
medical technology companies included as having biotechnological activities are
listed in Tables A5 and A6 as companies developing tools and techniques for
diagnostics, companies in the blood therapy and blood analysis area, companies
developing products used in fertility treatment and companies producing nutrition
solutions and plasma replacement. Companies producing equipment for dialysis
are not included.
The clients of the companies developing tools and techniques for diagnostics
are mainly the health-care sector and companies performing clinical laboratory
analysis in Sweden and abroad. According to Table A1, Appendix A, the
companies in the area of diagnostics had a total of 387 employees in 1999, which
corresponds to an increase of about 9 per cent since 1997. Of the employees in 16
out of 18 identified SMEs about 15 per cent had a doctor's degree in 199828. The
share of personnel with a post upper secondary school education was 22 per cent.
The companies in Table A5 had a turnover of SEK 394 million in 1999, which is
an increase of 7 per cent compared to 1997 (see Table A2, Appendix A). Out of
the 21 companies, approximately 50 per cent had a negative operating income
during 1999. The breeding value to employee ratio was positive for 85 per cent of
the companies.
These companies have close collaboration with groups at universities and
university hospitals in their innovation processes. A great difference compared to
the companies developing new drugs is that the process from idea to
commercialisation of diagnostic products, processes and services is much shorter.
Therefore these companies have the possibility of showing a profit much faster if
their product gives positive results. A change in this category since 1998 is that
Eurona Medical, a company engaged in bioinformatics, DNA-diagnostics ,and
pharmacogenomics, has been sold to Gemini Holdings, a British genetics
company.
The eight medical technology companies included had about 185 employees in
1999, which is an increase of 51 per cent - one of the largest of all categories
(Table A1, Appendix A). Of the employees in the nine companies for which we
28
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
31
have data on educational level, 11 per cent had a doctor's degree in 199829. The
share of personnel with a post upper secondary school education was 23 per cent.
The turnover has increased by 100 per cent in two years to SEK 225 million in
1999. The operating income was still negative, though, for 6 of the 8 companies in
1999. The breeding value to employee ratio was positive for 7 of the 8 companies
the same year.
4.4
Biotech supplies: new techniques, processes and equipment
The companies
Sweden is very successful in this area, with for instance one of the world’s
leading suppliers of technology for biotechnological research, Amersham
Pharmacia Biotech AB (owned by British Nycomed Amersham, 55%, and
Pharmacia Corporation, 45%). Amersham Pharmacia Biotech (APBiotech)
provides biotechnology systems, products and services for research into genes and
proteins, for the discovery and development of drugs and for the manufacture of
biopharmaceuticals. Nycomed Amersham plc recently announced its intention to
seek a listing on NASDAQ for APBiotech30. The listing is intended to be effected
through an initial public offering of approximately 10% equity interest in
APBiotech, which will be domiciled in the USA. APBiotech’s proposed board
and shareholding structure will ensure that Nycomed Amersham will maintain a
majority on the board and will appoint the Chairman and the Chief Executive.
Apart from APBiotech AB, there are also a number of smaller companies with
large potential for growth. The companies developing biotech supplies in Sweden
(see Table A9) cover areas like bioseparation and biomolecular analysis,
biosensors, genomics, bioinformatics, and fermentation equipment.
The category is dominated by APBiotech AB, which during 1999 had 1 130
employees in Sweden. The group consists of 25 companies, and during 1999 the
number of employees was 1390 in total, which corresponds to an increase of 13
per cent since 1997. The group of SMEs (i.e. excluding APBiotech AB) has
increased the number of employees by 51 per cent during the period. The turnover
has also increased, by approximately 54 per cent for the SMEs as a group and by
approximately 64 per cent for APBiotech AB individually. The operating income
during 1999 was negative for 16 of the SMEs. Approximately 25 per cent of the
SMEs had a negative breeding value to employee ratio in 1999, but for APBiotech
AB it was positive. As regards educational level, 10 per cent of the employees had
a doctor's degree in 1998, if APBiotech AB is excluded ,and the share of
personnel with a post upper secondary school education was 32 per cent31.
29
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
30
Press release August 7, 2000
31
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
32
Innovation processes
The customers of the companies in this area mainly consist of other
biotechnology companies, the pharmaceutical industry and university research
groups. Important sources of new ideas for products and services, apart from inhouse R&D, are customers and university researchers. The explorative research
phase of the innovation process is often characterised by close collaboration
between the companies and university groups. Refinement and development of
the products are performed in collaboration with subcontractors but also to some
extent with university groups. The subcontractors can, for instance, provide
expertise within areas such as software development, optics, mechanics, and
electronics. Outsourcing includes an interactive knowledge exchange between a
company and its subcontractor and leads to increased specialised expertise for the
subcontractor. This generates more efficient collaboration and at the same time
the biotech company becomes somewhat dependent on the subcontractor. The
close collaboration is facilitated by geographic proximity and sometimes the
consultants even spend some time in the client company when working on the
projects. For example Prevas (working in the software-area) has established
business in Uppsala in order to be closer to their clients (for example APBiotech
AB). An expected growth in the biotech supply sector will thus generate a growth
also for subcontractors in a number of different lines of business.
The ideas for new applications and further development of established products
are mainly received from the clients and in-house R&D but also from academic
research. This highlights the importance of maintaining the networks with
academic research and to acquiring knowledge of the most recent scientific
development. In addition to innovative ideas and testing of new products,
applications or services, the collaboration with university groups can generate
scientific publications that can later be used in marketing and for certification.
In biotech supplies, as in other subareas of the biotech industry, there is large
potential for starting new enterprises to develop exploratory-research ideas for
products that are not further developed in the established company. Some of the
projects are not in line with the current strategy of the company or the current
clientele. There are examples of successful new enterprises, based on projects
from an established company, that generate many jobs for highly qualified
personnel during a short period. The possibility of obtaining public funding for
collaborative research between a company and a university group in order to
verify, document, and test results from exploratory research would facilitate the
commercialisation of promising projects and promote spin-offs. It would increase
the incentive for the established company to take part in such a development.
Some interesting new companies
One such company is Gyros, which in the year 2000 became a spin-off from
Amersham Pharmacia Biotech AB. Gyros is developing a specially treated CD on
which it will be possible to perform a number of miniature laboratory experiments
using very small volumes. The company has about 20 employees today, and is
planning to employ about 100 researchers within three years. Amersham
Pharmacia Biotech is also planning to employ about 100 more researchers.
33
Another new company is Quiatech, which develops new techniques in the area
of nucleic acid chemistry. The techniques are used for DNA-chip applications and
are based on research performed at Uppsala University. A spin-off company from
KTH and Karolinska Institutet is Affibody Technology AB, working in the field
of protein engineering for applications in bioseparation, diagnostics, therapy, and
proteomics. The technique is based on combinatorial protein chemistry, and the
aim is to produce specific proteins for binding to different target molecules
(artificial antibodies).
4.5
Production of biological molecules, micro-organisms or cells
The companies
The companies producing biological molecules, micro-organisms or cells
(Table A10) have many of the other biotechnology companies, university groups,
the food and pharmaceutical industries as their customers. These companies often
have in-house R&D and also collaboration regarding the use of their products as
pharmaceuticals or functional food products. In this category we have identified
17 companies with a total of 444 employees in 1999. The number of employees
had increased by 29 per cent since 1997. The share of personnel with a doctor's
degree or a post upper secondary school education was 10 and 26 per cent,
respectively, in 199832. The turnover has in two years increased by 73 per cent to
SEK 692 million, and 4 of the 17 companies had a negative operating income in
1999. About 90 per cent had a positive breeding value to employee ratio the same
year.
4.6
Food and feed
As mentioned earlier, this study focuses on modern biotechnology or
innovative use of classical biotechnology. In the food industry these types of
technology are mainly found in the area of functional food. The term functional
food denotes a product with a documented, well-defined, product-specific diethealth relationship beyond the addition of ordinary nutritive substances such as
vitamins and minerals. As examples soured milk with a wholesome bacterial flora
or margarine with components lowering the cholesterol level may be mentioned.
The aim of the products is to reduce the risk of developing diseases and not to
cure them. The concept has, however, been used more widely, for instance for
products such as bread with a high content of fibres, vitamin and mineral enriched
products, even though they do not have a product-specific effect. The areas
included in the study are principally additives consisting of naturally occurring
bacterial stems with beneficial health effects in the gastrointestinal canal. Other
areas could, for example, be an increased use of enzymes in food processes or as
additives, or the development of quality control by means of the new techniques.
In future, genetically modified food may be a new biotechnological application
in the food sector, where the new raw materials have, for instance, an increased or
new content of healthy substances, like vitamins or proteins. An already existing
example of a genetically modified product is a type of rice developed in
32
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
34
Switzerland. The rice contains betacarotene that is transformed into vitamin A in
the body and also an enrichment of one form of easy accessible iron33. It is likely
that the product will be important in developing countries. Today, however, public
opinion is very sceptical about the gene modification of plants.
Biotechnological functional food products
Some of the companies call their product area probiotics (foods containing
living micro-organisms) or prebiotics (foods and nutrients that positively
influence the composition or activity of the intestinal flora). The products are
supposed to have a healthy effect depending on the specific additive they are
enriched with. In rules and regulations a line is drawn between diet-health
products, which have effects easily related to more general and established
scientific facts, and probiotic and prebiotic products, which have unique productspecific effects. An established scientific fact can, for instance, be the relation
between a high fibre content and a speedier passage through the intestinal tract,
which counteracts constipation caused by a low fibre intake. Today manufacturers
of probiotic and prebiotic products are not allowed to use product-specific health
claims in their marketing even if they can provide scientific results supporting the
claims. The Swedish National Food Administration is now investigating the
possibility of changing the rules so that specific health claims for these functional
food products can be used (see below). There are today about 25 probiotic
products on the Swedish market.
The companies
There are only a few companies in the food sector that are actively developing
biotechnological functional food products. An exception is Skånemejerier, a large
dairy company, which has played an active role in the development of probiotic
products. In larger companies there is sometimes an R&D unit working on this
category of products. Arla (Arla Foods) in 1999 founded a subsidiary company,
Arla Forskning & Utveckling AB, responsible for developing new products, e.g.
in the diet-health area. In this report only companies specialised in the
development of biotechnological food products are included.
In 1999 the number of employees in the seven companies (Table A11,
Appendix A) was 81 (Table A1, Appendix A), which corresponds to an increase
of 16 per cent since 1997. The share of personnel with a doctor's degree or a post
upper secondary school education was 18 and 42 per cent, respectively, in 1998
(excluding Lantmännens Foderutveckling, which would otherwise dominate the
statistics)34. Five of the seven companies had a negative operating income in
1999. The turnover of Lantmännens Foderutveckling decreased by 3.5 percent,
whereas that of the other companies increased by 40 per cent to SEK 41 million.
All the companies had a positive breeding value to employee ratio in 1999. Three
of the companies are situated in Lund, two in Stockholm, one in Umeå, and one in
Gothenburg.
33
Science, V285, p. 994, 1999
Source: Det svenska biotekniska innovationssystemet: Drivkrafter och hinder för innovationer
och tillväxt, Working paper, NUTEK, May 2000
34
35
A new company, Triple Crown, has an alternative approach to those mentioned
in Table A11. Triple Crown has developed a technique for producing a plant
extract that lowers the level of cholesterol in the blood. The business concept is to
sell the extract to the food industry, which can use the product as an additive in
food. The company is collaborating with Karolinska Institutet for documentation
of the effect by means of clinical trial procedures.
Innovation processes
The companies developing functional food products are often closely
connected to medical and nutritional research groups at universities and university
hospitals. One example is Probi, the company that developed the probiotic
product Proviva in collaboration with Skånemejerier. The product is based on
research at Lund University and Lund University hospital.
Driving forces and obstacles
A request from serious producers and developers of functional food products is
that new, clear rules for this type of products should be created. Today the
products are confined to a grey zone between the legislation for food and the
legislation for pharmaceuticals, and it is difficult for consumers to find what
products have well-documented effects. It is also requested that the new rules for
functional food should call for scientific documentation of effects in return for
permission to point to product-specific effects in the marketing of the products. If,
on the other hand, a manufacturer asserts that his product alleviates, cures or
prevents diseases, it should be classified as a pharmaceutical or a nature-cure
medicine, and then it has to be tested, approved and registered by the Swedish
Medical Products Agency35.
It is likely that the development of this area depends on whether new rules will
actually be created. If today's rules are retained, it will be difficult to cover the
R&D costs of a scientifically documented product since cheaper products without
scientific documentation can use the same marketing. The alternative is to classify
the products as nature-cure medicines or as pharmaceuticals. This will cost much
more and thus involve a greater financial risk. The producers might in this case
increase their collaboration with the pharmaceutical industry because of its
experience of clinical trials.
If, on the other hand, new rules are introduced, the chance to cover the costs of
development for scientifically documented products will increase. This will also
create incentives for potential entrepreneurs to take the risk and start a new
enterprise in the field. The potential is large, since many elderly people have
digestion problems and problems to assimilate nutritive substances, and this type
of products may help them.
35
Nature-cure medicines are drugs where the active substances have a natural origin and consist of
plant or animal extracts, bacteria, minerals or salt. The active substances must not be too refined or
chemically modified. Nature-cure medicines are intended for self-healing and for conditions that
do not require a doctor’s attention. The products may be sold freely. To have a product classified
as a nature-cure medicine puts high demands on it. In November 1999 about 80 nature-cure
medicine products were approved. Source: The Swedish Medical Products Agency (www.mpa.se)
36
In 1998 the Swedish Nutrition Foundation, in collaboration with and on
commission of the food branch, worked out a new proposal for the use of productspecific health claims in marketing36. This proposal involved an extension of the
earlier rules37 of the Swedish National Food Administration. These earlier rules
state that a description of content and nutritive substances can be used without a
link to possible health-effects. Moreover, eight established diet-health connections
are allowed to be expressed, for example that a low level of saturated fat can
reduce the level of cholesterol in the blood and that product X has a low level of
saturated fat. The eight established diet-health connections are the benefits of: a
lower content of calories, a low cholesterol content, a low level of salt (relation to
high blood-pressure), healthy fatty acids (related to vascular diseases), a high fibre
content, a calcium content, less sugar and iron enrichment. The present rules do
not support the companies in Table A11, which develop products without effects
stemming from any of these eight established connections between diet and
health.
The extended proposal includes the use of scientifically documented productspecific health claims. The new rules would apply to nutritive substances
(vitamins, proteins, carbohydrates, etc.) to a higher extent, in other
combinations/proportions or with a better or more regulated bio-accessibility than
traditional products, as well as to prebiotics, probiotics, and bio-active substances
(not nutritive substances), e.g. roughage and antioxidants. Expressions such as
curing, alleviating, or a reduced risk for development of specific diseases would
still be prohibited in marketing. Possible effects would instead be, for example,
effect on functions of the intestine, blood fatty acids, blood sugar value,
bioaccessibility of minerals, and physical capacity. It is proposed that a committee
should be established for inspection of the companies’ marketing. Similar
proposals are under preparation in Great Britain, Belgium, and France, and are
already applied in Holland. Within the EU the organisation CIIA (Confederation
of the Food and Drink Industries of the EU) prepared a proposal for rules
concerning this type of products with documented health effects. The reason why
countries create their own rules is the very time-consuming treatment of the
matter by the European Commission.
In April 2000 the Swedish National Food Administration presented its own
investigation38. It contained a proposal that an authority procedure and a
legislation consistent with that of the EU should be developed concerning these
products and be designed as follows.
Proposed rules for a new group of products qualified for Product Specific
Health Claims (PSHP):
•
The products should have the function of conventional food. Thus it should, in
the case of normal and regular consumption, be possible for PSHP products to
be included in food that is recommended for its nutritional value.
36
Source: Produktspecifika fysiologiska påståenden (PFP). Ett förslag till utvdgning av
egenåtgärdsprogrammet. The Swedish Nutrition Foundation 1998 (www.slv.se)
37
Source: Hälsopåståenden (hälsoargument) i marknadsföringen av livsmedel, The Swedish
National Food Administration 1990 and revised 1997 (www.slv.se)
38
Source: Livsmedel för hälsa och långt liv? - utredning om produktspecifika hälsopåståenden”,
Report 6 – 2000, The Swedish National Food Administration (www.slv.se)
37
•
Statements regarding the products should be approved by competent
authorities, and the products should have a label certifying this approval.
•
The products should have a scientifically documented health-effect. The type
of effect should be specifically stated on the package.
•
Decisions on composition, range of application, and safety documentation are
taken in connection with the approval of the products.
One of the differences compared to the investigation by the Swedish Nutrition
Foundation in 1998, is that authority inspection of statements regarding the
products should take place and be based on the presented documentation. The
companies are likely to be sceptical about a preliminary examination of their
statements and would probably prefer the proposal of 1998 with a committee
inspecting arguments used in marketing.
In the investigation performed by the Swedish National Food Administration
the following proposal was also made: While awaiting the decision on productspecific health statements internationally, it is suggested that prerequisites for
rules concerning product-specific health claims should be mapped ….. in
accordance with the proposal made by the Swedish Nutrition Foundation in 1998
(i.e. extension of earlier rules).
Both the proposal made by the Swedish National Food Administration and that
made by the Swedish Nutrition Foundation would probably help the companies in
the areas of prebiotics and probiotics that have produced or easily can produce
scientific documentation for their products in accordance with the demands. The
present rules do not give the manufacturers of this category of products any right
to use product-specific health statements in their marketing. Therefore it is
extremely important to extend the rules while awaiting new international
legislation.
4.7
Agrobiotechnology
In agrobiotechnology there is an increasing number of research-based
companies working at plant improvement, biological plant protection, quality
analysis, development of new biological raw materials and on new uses of
biological raw materials. In Table A12, Appendix A, 8 companies with employees
in 1999 are listed. Two medium-sized companies dominate the group, Svalöf
Weibull AB and Novartis Seed AB. The rest of the companies in the group are
micro- and small-sized companies with a total of 37 employees in 1999. In 1999
two of the companies had a negative operating income, and the breeding value to
employee ratio was negative for one of the companies.
At least two of the companies in the area of biological plant protection are
spin-offs from universities, Bioagri from the Swedish University of Agricultural
Sciences and Bionema from the University of Umeå. Agrivir was founded by
Bioagri in co-operation with the drug discovery and drug development company
Medivir. Almost one fourth of the employees in this group of companies have a
PhD degree. The advantage of the products is the reduced use of chemical
biocides and pesticides. Many farmers who are engaged in ecologically sound
farming e.g. KRAV farms, use these products, which are based on naturally
38
occurring and biologically degradable micro-organisms. All identified companies
are small and need access to a larger marketing and sales organisation in order to
grow. Venture capital could promote growth if the business is to be scaled up
through increased international marketing. Capital is also needed for field trials,
patenting, documentation, etc. The competition from large multinational
companies producing chemical pesticides is very hard, and some of them are now
developing similar products. However, Swedish research is in the front line, and
for companies engaged in exploratory research in collaboration with academic
groups flexible public financing in support of scientific verification, testing, and
documention of results would have good chances to promote growth.
Svalöf Weibull and Novartis Seed work at plant improvement and have the
permission of the Swedish Board of Agriculture to perform field trials with
genetically modified plants. In 1999 the two companies together had a total of 628
employees, which is a 3 per cent decrease in two years. Svalöf Weibull AB had 40
fewer employees in 1999 compared to 1997, which explains the decrease. The
operating income of Svalöf Weibull AB in 1999 was SEK 8 million, whereas that
of Novartis Seed AB was negative. Similarly, the turnover was constant for Svalöf
Weibull AB, whereas that of Novartis Seed AB showed a decrease of 19 per cent
since 1997. Another Swedish company with a corresponding permission to
perform field trials is Amylogene, which develops genetically modified potatoes
with an increased level of amylopectine and resistance to antibiotics.
A new company in this field is Scandinavian Biotechnology Research AB,
which develops genetically modified oil plants producing specific vegetable oils.
The company is closely connected to research at the Swedish University of
Agricultural Sciences. Lipogene is a company based on research at the
Department for Plant Improvement at the Swedish University of Agricultural
Sciences in collaboration with Svalöv Weibull AB. The aim of Lipogene is to use
gene transformation and plant improvement in order to develop plants with
enough unusual fatty acids in their seeds to be profitable.
Permission from the Swedish Board of Agriculture is needed for cultivation of
genetically modified agricultural and horticultural plants in Swedish field trials
according to the Board’s directions about intentional development of genetically
modified plants39. Since 1989, 76 applications for field trials with genetically
modified agricultural and horticultural plants have been approved. In more detail
the applications have involved40:
26 field trials of potatoes
33 field trials of rape
16 field trials of sugar-beets
1 field trial of apples
39
SJVFS 1999:124
Source: The Swedish Board of Agriculture,
http://www.sjv.se/genteknik/faltforsok/faltforsok.htm
40
39
Up to now, thirteen field trials have been approved by the Swedish Board of
Agriculture in the year 2000, eight of rape, three of potatoes and two of sugarbeets. An obstacle to the growth of companies developing genetically modified
crops is the scepticism shown by the general public about the products.
4.8
Environmental biotechnology
The companies in this field work at soil treatment, waste disposal, water
treatment, and laboratory analysis (Table A13, Appendix A). Their customers are,
for example, municipalities, construction companies, and industries needing
purification of the water used in their manufacturing processes. The first three
groups mentioned use effective and non-pathogenic naturally occurring microorganisms and develop improved techniques for the utilisation of microorganisms. The laboratory analysis companies develop testing methods and
analyse, for example, sewage as regards levels of toxic substances and microorganisms.
An area with great potential is the production of biogas from waste products,
i.e. these products undergo bacterial degradation, which produces methane gas.
The bacterial strains used occur naturally in, for example, dunghills and swamps.
The technique, though, needs further development, and the stench problem has to
be solved.
In the category Environmental biotechnology, eight companies with employees
during 1999 were found (Table A1, Appendix A). All of them are micro- and
small-sized companies with a total of 33 employees in 1999. From 1997 to 1999
the number of employees increased by 14 per cent. The turnover increased by 84
per cent during the two years to SEK 33.5 million in 1999. Three of the eight
companies had a negative operating income and one had a negative breeding
value to employee ratio in 1999.
4.9
Regional distribution of companies
The question why biotech companies choose different locations has many
possible explanations. By means of a model with the explanatory variables
”industry strength”, ”science base” and ”fixed effects”, a study has been made on
whether new biotechnology enterprises in the USA are attracted by the local
industrial strength of a sector or by the strength of its science base41. Industry
strength was measured as the number of employees in different industrial sectors
and science base as the number of people employed in research in relevant
scientific areas. The last variable, fixed effects, captured all state-specific effects
like venture capital or infrastructure. In biotechnology, the main attracting force
was found to be the presence of a strong research base and to some extent
industrial employment in key sectors, i.e. clusters of small companies developed
close to research centres rather than close to established industries.
Being in a cluster involves both benefits and costs. On the supply side,
specialised labour, specialised inputs (e.g. equipment, reagents and testing
41
Swann, P. and Prevezer M. (1996) A comparison of the dynamics of industrial clustring in
computing and biotechnology. Research Policy 25, pp. 1139-1157.
40
devices), and spill-over of knowledge attract companies. On the demand side, the
possibility of joining important users in other industries or domestic users
strengthens some clusters. It is also less expensive for customers to compare
alternatives. The costs of clustering are congestion costs (e.g. higher real-estate
prices and higher wages for qualified personnel) and reduced profitability due to
competition. Congestion effects, however, are not very important in
biotechnology, according to Swann and Prevezer.
Most Swedish biotech companies are located in metropolitan areas with large
universities (see tables below)43. The largest number of companies are found in
the regions surrounding Stockholm (about 37 companies), Lund/Malmö (about 37
companies), Uppsala (about 23 companies), Gothenburg (about 20 companies)
and Umeå (about 11 companies).
Thus far the following two strong regional clusters of biotechnology companies
in Sweden emerge from the analysis of our data:
•
The Stockholm-Uppsala region and within that the Uppsala cluster with many
contacts between companies, often due to the fact that many of their
employees have a background in Pharmacia.
•
The Lund-Malmö cluster. Today this region is establishing networks and
collaboration across the Sound to Copenhagen (see the Medicon Valley
Academy below).
The regional distribution of micro-, small- and medium-sized companies
in 1999 1,2
3
Category / County
Malmö
Stockholm
Gothenburg
Uppsala
Umeå
Other
Total
Agrobiotechnology
Bioproduction
Biotech supplies
Environmental biotechnology
Functional food and feed
Pharmaceuticals and medicine:
-Diagnostics
-Drug delivery
-Drug discovery and development
-Medical technology
3 (0)
6 (1)
4 (4)
4 (3)
3 (1)
17 (8)
5 (3)
3 (0)
7 (4)
2 (1)
1 (1)
1 (1)
7 (6)
1 (1)
2 (0)
25 (10)
5 (1)
3 (2)
16(7)
1 (0)
1 (1)
2 (1)
1 (1)
1 (1)
15 (9)
4 (2)
7 (5)
4 (2)
1 (0)
2 (2)
8 (5)
12 (6)
5 (1)
6 (5)
1 (0)
1 (1)
3 (1)
1 (1)
1 (1)
1 (1)
4 (3)
1 (0)
3 (3)
-
2 (2)
4 (2)
3 (2)
1 (1)
4 (4)
1 (1)
1 (1)
2 (2)
-
8
17
25
8
7
77
21
7
41
8
Total no. of companies
37 (17)
37 (19)
20 (13)
23 (13)
11 (8)
14 (11) 142(68)
1
The distribution is based on the seat of the county government.
The values in brackets are the number of companies belonging to the size class A (1-9 employees).
3
The large-sized company Amersham Pharmacia Biotech AB is included.
2
The largest number of micro, small, and medium-sized companies discovering
and developing drugs are found in the region surrounding Stockholm. With
approximately 390 employees, the region also accounts for the largest number of
employees in the category as a whole (see the table below). Stockholm, together
43
Source: The regional belonging was extracted from the database from the Swedish company
Svenska Market Management AB
41
with nearby Uppsala, also dominates in the area of diagnostics as regards the
number of employees.
In the county of Uppsala biotech supplies is the dominating category, and the
county accounts for 70 per cent of the employees in Sweden belonging to this
category (i.e. with the exclusion of Amersham Pharmacia Biotech AB). One
company, Biacore, employs 78 per cent of the personnel in the area of biotech
supplies in Uppsala.
The three categories bioproduction, drug delivery, and drug discovery and
development dominate in the region surrounding Malmö. These categories
account for approximately 80 per cent of the total number of employees in the
biotech industry of the county.
In the region surrounding Gothenburg there are about as many companies as in
the Uppsala region, but the majority are micro- and small-sized companies. The
subcategories of Pharmaceuticals and medicine account for approximately 90 per
cent of the total number of employees in the biotech industry in the Gothenburg
region, with the largest number found in the subcategory drug discovery and
development.
In the region surrounding Umeå, bioproduction is the dominating category.
Companies located outside the counties mentioned above, referred to as
“other” in the tables, account for about 11 per cent of the total number of
employees. Included here is the company DSM Anti-Infectives, with 191
employees and situated in Strängnäs in the county of Södermanland. In the figure
below, DSM Anti-Infectives is marked as if it was situated in Nyköping, which is
the seat of the county government in Södermanland.
The regional distribution of the number of employees in micro-, and smallsized companies in 19991
Category / County
Malmö
Stockholm
Gothenburg
Uppsala
Umeå
Other
Total
Agrobiotechnology
Bioproduction
Biotech supplies
Environmental biotechnology
Functional food and feed
Pharmaceuticals and medicine:
-Diagnostics
-Drug delivery
-Drug discovery and development
-Medical technology
12
169
14
19
30
479
57
155
246
21
4
5
23
2
46
644
143
57
390
54
1
18
1
1
136
54
42
40
11
4
181
218
112
35
71
4
53
1
9
4
27
20
7
-
6
212
22
2
12
1
1
10
-
37
444
259
33
81
1516
387
213
730
186
Total no. of employees
723
724
157
414
98
254
2370
Per cent (%)
30.5
30.5
6.6
17.5
4.1
10.7
1
The distribution is based on the seat of the county government. Only micro- and small-sized companies
means that AstraZeneca, Pharmacia Corporation, Amersham Pharmacia Biotech AB, Novartis Seeds,
and Svalöf Weibull are excluded.
42
The regional distribution of the number of employees (left) and the number
of companies (right) in 1999.The sizes of the circles are proportional to the
number of employees/companies. Only micro-, and small-sized companies
(<200 employees) are included*.
* The distribution is based on the seat of the county government. Only micro- and small-sized
companies means that AstraZeneca, Pharmacia Corporation, Amersham Pharmacia Biotech AB,
Novartis Seeds, and Svalöf Weibull are excluded.
43
4.10 Geographic collaboration pattern
The table below shows the results of the questionnaire survey (Appendix E)
concerning the share of companies that claim that they collaborate with research
groups at universities or institutes, either locally, in other parts of Sweden, or
abroad. In addition, the level of collaboration or outsourcing of R&D activities
between different companies, locally, in Sweden, and abroad is shown.
Geographic collaboration pattern
Collaboration with
academic research
groups
Outsourcing to
and/or collaboration
with other
companies
Yes [%]
Locally [%]
In Sweden [%]
Abroad [%]
93
71
67
64
66
29
56
49
Almost all companies claim that they collaborate with academic groups either
locally, in Sweden, or abroad (93%). This proportion is about the same for all
categories of companies. The fact that there is such a marginal difference between
the proportions of companies that are involved in local, national, or international
collaboration is a sign of the international character of the field. This is also
evident from the answers concerning outsourcing to and/or collaboration with
other companies. As many as 49% of the companies mention outsourcing of R&D
activities to and/or collaboration with companies abroad. The dependence on the
specific local environment in the case of collaboration (academic as well as
corporate) and outsourcing seems perhaps slightly less strong than expected,
considering that the dependence on local collaboration is often emphasised in
cluster analyses. The difference in importance, extent, and content between local,
national and foreign collaboration has, however, not been analysed in the present
study.
Looking at the distribution of collaboration geographically, some differences
between the different categories of companies can be identified. For instance,
companies in the areas of Bioproduction, Biotech supplies, and Pharmaceuticals
and medicine have the highest shares of collaboration with academia locally and
abroad and also high shares of collaboration in Sweden. Moreover, companies in
the area of Agrobiotechnology to a larger extent than the other categories of
companies seem to choose to collaborate locally, or nationally, or internationally.
As regards outsourcing and company collaboration, the companies in the area
of Bioproduction have a higher share of their collaboration with other companies
locally and in Sweden than the other categories of companies. The companies in
the area of Functional food have the lowest level of collaboration with foreign
companies.
44
4.11 Companies’ opinions concerning driving forces, obstacles, and what
should be done to promote growth
A set of issues brought up in the questionnaire (Appendix E) concerns various
subjects such as collaboration between companies and between the industry and
academia, forces enhancing and impeding innovation and growth and what public
authorities should do to promote the field. In the following sections responses
from the companies regarding these issues are analysed.
The answers to questions regarding driving forces, obstacles and what should
be done by public authorities to promote innovation and growth turned out to be
preferably analysed together. Of the companies receiving the questionnaire 56-58
per cent answered each of these questions. Since the questions were open-ended,
the analysis is more qualitative than quantitative. What most respondents mention
is the importance of high-quality academic research and collaboration with
academia, human capital issues, and investments in education, the need for more
public seed financing and support for start-ups and SMEs.
The importance of the presence of Astra and Pharmacia
Some respondents raise the importance of the presence of “Big Pharma”, i.e.
AstraZeneca and Pharmacia Corporation, in Sweden. Especially their roles as
purchasers of the products that the biotech industry produces and as a source for
recruitment of capable personnel are mentioned. Efforts to increase incentives for
these companies to invest and keep R&D units in Sweden are requested. As an
obstacle to growth a few respondents mention the lack of corresponding Swedish
companies in other areas of the biotech industry than the development of new
drugs.
Support for SMEs and the need for seed financing and venture capital
Among the most frequently appearing issues brought up by the respondents to
the questionnaire are the lack of capital for different phases in a company’s
development and the limited support offered to SMEs by public authorities. It is
especially pointed out that there is an increased need for public seed financing,
since venture capital companies rarely invest in early development phases and
since there is an increased number of start-up companies. The support could be in
the form of, for example, soft loans that are repaid when the company shows a
profit, loans guaranteed by the Government, favourable credits, or more support
for projects not only at universities but also in companies. The incentives to invest
both in start-up companies and SMEs should also be improved.
Some criticism is also brought up regarding the present support system (ALMI
Business Partner, NUTEK, the Technology Link Foundation, and the National
Industrial Development Fund), namely that they have become less prone to take
risks and are rather acting like venture capitalists. Less bureaucratic, faster, easier
and more flexible handling of financial support by perhaps fewer government
agencies is requested. A fund for investing only in academic spin-offs and
research-intensive companies is suggested. Some respondents also mention the
need for capital combined with competent advice and support. There is also a
need for help with networking, management, and knowledge of the market in the
45
early stages of a company’s development. It is claimed that this need is not met by
the existing venture capital companies or public authorities.
Other issues mentioned are, for example:
•
There must be a willingness on the part of inventors to allow complementary
competencies and to loosen some of their control over companies.
•
There is sometimes a difficulty in communication between academic inventors
and venture capital companies.
•
Government agencies should become better at supporting SMEs and start-ups
concerning knowledge of management, marketing etc, and concerning
networking, e.g. giving help to find financiers and partners for collaborative
projects.
•
One suggestion is to set up a database of individuals with specific
competencies regarding business development in biotechnology.
•
One respondent mentioned that development projects are often underfinanced,
even if they have public support, leading to loss of momentum and maybe
closure.
•
It is difficult to find long-term investors.
•
The focus on Information Technology has hampered the availability of
venture capital for the biotech industry. However, the situation is now
improving.
•
Venture capitalists are becoming better at knowing the value of biotech
companies, and this also applies to bank analysts and stock brokers.
Science, technology transfer and knowledge exchange
What almost all respondents mention is the necessity of high-quality academic
research and of collaboration between the industry and academia. Continued large
investments in education and academic life-science research are a prerequisite for
the growth and prosperity of this industry in Sweden. Few respondents mention
particular fields or whether the efforts should be concentrated on applied or basic
research. However, basic independent research is mentioned more frequently.
Multidisciplinary research should be promoted and barriers between disciplines
torn down. There should be increased knowledge exchange between disciplines,
so that the knowledge created in one field can be applied in another field. An
important multidisciplinary field that is mentioned is bioinformatics, where there
is today a lack of capable personnel. What is also mentioned is the inability, and
sometimes lack of willingness, of the universities to invest in new technologies
and new, often multidisciplinary, fields such as for example research into
probiotics.
46
Collaboration between industry and universities should be promoted. Among
the initiatives mentioned for promotion of knowledge exchange and technology
transfer are the following:
•
better functioning liaison offices at the universities for spreading easily
accessible information about the research being performed;
•
more realistic costs for university collaboration, especially reduction of
administrative costs;
•
tax reduction for supporting university research;
•
less bureaucratic, flexible support for collaboration projects between
university groups and companies;
•
a university group’s collaboration with industry should be promoted and not
hamper the prospect of receiving other funding;
•
support for initiatives concerning science and technology parks and incubators
close to the universities:
•
support for commercialisation of academic ideas with no need for the
innovator to leave academia.
Education and human capital
It is clear that many of the respondents are worried that the low number of
students interested in scientific and technical disciplines will not increase in the
future. The secondary-school education in these fields should be improved to
stimulate more students to enrol on higher education courses in life-science and
technical fields.
Many respondents mention a lack of capable personnel in general as an
obstacle to growth and a few point to specific areas in which there is a shortage of
capable personnel. They mention, for instance, competence in bioinformatics,
microbiology, knowledge of good manufacturing practice (GMP) and what is
needed for FDA (the US Federal Drug Administration) approval and also better
skills in management, project leadership, and business development, often with an
international angle.
47
Other issues brought up:
•
The support for graduate students and for departments educating graduate
students should be strengthened.
•
Better incentives for scientists to return to Sweden after a post-doctoral period
must be created, and the conditions for graduate students should be improved.
•
There should also be more initiatives to attract foreign top scientists to
Sweden.
•
The efforts that are needed are claimed to be most effective if they are
invested in established research environments with high-quality research.
•
The research and education system is said to be too fragmented today.
•
The demand that complete financing should be secured before the registration
of a PhD student is often difficult to fulfil.
Global market
As an obstacle to growth many respondents mention a small national market
and the need for international marketing at an early stage in a company’s
development. Some suggest that there should be more public efforts to support
companies entering the global market and claim that fewer such efforts are made
by public authorities in Sweden than in other countries.
Public opinion and awareness
Public opinion and, more frequently, the public awareness of the potential for
biotechnological applications and also misunderstandings of such applications,
due to too little knowledge, are mentioned as obstacles to growth. This applies
especially to politicians, public authorities, and the media.
The present study was mentioned as helpful to players in the system and also
useful in spreading information about the biotechnology innovation system. A
request was that the data should be continuously updated and published.
Rules and regulations
Clearer rules and regulations are requested by, for instance, companies
producing or using micro-organisms or developing biotechnological functional
food products. Rules and regulations have not been updated at the same rate as
technology is developing, and this has the effect that companies using the the
most recent technology are affected negatively.
48
Environment
It is mainly the companies in biological plant protection and soil, waste, and
water treatment that point to environmental issues as major driving forces behind
their business. However, the worry of public opinion concerning their products
and activities, due to too little knowledge of, for instance, the use of microorganisms for biological plant protection, is also mentioned. Moreover, the
companies voice the criticism that there is a great deal of talk and that many
reports are written about investing in improvement of the environment by means
of, for instance, soil remediation or in development of environmentally sound
technologies, but that little is actually being invested by public authorities.
Entrepreneurship
It is pointed out that there has been a change of attitude in Sweden. More
researchers are positive to collaborating with industry and becoming
entrepreneurs themselves. In this context, the appearance of good examples,
which show that it is possible to start a business based on academic research in
this field, has positively affected the development.
Taxes
An issue brought up by about 20 per cent of the respondents to the
questionnaire is that the Swedish taxation rules are an obstacle to growth. About
half of them do not mention any specific taxes, while others mention the taxation
rules regarding stock options, both for employers and employees, income taxes,
and capital gains taxes. Among the suggestions for taxation rules that should be
introduced in order to promote growth are a reduced tax for start-ups during the
first three years and/or for SMEs, and tax reductions as incentives for business
angels and venture capitalists to invest in the industry. A reduced tax for
companies when financing academic research or when investing in their own
business is also mentioned as an initiative that would promote growth.
Summary concerning driving forces, obstacles and promotion of growth
The most frequent answers regarding driving forces, obstacles and what should
be done to promote growth are summarised below.
Driving forces:
•
The quality of university research and collaboration industry-academia
•
Increasing global market
•
Presence of Astra and Pharmacia
•
Strong entrepreneurial spirit
•
Good examples
•
The positive environmental effects of products
49
Obstacles:
•
Lack of capital in different phases of a company’s development
•
Lack of incentives for entrepreneurs, venture capitalists and business
angels, and also high taxes
•
Lack of competence in management and business development in the early
phases of a new company
•
Lack of organisation and skills in marketing and sales in SMEs
•
Lack of personnel in specific areas
•
Public opinion concerning certain applications of biotechnology
•
Small national market
•
Inventors’ fear of losing control
What should be done by public authorities to promote growth:
•
Increased investments in education and research
•
Increased public seed financing
•
Flexible support for development projects
•
More incentives to become an entrepreneur and to invest in the biotech
industry
•
Strengthened general awareness of the potential of the area and monitoring
the development
•
Increased support for SMEs
•
Reduction of certain taxes
Conclusions drawn from the questionnaire survey
There is a positive attitude among the respondents concerning the potential of
the area. The presence of successful companies serving as good examples and of
Big Pharma, the development of the industry until today, an increasing global
market, the quality of research in academia, and the knowledge explosion in the
area are reasons mentioned for this. This leads to a positive trend and a strong
entrepreneurial spirit.
The importance of high-quality research and collaboration with academia is
evident from the responses to the questionnaire. Thus the clearest result is that
continued and increased investments in education and research in fields relevant
to the biotech industry are needed for a continued positive development of the
area. It is, however, less clear from the present study, what particular fields should
50
be prioritised. Concern regarding the continued availability of qualified personnel
is evident among the respondents. This concern is due to the lack of interest that
many young people today have in higher education in technical and life science
fields.
A few respondents brought up the risk that many Swedish inventions have
been, and will be, developed abroad instead of in Sweden. This was said to be due
to the comparatively better conditions in, for instance, the USA, concerning
availability of venture capital, a greater awareness of the potential of the area
(especially in the media, among politicians and also with the general public), and
a generally better business climate for this type of companies. Some respondents
also pointed out that the support system for SMEs and start-up companies is better
in some European countries than in Sweden. Increased seed financing, increased
support for collaboration with academia and also better functioning and better coordinated support for start-ups and SMEs were requests often mentioned. The
problem here, as always, is to strike a balance between a free market and
intervention by public authorities. It is, however, clear that the respondents to the
questionnaire believe that expanding the support system for SMEs and start-up
companies and increasing the incentives for investing in the biotech industry and
for becoming an entrepreneur would promote growth.
4.12 Biotech industry organisations
There does not exist a trade organisation specifically for biotech companies in
Sweden today. Many of the companies, however, are members of other trade
organisations such as the Swedish Association of the Pharmaceutical Industry
(LIF). Below some organisations are mentioned where biotech companies can be
found as members.
SIK Biotechnology Forum
The launch of this organisation is a very recent initiative by SIK, the Swedish
Institute for Food and Biotechnology. The organisation, which had its first
meeting in May 2000. is meant to be a forum for discussions on, for instance,
science, infrastructural conditions, possibilities and risks, rules and regulations,
and how public scepticism should be received and refuted.
The Swedish association organising R&D-active small and medium-sized
Pharmaceutical companies (IML)
The purpose of this organisation is to create a positive environment for
Swedish small and medium-sized R&D-based pharmaceutical firms, to offer the
member companies information and service, and to stimulate them to share
experience and skills. IML presently has 20 member companies which are all
active internationally.
Swedish Association of the Pharmaceutical Industry (LIF)
LIF is the trade organisation for pharmaceutical companies active in Sweden. It
has 64 member companies, which together were responsible for 94% of the sales
of pharmaceuticals in Sweden in 1999 and which have 16 700 employees in
51
Sweden. The aim of the organisation is to achieve a positive public view of the
industry and its products, to inform the public about prescription drugs and what
new drugs are available, to ensure that the medical-care sector appreciates the
value of innovative new drugs and the information and education that is given by
the industry in order to achieve cost-effective medical care, and to promote
clinical research and collaboration between academia and industry.
Association of Swedish Chemical industries (Kemikontoret)
The Association of Swedish Chemical Industries has members in the glass,
concrete, rubber, food, and pharmaceutical industries. The association wants to
activate and support the member companies in their efforts to achieve better
working conditions, to consider the environment, and to develop environmentally
sound products. The association is the body to which a proposed measure is
referred for consideration. Moreover, it represents the member companies in
contacts with the Government and government agencies regarding such matters as
rules and regulations and policy issues.
Medicon Valley Academy
The Medicon Valley Academy (MVA) has members from industry, academia
and hospitals in biotech and medical technology mainly in the Öresund region
(Lund/Malmö/Copenhagen). MVA offers collaborative and networking activities
such as workshops, seminars, and meetings and has an internet-based forum.
MVA also tries to promote the strength of the region within these fields through
marketing and lobbying.
52
5
Swedish research in life science fields
A strong science base is a prerequisite for innovations in the research and
knowledge intensive biotech industry. It can both attract prominent scientists to
public research organisations and lead to collaboration with, and establishment of,
research intensive high-tech companies. Collaboration with, for instance, the
pharmaceutical industry means external financing of research, access to advanced
equipment and increased academic awareness of industrial problems. A broad
exchange of knowledge between scientists in different countries is also an
important ingredient of the innovation system. The transfer of knowledge between
countries in the long run promotes Swedish science as well as Swedish industry.
In a previous analysis of the Swedish national innovation system aggregated
bibliometric data was used44. In relation to population size, Sweden was here
found to be one of the largest producers of scientific knowledge in the world
measured in terms of scientific publications per capita. Only Switzerland
produced more scientific knowledge per capita than Sweden both in 1986-1990
and in 1991-1995. If citations of scientific publications are used as an indicator of
the quality of scientific production, the quality of Swedish science is very high by
international comparison. Only Switzerland, the USA, and the Netherlands show
more citations per paper than Sweden. In 1997 however, Denmark also had higher
citation values than Sweden45. Universities and colleges completely dominate the
Swedish scientific output, expressed in terms of scientific publications. The rest of
the publications are evenly distributed on firms, non-academic hospitals, and other
sectors.
The Swedish publication portfolio is quite heavily geared towards life sciences,
particularly towards medical fields. In 1996 life science papers represented about
85 per cent of all papers in the higher education sector and more than two thirds of
all publications in business firms. These papers are in the majority in other sectors
as well and Sweden has a very strong position within most life science fields. This
pattern has not changed much during the last two decades. Other scientific fields
such as biology and physics & mathematics are also quite strong elements of the
Swedish science system. In technology, however, this system is much less
impressive, though the number of Swedish publications and Sweden’s share of the
universal field of technology increased during the 1990s. Admittedly, this data
was retrieved from the CD-ROM-editions of Science Citation Index, which
cover life science somewhat better than engineering.
5.1
Sweden – a large producer of life science articles
Together with Switzerland Sweden publishes the largest number of scientific
articles in the world in relation to population. The Swedish share is approximately
1.8 per cent of the worlds total publication volume. There are, however, signs that
44
Source: The Swedish National Innovation System, B 1998:9, NUTEK.
Source: Internationella jämförelser för näringslivets tillväxt – Tillväxtindikatorn, NUTEK R
2000:17
45
53
point to a reduction in quality, since the citation of Swedish articles is
decreasing46.
In the diagram below the Swedish percentage of the worlds total publication
volume within a selection of life science fields during three periods 1984 – 1998
is shown. The Swedish publication volumes had a top ranking in relation to
population in Neuroscience and Immunology. In Molecular biology & Genetics,
Microbiology, Biochemistry & Biophysics, and also in Cell & Developmental
biology, the Swedish publication volumes were second in the world after
Switzerland in relation to population and in third place after Denmark and
Switzerland in Biotechnology & Applied microbiology. There was a clear trend
towards a decreasing share of the world’s total publication volume in
Immunology, whereas the corresponding share was increasing in Biochemistry &
Biophysics.
The Swedish percentage of the world’s total publication volume within a
selection of life science fields during three periods
5.0
4.5
4.0
3.5
3.0
1984-1988
1989-1993
1994-1998
2.5
2.0
1.5
1.0
0.5
0.0
Bio
ch
e
s tr
mi
B io
5.2
te c
y&
o
hn
B
log
h
iop
y&
ysi
A
cs
lie
pp
dm
ob
ic r
ll
Ce
iolo
&D
gy
ev
p
elo
me
n
b
ta l
iolo
gy
Im
n
mu
olo
gy
Mi
Mo
b
cro
lec
u
iolo
b
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gy
iolo
gy
&
n
Ge
e ti
cs
Ne
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c
r os
ien
ce
What about the quality of the articles?
A measure of the quality of published articles is to what extent later articles are
citing them. If other scientists often refer to an article, it is a sign of large impact
and the paper is in this particular sense of high quality. In the diagram below the
relative citation levels of Swedish publications during three periods 1984-1998 are
46
Source: Olle Persson, University of Umeå, Studying National Innovation Systems Using Papers
and Patents – Methods and examples, NUTEK, Working Paper, June 2000
54
shown. A citation level of 1 means that the Swedish papers were cited as often as
the world average in that field, while a higher number indicates a larger impact.
Biotechnology & Applied microbiology was the life science field studied that
had the highest citation level for Swedish articles, even though this citation level
showed a slight decline during the three periods. Only Switzerland, the
Netherlands and Finland had higher relative impact factors in this field than
Sweden. The lowest citation levels were found for Cell & Developmental biology
and Immunology, where the Swedish articles were cited less than the world
average.
A recapitulation of the previous section on publication volumes shows that the
publication volumes in Biochemistry & Biophysics were increasing at the same
time as the citation levels were decreasing. The citation level of Neuroscience
declined, although the volume share remained at a relatively constant high level.
The largest share of the world’s publication volume was found in Immunology,
whereas Cell & Developmental biology was the only subject field with both a
relatively small volume share and a low citation level. The changes varied from
subject field to subject field. Despite more changes in citation levels being
negative than positive, there was no clear general trend regarding the quality or
quantity of Swedish articles in the studied life science subject fields during the
three periods 1984-1998.
Relative citation levels for Swedish articles within a selection of life
science fields during three periods (Index world=1)
1,80
1,60
1,40
1,20
1984-1988
1,00
1989-1993
0,80
1994-1998
0,60
0,40
0,20
0,00
y
y
y
e
gy
tics
og
og
nc
log
iol
iol
iolo
ne
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&G
nta
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Mi
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o
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i
is
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em
De
&A
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hn
c
e
t
Bio
ysi
ph
Bi o
cs
55
5.3
The Swedish science system
The use of bibliometry provides us with a dynamic picture of how the
publishing of articles by Swedish researchers in biotechnology-related fields has
developed. As mentioned in Chapter 2, we found a total number of 25 045 articles
with impact factors over five in the selected journal categories. In the following
sections, more thorough studies on the sources of the articles, impact factors, and
links between organisations through co-authorship are presented47.
The dataset covering biotechnology-related subject fields (see Chapter 2)
analysed in the present study shows the expected result that the major part of the
articles were authored by university researchers. As many as 95% of all the
articles in biotechnology-related science included at least one author from a
university or a university hospital, while firm authors contributed to 7% of them.
See Table B3, which also illustrates that the Swedish production of articles in
biotechnology-related areas peaked in 1993, but has ever since then fallen in
absolute terms. This negative development can be related to cuts in government
grants to public research organisations. As an example, Karolinska Institutet, a
large university of medicine, experienced a cut in its basic government funding by
approximately 15 per cent during a three-year period in the mid nineties.
However, we cannot exclude that the changes may have been due to differences in
coverage between the journal categories selected by ISI.
The public research organisations
A description of the publication pattern of public research organisations gives
important information about their science base and what organisations have the
highest prominence in different scientific subject fields. A strong science base is
often pointed out as being a prerequisite for innovation processes in research
intensive technologies. The publication pattern also elucidates the extent of
collaboration and interdependence between the organisations identified. This
forms a basis for the study of which firms and industrial research institutes the
organisations collaborate with.
The articles published in 1986-1997 by the companies studied were, however,
to a large extent co-authored with researchers at Swedish universities, as will be
shown further on in this chapter. A few prolific organisations in Sweden
accounted for the major part of all articles published in biotechnology-related
science (Table B4, Appendix B). Karolinska Institutet alone participated in 36 per
cent of all articles in biotechnology-related science (9 001 out of 25 045 articles).
The universities of Lund, Uppsala and Gothenburg each contributed to 13-18 per
cent of the articles. Karolinska Institutet is the only organisation focusing entirely
on medicine, whereas the other universities are active in other sciences as well.
For instance, Karolinska Institutet in 1999, had about 100 professors in life
science, whereas the Royal Institute of Technology had only three. We do not
have access to information on the number of researchers that are active in the
selected life science fields at the different universities. Comparisons between the
universities as regards performance per researcher can therefore not be made. The
47
Based on: A study of the Swedish biotechnology innovation system using bibliometry, NUTEK,
Working paper, May 2000
56
tenth and eleventh most productive organisations were the two large
pharmaceutical companies Astra and Pharmacia48.
In the figure below, the development of the publication volumes for the nine
public research organisation with more than 500 articles published in
biotechnology-related science is shown.
The number of articles published in 1986-1997 by the nine most
productive Swedish public research organisation in biotechnology-related
science*
1000
900
800
No. of publications
700
K A R O L IN S K A IN S T
L U N D U N IV
U P P S A L A U N IV
G O T H E N B U R G U N IV
S T O C K H O L M U N IV
U M E A U N IV
SLU
L IN K O P IN G U N IV
S M I*
600
500
400
300
200
100
0
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
Y ear
* SMI - The Swedish Institute for Infectious Disease Control; SLU - The Swedish
University of Agricultural Sciences
As always, it is not only quantity but also quality that counts. As mentioned in
Chapter 2, the impact factor of the journal in which an article is published can, if
it is a journal with a broad field, be an indicator of the relevance of research
performed. For journals with a narrower field the impact factor may instead be
misleading. Due to this, a large public research organisation like Karolinska
Institutet no longer uses impact factors as an indicator when distributing financial
support to its departments. An analysis of the impact factors of the journals where
scientists at Swedish universities publish their articles shows that researchers at
48
At present known as AstraZeneca and Pharmacia Corporation
57
Umeå University have had their articles published in journals with a very high
impact factor, giving the university a top ranking as regards mean impact.
Stockholm and Uppsala Universities closely follow Umeå University, and
Karolinska Institutet is found in fourth place.
Analysis of how the articles of an organisation were distributed on the selected
journal categories illustrates its scientific profile in biotechnology-related science
during a particular period. In Table B5, Appendix B, the research profiles of the
public research organisations with the largest publication volumes in 1986-97 are
given. Karolinska Institutet contributed to the largest number of publications in all
the selected journal categories with the exception of Mathematical methods,
Materials science, and Biotechnology & Applied microbiology. Gothenburg
University had a strong position in Biomaterials, and Lund University dominated
Biotechnology & Applied microbiology.
Firms and industrial research institutes
Most of the ideas leading to new innovations in biotechnology are sprung from
academic research49,50,51. These ideas, however, are developed and refined in
firms, often in collaboration with university groups, and the end product may in
many cases be very different from the original idea. It is therefore interesting to
analyse the collaboration pattern between firms and academic groups and also to
identify what firms seem to be involved in in-house basic research without
collaborating with university groups. In order to obtain information about the
scientific profile of Swedish firms, it is also important to see in what scientific
subject fields they have published the largest number of articles. This information
can be used in analysing the strengths of Swedish industry in different scientific
subject fields.
As mentioned before, the 120 firms identified on average contributed to seven
per cent of the articles in biotechnology-related life science fields during 19861997. The tenth and eleventh most productive organisations were the two large
pharmaceutical companies Astra and Pharmacia52 (Table B4, Appendix B). These
two companies authored 75 percent of all articles produced by firms. Of all the
firm articles 65 per cent were co-authored with a public research organisation.
The volume of the collaboration between firms resulting in scientific publications
was small and therefore difficult to draw any conclusions from (105 articles in
total, i.e. 6% of the articles authored by firms, and of those Astra and Pharmacia
together contributed to 25%).
The industrial research institutes that published articles in biotechnologyrelated science only contributed to 48 articles. None of these articles was coauthored with a firm and one third was co-authored with a public research
organisation. The reason for the small number of articles published by industrial
research institutes is a reflection of the fact that Sweden in general has few
49
L. Orsenigo, The Emergence of Biotechnology. Institutions and Markets in Industrial
Innovation., Pinter Publishers, London 1989.
50
A. Backlund, S. Modig, C. Sjöberg, Biotechnology and Pharmaceuticals - a literature study,
NUTEK, Working paper 1998.
51
Workshop on Innovation processes in biotechnology, NUTEK, 1999.
52
At present known as AstraZeneca and Pharmacia Corporation
58
industrial research institutes and none specialised in biotechnology53. SIK (the
Swedish Institute for Food and Biotechnology) is mainly active in the area of food
and the application of biotechnology in the food sector. It performs very little
commissioned research, mainly analytical testing, but can function as a coordinator of external research programmes. SIK has also initiated a programme
for senior researchers employed by SIK but stationed at academic institutions.
This new programme is intended to create links between industry and academic
researchers.
The amount of research (seen as published articles) performed in 1986-1997 by
firms and industrial research institutes in the various science classes followed the
production pattern of the public organisations. About 70 per cent of the research
was performed in Biochemistry & Molecular biology, Immunology, and
Neuroscience. This is not surprising since firms to a large extent collaborate with
public organisations. Table B6, Appendix B, illustrates the different research
interests of the firms identified. For instance, Astra dominated Neuroscience, and
Pharmacia had a strong position in Immunology.
By studying the organisational affiliation of the authors of an article,
collaborations between organisations can be identified. These collaborations gives
us information about knowledge exchange between different organisations, how
central the organisations are, how the pattern of collaboration has changed over
the years and how dependent organisations may be on one another.
The collaboration between public research organisations
All the eleven major public research organisations in the field of
biotechnology-related science collaborated with one another in 1986-1997.
Karolinska Institutet has the largest number of researchers in this field and, as a
consequence, had the largest number of co-authorships with the other public
research organisations54. Both Uppsala and Gothenburg had more than 1 000 coauthorships with the other organisations and Lund and Stockholm University
followed with about 800. The strongest science cluster (in terms of number of coauthorships) was the Stockholm-Uppsala area, due to the large number of coauthorships between Karolinska Institutet, Uppsala University, Stockholm
University, and SMI (the Swedish Institute for Infectious Disease Control).
Karolinska Institutet and Uppsala University had 592 co-authorships, Karolinska
Institutet and Stockholm University 461 co-authorships, and Karolinska Institutet
and SMI 465 co-authorships, whereas Karolinska Institutet and Lund University
only had 197 co-authorships55.
The collaboration pattern between the public research organisations with the
largest publication volumes in biotechnology-related science is presented in the
figure below. The thickness of the lines is proportional to the number of co53
The industrial research institutes publishing in biotechnology-related science are YKI = Swedish
Institute for Surface Chemistry, STFI = Swedish Institute for Pulp and Paper Research (Svenska
Träforsknings Institutet), IVL= Swedish Environmental Research Institute, KI= Swedish
Corrosion Institute, Trätek= Swedish Institute for Wood Technology Research.
54
Karolinska Institutet had 3 310 employees in 1998, of whom 1 741 were researchers and PhDs.
55
SMI, Stockholm University and Karolinska Institutet are located in Stockholm and Lund
University is located about 600km south of Stockholm.
59
authorships found between two organisations and the sizes of the circles are
proportional to the total publication volume of each organisation.
Co-authorship pattern between public research organisations *
* SMI - The Swedish Institute for Infectious Disease Control; SLU - The Swedish
University of Agricultural Sciences
The collaboration between firms, industrial research institutes, and public
research organisations
The question of to what extent public research organisations collaborate with
industrial companies and the dynamics of this collaboration is very interesting,
since many public efforts are directed towards increasing the knowledge exchange
between these two types of organisation. In particular, the collaboration pattern of
AstraZeneca and Pharmacia Corporation (formerly Astra and Pharmacia) is
important since these large companies dominate the private sector of the
biotechnology innovation system in Sweden.
The number of articles that the public organisations with the largest publication
volumes co-authored with firms and industrial research institutes in 1986-1997 is
displayed in Table B7, Appendix B. Karolinska Institutet had the highest number
of co-authorships with firms and industrial research institutes in absolute terms.
Relatively speaking, however, all but two of the other public organisations had
60
more collaboration with firms and industrial research institutes than Karolinska
Institutet. A striking result is that a very large part of Uppsala University’s
collaboration with firms, as manifested in co-authorships, was with Pharmacia.
The Royal Institute of Technology had, compared to the other public research
organisations, the largest share of co-authorships with firms and industrial
research institutes in relation to total publication volume (14 %). One explanation
may be that universities of technology, through their other areas of science, have a
longer tradition of working with industry, which has created a culture that
encourages researchers to direct their thinking more towards applications.
Universities that mainly focus on basic research may not have had the same
tradition. In 1996, the so-called third task of public universities was more strongly
emphasised by law. This task is an obligation for institutions of higher education
to co-operate with the surrounding society and to provide information about their
activities. Universities, regional and local governments, and also other
government agencies have now initiated a multitude of technology transfer
initiatives.
In the interviews with experts that we performed it was pointed out that there is
now a more positive attitude at the universities towards collaborating with
industry than there used to be. One reason why researchers are now more prone to
collaborate with industry is an increased need for other sources of income than
government funding. It is also often pointed out that a way of increasing
knowledge exchange between universities and industry would be to stimulate
greater mobility between these two types of organisation. The extent to which
such stimulation takes place, however, is difficult to assess by means of
bibliometry. In order to analyse mobility, studies of individuals need to be
performed.
It is interesting to note that although the number of firms involved in scientific
collaboration with public research organisations increased during 1986-1997, the
number of co-authored articles did not (Table B7, Appendix B). An important
reason is the decrease in the total number of co-authorships between Swedish
public research organisations and Astra and Pharmacia in 1994-1997 (Table B8,
Appendix B). An explanation of the increase in firms involved in scientific
collaboration leading to publications may be the emergence of many new firms in
the area of biotechnology. Many of these are university spin-offs and it is natural
for them to collaborate with public research organisations. It is also to be expected
that newly started business enterprises do not have a large enough publication
volume to compensate for the reduction caused by the decrease in the number of
co-authorships with Astra and Pharmacia. That could explain why the number of
co-authored articles did not grow in proportion to the number of firms involved.
It is difficult to determine the possible reasons for the reduction in the
publication volumes of Astra and Pharmacia. It could be due to a changed strategy
concerning publishing or to a real reduction in the two companies’ R&D activities
in Sweden. It is also possible that their collaboration with small biotech
companies was increasing at the expense of their university collaboration. That
type of collaboration would not be found in the publication statistics to the same
extent. The question whether the two organisations were increasing their in-house
capabilities at the expense of external collaboration could perhaps be addressed by
comparing the development of the publication volumes published with and
61
without external co-authors. It is, however, likely that there was much less
incitement for publishing data when only internal researchers were collaborating.
The result is that there was an increase in the number of articles co-authored by
Pharmacia and external organisations in 1990-1993 compared to the other periods.
However, in 1994-1997 the number of internal articles increased, while the
number of articles with external co-authors decreased drastically. The
corresponding result for Astra was a steady decrease in both the number of
publications and co-authorships between Astra and other organisations and in the
number of internal articles published. The reason for this can be either that the
publication of results was given a lower priority or that fewer publishable results
were being produced. As regards collaboration strategies the present company
AstraZeneca has publicly stated that it intends to increase its collaboration with
small biotechnology enterprises56.
Both companies to a large extent relied on collaborations with external
oganisations in writing scientific articles. Pharmacia had external co-authors for
65% of its published articles, and the corresponding share for Astra was 64%. An
interesting fact is that firms collaborating with Pharmacia did not collaborate with
Astra and vice versa. The figure below illustrates the Swedish collaboration
pattern of the two large pharmaceutical companies Astra and Pharmacia in
scientific publications in biotechnology-related science in 1986-1997. In Table
B8, Appendix B, the development of these organisations divided into three
periods is displayed. It must, however, be pointed out that information about
articles from non-Swedish subsidiary firms is not shown here (since we do not
have access to data on their publications).
56
Ny Teknik, Nr 51-53, 1998.
62
The collaboration pattern of Astra and Pharmacia in biotechnology-related
scientific publications 1986-1997
Table B8 shows that the two companies’ volume of co-authorship with
Swedish organisations decreased in 1994-1997 compared to earlier periods. The
decrease cannot be explained by the incompleteness of the publication volume in
1997 in our dataset (see Chapter 2), but must be a sign of some change in the
collaboration strategies of the two companies. One possible explanation would of
course be that they to an increasing extent collaborated with non-Swedish
organisations. In fact, the globalisation of pharmaceutical companies is a strong
driving force, and it is often pointed out that geographical factors need not be
taken into account as much as earlier in choosing collaboration partners. To a
larger extent than before Swedish universities compete with non-Swedish centres
of excellence if they want to collaborate with industry. It does not, however, seem
to be the case that Astra and Pharmacia collaborated more with foreign
organisations, since their international collaboration, as manifested in scientific
publications, was rather constant during the periods studied (Table B9, Appendix
B). However, in relation to the two companies’ total publication volume, which
was decreasing, the share of international collaboration was increasing. Pharmacia
had the largest increase. Its international collaboration share amounted to 43 per
cent on average in 1991-1997 compared to 34 per cent in 1986-1991. The
corresponding increase for Astra was 35 per cent compared to 29 percent.
63
5.4
International collaboration in life science research
International collaboration is very important in life science. Almost a third of
all articles within the subfield of life science studied57 with at least one Swedish
author had co-authors from other countries in 1986-199758. As regards four per
cent of the articles authors from more than two countries collaborated. The most
important collaboration partner for Sweden in biotechnology-related science is the
United States. Researchers in the two countries co-authored 3 112 published
articles in 1986-1997, which is 12 per cent of all articles with Swedish authors.
However, the countries of the European Union together had a larger proportion of
collaboration with Sweden. In an analysis of the Swedish international coauthorship pattern in general, including all scientific subject fields, the share of
international collaboration that the USA represents was decreasing. However, in
the life science subfields discussed above this was not a clear trend. The share of
collaboration with the USA was instead fairly constant, whereas there was an
increased share of collaboration with Japan, Germany, and Finland. For the other
countries in the figure below no clear trends were found.
The figure shows the Swedish collaboration with the 14 countries that had the
most intensive scientific co-authorship with Sweden. The thickness of the black
lines and the sizes of the circles are proportional to the number of co-authorships
each country had with Sweden. In Diagram B1, Appendix B, the development of
Swedish co-authorship with scientists in other countries is depicted.
57
Molecular biology, Cell & Developmental biology, Neuroscience, Immunology, Biochemistry,
Biomaterials, Biophysics, Microbiology, Biotechnology & Applied microbiology, Virology,
Medical chemistry and Mathematical methods within biology and medicine.
58
Over half (55 %) of the articles only had Swedish authors. The remaining 11 percent had
discrepancies in the identification of collaborating countries.
64
The Swedish co-authorship pattern with other countries in biotechnologyrelated science during 1986-1997 *
* Both the thickness of the black lines and the sizes of the circles indicate co-authorship
volume. The light green lines indicate collaboration between Sweden and at least two
other countries. A particular co-authorship pair is only counted once per article.
For Germany the co-authorship articles with East Germany and West Germany before
1989 have been added to the collaboration volume with Germany after 1989.
The share of internationally co-authored articles in relation to their total
publication volume varied between the organisations. Of the eleven organisations
with the largest publication volumes, SMI had the smallest share of articles only
authored by Swedes (53%), whereas Linköping University and Astra had the
largest shares of articles only authored by Swedes (74 per cent and 70 per cent,
respectively). The shares of internationally co-authored articles for the others
ranged between 59 and 65 per cent. The pattern of collaboration with individual
countries also varied between the organisations. The majority of them
collaborated most intensively with the USA, followed by Germany or Great
Britain. After these three countries the pattern differs extensively between the
organisations. For instance, Karolinska Institutet had a relatively large coauthorship volume with Italy, whereas Pharmacia and the universities of Lund and
Linköping collaborated much with Denmark.
5.5
Summary concerning scientific publications
A significant result of our analysis is the strong dominance of Karolinska
Institutet in the area of scientific publications in the studied subject fields.
Karolinska Institutet contributed to more than a third of all articles and to the
65
largest number of publications in almost all of the selected journal categories with
the exception of Mathematical methods, Materials science, and Biotechnology &
Applied microbiology.
The collaboration pattern of the public research organisations indicates a strong
science cluster in the Stockholm-Uppsala region. As regards collaboration
between firms and industrial research institutes and public research organisations,
it was found that in relation to the total publication volume of an organisation,
Karolinska Institutet had not been as active as most of the other universities. In
relation to publication volume the Royal Institute of Technology had the highest
share of firm collaboration in its articles, but Lund University also had a high
percentage of firm collaboration. Uppsala University was the university that had
the largest number of co-authorships with Pharmacia, but at the same time it had a
relatively small number of co-authorships with other firms.
In the seven per cent of all articles authored by firms the dominance of Astra
and Pharmacia is apparent. Together they contributed to 75% of these articles and
they also dominated the firm-university collaboration pattern. However, the
number of firms that co-authored articles with public research organisations was
increasing at the same time as the total number of co-authorships between the two
types of organisation was decreasing. The decrease was found to be largely due to
a decrease in co-authorships between Astra and Pharmacia and public research
organisations. It was also found, however, that the two pharmaceutical companies
had not replaced the Swedish collaboration with international collaboration, which
might have been expected.
The strong dependence on university research that the innovation processes in
biotechnology seem to have was indicated by the bibliometric data since as much
as 65 per cent of the firm articles were co-authored with a public research
organisation. A similar conclusion can also be drawn from preliminary results
when combining the bibliometric data with patenting statistics. The data shows
that one third of the companies that have been granted biotechnology-related
patents in the US patent system also have published at least one scientific
publication in biotechnology-related science and one fourth have co-authored an
article with a public research organisation.
The clearly international character of this field was apparent from the
bibliometric data with one third of the publications being co-authored with nonSwedish scientists.
The publication volumes and relative impact factors of papers published by
Swedish authors in life science fields relevant to biotechnology innovation
processes are high. Especially in Neuroscience and Immunology the publication
volumes in relation to the world’s total publication volume are large. For all the
subject fields studied in the present paper the publication volumes in relation to
the world total are larger than the Swedish average. In Biotechnology and Applied
microbiology the articles written by Swedish authors have an exceptionally high
impact factor and the value is also high in, for example, Neuroscience. In the
journal category Biochemistry & Biophysics, the relative impact factor is
decreasing, although from a rather high value. The publication volume in this
journal category is however increasing.
66
5.6
What conclusions can be drawn from the publication statistics?
Bibliometry is very useful when studying a research intensive area such as
biotechnology. It provides information about, for instance, the most prominent
organisations involved and both national and international collaboration patterns.
The publication statistics illustrate that very few organisations are responsible for
a large share of the production of published scientific results in the field of
biotechnology-related science in Sweden. It also gives insights into the
international character of biotechnology-related science.
Even if the number of internationally co-authored articles for Astra and
Pharmacia did not increase during the period studied, the internationally coauthored share of their total publication volume did, due to a decrease in this
volume. The result is not likely to have been influenced by the recent mergers
since the first merger during the period took place in 1995. It is also difficult to
draw any conclusions whether the companies gave priority to collaboration with
foreign centres of excellence. Even if the volume of international collaboration
was not increasing, it is alarming that the collaboration with Swedish
organisations was clearly decreasing.
In some science fields researchers seem to prioritise quantity before quality to
an increasing extent. This is probably due to the academic qualification system,
where the number of published articles is very important for receiving positions
and grants. Today more students are taking a doctor’s degree, but it appears
difficult to increase the number of results achieved to the same extent, especially
since there is an increasing demand for shorter education periods. Since the
requested number of publications for a PhD thesis has not decreased, it is likely
that the produced publications on average do not have the same quality as before
and therefore are not cited to the same extent.
67
6
Patenting in biotechnology and biotechnologyrelated fields
6.1
Introduction
An important part of the innovation system approach is the role of institutions.
These institutions, which function as the rules of the game, could be of a formal
kind, i.e. laws and regulations, or of an informal kind, e.g. the public opinion of
new areas, for instance GMOs. Examples of formal institutions are the regulatory
process, the role of patents, and the protection of intellectual property. Intellectual
property law is important to the biotechnology industry, but the national systems
are seldom adapted to biotechnology, as shown by, for example, the difficulty of
patenting biotechnological inventions. The fact that European patent law has not
been particularly harmonised has also hampered the development of the European
biotechnology industry. Other regulations regarding, for example, food and
pharmaceuticals, are also important for innovations. Here national authorities,
including the FDA (the Federal Drug Administration) in the USA and EMEA (the
European Medicines Evaluation Agency) are of importance.
In a study by Greis et al. (1995)59 on innovation barriers for US companies, it
was found that the highest rated barrier to commercialisation was the FDA,
followed by US patent decisions and management expertise. A study by Senker &
Sharp (1997)60 on how European companies have used co-operative alliances in
their learning process shows that a clear account of intellectual property rights is
important, as in most cases a collaboration of this kind functions as a transfer of
technology and not of proprietary knowledge.
A number of policy measures have been taken on different levels to tackle
dysfunction in the subjects identified above. Key targets are strengthening of the
science base, facilitating technology transfer, making it easier for biotech firms to
find venture capital, and developing the patent system. For example, the EU
Parliament has passed a biotechnology directive, through which the member
countries will have a set of common rules for what can be protected by
biotechnological patents.
In the following sections the rules and regulations regarding patenting in
different countries will be described. In Sections 6.3-6.7 the Swedish patenting in
in the US patenting system in biotechnology and biotechnology-related fields will
be analysed. Besides questions such as what subfields of biotechnology Swedish
inventors patent within and who owns the patents, the analysis covers
international collaboration, the dynamics of biotechnology patenting and an
international comparison of Swedish patenting.
59
Greis, N. P., Dibner, M. D., Bean, A. S. (1995) External partnering as a response to innovation
barriers and global competition in biotechnology. Research Policy 24 (4).
60
Senker, J. and Sharp, M. (1997) Organisational Learning in Cooperative Alliances: Some studies
in Biotechnology. Technology Analysis & Strategic Management 9(1), pp. 35-51.
68
6.2
Regulation - patents for biotechnological inventions61
The substance of the solitary right
The solitary right provided by a patent makes it possible for patent holders to
obtain economic return from an invention and for inventors to recoup investment
costs. A patent right is a ‘negative’ right in that the holder of a patent has the right
to exclude others from making, using, or selling the patented product or process62
during a certain period, in most countries 20 years. This means that the right to
commercial use is reserved for the patent holder. However, the granting of a
patent does not give the patentee a right to use the invention, since for various
reasons different laws and regulations may prescribe the actual use of it.63 A
patent may be licensed to others for commercial use, and cross-licensing is a
common means to control the use of biotechnological inventions.
A patent right is territorial
A patent must be applied for and granted in every country where the inventor
wants the invention to be protected against third parties. Since the solitary right is
territorial, the invention is free for commercial use in countries where no patent
has been applied for and granted, which is the reason why it is necessary to apply
for a patent in every country where protection is wanted.
Different procedural ways to apply for a patent
There is no such thing as a ‘world patent’, but it is possible to apply for patent
protection in several countries simultaneously using the same procedure by filing
under the ‘PCT-route’64 and/or the ‘EPC route.’65 Patents so granted are, however,
national patents, and the different countries’ patent laws regulate the right.
Infringement litigation, i.e. when a product or process allegedly infringes the
patent right, is always tried and judged under national patent laws in national
courts. There is always the possibility of applying on a country by country basis
under national laws.
Swedish patent law is in conformity with the EPC. In a landmark decision66 the
Swedish Supreme Court stated that Swedish courts should follow the case law
under the EPC. Therefore the Swedish patent law does not involve the difficulties
61
This section was written by Li Westerlund, Stockholm University. Her doctoral dissertation is
entitled: Biotechnological Challenges - Equivalency and Exclusions under European and U.S.
Patent Laws by LL.M Li Westerlund, Stockholm University, 2001.
62
3 § 3 Patentlagen (1967:837) – PL.
63
There are many different laws and regulations that may affect the actual use of an invention.
64
This is called an international patent application, which is filed in accordance with the PCT
system under the Patent Co-operation Treaty. A PCT application is filed with the national patent
office and makes it possible to designate the respective PCT countries in which a patent is wanted.
3rd Chapter, PL.
65
This is called a European patent application, which is filed in accordance with the EPC system
under the European Patent Convention. EPC applications must be filed with the European Patent
Office and makes it possible to designate the EPC countries in which a patent is wanted. Art. 78
EPC.
66
RÅ 1990 ref 84, NIR 1990, at 486.
69
in granting patents for biotechnological inventions that the rest of the European
countries adhering to the EPC are subject to.
Differences in costs from a market perspective
One difficulty for Europe regarded as a whole and compared to the USA are
the basic patent costs (not including litigation, which is more frequent in the
USA), i.e. administrative costs to maintain the patent and counselling costs to
patent attorneys for drawing claims, etc. There is no requirement for actual use of
a patented product or process, but a patentee must pay the application cost and the
annual fees to hold the patent. To cover the US market one patent is necessary,
while covering the European market requires several patents and therefore
amounts to higher costs, since a patent is required in every country where
protection is considered necessary.68
The right to inventions made by an employee
In Sweden researchers at universities have the right to their own inventions, i.e.
the right to apply for a patent or to publish a report. To have in mind when
publishing is that it ends every possibility of patenting that particular invention,
i.e. not even the inventor can patent it.69 This, however, depends on the actual
contractual agreements for the employment or the research project and is an
exception to the Swedish law that confers the right to an invention on the
employer and not the employee. In the USA – depending on the university in
question - the universities often have the right to inventions and their patenting.
Exhaustion of patent rights and parallel import
The first sale of a patented invention, however, exhausts the patent right as to
that particular item, and the purchased item is subsequently free for use and
reselling. The exhaustion of the patent right is decisive for the lawfulness of
parallel import. Briefly speaking, a patented product sold with the consent of the
patent holder anywhere within the EES region makes parallel import lawful in
any country belonging to that region. As regards sale of the product in countries
outside the region, the patentee still has the right to stop parallel import from such
countries to any EES country in which he holds a patent.
Procedural issues with respect to the granting of a patent
The US granting procedure is different from that of Europe in some respects.
Discussions back and forth with the examiner often precede the granting and there
is no opposition proceeding. Third parties will have to go to court in order to
challenge a granted patent. Discussions with the examiner often take place under
the European patenting practice as well. In Europe, however, a nine months term
for filing oppositions70 follows the granting of a patent. After that period, if not
68
A US inventor who wants a solitary right to the European market must of course also apply and
pay for a patent in each country, but many US inventors no doubt think that the US market is
sufficient.
69
See the novelty requirement. Observe the one-year grace period under the US patent law.
70
Any person may give notice to the European Patent Office of opposition to a granted European
patent. See further Art. 99 – 105 EPC.
70
revoked, a patent cannot be challenged under the EPC. A patent may, however,
always be challenged before national courts in accordance with their respective
patent laws.
Yet another procedural difference under the US patenting practice compared to
that of Europe is the time limit put on US examiners for examining each patent.
Within European practice there is no official time limit. Many plant and animal
patents are still pending under the EPO granting procedure because of uncertainty
regarding the law in that respect. The EC Directive on the legal protection of
biotechnological inventions71 was expected to solve certain issues.72 It it has not
done so, but the pending applications will soon be decided. Patents for many of
those inventions have already been issued in the US
The legal criteria for patentability and the substantive solitary right
Biotechnological inventions are patentable like inventions in every other
technological field. With respect to biotechnological inventions the following four
issues under patent law are of particular interest and will be described in detail
below: (I) The different fundamental patentability requirements and their
assessment for biotechnological inventions. (II) European exceptions to
patentability for certain types of biotechnological inventions (these exceptions
cannot be found under the US patent law). (III) The extent of protection provided
for biotechnological inventions and the differences between countries in
determining the legal scope of protection, which forms the basis for a decision on
infringement. (IV) The experimental use exception and the effect it may have on
research possibilities.
Patentable invention as opposed to non-patentable discovery
Only inventions may be patented, which means that they must have a technical
effect and be the solution to a technical problem. With respect to biotechnological
inventions the dividing line for patentable and not patentable subject matter is at
the point of discovery, which cannot be patented under any patent law. The notion
of discovery as interpreted in patent law may slightly differ from its ordinary
linguistic meaning. Subject matter that exists in nature and is only there to be
discovered is not patentable. However, biological material that occurs naturally
but has been isolated from its natural surroundings or has been produced by a
technical process is patentable subject matter.73
This means that biological material that has been modified in some way by man
is in spite of its existence in nature considered an invention as interpreted by
patent law. The isolated biological material derived directly from nature must,
however, have an indication of function. An example is the human ‘purified’
hormone Relaxin74 for which a patent is claimed in terms of cDNA. Biological
71
Directive 98/44/EC, 6 July 1998.
The Directive neededto be implemented to Swedish law and the Ministry of Justice was working
on that during the summer and autumn of 1999. There will be changes in Swedish law, but in the
main they will only involve clarifications of what already has been the law under the EPC, except
for the new ‘farmer’s exception’.
73
See for example, the EC Directive in its Art. 5 and the EPO Examination Guidelines CIV 2.3.
74
Opposition Division - RELAXIN - EP-B1 112 149, OJ EPO 1995, 388.
72
71
material existing in nature that has been molecularly modified to something that
has not before existed in nature may be invention. An example of such a
biotechnological invention is where a naturally occurring plant has been
genetically modified to be herbicide-resistant.75 Very briefly, the dividing line is
where man is needed to obtain the exact product and he has to overcome
biological obstacles to achieve this result.
Industrial applicability/utility
The first of the three major patentability requirements is that an invention must
have industrial applicability (European patent law) or utility (US patent law). To
meet the industrial applicability requirement within EPC law it suffices to show
that it is possible to make use of the invention in industry. It must be perceivable
that the invention can be produced in some kind of industry, either on a research
and laboratory scale in small quantities or on a production scale in large
quantities. An actual use need not additionally be shown.76
The utility requirement within US law is more strictly interpreted and requires
that the invention is shown to be operativein some practical way. In contrast to its
European counterpart, it does not suffice for the invention merely to be produced
in an industry. An actual use must be shown.77
Novelty
The second patentability requirement is that the invention is new in relation to
the state of the art, which is viewed objectively world-wide.78 In Europe the state
of the art comprises everything made available to the public by means of a written
or oral description, by making use of it, or in some other way, before the date of
filing. Under the US patent law the applicant has a grace period of one year,
which is a major practical difference compared to European patent law. This
means that a public statement in a journal or a lecture that describes the invention
in such a way that a person skilled in the art may cause it to work suffices to
destroy the patent possibilities. In Europe the critical period is before the filing
date and in the USA one year before the filing date, because of the grace period
under US patent law, which means that an invention can be made public but is
still patentable during one more year.
The meaning of novelty according to patent law differs from the way the word
would generally be understood, i.e. as something that did not exist before. The
relevant question in patent law is not whether it existed before, but whether
somebody could have known about its existence. Since DNA sequences have to
be recognised and isolated from very complex natural surroundings, they are
patentable subject matter if the inventor can indicate a method for repeatable
production and a function. The biological novelty is the reason why it is relatively
easy to have a cDNA patented. Since cDNA coding for a normal cellular protein
75
Such a plant may, however, be excluded from patentability for another reason, namely under
Art. 53(b) EPC, see below under 3. See also T 356/93, Plant Cells/PLANT GENETIC SYSTEMS,
OJ EPO 1995, 545.
76
1 § 1 PL and Art. 52 EPC.
77
The utility requirement is based upon the term ‘useful’ in 25 U.S.C. § 101.
78
2 § 1 PL; Art. 52 and 54 EPC; Section 101 of the US Patent Law.
72
is not ‘natural’, the question of novelty arises almost only with the process of
reverse transcription of mRNA, which is usually not natural and is novel for that
reason alone. Such DNA sequences lack novelty only if their earlier existence was
recognised by being made publicly available.79
Inventiveness
The third criterion for patentability is that the invention must display
inventiveness. Merely slight changes with respect to the state of the art cannot be
awarded patent protection. Whether inventiveness is displayed is decided by
looking through the eyes of a skilled person using his general knowledge. Could
the skilled person arrive at the invention without using inventive skill, the
invention is obvious and therefore not patentable.80
Inventiveness may be found in the manner in which the gene sequence or
interaction information was discovered or in the way in which a gene sequence
expressing a desirable trait is developed. It will not be sufficient if the gene
sequence responsible for an obviously desirable function is discovered merely
through the use of standard techniques. Inventiveness may also be found in the
manner in which information relating to gene sequences and interactions is used.
The particular method of using the information could thus display inventiveness,
regardless of whether the discovery of the development of the gene sequence
displayed inventiveness. As biotechnology matures, obviousness is more likely to
be found in biotechnological inventions.
Currently the claim to a DNA sequence as such requires that there exists some
difficulty in achieving a successful result. The reason is that the isolation of it is
considered standard procedure, at least under the EPC. The level of inventiveness
required differs between countries. Allegedly, the USA requires less than most
European countries with respect to this patentability requirement. In Europe the
British practice is less demanding than that of the European Patent Office.81
Exclusions from patentability under the European patent laws that do
not have their counterpart under the US patent law82
Plant and animal varieties excluded from patentability
Excluded from patent protection, even though they are inventions within the
meaning of patent law, are plant and animal varieties.83 The main purpose seems
to be the exclusion from patent protection of certain subject matter protectable
under national Plant Breeder’s Right acts, but a similar protection for animal
varieties does not exist. Plants and animals that are not considered varieties are,
however, patentable.
79
They must also have a function to be considered an invention and not a discovery. See, for
example, Opposition Division - RELAXIN - EP-B1 112 149, OJ EPO 1995, 388.
80
2 § 1 PL; Art. 52 and 56 EPC; Section 101 of the US Patent Law.
81
See for example from the EPO: T 589795, T 72/95, T 207/94.
82
This section is very briefly described in all its complexity.
83
1 § 4 PL; Art. 53(b) EPC. EC Directive Art. 4.
73
The EC Directive and the case law concerning the notion of plant variety refer
to the definition given under the act protecting a plant breeder’s right.84
Accordingly, a plant variety means a plant grouping within a single botanical
taxon85 of the lowest known rank. This grouping can be distinct, uniform, and
stable.
The exclusion from patent protectin has resulted in problematical factual
assessments and is still not entirely clear as to its interpretation, but plants and
animals found modified at a ‘higher level’ are not excluded from patentability.
For example, a patent for a mouse that had been genetically modified by the
insertion of an onco-gene to make it rapidly develop cancer was not considered a
variety and therefore found patentable.86 However, a genetically modified
herbicide-resistant plant was found not patentable because it was classified as a
variety in spite of the fact that insertion of a herbicide-resistant gene into the
genome was the same type of technical modification.87
Essentially biological processes are not patentable
Excluded from patent protection are also essentially biological processes for
the production of plant and animals.88 The dividing line for patentability has been
set by the case law89 at the point where the process is technical. The EC Directive
on biotechnological inventions defines a process as essentially biological if it
consists entirely of natural phenomena, such as crossing or selection. Processes
that include genetic engineering are patentable since they are considered technical
in nature. However, a multi-step process in which each step is purely biological
may also be patentable as a technical process if the manner in which the
sequences of the steps are put together is not merely conventional breeding or a
natural process.90
Microbiological processes and their products are patentable
The patent possibility is restored for microbiological processes, and thus they
and their products are patentable.91 As a consequence varieties produced by a
microbiological process are also patentable. The EC Directive defines a
microbiological process as any process involving, performed upon, or resulting in
microbiological material.92 This process can be described as an exception to the
exclusion.
84
The 1991 Act of the International Convention for the protection of New Varieties of Plants; EC
Regulation (EC) No 2100/94. EC Directive Art. 2.3.
85
The word ‘taxon’ is derived from ‘taxonomy’, in order to classify all the plants belonging to the
plant kingdom. Linnaeus et al. devised a system in which these taxa play an important role. In this
system every ‘higher’ taxon covers all the ‘lower’ taxa. This means that an order covers one or
more families, a family covers several genera, a genus covers species and a species, which is the
lowest taxon, covers the subject matters considered to be varieties.
86
T 19/90 Onco-mouse/HARVARD,EP-A 169 672, OJ EPO 1990, 476.
87
T 356/93, Plant Cells/PLANT GENETIC SYSTEMS, OJ EPO 1995, 545.
88
1 § 4 PL; Art. 53(b) EPC. EC Directive Art. 4 and a definition in Art. 2.2.
89
Briefly described, case law is an expression for the important cases which further define the
interpretation of different provisions and the notions therein.
90
See, for example, T 49/83 Propagating material/Ciba Geigy, OJ EPO 1984, 112; T 320/87,
Hybrid plants/Lubrizol, OJ EPO 1990, 476.
91
1 § 4 PL; Art. 53(b) EPC. EC Directive Art. 4.
92
EC Directive Art. 2.(1)(b).
74
Disclosure
Full disclosure of the invention is required
The inventor must make a full disclosure of the invention to the public and
submit a specification containing a detailed description of the invention, of its
uses and also detailed examples of how to utilise the invention within the whole
range of the claim.
According to European patent law an invention must be disclosed sufficiently
clearly and precisely for it to be carried out by a person skilled in the art.93
The US counterpart is the requirement of enablement,94 which means that an
invention must be described in such full, clear, and exact terms as to enable any
skilled person in the art to take advantage of the invention for production and
use.95
Differences in the required level of disclosure/enablement
A comprehensive analysis of the disclosure requirement under the EPC
compared to that of enablement under the US practice indicates the US
requirement is slightly more demanding, particularly because of its strict demands
for practical utility. Too broad claims, i.e. more prediction than operable methods,
risk blocking the development by way of stopping others from pursuing research.
The level of unpredictability still inherent in biotechnological research is a
problem with respect to disclosure.
A patentee’s difficulty in describing a biotechnological product in words may
in part be overcome by deposition of the biological material, so that a skilled
person on the basis of the description and this material may be able to test the
operability of the invention. For instance, the patentee may not need to give an
exact description of the structure of the biological material.
Scope of protection96
National courts decide infringement under national law.
In an infringement situation national court decides according to national laws.
Patent law is an area in which the application of the law to certain facts often
produces different outcomes in different courtrooms in substantially similar cases.
However, endeavours are made to achieve predictability and certainty for all
parties.
The British and German approaches
The extent of protection differs between countries. Endeavours towards a
harmonised European assessment have been made as regards the EPC, but still the
national courts assess and interpret the provision and tend to do so in accordance
with their respective historical way of determining the scope of protection. It is
asserted that the extent of the protection conferred by a European patent shall be
93
Art. 83 EPC.
The EPO frequently uses the enablement criterion.
95
35 U.S.C. § 112 para 1 (2).
96
As it is an extremely complex matter, this is only very briefly addressed below.
94
75
determined by the terms of the claims.97 Nevertheless it is maintained that a
description and drawings shall be used to interpret the claims. This means a
position between pure reliance on the claim language and regarding the claims
merely as a guideline to what subject matter actually falls within the protection.
The approach should combine a fair protection for the patentee with a reasonable
degree of certainty for third parties.
The references to narrow and broad scopes apply to those of the British and
German patent systems, respectively. The British practice still very much relies
on the claim language and results in a protection where the allegedly infringing
form must be read from the claim in order to constitute an infringement and all
essential elements of the claim must be included.98 The German practice, on the
other hand, results in a broader scope of protection. The German practice puts
more emphasis on the patent holder and extends the protection beyond the
language of the claims to equivalent means of expression viewed in light of the
essence of the invention including all essential elements. The extent of the scope
is measured from the date of application.99
The US approach
The issue of scope under the US patent100 law is similar to that discussed under
the European patent practice and is also divided into literal understanding of
claims and substantive infringement by the doctrine of equivalents.101 One source
of uncertainty and unpredictability in patent practice is the doctrine of
equivalents. The doctrine may be applied to provide inventors with a fair scope of
protection for their patents, but if not assessed consistently and with established
criteria it might result in the extension of the scope beyond ‘fair’ with respect to
third parties.
The intent of balance between the patentee and the public clearly supports the
US system. A comprehensive analysis102 points to the conclusion that the US
scope of protection is found to be somewhere between the British and German
scopes. All elements of a claim must be found in an allegedly infringing device
under the US practice to constitute an infringement. The range of equivalents is
measured from the date of infringement and with respect to biotechnological
inventions mainly in relation to the insubstantiality of differences of the function,
way, and result.103 This means that the protection encompasses devices that differ
97
Art. 69 EPC and its Protocol.
See for example: Catnic Components Ltd v. Hill & Smith Ltd (1982) RPC 183 (HL); Improver
Corp. v. Remington (1989) RPC 69 (CA); Kastner v. Rizla Ltd, (1995) R.P.D. & T.M. 585 (C.A.)
99
Formstein (Moulded Curbstone) Germany, OJ EPO 12/1987, 551; BGH X ZR, 17-03-1994,
Mitt. 1994, p. 181 Zerlegvorrichtung für Baumstämme.
100
35 U.S.C. § 271 (a) “Whoever without authority makes, uses or sells any patented invention,
within the United States during the term of the patent infringes the patent.”
101
The doctrine of equivalents means briefly that equivalents of what the patent claims fall within
the protection of that patent and therefore broaden the extent of that protection.
102
This analysis is included in a doctoral dissertation entitled Biotechnological Challenges Equivalency and Exclusions under European and U.S. Patent Laws by LL.M Li Westerlund,
Stockholm University.
103
Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 US 605, 85 U.S.P.Q. (BNA) 328
(1950).); Warner-Jenkinson Co. v. Hilton Davis Cem. Co., 520 U.S. 17, 41 U.S.P.Q.2D (BNA)
1865 (1997).
98
76
from the patented device but are considered equivalent to it, and the comparison is
made between those three aspects.
The experimental use exception
The use of an invention for purely experimental reasons outside any
commercial purposes does not constitute an infringement. Many biotechnological
patents are in fact used in research and contribute to and make up part of later
patented inventions. The experimental use exception is poorly analysed as to its
factual consequences for biotechnological patents. No clear boundary line
between lawful and unlawful use is perceivable from the jurisprudence.
One major difference between the European laws and the US law that affects
pharmaceutical patent holders is the Bolar exemption under the US law. The
Bolar exemption allows competitors to conduct the research necessary to obtain
approval for a competing drug from the authorities from the date of the patent
expiry. Such work would constitute an infringement in Europe.
In order to protect discoveries in biotechnology-related science that can be
exploited commercially, a patent has to be applied for. The inventor may choose
to sell the patent rights to another player before or after the patent is granted.
From a policy point of view it is of great interest to see where the results of
national research are commercially exploited.
77
6.3
Swedish patenting in the US patent system
A commonly used measure of innovativeness are patenting statistics in
different areas and for different nations. Since the USA is such a large market in
biotechnology and other areas, the US patent system was chosen for the analysis
given below of Swedish innovativeness in biotechnology-related fields. The
sections that follow describe the dynamics of Swedish patenting including a
comparison between Swedish and international patenting and some information
on who patents and who owns Swedish inventions.
In 1984-1998 the Swedish share of the world’s total patenting volume (number
of issued patents per year) in the US patent system was on average 1 per cent,
which corresponds to a fourth position in the world in relation to population104. In
Biotechnology105 Swedish inventors contributed to 0.5-1.0 per cent of the patents.
This may seem to be a modest share, considering the publishing volumes in
biotechnology-related science fields and compared to the Swedish average share.
The patenting shares were larger in Pharmaceuticals, Medical electronics and
Medical equipment (see the diagram below).
104
Internationella jämförelser för näringslivets tillväxt – tillväxtindikatorn, NUTEK, R 2000:17
The data is based on inventor fractions (i.e. if one inventor of four is Swedish, this counts as
0.25 Swedish patents). Included in the biotechnology patent class are a few IPC patentclasses
which were given as a first classification in the patent application. The following areas are
included: Instruments and methods for analysis in enzymology and microbiology, microorganisms
and enzymes and also parts of these and production of such substances, production processes and
separation techniques using fermentation or enzymes, use of gene technology when producing
medical products and gene therapy.
105
78
Swedish inventor shares of the world’s total patenting volume
during three periods in different areas compared to
the Swedish average share in all fields
3 ,0
2 ,0
1 9 8 4 -1 9 8 8
1 9 8 9 -1 9 9 3
1 9 9 4 -1 9 9 8
1 ,5
1 ,0
0 ,5
Bi
o
ed
79
re
as
la
al
ea
n
te
ch
no
l
ip
m
ic
al
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u
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ed
i
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M
A re a
M
en
t
cs
ec
t ro
ni
ar
m
ac
eu
t ic
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s
og
y
0 ,0
Ph
Per cent of the world total
2 ,5
Inventor origin for biotechnology patents
in the US patent system in 1999106
Great Britain
Germany 4%
Sweden
5%
<1%
France
4%
Canada
4%
Japan
7%
Other
8%
USA
68%
6.4
The dynamics of Swedish patenting
In patenting statistics a distinction is made between two players: the assignee
and the inventor. The patenting statistics analysed in this section are based on a
database with 11 900 patents issued in the USA in 1986-1997 and still active in
1998, with a Swedish inventor and/or assignee. The table below shows the
distribution of the patents on the categories described in Table C1, Appendix C .
In Table C2 the development of Swedish patenting in those categories in 19861997 is shown. The average time from filing a patent application until the patent
was issued was 2.4 years for the analysed 784 patents in biotechnology and
biotechnology- related fields. In many of the patent classes there were not enough
patents issued during the period to allow any conclusions regarding the
development.
106
Source: Bioteknikindustrin i USA leder utvecklingen, Nilsson, A., and Runeberg, K., Swedish
Office of Science and Technology, May 2000
80
Distribution of the 784 identified biotechnology or biotechnology-related
active patens with a Swedish inventor and/or assignee in 1986-1997
BIOTECHNOLOGY PATENTS
Class
Sub-class
Agriculture
Agricultural technique
Animal food
Process
Food technique
Functional food
Wood or pulp treatment
Bioprocess
Food
Wood, pulp or paper
Biotech supplies &
processes
Biosensors
No. of
issued
patents
7
4
11
3
3
8
6
BIOTECHNOLOGY Total
49
9
74
1
8
43
1
102
329
BIOTECHNOLOGY-RELATED
New or improved chemicals or processes
Environmental technique
Food technique
Functional food
Quality control
Wood, pulp or paper
Wood or pulp treatment
Laboratory technique
Laboratory equipment
Medical technique
Nutrient solution and plasma replacement
Contrast agents
Tissue treatment
Wound treatment
Other
Pharmaceuticals
Diagnostics
Drug delivery systems
Drugs and their preparation
BIOTECHNOLOGY-RELATED Total
TOTAL NUMBER OF ISSUED PATENTS
42
9
3
7
5
3
15
10
28
10
12
8
4
73
226
455
784
Medical technique
Pharmaceuticals
Genomics and functional genomics
Laboratory equipment
Process
Transgenic animal
Tissue treatment
Diagnostics
Drug delivery systems
Drugs and their preparation
Chemistry
Environment
Food
As expected, the largest number of patents were found in the area of
Pharmaceuticals. More pharmaceutical patents were classified as biotechnologyrelated than biotechnological according to our definition. The biotechnological
drugs identified were often vaccines. The large number of patents in Chemistry
and Biotech supplies and processes were also probably related to the
pharmaceutical or biomedical fields. Few patents were found in Agriculture,
Food, and Wood, pulp and paper.
The number of patents in biotechnology clearly increased during the 90s
compared to 1986-1991 (see Table C2). The increase was mostly found in Biotech
supplies & processes and Pharmaceuticals. For instance, 46 patents were granted
in Genomics and functional genomics during 1992-1997 compared to only 3
issued patents in 1986-1991. In Biosensors all six patents were issued in 199381
1996. It must, however, be taken into consideration that if a patent is not
commercialised within a few years, it is possible that the owner of the patent does
not continue to pay the annual fees. Then the patent is inactivated and excluded
from the USPTO database107. It is therefore necessary to be cautious as regards
the interpretation of the dynamics of the number of issued patents.
Under the heading “Biotechnology-Related” a dramatic increase took place for
Drug delivery systems and Drugs and their preparation in 1997. Also, six of the
eleven patents in Environmental technique were issued in 1997. Of the 28 patents
for Contrast agents, 17 were issued in 1996-1997.
The general trend was that the number of patents issued in the USA and related
to Sweden in the biotechnology and biotechnology- related fields increased during
1986-1997.
6.5
Who owns the patents?
The name of at least one inventor is always entered in a patent application and
also often the name of an assignee. The inventor may choose to sign over the
patent to an assignee, who will then own all rights to the patent. The assignee is
often a company, whereas the inventor is always a private person, whose
organisational affiliation is not entered. For that reason only the identity of the
assignees will be discussed below. After a patent has been granted, the USPTO
database is not updated regarding any changes in the ownership of the patents.
Therefore all discussions regarding who owns the patents are based on the
ownership at the time the patent was granted. In Table C3 the Swedish assignees
of the 784 biotechnology or biotechnology-related patents are listed and also the
development during 1986-1997.
The dominance of Astra (including Hässle and Draco) and Pharmacia
(including subsidiaries such as Pharmacia Biotech) is apparent. The two
companies together were assignees of a third of the identified patents (about 15%
each). This was especially the case in Pharmaceuticals, but Pharmacia was also a
dominant company in Biosensors, with 4 out of 6 patents, and Biotech supplies &
processes, with 15 out of 73 patents. Astra dominated in Drugs and their
preparation in the biotechnology- related patent class, with 85 out of 226 patents.
Astra was one of the companies that had a large increase in the number of
inventions with issued US patents in 1997, whereas Pharmacia had a more steady
development during 1995-1997. In general Pharmacia had more patents in
biotechnology, while Astra dominated the biotechnology- related class.
6.6
Is Sweden giving away Swedish inventions?
In this section the role of international collaboration in innovation processes is
discussed in the light of patent statistics. Studying who the inventor and the
assignee of a patent are gives an indication of whether a country is good at
keeping innovations and also of its ability to acquire innovations of foreign origin.
The extent to which co-inventors come from different countries indicates the
importance of international networks in innovation processes. It is also clear that
107
Our database is based on the patents found in the USPTO database in 1998, which might lead to
an overestimation of the number of commerciable patents in recent years.
82
it is quite often the case that an invention is not owned by an assignee from the
same country as the inventor.
The statistical result reveals the international character of biotechnology. Thus
almost a third of the 784 patents had co-inventors from more than one country.
The analysis also shows that almost 10 per cent of the 784 patents had only
foreign inventors but Swedish assignees, which can be a sign of Swedish
capability to “take home” inventions. The data also indicates that Sweden is good
at keeping Swedish inventions since about the same share of the patents were
owned by Swedes (64%) as were invented by Swedes (65%). These figures have
not, however, been compared with the corresponding figures for other fields.
Tables C4 and C5 show constellations found of collaboration between inventor
and assignee countries. These tables are summarised in the table below, where the
percentages of Swedish and non-Swedish inventors and assignees are given.
The distribution of biotechnology and biotechnology-related patents on
Swedish and foreign inventors/assignees or on co-inventors/co-assignees
from both Sweden and other countries
Not found
Swedish
Mixed
Foreign
Total
Inventor
(No. of
patents)
0
506
208
70
784
Inventor
(%)
Not found
Swedish
Mixed
Foreign
Total
0
65
27
9
100
Assignee
(No. of
patents)
93
503
16
172
784
Assignee
(%)
12
64
2
22
100
The foreign assignees that owned the largest number of patents were
companies such as British Nycomed, Danish NeuroSearch, and Novo nordisk, and
the US companies Upjohn, Biopool International, and Genentech. Some of the
patents were also owned by US universities and institutes such as the Ludwig
Institute for Cancer Research, the Scripps Research Institute, the Massachusetts
Institute of Technology, and the University of Southern California. For example
Nycomed owned 22 out of 28 patents for Contrast agents. In the case of Genomics
and functional genomics, 23 of the 49 patents (45%) had only non-Swedish
assignees, and 16 of those patents were US-owned. Two patents for Genomics and
functional genomics were co-owned by the Swedish and Japanese companies
High-tech Receptor AB108 and Sumitomo Pharmaceuticals Company, Ltd.
In 58 per cent of the biotechnology patents and in 68 per cent of the
biotechnology-related patents there were assignees only from Sweden. On the
inventor side 24 patents in biotechnology (7%) and 46 in biotechnology-related
fields (10%) had non-Swedish inventors, which means that these patents had
Swedish assignees. It thus seems as if Swedish companies were better at acquiring
biotechnology-related innovations from researchers abroad. At the same time
108
Changed name to Active AB, 1997.
83
Swedish inventors to some extent contributed to 172 patents (22%) that were
completely owned by foreign assignees.
In total, Swedes or Swedish companies owned 73 per cent of the 784 patents
and were partial owners of another 5 per cent. After being issued the patents may
of course have changed owners or been licensed to another company. It is
therefore not clear which firm or country will benefit from the innovation in the
end. An indisputable conclusion from the statistical analysis is that international
collaboration often led to new innovations since 27 per cent of the patents had coinventors from different countries.
6.7
What conclusions can be drawn from the patenting statistics?
The dominance of the two large pharmaceutical companies, Astra and
Pharmacia, among private organisations in the Swedish biotechnology innovation
system is as clear from the patenting statistics as from the publication data in
Chapter 5. Either Pharmacia or Astra owned a third of the identified patents. The
international character of the field is also seen in the patenting statistics since
almost a third of the patents had co-inventors from more than one country and
since it is often the case that the assignee is not from the same country as the
inventor. Concerning the Swedish patenting volumes, it is clear that the results
were more impressive in areas such as medical equipment, medical electronics
and pharmaceuticals than in biotechnology. A proof of the dynamics of Swedish
patenting is that the volumes were increasing in many fields in the nineties
compared to 1986-1990, for instance in genomics and functional genomics and
drugs and their preparation.
84
7
Financing of biotech research and enterprises
7.1
General university funds109
In a report by FRN (the Swedish Council for Planning and Co-ordination of
Research) it was estimated that about SEK 200 million of general university funds went
to academic groups for biotechnology research in 1995/1996110. It is very difficult to
find exact figures concerning the general university funding of biotechnology research,
since the statistics are almost exclusively distributed on different university faculties
and not on different research areas. There are, however, two exceptions, namely the
financing of biotechnology research at technical faculties and of microbiology research
at medical faculties. In Appendix D, Table D1, all different sources of funding in 1997
for these two subject fields, including general university funds, are listed.
In biotechnology at technical faculties, the Royal Institute of Technology (KTH) in
1997 received more than half of the general university funds allocated to the four
universities listed in Table D1 and almost half of the total sum of SEK 70 million. In
attracting external funding from Swedish companies, the University of Lund had the
greatest success. In microbiology at medical faculties, Karolinska Institutet received
more than four times as much general university funding as any of the other five
universities listed. Karolinska Institutet also received the most external support from
Swedish companies, even if the total amount was only slightly higher than that received
by the University of Gothenburg. Swedish companies accounted for about 20 per cent of
the funding of biotechnology research at technical faculties; in fact, the Universities of
Uppsala and Lund received more than half of their funding in this area from Swedish
companies. In contrast, the funding of microbiology by Swedish companies only
amounted to about six per cent of the total funding. The University of Gothenburg
received the largest share of its total funding from Swedish companies (16%). Within
both research areas, the general university funds accounted for approximately one third
of the total funding.
7.2
Participation in the EU 4th Framework Programme
Another source of research financing is participation in EU Framework Programmes.
These programmes also illustrates the extent of international collaboration in the EU
between different organisations. For the specific biotechnology and biomedicine
programmes under the 4th Framework Programme the budget was 552 and 336 million
ECU, respectively (SEK 4 970 and SEK 3 020 million, respectively). Below the number
of participations in projects of these specific programmes is presented.
109
Fakultetsanslag
”Kunskap på gott och ont. Översikt över bioteknologins användning, risker och möjligheter”, FRN,
1997
110
85
Number of participations per organisation in biomedicine and biotechnology
projects under the EU 4th Framework Programme
Organisation
Biomedicine
Biotechnology
54
28
LUND UNIV
32
27
UPPSALA UNIV
10
20
GOTHENBURG UNIV
29
11
STOCKHOLM UNIV
5
11
UMEA UNIV
3
4
SLU
5
13
KAROLINSKA INST
LINKOPING UNIV
5
0
CHALMERS
2
0
KTH
Programme share of total
Swedish participation
3
9
25%
11%
The table shows that the projects in biomedicine and biotechnology accounted for a
very large share of the total Swedish participation in the 4th Framework Programme.
The number of participations seems related to the publication volumes, with Karolinska
Institute at the top followed by Lund University (including the Lund Institute of
Technology). Gothenburg, however, had a very large number of participations in
relation to its publication volume in the selected journal categories (see section 5.3).
7.3
Public research councils and foundations, NUTEK and FOA
A recent EU report included a comparison between 17 European countries as regards
their public financing of biotechnology research (excluding general university funds)111.
According to the report, the Swedish system of funding of research has three special
features. Firstly, the system is pluralistic with a large number of players, including
charities that contribute considerably to the total funding. Secondly, the system is more
focused on science than on technology, and the EU report finds that the linkages
between science and technology policy are weak at the national level. Finally, the
administration of support is performed with a ”bottom-up” approach, to a large extent
relying on open calls for proposals. With the exception of the Swedish National Board
for Industrial and Technical Development (NUTEK), there have been few attempts at a
national biotechnology policy or co-ordination of funding. Funding is to a great extent
oriented to the public sector, mainly the universities, as there are no large institutes in
the area of biotechnology. Funding for industrial research is limited, and only allocated
by NUTEK and the Swedish Council for Forestry and Agricultural Research (SJFR).
111
Inventory of Public Biotechnology R&D Programmes in Europe, Vol 3 National Reports, DG
Research EUR 18886/3, 1999.
86
Research Councils
The main roles of the research councils are to finance high quality research at
research institutions in Sweden and to manage the Swedish contribution to international
organisations performing basic research. A very large part of the funding for Swedish
organisations goes to universities, mainly as research grants.
The main financing body for biomedical research is the Swedish Medical Research
Council (MFR). Its long-term goal is to support R&D that leads to the prevention,
diagnosis, and treatment of diseases. The other research councils also fund
biotechnology to some extent. The Swedish Natural Science Research Council (NFR),
funds, for example, basic research in physics, chemistry, and biology, including
biotechnology. The Swedish Research Council for Engineering Sciences (TFR) gives
support to basic engineering research in 15 areas, one of them being biotechnology.
Compared to NFR, TFR puts more emphasis on engineering and technical topics, while
NFR is more concentrated on basic research. The sectoral funding organisation, the
Swedish Council for Forestry and Agricultural Research (SJFR) supports basic and
applied research that promotes sustainable use of biological natural resources, especially
in forestry and agriculture. Industrial involvement is limited in the research councils,
though each board has at least one industrial member. The Swedish Council for Forestry
and Agricultural Research has no industrial representation.
Research Foundations
The seven national research foundations were created when the Swedish wage-earner
funds were dissolved in 1994. The foundations support strategic research within various
areas. They are private foundations and were initially put out of reach of governmental
control. The law governing the foundations has since been changed, so that the
Government now appoints their board members and chairman.
The Swedish Foundation for Strategic Research, SSF
The Swedish Foundation for Strategic Research (SSF) is the largest of the new
research foundations. It was granted SEK 6 billion by the Government in 1994. Its focus
is support for basic and applied research within natural sciences, technology, and
medicine. SSF is more oriented towards industrial applications of research than the
research councils, since its research areas should be of strategic importance to Sweden.
One of SSF’s prioritised areas is life science. Its aim is to establish ”centres of scientific
excellence” and to promote interdisciplinary work and co-operation between academia
and industry. SSF receives proposals for new research programmes from universities
and research institutes. The working groups, in which both academia and industry are
represented, may also contact research groups and suggest that they submit proposals
for research in specific fields.
In 1999, SSF had some 17 biotechnology-related programmes, e.g.in the areas of
medicine, bioinformatics, and plant and forest biotechnology. SSF has created
multidisciplinary research centres, national thematic networks, and local graduate
schools. There are six local biomedical graduate schools (in Gothenburg, Linköping,
87
Lund, Stockholm, Umeå, and Uppsala) and one graduate school for forest and plant
biotechnology. The biomedical graduate schools consist of a preparatory year. During
the year, the students attend general scientific and subject-specific courses, interspersed
with shorther courses. The students are given the possibility of performing their studies
at a company. After this first year, the students apply for admission to regular graduate
education. About half of the students are expected to complete their graduate education
within one of SSF’s network programmes.
The Foundation for Knowledge and Competence Development, KK-stiftelsen
In 1994 the Government granted the Foundation for Knowledge and Competence
Development SEK 3.6 billion, which today amounts to SEK 7 billion. The Foundation
only to a little extent supports biotechnology research. It gives support, however, to
biotechnology activities at the Swedish Institute for Food and Biotechnology (SIK). At
the end of 1999, the Foundation allocated SEK 60 million to a consortium that will
provide education and expertise in some areas tailored to SMEs working at
biotechnology and food, namely functional food, process technology, product safety,
microbiology, and protein chemistry. The Swedish University of Agricultural Sciences
(SLU) and SIK were commissioned to form the consortia, which will also include
Kalmar University College, Lund University, and Umeå University. Furthermore, the
Foundation funds by 50 per cent a PhD programme called Biotechnology with an
Industrial Focus, based at the Centre for Medical Innovations (CMI) at Karolinska
Institutet. The rest of the financing comes from sponsoring companies. The programme
aims to provide research training in biotechnology for graduate students in a way that
prepares them for an industrial career. Industry is represented on the programme board,
which decides content, organisation, and financing.
The Foundation for Strategic Environmental Research, MISTRA
In 1994 the Government granted the Foundation for Strategic Environmental
Research (MISTRA) SEK 2.5 billion, which today amounts to SEK 4.5 billion.
MISTRA supports two biotechnology research programmes, which are based at SLU
and concern insect biology, pest management, and the use of micro-organisms to
protect plants from fungi. Research into bioremediation by means of fungi and microorganisms at Lund university is another programme which has received funding from
MISTRA.
88
Biotechnology-related programmes that are supported by MISTRA
Period 1
Period 2
Total
(MSEK)
(MSEK)
(MSEK)
Insect biology and pest
management
12 (1996-1999)
25 (2000-2002)
37
Fungi management
23 (1996-1999)
42 (2000-2003)
65
Bioremediation
15 (1997-1999)
24 (1999-2002)
39
Programme area
The Swedish National Board for Industrial and Technical Development, NUTEK
The Swedish National Board for Industrial and Technical Development (NUTEK) is
the major governmental sponsor of technological research and industrial development,
if the funds that NUTEK allocates to research at universities, industrial research
institutes, and competence centres are added together. In 1999 NUTEK had two major
programmes in biotechnology: the bioprocess technology programme and the
biomedical co-operation programme. These were run with the help of steering groups
with representatives from industry and academia.
NUTEK has established 28 competence centres at Swedish universities. These are
academic research environments in which industry can take an active part. The aim is
competence building in industrially relevant research areas and knowledge transfer from
academia to industry. Funding comes from NUTEK, industry, and the universities
involved. There are three centres related to biotechnology. Their research areas are
bioprocess technology, bioseparation, and biosensor technology. In addition, NUTEK
gives support to the Swedish Institute for Food and Biotechnology (SIK).
The Swedish Defence Research Institute, FOA
The Swedish Defence Research Institute (FOA) has one department for biomedicine
and one for microbiology. Their work in these areas is related to weapons and defence
systems.
7.4
Financing of biotechnology research in figures
In the table below the findings of the EU report on financing of biotechnology
research in Europe are summarised. General university funds are not included112.
112 Inventory of Public Biotechnology R&D Programmes in Europe, Vol 3 National Reports, DG Research
EUR 18886/3, 1999.
89
Financing of biotechnology research *
Organisation
(share of
biotech) **
1995/1996
(12 months,
MECU)
1997
(MECU)
1998
(MECU)
Average
funding per
year
(MECU) ***
9 (15%)
10 (16%)
2 (4%)
2 (3%)
3 (6%)
NFR (46%)
8.8
9.6
X
MFR (48%)
9.25
X
X
TFR (4%)
3.8
1.9
2.5
FRN (4%)
1.9
X
X
SJFR (6%)
X
3.3
X
NUTEK:
Technical R&D
5.5
4.2
4.2
SIK
0.1
0.2
0.2
Competence
0.9
0.9
1.7
centres
Industrial
0.9
0.6
0.6
research
NUTEK total
7.4
6.0
6.7
7 (11%)
(12%)
SSF (11%)
5.5
11.7
13.1
12 (20%)
MISTRA (1%)
X
0.4
X
0 (1%)
Cancer Society
3.1
X
X
3 (5%)
(6%)
Heart and Lung
Foundation
0.8
X
X
1 (1%)
(1%)
Wallenberg
Foundation
X
10.5
X
11 (18%)
(19%)
Total
40.6
43.4
22.3
60
* X means that the funding for that year is not known.
** In parentheses the biotechnology share of the organisation’s total funding is shown.
Biotechnology research includes micro-, cell-, and molecular biology, genetics and also
research concerning infectious diseases.
*** In parentheses the share of the total annual funding of biotechnology research is given (i.e.
of 59.8 MECU)
The most striking result of this survey of funding bodies is the great importance of
the new research foundations based on assets from the wage-earner funds. For instance,
SSF is today the largest financial contributor to biotechnology research in the funding
system. After the foundations were established, there were cuts in the amount of money
distributed by the public research councils and NUTEK. Part of what was previously
funded by NUTEK is today financed by the foundations (e.g. part of the industrial
research institutes and the materials consortia). The changes have caused especially
scientists at the universities to fear that less funding will be given to curiosity-driven
basic research initiated by scientists than to more applied research deemed to be
strategically important. Programmes initiated by scientists must also be of strategic
importance to Sweden in order to receive funding from SSF. It is likely that a shift from
basic to applied research has actually taken place to some extent, but what this will
mean for biotechnology research and the biotechnology innovation system will not be
addressed in the present study.
90
7.5
Financing of innovations and the formation of new companies 113
If a university scientist has a commerciable idea and does not publish it (in the public
domain), there are three principal ways for the innovation process to leave academia and
be continued in commercial activities. Firstly, an established company can buy the
results or acquire access to the results through licensing. Usually the researcher will in
this case stay at the academic institution and may co-operate with the company.
Secondly, the academic researcher may start a development company whose sole
purpose is to own the intellectual property right to the research results. This right can
then be licensed to other companies. Thirdly, the researcher may opt to start a new
company commercialising the idea. Small biotech companies introduce a large variety
of innovative activities into the biotechnology innovation system. They have therefore
become important for instance when the large pharmaceutical companies have tended to
concentrate on fewer projects. However, the supply of seed financing and venture
capital (VC) is a determining factor for the start-up of new biotech companies.
What distinguishes VC companies from banks, customers and other possible
providers of financing is the active support in the form of expertise they give to the
companies in which they invest [1, 2]. The expertise can be related to technology,
products, market, management, and networking. This aspect makes the VC industry
especially interesting for this study, since biotechnology is a high-tech area and many
new biotechnology companies are founded by people with little experience of
management and market issues. Venture capital combined with competent counselling
and advice is especially important in R&D intensive areas like biotechnology, since the
value of the portfolio company is to a large extent based on immaterial assets, and hence
its future potential is more difficult to assess [1]. We have therefore chosen to study the
VC industry and its involvement in the biotechnology area.
We have also studied the public start-up and seed financing of biotechnology
companies, because it provides financing in the early stages of an innovation process.
VC companies have been less prone to accept the high risks of such early investments.
If a venture capital company invests in the very early stages of a biotech company’s
development, it often demands a substantial return in terms of ownership shares. In
other areas than biotechnology and perhaps more often in other countries, so-called
business angels, i.e. individuals who invest their own money, may play an important
part in early stages. As yet this appears not to be the case in the biotechnology area in
Sweden.
Development of the Swedish VC industry
The Swedish VC industry is one of the largest in the OECD in relation to population
[2]. In the first half of 1999 there were at least 93 VC companies in Sweden. This figure
is taken from the report “Nya förvärv och fusioner” (New take-overs and mergers) [3],
which contains to our knowledge the most extensive collection of data on Swedish VC
companies and their investments. There are, however, Swedish VC companies that are
not listed in this publication, and the figure should be seen as approximate.
113
The refereces are found at the end of section 7.5
91
The strong position in the number of VC companies is newly won; in fact more than
half of them were founded in the late 1990s [2]. In the first half of 1999 the 93 VC
companies listed in “Nya förvärv och fusioner” made 127 new investments and only 34
withdrawals - a reflection of the fact that a large number of new VC companies are in a
process of building up their investment portfolios. Many of the new companies have so
far invested only a small share of their capital [4].
The initial development of the VC industry in Sweden took place through direct
government participation in the market [2]. In the late 70s and early 80s central and
regional government established VC companies. Today most VC companies are private,
but there are still a number of VC companies that were founded by the Government.
The Swedish VC industry is in a process of diversification, partly driven by
increased competition. Many companies today direct their investments to an industry
sector, a region or a specific stage of a company development process [5]. There is,
however, still a lack of expertise in the VC industry, hampering its capability to support
the companies invested in [2]. Isaksson points out that the VC industry mainly gives
advice concerning financial issues. Less than every fifth company in his study was of
the opinion that the VC industry supplies other important competencies, e.g. regarding
company strategy or help with contacts and networking [6].
An important aspect of the VC industry is in what stage of the company start-up
process it invests. Braunerhjelm uses a description based on four stages: seed stage,
early growth, expansion, and maturity [1]. According to his study, around 5 % of the
number of investments in 1998 were made in the seed stage and 35 % in the early
growth stage. The average investment size was SEK 2 million in the seed stage and
SEK 90 million in the maturity stage. These averages are misleading in that they hide a
large variation; nevertheless they indicate that the late-stage investments were larger. A
smaller share of the investments, measured in financial terms, thus went to the earlier
stages. Only 0.1 % of the invested capital went to the seed stage and 2.9 % to the early
growth stage, according to Braunerhjelm. Considering that many VC companies have
invested only a small share of their total capital, the funds aimed at investments in early
stages could be higher. Karaömerlioglu and Jacobsson, in discussing this point,
maintain that 12 % of VC funds are aimed at the early stages. Isaksson also claims that
there is a trend towards higher investments in early stages [6].
Biotech VC investments
According to the data in the report “Nya förvärv och fusioner”, 12 % of the number
of investments made by Swedish VC companies were investments in biotechnology
companies (according to our definition). An indicator that the trend is at least not
decreasing is that approximately the same share (11 %) of all new investments was
made in biotechnology companies114.
28 out of the 93 VC companies listed in the report (30 %) were investing in
biotechnology companies (according to our definition). As can be seen in Table D2,
114
There were 14 new biotechnology investments and only one biotechnology withdrawal.
92
Appendix D, there were only two VC companies that whole-heartedly specialised in
biotechnology and totalled more than one or two investments: Health Cap and Ryda
Bruk. An example of a company that invests in Biotech companies but is missing in
Table D2 is Biolin Medical AB, which during the spring of 2000 had three out of five
investments in biotech.
A number of new large VC organisations focusing on the health area are presently
being established, e.g.the private organisations Medicon Valley Capital (about SEK 400
million) in the Öresund region115 and the Karolinska Investment Fund [7] (SEK 500
million). The establishment of these new organisations will no doubt strongly increase
the available VC for biotechnology companies in Sweden. The capital invested in
Swedish biotech by foreign players also seems to be increasing [8]. VC companies such
as British 3i and Norwegian Industrifinans Ventures are opening offices in Sweden.
Other companies that are expected to increase investments in Sweden are Dubai-based
Damac Group, Norwegian The Growth Factory and Apax Partners.
Public early-stage financing
NUTEK is the organisation that is to the greatest extent involved in the very early
stages of development projects and in companies based on high-tech innovative ideas
[9]. The Swedish Industrial Development Fund (SIDF) is also involved in financing
development projects, mostly in more mature stages. Moreover, an increasing number
of organisations active in this field work close to the universities and university
colleges. In this report we will describe NUTEK and SIDF.
NUTEK
NUTEK provides start-up and seed-financing services including information, advice,
brokerage, and R&D support. The maximum financing is 50 % of the development
costs. The financial support is given in the form of grants and soft, conditional loans
that are paid back when the company shows a profit. The services target technologybased companies in general, and some of these are biotechnology companies. In
Appendix D, Table D3, the companies that received financing from NUTEK in 19971999 are listed. From the table below it is clear that the share of NUTEK support that
went to biotechnology during these years showed an increase.
Total seed financing decided by NUTEK and
approximate biotech share in 1997-1999, MSEK
Grants
Loans
Total
(biotech share)
(biotech share)
(biotech share)
1997
4.6 (4%)
45.9 (3 %)
50.5 (3 %)
1998
2.5 (4 %)
58.3 (5 %)
60.7 (5 %)
1999
5.1 (10%)
68.4 (13 %)
73.5 (13 %)
Sources: NUTEK annual reports, administrative registers, and programme managers
115
The region comprises parts of Sweden and of Denmark.
93
The Swedish Industrial Development Fund [10, 11].
The Swedish Industrial Development Fund (SIDF) provides financing of industrial
development and market projects, usually at least SEK 4 million per project, and equity
capital to small and medium-sized firms. When SIDF steps in as a part owner, the share
should be at least 10 per cent. SIDF is also a majority or part owner of six VC
companies. In 1999 SIDF was a part owner of 23 portfolio companies, three of which
(13%) were biotechnology companies. SIDF focuses its project financing on four
business areas, one of which is medicine and biotechnology. In 1999 SIDF was
financing projects in 64 companies, 26 of which (41%) were biotechnology companies
according to our definition.
References to section 7.5
[1]
Pontus Braunerhjelm,Venture capital, mångfald och tillväxt, Ekonomisk Debatt
no. 4, 1999
[2]
Karaömerlioglu and Jacobsson, The Swedish venture capital industry – an infant,
adolescent or grown-up? Chalmers University of Technology, 1999
[3]
Magnus Heinstedt, Nya förvärv och fusioner, Förvärv och fusioner förlag, 1999
[4]
Riskkapital, en tillväxtbransch, InnovationsFokus no. 4, 1999
[5]
Magnus Heinstedt, 100 miljarder till nya bolag, Finanstidningen, Feb. 15, 2000
[6]
Anders Isaksson, Effekter av venture capital i Sverige, NUTEK, 1999
[7]
Press release from Karolinska Institutet, 1999
[8]
Dagens Industri, Aug. 16, 2000
[9]
Guide för innovationer & industriell utveckling, NUTEK and others,1999
[10] Kompetent kapital, The Swedish Industrial Development Fund, 1999
[11] Årsredovisning 98/99 (Annual Report 98/99), The Swedish Industrial
Development Fund, 1999
94
8
Promoting growth within Swedish biotech: initiatives,
players, and government agencies
8.1
Initiatives promoting enterprise
As was described in section 5.3, the Swedish universities completely dominate the
research that leads to scientific publications in life science fields that are of special
relevance to biotechnology innovations. In 1996, the so-called third task of public
universities was more strongly emphasised by law in the Higher Education Act. This
task makes it an obligation for institutions of higher education to co-operate with the
surrounding society and to provide information about their own activities. Since the
introduction of the third task, a large number of different co-operation and information
organisations attached to the Swedish universities have appeared. There is today an
increasing interest in supporting the commercialisation of results from academic
research and in initiating new enterprises in research-intensive areas such as
biotechnology. Through different initiatives, often linked to the universities, scientists
and start-up companies can get advice on patenting, licensing, laws and regulations,
business plans, etc. Below a few of these initiatives are described. In addition, local
governments, county councils, etc., take initiatives with similar content. Very few,
however, are specifically aimed at biotechnology.
Science and technology parks
The majority of the Swedish science and technology parks are linked to universities
and organised in the Swedepark association116. They offer a supportive environment for
the establishment of new firms, product development, and co-operation between firms
and universities. There are mainly two types of firms in the parks: spin-offs, started by
one or more researchers, and R&D-intensive firms, located in the parks in order to have
access to new knowledge and highly educated personnel. Often university holding
companies for commercialisation of research results are located in the parks and also
consultancies on patenting, business plans, etc. An investigation performed by
Linköping University shows that companies located in these parks have a tendency to
grow faster than other companies in the same business.
The ”tenants” of the park premises are offered various services, depending on their
needs. Services directed to new enterprises are important, such as:
•
advice on patenting
•
legal advice
•
financial support
•
information
116
http://www.swedepark.se/
95
Some science and technology parks are focused more or less on biotechnology, e.g.
Uppsala Science Park and Novum Research Park in Stockholm. In Gothenburg,
Sahlgrenska BioMedicinska Innovationscentrum AB has activities in the area. A number
of biotechnology firms are located at Uminova in Umeå, and in Linköping both
Mjärdevi Science Park and Berzelius Science Park have medical technology as one of
their focused areas. About 40 life science companies are located at Ideon in Lund, and
approximately 20 of these are engaged in biotechnology. At present approximately 500
companies have been established in the Swedish science and technology parks.
Technology link foundations
In Sweden, there are seven technology link foundations117. They were founded in
1994 and are financed until 2007. Their mission is to increase co-operation between
industry and universities in order to stimulate development, above all in SMEs. They
strive to facilitate patenting, establishment of spin-offs, licensing, commercialisation of
academic research results, firms’ and individual innovators’ search for knowledge at the
universities, and increased transfer of knowledge between the universities and SMEs.
They support, for instance, early-stage projects by means of scholarships, grants, loans,
or seed financing, and also provide time-limited aid in acute development-phase
situations, and they assist collaborative projects between university groups and SMEs.
The Technology Link Foundation in Umeå has, for instance, financed the establishment
of a company, Swe Tree Genomics AB, the purpose being that it should take advantage
of the commercial value of the world-leading research in plant genomics that is
performed at the Swedish University of Agricultural Sciences (SLU), the University of
Umeå, and the Royal Institute of Technology.
Technopoles
Sweden has nine different technopoles through which innovators can come into
contact with financiers, other technology-based companies, scientists, mentors, etc. The
technopoles, in collaboration with, for example, NUTEK, focus on new technologybased businesses and on researchers who want to have their ideas developed into
products.
Connect
The Connect initiative is based on an idea from the University of California in San
Diego. The purpose of Connect is to link entrepreneurs to the financial, technical, and
voluntary managerial resources that are necessary to create and develop high-growth
firms in Sweden for exploitation of inventions and research results. Players involved are
researchers/innovators, entrepreneurs, venture capitalists and private investors, service
companies, large companies, and organisations. A group within the Royal Swedish
Academy of Engineering Sciences (IVA) acts as a network resource. There are regional
activities adaped to each region’s needs and capabilities to develop high-growth firms.
117
http://www.teknikbroarna.com/
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Connect activities include so-called springboards, a financial forum, a strategic
partnership forum, and seminars and courses. In the springboard activity, entrepreneurs
are helped to develop their business strategy, improve their business plan, and prepare
for contacts with investors. Experienced persons, e.g. management consultants and
venture capitalists, act as sounding boards. In the financial forum, new firms looking for
financing can meet Swedish and international venture capitalists and also
representatives of professional service companies. The strategic partnership forum gives
small firms an opportunity to present themselves to Swedish and international
companies in the same, or a similar, line of business. As in the case of the financial
forum, the firms are given help to prepare for these meetings. Finally, in the seminars
and courses, experts elucidate topical issues.
Biotechnology was the theme of a meeting held in Gothenburg with representatives
from Connect West, Connect Sweden, and biotech/biomedicine specialists. It was
decided to arrange a biomedical partnership forum in Gothenburg in November 2000.
Education in entrepreneurship
In Sweden, as in many other countries, an obstacle to the commercialisation of
research results is often claimed to be that academic researchers are seldom the best
entrepreneurs. Many universities today give undergraduate and graduate courses in
entrepreneurship. These courses vary in length and content at the different universities,
but they often include such topics as how to write a business plan, corporate
intelligence, financing and economics for newly started businesses, leadership,
negotiating tactics, rules and regulations, patenting, etc. Examples of initiatives are the
Stockholm School of Entrepreneurship (SSES), in which the Stockholm School of
Economics (SSE), the Royal Institute of Technology (KTH), and Karolinska Institutet
(KI) collaborate, the SMIL Entrepreneurship School at Linköping University, initiated
by the Centre for Innovation and Entrepreneurship (CIE), the all-year programme
offered by Chalmers School of Entrepreneurship (CE), and the courses and seminars
arranged by the Centre for Entrepreneurship and Business Development in Uppsala
(CEF).
8.2
Industrial research institutes
The Swedish Institute for Food and Biotechnology (SIK)
Sweden has few industrial research institutes, and no institute is specifically aimed at
biotechnology. SIK (the Swedish Institute for Food and Biotechnology) was founded in
1996, when the Biotechnology Research Foundation (SBF) merged with the Institute for
Food Research. About 120 companies belong to the SIK Members' Association, which
holds 70 per cent of SIK's shares. In 1998, the total turnover was approximately SEK 95
million. One third of the turnover comes from public resources and two thirds from
industry, mainly as commissions, but also as membership fees. SIK is mainly engaged
in the area of food, but the former activities of SBF are continued in a business area
dedicated to biotechnology. In this area, SIK works on biotechnological problems and
the application of biotechnology, primarily in the food sector. The ambition is to
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increase the biotechnology activities, and an example of this is the recently started
Biotech Forum described in section 4.11.
SIK’s biotech activities are designed in accordance with the results of a study based
on interviews with former SBF member companies, some SIK member companies, and
a number of research-funding organisations. In the interviews, performed in 1997, the
dissemination of information was given the highest priority by a large majority of the
companies. The companies said that functioning as a node in Swedish/Nordic
biotechnology was one of SIK’s most important functions. The companies were also
highly interested in courses, seminars, symposia, and newsletters. Furthermore, the
study showed that the Institute has a role in the management of projects. For example,
there was an interest in using SIK as a co-ordinator of external research and
collaboration programmes. The companies were also positive to the creation of
positions where senior researchers are shared between SIK and a university (described
below).
Regarding the question whether SIK should conduct its own research, it was clear
that neither the companies nor the research-funding organisations wanted SIK to build
up competence for pre-competitive research. The arguments against this were related to
financing, competition with academic research, difficulties in choosing research areas,
etc. As regards applied industrial research, the picture was less clear. It was not
recommended that the Institute should build a research laboratory of its own. The
companies’ own high level of technological expertise can probably explain their lack of
interest. However, there was a certain interest in a laboratory for standardised routine
analyses of the type performed by commercial laboratories.
Influenced by the member companies’ wishes, SIK offers the following services and
activities:
•
Knowledge transfer via personal or computer networks. For example, there are
formal thematic networks in the areas of biomolecular recognition (BioRecNet),
bioremediation (NordSoil), and food allergy. There are also regional networks in
Lund, Uppsala, and Umeå. One person is employed at SIK to handle the
administration of the networks. There is also a discussion group on GMOs in food
handling. One goal of these activities is that companies should meet.
•
Co-ordination of external research programmes. SIK can function as a co-ordinator
of research programmes, current examples being programmes in the areas of
biomolecular recognition, allergy, and the use of enzymes. One person has special
competence regarding the EU Framework Programmes, where SIK may provide
assistance in writing applications and handling the administrative co-ordination.
•
Information. Publication of periodical newsletters, arrangement of courses,
symposia, conferences, etc. SIK also represents Sweden in EuropaBio.
•
Internal research projects. SIK runs a programme for senior researchers, described
more closely below.
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•
Commissions. So far, the amount of commissioned work has been limited, as SIK is
building up this service. Today only analytical testing is performed.
•
Pilot studies
SIK has initiated a programme for senior researchers employed by SIK but stationed
at academic institutions. The programme is intended to create links between the
biotechnology/food industry and academic researchers. These researchers devote half
their time to SIK’s customers as consultants, educators, and project co-ordinators. The
other half of their time is devoted to research at prominent research institutions.
Currently, three researchers are employed in areas such as analytical biotechnology and
immunotechnology/allergy. This arrangement gives industry access to new knowledge
through an established channel, i.e. SIK. The research institutions in their turn get more
contacts with industry, which increases the diffusion of research results and allows an
influx of ideas for industrially relevant research. SIK, finally, broadens its knowledge
base and is thus able to provide new and more comprehensive services to its industrial
members.
Since 1995, SIK has had a business area for the development of SMEs engaged in
food and biotechnology. The objective is to increase their competence and to improve
their competitiveness. The target group are enterprises with less than 250 employees.
The goal is that eventually these SMEs will find it natural to turn to SIK for help with
development and problem solving. If possible, they should take an active part in the
activities.
Other industrial research institutes with biotechnology activities
Some of the other industrial research institutes work in the area of biotechnology, but
it is not their main field of research. The leading institutes in this group are the Swedish
Pulp and Paper Research Institute (STFI), the Institute for Surface Chemistry (YKI), the
Swedish Institute of Agricultural Engineering (JTI), and the Swedish Environmental
Research Institute (IVL).
Their functions are in general:
•
basic research programmes
•
industrial research programmes
•
contract research
•
equipment facilities, such as analysis and testing equipment
•
courses and meetings
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8.3
Public organisations important to the innovation system
The Swedish Institute for Infectious Disease Control, SMI
Besides being an important performer of scientific research (see section 5.3), the
Swedish Institute for Infectious Disease Control (SMI) is an expert agency with the
mission of protecting the Swedish population from communicable diseases118. An
important part of communicable disease control is the surveillance based on the
statutory notifications of certain infectious diseases according to the Communicable
Disease Act. The analysis of data on clinically notified diseases, in combination with
parallel reporting from the clinical microbiology laboratories on isolated microbes,
provides a good overview of the epidemiological situation in the country.
The research of the SMI is financed both by the Government and through external
grants. The activities financed by the Government are largely applied research, mainly
development of new methods and techniques that are of relevance to the other activities
of the Institute. The externally financed research is vital in order to keep the
communicable disease control activities at a high scientific level.
The National Veterinary Institute, SVA
The National Veterinary Institute, SVA, is a government organisation which
promotes animal health by preventing, diagnosing and controlling infectious diseases
among animals119. SVA also works at the preservation of human health and the
environment. SVA´s main public responsibilities are monitoring and diagnosing
infectious animal diseases. Apart from the public obligations, the Institute’s role as a
consultancy increases.
SVA spends about one fourth of its budget on R&D. Other financial sources are the
EU Framework Programmes, the Swedish research councils, the Federation of Swedish
Farmers,and several other bodies. SVA’s research is devoted to veterinary medicine and
the diagnostics of animal diseases.
Through SVANOVA Biotech, SVA develops and sells diagnostics kits for use in
veterinary medicine. SVANOVA also provides technical support and advice.
The Swedish National Food Administration, SLV
The National Food Administration, a government agency under the Ministry of
Agriculture, is the central administrative authority for matters concerning food. In the
interests of the consumers, the Administration is working towards three goals: safe
foods of good quality, fair practices in the food trade, and healthy eating habits. The
organisation consists of five departments, which are responsible for, respectively,
research and development, regulations, control, information and nutrition, and
administration.
118
119
http://www.smittskyddsinstitutet.se
http://www.sva.se/
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The Swedish Medical Products Agency
The Swedish Medical Products Agency is a government agency under the Ministry
of Health and Social Affairs. The role of the Medical Products Agency is to make sure
that individuals and the health-care sector have access to effective and safe medical
products of high quality and that these are used in a cost- effective way.
During the development of a new drug the Medical Products Agency examines the
necessary clinical trials from the point of view of security and scientific correctness. For
a drug to be marketed in a country, a marketing licence has to be issued. The Swedish
Medical Products Agency ensures that drugs on the market fulfil all demands according
to the new European system and examines the documentation for newly developed and
updated drugs. The Medical Products Agency continuously assesses the safety of drugs
through compilation of reports on side effects and gives producer-independent
information and advice to the medical-care sector and pharmacies. The quality of
production and distribution is controlled by inspection of producer plants and
pharmacies.
The Swedish Board of Agriculture
The Swedish Board of Agriculture is the Government’s expert authority in the field
of agricultural policy and has sectoral responsibility for agriculture, horticulture, and
reindeer husbandry. Its duties include monitoring, analysing, and reporting to the
Government on developments in these areas and implementing policy decisions in its
own field of activities . The Board is also responsible for work on genetically modified
plants, animals, and feedstuff.
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9
Conclusions120
Although the Swedish biotechnology innovation system involves a relatively small
number of companies, the system has potential to be of great strategic importance for
Sweden. The knowledge that is produced in life science internationally, for instance in
the genome mapping projects, and the fast technical development in electronics, IT, etc.,
generate great possibilities for growth in the area of industrial life science applications.
This will also affect other business sectors and is likely to be an important driving force
behind societal and industrial development in the foreseeable future. The increased
knowledge will, as one scientist put it, “trigger more innovations than the previous
space programmes world-wide”. There is a large market for developers of new drugs
and therapies, functional foods, research equipment, and biomolecular processes and
services, etc. Despite this, most of the growth will perhaps not be found in the biotech
industry itself but in the industries of its clients and partners. The growth thus
encompasses the knowledge and research intensive companies that lead the
development, often in close collaboration with scientists at the universities. Moreover,
the growth will affect subcontractors, owners of production facilities, and their
collaborative partners. Besides this, there is potential for growth if the technology can
be transferred to businesses that today only to a little extent use modern or classical
biotechnology in innovative ways. The Swedish position as a large producer of life
science research in relation to population and the fact that Sweden is ranked as the
fourth nation in Europe as regards the number of biotech companies121 indicate the need
to make this field a highly prioritised area for policy makers.
Much of the driving force behind a positive development lies in multidisciplinary
research and collaboration between academia and industry. The combination of life
science with IT, electronics, engineering, materials science, etc., is needed to achieve
new research results and to bring about new products and services. In the future there
will be a demand for large-scale investments in equipment and resources at the
universities in order make it possible to handle both new technology and new
knowledge such as the genetic code of different organisms. These investments will
create an increased need for co-ordination of public efforts.
There seems to be a stronger entrepreneurial spirit in Swedish society today. For
example, academia appears to have changed its attitude to entrepreneurship and
collaboration with industry, and personnel in established companies are more willing to
take the risk of accepting jobs in start-up companies. Established companies seem more
prone to spin off business areas that do not fit their present strategies instead of simply
closing them down. Other factors promoting a positive development are increased
availability of venture capital, an expanding global market, and the appearance of good
examples which demonstrate that it can be lucrative to start new companies for
commercialisation of life science research.
120
The conclusions mainly stem from our interview data, the questionnaire, and the workshop
"Biotechnology in Sweden: what drivers and obstacles are there for innovation and growth - what role
does the government and government agencies have?” in November 1999.
121
Ernst & Young, 1999.
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9.1
The biotech industry
In Sweden new biotechnology firms are either formed to exploit the research of a
university group or they are spin-offs from a large company when that company’s
strategies have changed through reorganisations, mergers, or concentration on fewer
business areas. The most significant characteristic of these companies is that they are
very research and knowledge intensive. Of the employees 10 to 20 per cent have a PhD
degree, and for many of the companies an extensive network and collaboration with
academic researchers are essential elements in their innovation processes.
Both small and big companies in the different biotechnological areas generate a large
number of product ideas in their exploratory research. These ideas are often developed
in collaboration with research groups at the universities but are in many cases not
commercialised. The reason may be that the ideas do not fit the company’s current
strategy or customers. Perhaps these ideas could be commercialised and be a source of
new spin-off companies, if public financing for short collaborative projects between the
company and a university group could be found. Such projects could include scientific
verification, documentation, and testing of results from exploratory research. The
financing would be an incentive for companies to contribute to developing and perhaps
commercialising promising ideas that would otherwise not be further developed. The
projects could, for instance, concern new products or applications for biomolecular
analysis, field trials of biological plant protection products or clinical documentation of
a potential functional-food product.
Despite the fact that much more venture capital is available today than only a few
years ago, there is an increasing need for seed financing to new technology-based firms.
The venture capital companies seldom finance early product development since it is too
risky. The seed financing should include services or advice concerning networking,
development of business plans, further financing, patenting, rules and regulations,
management, etc. It is often insufficient knowledge of these matters that prevent
academic researchers from starting a successful new business. An increase in public
seed financing of biotech start-ups is likely to increase the growth potential of the field.
The incentives for an entrepreneur to start a company, either as a spin-off from an
existing company or from a university, could be improved according to entrepreneurs
and industrialists. One of the problems that is often brought up is the Swedish tax
legislation, especially that which concerns stock options. Stock options can be an
incentive for a scientist at a university to quit an academic career (due to the rigid
academic qualification system, this is what accepting a position in industry often means)
or for an employee at an established company to take the risk of starting a new business.
Stock options are taxed before they can be sold, i.e. when the company is listed on the
stock exchange. They can thus prove worthless if the company for some reason cannot
be listed. Changed taxation rules may improve the incentives to start new companies.
The present study was, by respondents of the questionnaire, thought to be helpful to
players in the system and also useful in spreading information about the biotechnology
innovation system. A suggestion was that the development of the innovation system
should be continuously monitored and the results published regularly.
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Drug discovery and development
The companies discovering and developing new drugs are an essential part of the
biotechnological innovation system, and the pharmaceutical companies Pharmacia
Corporation and AstraZeneca have been of great importance to this group of companies.
The two companies have collaborated with academic groups at the universities, financed
research, and increased academic researchers’ awareness of industrial problems. They
have been the customers and collaborative partners of intermediary companies and a
source of recruitment of competent personnel. Some of the smaller drug discovery and
drug development companies are spin-offs from the former companies Astra and
Pharmacia. In many of these small companies, including the university spin-offs,
personnel previously employed by Astra or Pharmacia are found in prominent positions.
They contribute experience of project management, business development, and R&D in
the pharmaceutical industry. In this context it is worth pointing out that restructuring
and priority changes in the pharmaceutical companies have not always been negative for
the development of the biotech industry. If it has been possible for closed-down projects
to be commercialised in new start-up firms, and if there has been a demand for qualified
personnel in other companies, the changes have had a positive effect. That Pharmacia
Corporation and AstraZeneca continue to locate R&D investments in Sweden is very
important both for the appearance of new businesses and for increasing the incentives of
intermediary biotech companies to stay in Sweden.
Scientific discoveries in molecular medicine, pharmacogenomics, and DNA
diagnostics are likely to revolutionise the pharmaceutical industry. This will mean
individually designed treatments and choices of drugs and also more and more easily
developed drugs with specific molecular targets. It is likely that in the future drug
discovery and drug developing SMEs can develop their products further, since the phase
before clinical trials is becoming shorter.
Biotech supplies: new processes, techniques, and equipment
There are many explanations of the strong Swedish position in biotech supplies. One
is the prominent university research and another is the presence of a company that is a
world leader in this field, Amersham Pharmacia Biotech AB. The two pharmaceutical
companies Astra and Pharmacia have also been important to the field, since together
with university research groups, they buy the products of the biotech supply industry,
which would otherwise be mainly dependent on international markets.
The biotech supply companies, then, have pharmaceutical companies, universities,
and other biotech companies, as their main customers. Important sources of ideas for
new products and services developed by the companies are, apart from persons engaged
in in-house R&D, customers and university researchers. The companies’ own
exploratory research is often conducted in collaboration with university groups. The
development of the products and services is to some extent performed in collaboration
with academic groups, but most of it is carried out in-house or in collaboration with, or
through outsourcing to, subcontractors. A subcontractor can, for instance, provide
expertise within areas such as software development, optics, mechanics, and electronics.
Outsourcing includes an interactive exchange of knowledge between a company and its
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subcontractor. It increases the subcontractor’s specific competence, and the
collaboration becomes more efficient. At the same time, however, the biotech company
runs the risk of becoming somewhat dependent on the subcontractor. The close
collaboration is facilitated by geographic proximity, and often the consultants even
spend some time in the client company when working on the projects. Growth in the
biotech supply sector will thus generate growth also for the subcontractors. Moreover,
the collaboration with university groups can, apart from giving rise to innovative ideas
and testing of new products, applications, or services, generate scientific publications
that can later be used in marketing and for certification.
Within biotech supplies, as in other sub-areas of the biotech industry, there is large
potential for starting new enterprises based on product ideas from exploratory research
that are not further developed in the established company. There are examples of
successful new enterprises which generate many jobs for highly qualified personnel
within a short time. The possibility of finding public funding for collaborative research
between a company and a university group in order to verify, document, and test results
from exploratory research would facilitate the commercialisation of promising projects
and promote spin-offs.
Functional food
The potential for biotechnological functional-food products is large, since for
instance many elderly persons experience gastrointestinal problems, which this category
of health-promoting products can relieve. Today there are approximately 25 so-called
probiotic products on the Swedish market. The area has to overcome certain obstacles in
the form of unclear rules and regulations and apprehensive attitudes to biotechnology
shown by the general public as well as politicians and the media. For this reason large
companies are sometimes reluctant to use their brands to promote new innovative
products. The work on regional growth agreements that is presently going on in Sweden
indicates, however, that many regions want to promote commercialisation of such
products, and studies of public views and consumer attitudes would benefit them since
these studies would generate more knowledge of the potential market.
The companies that develop biotechnological functional food products often
collaborate closely with universities and university hospitals. A request from these
companies is that there should be clearer product rules, since today these rules fall
between the legislation for food and the legislation for drugs. The companies are not
allowed to use scientific evidence in the marketing of their products, and this makes it
difficult for consumers to identify products with well-documented effects. The rules, in
the companies’ opinion, should demand product-specific scientific documentation of
effects in exchange for permission to use health claims in marketing more openly than is
allowed today. Such rules are today being developed in Great Britain, Belgium, and
France, and are already applied in Holland. Within the European Union the organisation
CIIA (Confederation of the Food and Drink Industries of the EU) has prepared a
proposal for rules concerning products with documented health effects. In the European
Union the process is very slow, however, which is the reason why individual countries
are developing their own rules while waiting for international legislation.
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The Swedish rules regarding health and nutritional claims do not allow
manufacturers of this type of goods to use any product-specific health claims in their
marketing. A proposal for how the rules might be changed has, however, already been
drawn up. The Swedish National Food Administration suggests that a legislation in line
with the upcoming legislation of the European Union should be introduced and that in
the meantime Sweden should investigate the possibility of extending the present rules to
include, for instance, product-specific health claims in accordance with an already
drawn-up proposal. It is thus of great importance that the present rules be extended so
that Swedish companies will not be subject to a competitive disadvantage while waiting
for the new international legislation.
Biological plant protection
Companies working at biological plant protection are often spin-offs from university
research, and almost one fourth of their employees have a PhD degree. The advantage
of using these products is a decreased use of chemical pesticides compared to traditional
methods (many farmers engaged in ecologically sound farming, e.g. KRAV farmers,
use these products). The products are based on naturally occurring biodegradable microorganisms. All the biological plant protection companies identified in this report are
small and, among other things, need access to a larger marketing and sales organisation
in order to grow. There is strong competition from large multinational producers of
chemical pesticides who are now making an effort to develop similar products. Swedish
research, however, is in the front line. For this category of companies, flexible public
financing to allow scientific verification, testing, and documentation of results from
exploratory research would be likely to promote growth.
Environmental biotechnology
An area with great potential, although with some technical problems that need to be
solved, is the production of biogas from waste. The technique involves micro-organisms
that degrade the waste and at the same time produce methane. The micro-organisms
used occur naturally in for instance dunghills and swamps. The technical problems
involve reducing the odour from production plants.
9.2
The importance of an environment with a good innovative climate
In Uppsala an environment with a good innovative climate for the commercialisation
of life science research has evolved. Entrepreneurs and industrialists point to several
reasons why they chose to locate their businesses in Uppsala. Within the region there
are important research environments such as Uppsala University, the University
Hospital, and the Swedish University of Agricultural Sciences (SLU). Another
advantage is that although the Stockholm region and Arlanda airport are within easy
reach, Uppsala is not to a great extent exposed to a big city’s problems in the area of
housing and business premises. The presence of large biotech companies such as
Pharmacia Diagnostics and Amersham Pharmacia Biotech AB has also promoted the
growth of the region’s biotech industry. Networks between companies have been
established, largely based on personal contacts between the many employees at for
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example the biotech companies and technology transfer offices who earlier worked at
Pharmacia. Companies working at optics, software development, etc., are also located in
the region. A similar environment is found in the Lund-Malmö region, where efforts are
now being made to go across the water and connect universities and industrial
companies with the corresponding establishments in Copenhagen in order to create an
even better innovative climate.
9.3
Research and education
A strong science base is an important prerequisite for innovations and growth in
research intensive technology-based companies such as those in biotechnology. A
strong science base can not only attract top scientists but also lead to collaboration with
research-intensive companies and establishment of new ones. Swedish research in
scientific fields relevant to innovation processes in biotechnology is extensive. This is
manifested in the publication volumes, which are large in relation to population. The
biotechnology-related fields that during 1984-1998 showed decreasing quality in terms
of citation levels outnumber those showing increasing quality. In some fields scientists
seem to prioritise quantity before quality to an increasing extent. This is probably due to
the academic qualification system, where the number of published articles is very
important for obtaining positions and grants. Today more students are taking a doctor’s
degree, but it appears difficult to increase the number of results achieved to the same
extent, especially since there is an increasing demand for shorter education periods.
Since the requested number of publications for a PhD thesis has not decreased, it is
likely that the produced publications on average do not have the same quality as before.
Continued public investments in research and education in biotechnology-related
science fields are of utmost importance to the promotion of innovation and growth in
these fields. This requires efforts to support not only areas that are deemed to be of
strategic importance but also curiosity-driven basic research. More people with PhD
degrees are needed in the future both as teachers at the universities and as qualified
personnel in industry.
It is often pointed out by academic researchers and entrepreneurs that money in
support of research will be most efficient, if it is invested in established strong research
environments, since the Swedish public science system today is fragmented and has few
environments with sufficient critical mass. There are few incentives for a university to
focus its efforts on creating so-called centres of excellence in specific fields. Instead
there is a tendency towards even distribution of resources on scientific fields and
research groups. However, there are exceptions; for instance Karolinska Institutet
recently announced its intention to increase investments in its most successful scientists.
At Linköping University great efforts are also presently being made to boost the biotech
area with 14 new professorships in biotechnology-related fields, many of them related
to the prominent position that the university already has in information technology
research.
The expected and to some extent already existing shortage of university teachers will
increase the need to induce more researchers to stay at the universities after obtaining
their PhD degree. Many scientists spend a few years abroad to do post-doc research.
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This gives them invaluable experience, which benefits the Swedish innovation system
when they return to Sweden. Their post-doc research is therefore considered an
important additional qualification, when they apply for a position. A problem, however,
that has to be solved is that the Swedish financing for these stays abroad is in the form
of grants, since this has the consequence that the scientists are not covered by the
Swedish social security system, i.e. they are not the entitled to sick leave benefits and
parent leave benefits in relation to their earlier income. For this reason many scientists,
especially women, are not interested in this type of academic career. Another important
improvement needed are increased incentives for Swedish scientists to return to Sweden
after their post-doc stay abroad, for instance in the form of suitable positions and
research grants.
Some scientists claim that the Swedish science system is focused too much on
education and not enough on science. The PhD students who perform most of the
hands-on research have positions that presuppose some amount of teaching. A rigid
academic qualification system; with too little variation between the different types of
positions available, and few positions that do not include a large teaching volume, is a
problem for senior scientists who want to focus on research and supervision of PhD
students. It also makes it more difficult to recruit foreign top scientists to Sweden.
The initiatives with courses in entrepreneurship that have been initiated during the
last decade are positive complements to undergraduate and graduate education. Their
focus varies from university to university, but in general they seem to be thought of as
an important complement to other education in all subject fields, and perhaps they
should be made available to all university students. A need for more courses in
industrial project management and international business development in undergraduate
education is also often mentioned by company representatives. Another need, often
referred to by the biotech industry, is more undergraduate and graduate education in
good manufacturing practice.
There will be a continued demand for natural scientists and engineers in the future.
This requires efforts to stimulate and improve the nine-year compulsory school and
upper secondary school education, so that more children and young people than today
become interested in science and technology.
9.4
The importance of research on the innovation processes
University research has been pointed out as the most important source of innovations
in biotechnology-related fields. The ideas conceived by academic researchers are
refined and developed in firms, often in collaboration with university groups and other
firms. The end result is often very different from the original idea. Since more
knowledge-intensive technology-based firms are being started, it is likely that more
ideas will come from this category of firms. Knowledge-intensive SMEs often generate
leading-edge knowledge in collaboration with university groups within their narrow
fields of expertise. They also supply product embryos to larger companies, which then
handle the expensive product development and take the finished products to the market.
108
A prerequisite for the success of many of the biotech companies are functioning
networks which include university research groups. These networks are needed for
direct collaboration and for identification and commercialisation of the most recent
developments within specific fields of interest. This need is especially evident for
companies that develop drug candidates in close collaboration with academic scientists.
The companies that develop new technologies, instruments, and processes have
university groups as clients, and these groups and other clients are often the source of
ideas for new applications and products and also a source of information about
problems and interesting questions at issue. It also happens that they test their products
in collaboration with university groups.
The importance of university research is also apparent from our bibliometric and
patenting data. It is therefore of utmost importance to continue the present efforts to
maintain and develop basic research and education in biotechnology-related fields.
There is also a need for creating multidisciplinary environments where new ideas for
innovations can be initiated. In order to access and productively and profitably use the
new information that is presently being created, it is necessary to bring about
collaboration between scientist in the fields of biology, medicine, and chemistry and
those in engineering, electronics, and information technology. In the field of functional
food more collaboration between scientist engaged in nutrition research, medicine,
microbiology, and food technology is needed. This multidisciplinary research may be
promoted by creating multidisciplinary centres or by arranging joint seminars,
workshops, conferences, courses, etc., where researchers can meet and exchange ideas
and experience. It is possible for specialists within the same discipline to communicate
over large distances using information and communication technology, but for scientists
from different disciplines direct communication is vital in order to avoid interpretation
problems.
Our data on scientific publications shows the extent to which universities, firms, and
industrial research institutes collaborated during the period studied and their respective
share of the total publication volume. The strong dependence on university research that
the innovation processes in biotechnology seem to have was indicated by the
bibliometric data, according to which as many as 65 per cent of the firm articles were
co-authored with public research organisations. A similar conclusion can also be drawn
from results where bibliometric data was combined with patenting statistics. This data
shows that one fourth of the companies that were granted biotechnology-related patents
in the US patent system also co-authored at least one scientific publication in
biotechnology-related science with a public research organisation. When a firm is the
assignee of a patent, this does not automatically mean, however, that it is involved in the
innovation process. Also, 93 per cent of the managing directors responding to the
questionnaire claimed that their companies collaborate with academic research groups.
The most important source of ideas for innovations in drug discovery and
development is often said to be university research. The companies develop drug
candidates or knowledge of certain diseases and biological areas in close collaboration
with academic research groups. They often have established network contacts with such
groups, which can sometimes be seen as their extended R&D units. Usually the
companies collaborate with university groups or clinical scientists throughout the
109
innovation process. Improved techniques for producing biological molecules and for
discovering new drug targets by genome mapping and research on functional genomics
and proteomics increase the growth potential and the possibility of starting new
businesses in the pharmaceutical area. The use of recombinant DNA techniques, new
and improved techniques for bioseparation, and the development of equipment for
biomolecular analysis and DNA sequencing are likely to grow as a result of the
increasing knowledge. Thus, development and growth of the research-intensive drug
discovery and drug development companies will lead to growth in a number of other
areas. It is important to point out that investments in clinical research are also very
important. Clinical research and traditional development of drugs and therapies are
essential complements to research in molecular medicine. Also, if biomedical research
is to be applied it has to be tested and documented in clinical trial procedures. Therefore
high-capacity clinical research will have a positive influence on the growth of drug
discovery and drug developing companies using biotechnological tools.
Our publication and patenting statistics illustrate the importance of the companies
Astra and Pharmacia in the Swedish biotechnology innovation system. In fact, during
the period studied Astra and Pharmacia produced 75 per cent of the biotechnologyrelated publications authored by companies and were the assignees of a third of the
patents. Even if the number of internationally co-authored articles for these two
companies was constant, the share of international collaboration in relation to the two
companies’ total publication volume was increasing. This was due to a decrease in
national collaboration leading to scientific publications. The result is not likely to have
been affected by the recent mergers of the two companies with other companies, since
the first merger during the period occurred in 1995. It is also difficult to assess whether
the companies prioritised collaboration with foreign centres of excellence or with small
intermediary biotech companies, which is sometimes claimed. Summing up, it is evident
that even if the volume of international collaboration was not increasing, the result
indicates an alarming decrease in the two companies’ collaboration with Swedish
organisations.
9.5
Technology transfer and knowledge exchange
There is currently a multitude of technology transfer initiatives at local, regional, and
national levels. It is claimed, however, that there is a lack of co-ordination of these
efforts and that the resources available are often small. The initiatives taken by the
universities usually focus on the right areas such as help with patenting and licensing,
seed financing, etc. It is sometimes stated, however, that the universities have had a
tendency not to recruit personnel with the required competence, such as a broad
experience from industry. Perhaps one organisation per region, with more resources for
networking and counselling concerning the creation of new businesses, patenting, rules
and regulations, etc., would be more efficient. These regional organisations should also
have specialised knowledge and competence in different fields and technologies, since
there are different needs for different areas. Others think that it is fine that many
different initiatives are taken as long as they fulfil their purpose.
110
There is not only a need for technology transfer from universities to industry but also
of an increased academic awareness of industrial needs and problems. This is especially
true for sectors that today use biotechnology only to a small extent, like the pulp and
paper industry or the food sector. One way that this could be achieved would be by
increasing the mobility between the two types of organisation. For that to happen, the
rigid and conservative universities have to be more flexible, both as regards
organisational structure and their attitude towards industrial experience. This is
especially true at medical and natural science faculties, where it is often not regarded as
a special qualification to have worked in industry. Moreover, to collaborate with and
receive financing from industry should not hamper a research group’s prospects of
receiving public financing. Many companies also need to increase their awareness of the
value of getting acquainted with new technologies worth investing in.
The Swedish university teachers’ exemption from the employer’s right to an
employee’s inventions is often referred to as a good principle and should not be
removed. Only one respondent to the questionnaire sent out had a negative attitude to
this exemption. At the workshop arranged and in the interviews performed it was often
asserted that the exemption reduces the amount of bureaucracy when an established
company wants to make an agreement concerning a specific patent and when a scientist
wants to commercialise his/her patent in a new company. The Swedish system can even
be seen as a competitive advantage for the universities, since it may seem easier for
companies to collaborate with Swedish university groups, when the scientists own the
right to their own inventions. Too much emphasis should not, however, be put on
patenting academic ideas. The patenting procedure is both time-consuming and
expensive, and unless a firm is started to develop a particular idea or an existing firm is
planning to use it, the patent runs the risk of never being used. It must also be kept in
mind that the costs do not end when the patent has been issued. An active patent is
associated with annual costs.
Other things mentioned by the respondents to the questionnaire were the need of
better functioning liaison offices at the universities who could help companies to get
into contact with relevant scientists and to find easily accessible information about the
research performed at the universities. The respondents also suggested that perhaps
there should be less emphasis on turning academics into entrepreneurs. Another
suggestion was that more efforts should be made to contact people with the right
industrial experience and help them to form a new company to exploit an innovation.
The inventor could opt to stay at the university and collaborate with the new company
or leave academia for a position in the company. Alternatively, he/she could be helped
to draw up an agreement with an established company for commercialisation of the
innovation. Moreover, flexible programmes with few restrictions regarding the number
of participants, duration of projects, etc., were requested in support of collaborative
projects between companies and university groups. Company incubators in
environments close to academic centres were also said to stimulate growth.
111
9.6
Concluding remarks
The aim of the present study has been to identify forces and obstacles that enhance or
impede innovations and growth in the Swedish biotechnology innovation system. This
has facilitated the identification of public measures that will promote progress and
growth. The study has illustrated the usefulness of applying an innovation system
approach. Several aspects of the system have been analysed to a varying extent.
Different methods and indicators have been used to identify individual players, their
individual roles in the system, their interconnections, and the dynamics of the system.
The statistical data was complemented with interviews, a workshop, and a questionnaire
in order to provide a more in-depth knowledge of the system. The policy implications,
mainly found in this chapter, are thus a combination of an analysis based on the data
collected and a summary of the issues most frequently brought forward by different
players in the system.
The most indisputable conclusion that can be drawn from the study is the importance
of a strong science base, since it is a prerequisite for innovations and growth in
research-intensive technology-based enterprises such as biotechnology companies. A
strong science base can not only attract top scientists but also lead to collaboration with
research-intensive firms and establishment of new ones. A continued public
commitment to investments in scientific fields relevant to biotechnology is thus of
utmost importance. Scientific progress requires a more flexible attitude towards
academic organisational structure and towards academic achievements, better incentives
for scientists to stay in academia and for students to invest in higher education, and a
greater variety of academic positions. Some companies also need to increase their
awareness of the value of getting acquainted with new technologies to invest in. Efforts
should also be made to increase the public awareness and knowledge of new
technologies.
Other policy issues brought forward by players in the Swedish biotechnology
innovation system concern support to industry:
•
•
•
•
more flexible support for collaboration between academia and industry
increased public seed financing for start-up companies
increased incentives to invest in the biotech industry and to become an entrepreneur
better functioning and better co-ordinated support for start-ups and SMEs
The question is how to strike a balance between a free market and intervention by
public authorities. It is clear, however, that many of the players in the system believe
that increased support for SMEs and start-up companies, better incentives to invest in
the biotech industry, and stimulation of entrepreneurship would promote growth in the
biotech industry.
112
10 Appendix
A.
The biotech industry in 1999
Turnover and number of employees in 1999, compared to 1997
Table A1. Number of employees
Category
1
The biotech industry in total
Agrobiotechnology
Bioproduction
Biotech supplies
Environmental biotechnology
Functional food and feed
2
Pharmaceuticals and medicine
-Diagnostics
-Drug delivery
-Drug discovery and development
-Medical technology
AstraZeneca
3
Pharmacia & Upjohn
Amersham Pharmacia Biotech
1997
1999
Change (%)
2312
660
345
172
29
70
1036
354
158
401
123
7310
5249
1060
2998
665
444
259
33
81
1516
387
213
730
186
8547
5114
1130
29.7
0.1
28.7
50.6
13.8
15.7
46.3
9.3
34.8
82.1
51.2
16.9
-2.6
6.6
1999 [MSEK]
3548.7
603.9
691.9
379.7
61.9
75.5
1735.8
394.4
236.4
879.7
225.3
25687.0
n/a
2572.5
Change (%)
32.1
-6.4
73.0
53.7
84.6
15.8
34.0
7.2
24.4
40.6
102.0
48.4
n/a
53.7
Table A2. Turnover
Category
1
The biotech industry in total
Agrobiotechnology
Bioproduction
Biotech supplies
Environmental biotechnology
Functional food and feed
2
Pharmaceuticals and medicine
-Diagnostics
-Drug delivery
-Drug discovery and development
-Medical technology
AstraZeneca
3
Pharmacia & Upjohn
Amersham Pharmacia Biotech
1997 [MSEK]
2686.5
645.4
399.9
247.1
33.5
65.2
1295.4
367.8
190.0
625.8
111.8
17309.0
n/a
1673.2
n/a means that we had no information available
1
The biotech industry in total includes all micro-, small, and medium-sized companies in the categories below (<500
employees), i.e. the large companies AstraZeneca, Pharmacia & Upjohn, and Amersham Pharmacia Biotech are
excluded.
2
Included in the pharmaceuticals and medicine category are diagnostics, drug delivery, drug discovery and development,
and medical technology.
3
Now Pharmacia Corporation, and because of the fusion with Monsanto some of the economic data is missing.
113
Companies in the area of pharmaceuticals and medicine122
Table A3. Drug discovery and development
Size
class1
Business area, R&D activities,
and/or products
Company
2
F
F
AstraZeneca AB
2
Pharmacia & Upjohn AB
D
Active Biotech AB
Immunology, vaccines, drugs
D
C
SBL Vaccin AB
Karo Bio AB
Vaccines
Nuclear receptors
B
Medivir AB
Infection
B
Biora AB
Dental products
B
Amgen AB, Applied
Molecular Genetics
Engineering
Mainly clinical trials in Sweden
3
B
Pharmalink
B
Medicarb AB
B
AstaCarotene AB
B
Medi Team AB
B
BioInvent Therapeutic AB
B
ABIGO Medical AB
B
B
B
A
Oxigene Inc
BioPhausia AB
Swedish Orphan AB
NeoPharma Production AB
A
Tremedic AB
A
Conpharm AB
A
Esperion AB
n/a
n/a
Field of application
n/a
n/a
Vaccines (Cholera, ETEC), multiple
sclerosis and cancer. Infectious
diseases and
autoimmunity/Inflammation.
Polio, cholera and ETEC
n/a
Virological and bacterial infectious
diseases
Proteinproduct preventing loosening
of the teeth
n/a
Products for initial replacement of
Nephrology, fluid therapy and hospital plasma volume, blood flow
improvement and the prevention of
devices.
thrombosis
Research on biologically active
carbohydrates (mainly heparin and
n/a
kitosane) for drug development and
medical device applications
Biological effects of the algae extract Dyspepsia, fertility, and muscle
astaxanthin
physiology
A a chemo-mechanical method for
removing caries using an aminoacid
Dental products
based gel.
Antibodies, combinatorial biology
n/a
Development, manufacturing and
n/a
marketing of drugs
Cancer therapy
Cancer therapy
Connective tissue research
n/a
Rare diseases, database
n/a
n/a
Parkinson
Womens' health-care medicines and
Sore cleansing products and
wound-care medical devices
treatment of vaginal infections
Podophyllum plant extract
Condylom, rheumatoid arthritis
Metabolic diseases that may stem
Arteriosclerosis research
from low levels of plasma high density
lipoprotein
122 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
114
A
Melacure Therapeutics AB
A
Miljökontoret
Melanocortin receptor biology; drug
design based on chemometrics
combinatorial chemistry, receptor
screening assays
n/a
A
A Carlsson Research AB
CNS research
A
Diamyd Therapeutics AB
A
A
A
Pharma Swede AB
Anamar Medical
Cortendo AB
A
UmanGenomics AB
A
A
A
A
A
A
A
A
A
A
A
A
A
A
N
N
N
N
Tripep AB
Nordvacc läkemedel AB
Biosurface Pharma AB
Got A Gene AB
Neuronova
Bacterum AB
Actinova AB
ProCell Bioteknik
Resistentia AB
Arcana Research AB
Duotol AB
Creative Peptides
T.M.S Chem AB
Isconova AB
Immunonative AB
Xylogen AB
BioStratum AB
Arcimboldo
N
Biora BioEx AB
4
N
N
N
N
N
New Pharma Research
Sweden AB
MIP Technologies
Oncopeptides
Accuro Immunology AB
Arexis AB
Innate Pharmaceuticals AB
N
Angio Genetics AB
N
N
N
N
Apodemus AB
Appetite Control AB
Actar
Rossix
N
Glutamic acid decarboxylase-based
vaccine
n/a
Connective tissue research
Cortisol hormone research
Genomics, identifying disease-related
genes and polymorfisms
Peptide research
Veterinary medicine
Dental products
Genetherapy
Neurology
Penicillin spray and diagnostics
Protein engineering
Protein-based sore cleansing product
Vaccines
Dental products
Immunology
Peptides
Preclinical research
Vaccines
Antibodies from hens
Cancer therapy
Connective tissue research
Dental products
Proteins responsible for wound
healing and osteogenesis
n/a
Metabolic disorders, inflammatory
disease, cardiovascular disease
n/a
Parkinson’s disease, schizophrenia
etc
Diabetes
Veterinary medicine
Rheumatology
Metabolic syndrome
n/a
HIV
Vaccines, streptococcus infection
Antimicrobial product
n/a
Stemcell-based therapy
n/a
Vaccines
Veterinary medicine
Allergy
Paradontosis
n/a
Diabetes
Cancer and immunotherapy
Mainly veterinary medicine
n/a
Cancer therapy
n/a
Enzyme containing product
n/a
n/a
Artificial antibodies, drug design
Cancer
Cancer therapy
Genomics
Immunology
Research on development of blood
vessels
Virology
n/a
n/a
n/a
1
n/a
n/a
n/a
Metabolic diseases
n/a
Cancer, diabetes, and cardiac
diseases
The Ljungan virus
n/a
n/a
n/a
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998). n/a means that we had no information available or that there are many fields of application.
2
AstraZeneca AB and Pharmacia & Upjohn (now Pharmacia Corporation) are not included in the analysis, since because
of their size they would have dominated the statistics.
3
The subsidiary Active Biotech Research AB is included in Active Biotech AB.
4
Former name: MicroActiveProtein AB
115
Table A4. Drug delivery
Size class
1
Company
D
Bioglan AB
C
B
B
A
A
A
N
N
O
Scotia LipidTeknik AB
2
Amarin
Camurus AB
Medinvent AB
Epiport Pain Relief AB
Pharmatrix AB
Eurocine AB
Galenica AB
Dermaseal
Business area, R&D activities, and/or products
Parenteral programmed release technology, especially well suited for
proteins and peptides
Natural lipids for drug formulation
Improved oral controlled release products
Lipid-based drug formulations for substances difficult to dissolve
n/a
Pain releif drug delivery through skin
Nasal vaccines for human and veterinary applications
Nasal vaccines for human and veterinary applications
n/a
Supply of drugs through the abdomen
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998). n/a means that we had no information available.
2
Former name: Ethical Pharmaceuticals.
116
Table A5. Diagnostics
Size
class1
C
C
B
B
B
Company
Business area / Field of application
2
Gemini Genomics
Sangtec Medical AB
Chromogenix AB
Biodisk AB
3
Boule Diagnostics International AB
B
Biopool AB
B
B
B
B
B
B
A
A
Euro Diagnostica AB
CellaVision AB
IDL Biotech AB
CanAg Diagnostics AB
PGL Professional Genetics Laboratory
AB
Idexx Scandinavia AB
Cavidi Tech AB
Mercodia AB
Wieslab AB
A
Glycorex AB
A
A
A
Sinovus Biotech AB
LightUp Technology AB
Noster System AB
A
Diagnostika & AnalysService AB
A
N
O
O
MIAB
Genovis AB
Gramma Diagnostik AB
Neoprobe Europé AB
B
Pharmacogenomics, genomics, bioinformatics
Cancer, tumor markers and DNA-diagnostics
Hemostasis
Microbiology (choice of antibiotic)
Microbiology
Hemostasis, cardiovascular disease, monitoring and
measurement of the presence of drugs of abuse
Immunology
Analysis of cells and cell mutations using automated microscopy
Diagnosis of cancer, tumor markers, and DNA-diagnostics
Immunoassays, cancer
DNA-diagnostics/Pharmacogenomics
Veterinary medicine, infectious and viral diseases
Virology
Immunoassays for cardiovascular disease and diabetes
Immunoassays, autoimmune diseases.
Reagents, carbohydrate binding cells and proteins and biological
synthesis of complex carbohydrates
Virology
DNA-diagnostics
Ulcer infection, diagnosis of Helicobacter Pylori infection
Diagnostic reagents and tests within microbiology and
blodchemistry
Allergy
n/a
Infection
Isotope-labelled antibodies
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998). n/a means that we had no information available.
2
Former name: Eurona Medical AB.
3
The subsidiaries included in Boule Diagnostics International AB are Boule Diagnostics AB and Boule Nordic AB.
117
Table A6. Medical technology
Size class1
Company
Business area / Product
C
C
B
Q-Med AB
CMA/Microdialysis AB
Excorim AB
B
Vitrolife AB
B
A
Artimplant AB
Nidacon International AB
A
Glycorex Transplantation AB
A
F
D
C
A
A
A
A
A
Scandinavian QC Laboratories AB
Fresenius Kabi AB
HemoCue AB
3
Nycomed Amersham international
Gematron AB
Biolight International AB
Haemonetics AB
Mitra Medical Technology AB
Nutritional Research Institute AB
Hyluronic acid based implants for esthetic and medical use
Microdialyses
Immunadsorption
Media and systems for fertility treatment, cell therapy, tissue
engineering
Biocompatible materials
Media and systems for fertility treatment
Blood treatment, removal of antibodies from blood when
transplanting organs
Media and systems for fertility treatment
Intravenuous infusion nutrients
Blood analysis
Contrast agents
Analysis of blodcells
Wound treatment
Separation of blood components
Blood treatment, removal of chemicals after cancer therapy
Nutrient solution
2
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999).
2
The subsidiaries included in Vitrolife AB are Vitrolife Research and Development AB and Vitrolife Sales AB.
3
Subsidiaries included are Nycomed AB and Nycomed Innovation AB.
118
Table A7. Clinical research and applications
Size class1
Company
Clinical research organisations, CRO
D
Quintiles AB
D
Clinical Data Care
B
Göteborg University Clinical Research Institute AB
A
Hylae AB
A
Diabact AB
A
Kineticon AB
A
SEDOC Pharmaceutical Medicine AB
A
Bioperm
A
Cardiocon
A
Fyzikon AB
A
Novecon Research AB
A
Pharmacure AB
N
Northern Sweden CRI AB
N
Scandinavian CRI AB
O
Innovex Nordic AB
Laboratory analysis
E
Nova Medical
D
Medilab AB
B
Analycen liva AB
B
Mikro Kemi (MIKE) AB
A
Histo-Center AB
A
Wieslab Analys AB
A
Mybac-Vettech
Software solutions
C
PharmaSoft AB
B
Spotfire
B
Wilnor
B
Umetrics AB
B
Bosnext AB
A
Meditelligence
A
Clinitrac AB
A
Mclint Software systems
A
MiniDoc AB
N
InternetMedicin i Göteborg AB
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999).
119
Table A8. Biocompatible materials
1
Size class
E
B
B
B
A
A
A
A
A
O
O
Company
Nobel Biocare AB
Entific Medical Systems AB
Carmeda AB
2
Dental Holding AB
Limedic AB
Pharmadent ABDentallaboratorium
Integrum AB
JCL Technic AB
P & B Research AB
Ellem Bioteknik AB
Guidor AB
Business area / Field of application
Dental implants and bone anchored hearing aids
Facial rehabilitation and bone anchored hearing aids
Heparin coating
Dentistry
Cardiology, e.g. cardiac valves
Facial reconstruction
Bone anchored prosthesis
Cardiology
Bone anchored hearing aids
Consultancy
Products for oral reconstructive surgery
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998).
2
The subsidiaries included are Decim AB and Decim Center AB.
120
123
Companies in the area of biotech supplies
Table A9. Biotech supplies
Size class1
Company
Business area, field of application or product
Micro-, cell-, and molecular-biological tools, genomics, bioinformatics
2
F
B
A
A
Amersham Pharmacia Biotech
3
Alphahelix AB
Charles River Sverige AB
Belach Bioteknik AB
A
BioThema AB
A
A
B
B
A
Biomun
Sequant
Pyro Sequencing
CyberGene AB
Perbio Science AB (Publ)
A
InBio Institutet för bioaktiva AB
A
NNI Biotech
A
A
Novaferm AB
Inovata AB
A
Interactiva
A
A
A
A
A
N
N
N
N
John Curling Consulting
PerCell Biolytica AB
Virtual genetics laboratory AB
Chemodesign AB
Nordic Genomics
Quiatech AB
Visual Bioinformatics
Global Genomics
Decipher Genetics AB
O
Isosep AB
Micro-, cell-, and molecular-biological tools, genomics, bioinformatics
Equipment for adding PCR-reagent to samples
Biomolecular analysis and bioseparation
Fermentors
Luminiscence instruments and reagents for bacterial analysis and
food quality measurement
Biopolymeric analysis
Columns and column material
DNA-sequencing instruments
DNA-analyses, oligonucleotide synthesis and bioinformatics
Cell growth and cell biology equipment
Consultancy within natural products extract, e.g. for pharmaceutical
purposes
Microtiterplates with covalently bound modified biologically active
carbohydrates
Fermentors and bioreactors
Columns and Column material
Bioinformatics, biomolecules production (e.g. peptides and nucleic
acids) and biochiptechnology
Consultancy within e.g. Bioseparation
Cell growth media
Bioinformatic software
Fermentors
Gene discovery programs directed at human disease genes
Nucleic acids research and DNA-chip technology
Software for analysis of gene expression
Genomics
Genetic identification using new technology platforms.
Consultancy within biologically active carbohydrates, analysis and
synthesis
Sensors and biosensors
5
D
B
Biacore international AB
Diffchamb AB
A
Biosensor Applications AB
A
A
Q-sense AB
Chemel AB
O
Beta Sensor AB
A
Nordic Sensor Technology AB
A
Samba Sensors AB
Detection of biomolecular interaction
Microorganism detection for quality control of food
"Electronic nose" that detects narcotics and explosives using antibodbased technology
Measurement of structural and mass changes on surfaces
Detection of small molecules in fluids based on enzymatic reaction
Electrochemical and potentiometrical sensors for clinical,
environmental, and industrial applications
"Electronic nose" that recognizes, differentiates and classifies odours
Fiberoptic pressure sensor ,e.g. for invasive disc pressure
measurement
123 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
121
Other
6
F
E
C
Getinge Industrier AB
Prevas AB
Chematur Engineering AB
B
B
B
B
B
A
A
A
A
N
APV Steridose AB
Pharmadule AB
7
Personal Chemistry AB
Leica Microsystems AB
Synthelec AB
Xcounter AB
Åmic AB
Coricon AB
Flux Instruments AB
Gyros
Industrial and medical disinfection equipment
Software with bioinformatics as one of four business areas
Design and construction of equipment for chemical plants, e.g.
fermentors
Separation techniques
Building of modular laboratories
Microwave-aided organic synthesis
Microscopy
Organic synthesis
Digital X-ray imaging equipment detecting and counting photons
Microstructures
Chromatography
Chromatography
Miniatyre laboratories, lab on a CD
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998).
2
Astra AB and Pharmacia & Upjohn are not included in the analysis, because of their size they would have a dominating
role in the statistics.
3
The subsidiaries included in Alphahelix AB are Alphahelix production AB and Alphahelix development AB.
4
Former name: Search&Find Technology AB.
5
The subsidiary Biacore AB is included in Biacore international AB.
6
Subsidiaries included in Getinge Industrier AB are Getinge AB and Getinge Disinfection AB.
7
Former name: Labwell.
122
Companies in the area of bioproduction (biological molecules, micro-organisms or
cells) 124
Table A10 Bioproduction (biological molecules, micro-organisms or cells)
Size class1
Company
2
Technique or Business area
Product
Fermentation
Synthesis
n/a
Fermentation
Fermentation
Fermentation
Antibiotics
Peptides
Interferon
Bacterial production of proteins
Microorganisms
Microorganisms for food and feed
Mammalian cell production of
protein, monoclonal antibodies
D
C
B
B
B
B
DSM Anti-infectives
Polypeptide Lab
BioNative AB
BioGaia Fermentation AB
Kemikalia AB
Medipharm AB
B
Bioinvent International AB
Fermentation
B
Scandinavian Gene
Synthesis
B
AgriSera AB
A
OVA Production AB
A
Mabtech AB
A
Medicago AB
A
InRo BioMedTek AB
DNA/RNA synthesis mainly for
diagnostics, DNA-diagnostics
Production of antibodies from hen
eggs, immunisation technology,
synthesis of peptides
Production of antibodies from hen
eggs, production of cock´s crests,
immunisation technology
n/a
Recombinant proteins from both
prokaryotic and eukaryotic cells as
well as from human, animal, and plant
tissues
Hybridomtechnology
A
Innovagen
Synthesis
A
Medisera AB
Swedish BioScience
Laboratory AB
n/a
Antibodies
Sequencing of DNA and syntesis
of peptides and oligonucleotides
Mono- and polyclonal antibodies
n/a
Animal protein used in glue
3
A
A
Immunsystem I.M.S AB
Immunisations, production
N
O
Insudev Technology AB
T&M Biopolymer AB
O
Alfanative AB
n/a
Glycosilation
Production of leukocyte interferonalpha and clinical research
DNA/RNA
Antisera, viruses, and polyclonal
and monoclonal antibodies
Antibodies from hens
Monoclonal antibodies
Recombinant proteins
Antibodies from hens and kits for
detection of bacterial proteins
Insulin
n/a
Interferon
1
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998). n/a means that we had no information available.
2
Former name: Gist-Brocades AB.
3
The subsidiary Bioinvent Production AB is included in Bioinvent International AB.
124 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
123
Companies in the area of functional food and feed125
Table A11 Functional food and feed1
Size class2
Company
Field of application
B
Lantmännens Foderutveckling AB
B
BioGaia Biologics AB
B
Gramineer International AB
B
Probi AB
A
A
A
A
Essum AB
Clas Lönner AB
Wasa Medicals AB
Multipharma Sweden AB
A
Biodoc
Functional animal feed, e.g. to reduce use of antibiotics
Probiotics, e.g. Lactobacillus reuteri for functional food
and clinical purposes
Probiotics
Probiotics for functional food, functional feed, and clinical
purposes
Probiotics
Microbial startercultures
Probiotics
Nature-cure medicines
Nutrition: functional- and medical food (for specific
medical use)
3
1
Some of the companies in this category also develop new drugs.
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998).
3
A subsidiary included in Gramineer International AB is Gramineer Technology AB.
2
125 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
124
Companies in the area of agrobiotechnology 126
Table A12. Agrobiotechnology
Size class*
Company
Field of application / Product
Genetically modified products
E
E
N
N
N
Svalöf Weibull AB
Novartis seed AB
Lipogene AB
Scandinavian Biotechnology Research AB
Amylogene
Rape, grain, potatoes, etc
Sugar-beets
Lipids
Vegetable oil production
Potatoes
Biological plant protection
B
BioAgri AB
A
Agrivir AB
A
A
Bionema AB
BINAB Bio-innovation Eftr. AB
B
Plant science Sverige AB
A
Bio Bact
A
A
O
Funginova AB
Cantharellus AB
Illuminova AB
Natural soil bacteria
Bacterial metabolites for protection of plants and seeds
from fungi
Nematodes for insect control
Trichoderma
Other
Plant biotechnology
Plant nourishment and soil improvement through
fermentation of organic materials
Mushroms
Mushrooms
Photosynthesis, instruments for plant analysis
* Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200499; F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997
and/or 1998).
126 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
125
Companies in the area of environmental biotechnology 127
Table A13. Environmental biotechnology
Size class1
Company
Field of application
Water, waste, or soil treatment
B
ANOX AB
A
A
A
A
A
A
A
O
EkoTec AB (Ekologisk Teknologi i Skellefteå AB)
Marksanering i Sverige AB
Cenox AB
Abitec AB
Alron Chemical
Sysav Utveckling
Biologisk miljöåterställning AB
Terramek AB
Development of industrial wastewater analysis
and microbiological treatment processes.
Soil treatment
Biological treatment of soil contaminated by oil
Water analysis
Soil treatment
Soil treatment
Waste treatment
Soil treatment
Soil treatment
Laboratory analysis
1
D
B
A
Svelab miljölaboratorier AB
Pegasus Lab AB
Thalassa AB
Water, food, clinical animal tests, etc
Indoor environmental analysis
Biological toxicity tests
Classes according to the number of employees in each company: A: 1-9 (1-5); B: 10-49; C: 50-99; D: 100-199; E: 200-499;
F:>500; and N (new, without employees in 1999); O (old, without employees in 1999 but with employees in 1997 and/or 1998).
127 Companies marked in grey colour do not belong to the group of biotechnology companies, according to the
defintion chosen.
126
B.
Scientific publications
Table B1. Development of publication volume and mean impact factors in the selected
journal categories 1986-1997, including journals with an impact factor > 5*
Science classes (ISI) /Year
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Total
Biochemistry & Molecular biology
609
717
762
631
751
818
769 1023 884
852
926
874
9616
Immunology
401
510
439
423
578
403
456
455
476
480
500
456
5577
Neuroscience
389
348
407
372
465
429
479
548
541
564
495
479
5516
Cell biology
184
193
172
167
193
194
200
284
294
330
268
221
2700
Biophysics
177
177
173
155
189
191
194
303
158
150
170
163
2200
Microbiology
162
169
153
159
188
156
199
215
168
174
168
188
2099
Biotechnology & Applied microbiology
56
56
58
64
67
84
72
82
94
96
94
89
912
Virology
53
61
49
42
53
73
71
39
60
64
65
58
688
Chemistry, medical
42
39
27
39
36
26
34
45
23
35
25
34
405
Material science, biomaterials
Mathematical meth., biology &
medicine
Total number of articles
6
6
8
6
6
3
6
29
19
16
23
22
150
2
3
2
5
2
2
6
8
2
4
7
43
1741 1947 1911 1737 2112 1970 2092 2463 2322 2321 2264 2165 25045
Mean impact factor
16.5 15.9 16.9 16.8 16.8 17.7 16.9 17.1 17.3 17.0 18.1 17.3
17.1
* Note that the total number of entries of journal categories exceeds the total number of articles, since a journal can be
classified as belonging to more than one journal category.
Table B2. Journals in biotechnology-related sciences, with an impact factor>5, in which
Swedish authors published more than 300 articles in 1986-1997
JOURNAL
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Total
80
77
91
114
87
102
109
941
36
63
22
27
36
40
39
620
53
53
52
87
48
56
44
52
604
37
34
53
51
67
47
58
48
56
560
39
50
42
45
81
60
37
36
33
550
37
68
21
64
6
57
57
19
39
516
44
43
48
44
446
JOURNAL OF BIOL. CHEMISTRY
45
59
47
60
SCANDINAVIAN JOURN. OF IMMUN.
76
140
75
66
70
FEBS LETTERS
44
39
43
33
EUROPEAN JOURNAL OF BIOCHEM.
33
36
40
BRAIN RESEARCH
38
42
47
TRANSPLANT. PROCEEDINGS
48
57
43
BIOCHIMICA ET BIOPHYSICA ACTA
62
58
58
57
58
50
53
85
BIOCHEM. & BIOPH. RES. COMM.
24
34
22
26
30
41
34
56
481
NEUROSCIENCE LETTERS
41
45
35
34
32
43
31
31
33
46
33
33
437
BIOCHEMISTRY
15
21
27
26
26
31
29
74
32
31
41
58
411
BIOCHEMICAL JOURNAL
28
28
40
37
35
35
33
32
21
36
33
38
396
ALLERGY
31
28
24
21
25
24
19
37
32
37
28
32
338
NEUROSCIENCE
14
15
27
18
19
16
27
49
26
33
38
24
306
TOTAL
499
602
528
491
500
525
578
718
541
557
510
557
6606
127
Table B3. Shares of articles in biotechnology-related sciences distributed by the year of
publishing and the organisational affiliation of the Swedish authors*
Organisations /Year
Universities and University
Hospitals
Firms
Hospitals and Animal Hospitals
Other Public Organisations
Defence Units
Industrial Research Institutes
Other
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Mean
92.3 93.6 93.8 94.4 95.1 95.1 95.5 96.4 95.5 95.6 95.2 95.4
94.9
9.0
4.1
4.9
0.3
0.2
0.2
7.0
3.3
4.5
0.6
0.2
0.2
7.1
4.0
4.1
0.6
0.2
0.3
8.1
3.8
4.8
0.6
0.6
0.3
8.7
4.3
5.9
0.5
0.1
0.5
7.8
3.2
4.2
0.7
0.2
0.1
7.8
3.0
5.2
0.5
0.2
0.1
5.8
3.1
5.8
0.6
0.2
0.0
5.9
3.3
4.0
0.3
0.1
0.1
6.0
3.1
4.7
0.5
0.1
0.1
6.2
3.3
3.4
0.7
0.1
0.3
6.1
2.0
3.7
0.7
0.2
0.3
6.4
2.5
3.9
0.7
0.1
0.1
* Since authors from different organisations often co-operated on one article, the sums of the shares exceeds 100 per cent
Table B4. Swedish organisations with more than 500 published articles in biotechnologyrelated science, 1986-1997
Organisation / Year
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Total
KAROLINSKA INST
560
629
641
630
756
721
748
878
863
911
862
802
9001
LUND UNIV
289
323
357
339
412
343
382
481
432
408
369
350
4485
UPPSALA UNIV
291
362
324
281
335
311
349
398
353
341
323
349
4017
GOTHENBURG UNIV
247
286
266
245
282
262
266
301
299
298
330
274
3356
STOCKHOLM UNIV
118
157
158
135
154
154
163
183
167
151
159
180
1879
UMEA UNIV
158
156
147
115
148
143
173
155
149
177
175
175
1871
SLU
43
84
65
50
71
88
87
89
94
111
81
100
963
LINKOPING UNIV
44
54
66
72
84
58
69
100
89
101
102
83
922
SMI
52
59
67
72
57
70
86
62
60
44
44
45
718
PHARMACIA*
51
66
47
62
57
63
41
67
48
50
59
52
663
ASTRA**
77
48
67
54
67
53
45
45
50
52
42
48
648
* Now Pharmacia Corporation (including all subsidiaries such as Pharmacia Biotech)
** Now AstraZeneca (including all subsidiaries such as Hässle)
128
47
126
2508
199
274
10573
939
9
78
130
357
48
98
46
9
96
14
54
2974
5
34
1061
383
556
306
219
171
91
129
19
393
1
83
76
72
68
21
15
3
52
2
6587
6
30
2453
763
945
834
345
441
160
230
380
174
11
5
23
37
3
54
1
4
1
35
Note that the journal that an article is published in can be classified as belonging to more than one journal category.
626
421
369
248
222
291
72
84
2
2859
1747
1647
1062
857
1069
539
289
31
50
4
3
8
2
7
4
3
9
5
5
2327
4
44
473
466
224
331
265
55
163
54
248
6078
4
13
2570
1040
765
965
306
195
13
194
13
Biochemistry BioBiotechnology
Cell
Chemistry, ImmuMaterials
Mathematical Micro- Neuro&
physics
&
biology medical
nology
science,
methods,
biology science
biology &
Molecular
Applied
biomaterials
biology
microbiology
medicine
SLU - Swedish University of Agricultural Sciences; SMI - Swedish Institute for Infectious Disease Control
*
KAROLINSKA INST.
LUND UNIV.
UPPSALA UNIV.
GOTHENBURG UNIV.
UMEA UNIV.
STOCKHOLM UNIV.
SLU
LINKOPING UNIV.
SMI
ROYAL INST.
TECHNOLOGY
CHALMERS UNIV.
TECHNOLOGY
TOTAL
Subject field
Organisation/
831
2
8
349
60
102
64
54
14
31
1
146
33434
445
462
10630
5359
4736
4035
2336
2272
1171
1089
899
ViroTOTAL
logy
Table B5. Number of articles by Swedish public research organisations with the largest publication volume in biotechnologyrelated science, distributed on different journal categories 1986-1997*
3
9
42
1
83
1
91
3
56
1
8
507
2
20
4
Biotechnology
Cell
Chemistry, ImmuMaterials
&
biology medical
nology
science,
Applied
biomaterials
microbiology
31
2
29
109
23
56
346
18
4
1
3
2
6
2
1
4
9
7
0
57
10
1
304
6
Mathematical Micro- Neuromethods,
biology science
biology &
medicine
34
250
11
48
1
Note that the journal that an article is published in can be classified as belonging to more than one journal category.
18
2
6
555
Biochemistry
Bio&
physics
Molecular
biology
220
37
194
23
66
10
27
9
7
1
15
2
IVL - Swedish Environmental Research Institute; Biocarb and Symbicom do not exist any more.
*
ASTRA
PHARMACIA
BIOCARB
KARO BIO
FERRING
SYMBICOM
BIOINVENT
INT
PERSTORP
IVL
EXCORIM
TOTAL
Organisation
/Subject field
22
1
16
5
24
22
14
1721
24
728
728
89
38
29
25
ViroTOTAL
logy
Table B6. Number of articles by Swedish firms and industrial research institutes with the largest publication volume in
biotechnology-related science, distributed on different journal categories 1986-1997*
Table B7. Number of articles that the largest public research organisations copublished with companies or industrial research institutes in biotechnology-related
science in 1986-1997 1
Share of the
Total
organisation’s
No. of
total publication
2
articles
volume (%)
365
4
(75%)
311
7
(63%)
251
6
(86%)
172
5
(82%)
89
5
(70%)
84
4
(64%)
54
14
(70%)
50
5
(84%)
32
4
(40%)
22
2
(45%)
19
7
(0%)
18
5
(83%)
Year
86-89
Year
90-93
Year
94-97
KAROLINSKA INST.
111
133
121
LUND UNIV.
83
126
102
UPPSALA UNIV.
96
85
70
GOTHENBURG UNIV.
69
50
53
STOCKHOLM UNIV.
38
27
24
UMEA UNIV.
29
36
19
ROYAL INST. TECHNOL.
10
20
24
LINKOPING UNIV.
19
17
14
SMI
14
8
10
SLU
7
6
9
MALMO HOSP
9
4
6
CHALMERS UNIV. TECHNOL
5
10
3
Number of co-authorships
490
522
455
1467
Number of companies
38
47
61
120
3
1
A particular co-authorship pair is only counted once per article, even if more than one author from a
certain organisation is found.
2
In parentheses the share of collaboration with industry, that is with either Astra or Pharmacia, is
shown (Astra and Pharmacia includes all subsidiaries with a Swedish address, for instance Pharmacia
Biotech, now Amersham Pharmacia Biotech)
3
The total number of firms that co-authored articles with public research organisations during 19861997 was 120. The sum of the number of firms active in the three periods exceeds 120, since several
firms were active in more than one period.
.
131
Table B8. Number of papers in biotechnology-related science co-published by Astra
and Pharmacia with other Swedish organisations during three periods
ORGANISATION
KAROLINSKA INST.
UPPSALA UNIV.
GOTHENBURG
UNIV.
LUND UNIV.
STOCKHOLM UNIV.
UMEA UNIV.
LINKOPING UNIV.
SMI
ROYAL INST.
TECHNOL
MALMO HOSP
CHALMERS UNIV.
TECHNOL
FOA
SLU
Public research org.
ACO AB
ALFA LAVAL AB
APOTEKSBOLAGET
AB
ASTRA AB
EXCORIM KB
FERRING AB
PERSTORP AB
PHARMACIA AB
SYMBICOM AB
MABTECH AB
BIOINVENT INT AB
MERCODIA AB
BIACORE AB
Firms
TOTAL no. of
co-authorships
TOTAL no. of
articles by Astra
and Pharmacia
19861989
62
27
AB ASTRA*
199019941993
1997
50
41
21
26
153
74
19861989
36
62
TOTAL
PHARMACIA AB**
19901994TOTAL
1993
1997
121
50
35
143
57
24
18
23
27
68
40
21
13
74
28
7
13
2
11
32
9
18
4
28
8
8
8
1
88
24
39
14
12
13
18
7
15
1
54
10
5
11
41
10
3
2
108
38
15
28
1
1
2
1
4
6
13
15
34
4
1
3
8
2
2
4
2
6
1
9
2
1
6
1
4
498
0
0
2
3
207
2
1
1
176
1
167
3
155
3
1
225
2
148
1
1
2
6
580
2
1
0
3
7
3
0
0
1
0
5
4
2
0
0
0
13
179
174
158
511
213
229
151
593
246
210
192
648
226
228
209
663
1
1
2
3
2
2
1
6
4
1
3
5
1
0
1
0
0
0
1
1
1
13
1
1
132
2
1
1
1
* Now Pharmacia Corporation (including all subsidiaries such as Pharmacia Biotech)
** Now AstraZeneca (including all subsidiaries such as Hässle)
2
Table B9. Number of international articles in biotechnology-related science copublished by Astra och Pharmacia with foreign scientists during three periods
ORGANISATION
Period
Astra*
Pharmacia**
86-89
90-93
94-97
Total
no. / %
18
15
18
203
18
30
29
37
31
32
Average nr of
internationally copublished articles
per year
Share of the
organisations total
publication volume
(%)
94-97
Total
no. / %
24
22
255
42
43
38
86-89 90-93
* Now Pharmacia Corporation (including all subsidiaries such as Pharmacia Biotech)
** Now AstraZeneca (including all subsidiaries such as Hässle)
Diagram B1 The development of international collaboration in biotechnology-related
science 1986-1997
350
Number of co- authorship articles
300
250
USA
UK
FRANCE
GERMANY
DENMARK
ITALY
FINLAND
NETHERLANDS
NORWAY
JAPAN
CANADA
200
150
100
50
0
1986
1987
1988
1989
1990
1991
1992
Year
133
1993
1994
1995
1996
1997
C.
Patenting
Table C1. Classification system for Biotechnology and Biotechnology-related patents
128
BIOTECHNOLOGY
CLASSIFICATION
EXPLANATION OR EXAMPLES
Agriculture
Agricultural technique
Animal food
E.g. egg inoculation with living cells of a micro-organism, feed
optimisation, genetics, plant protection using micro-organisms.
E.g. food additives such as growth hormones and bacteria.
Bioprocess
Process
Food
Functional food
Food technique
Wood, pulp, and paper
Wood, pulp, or paper
treatment
Production of chemicals (e.g. ethanol, carbohydrates, epoxy
compound, esterification of glycosides, etc) using bioprocesses.
E.g. enzyme or bacteria addition to foodstuff
E.g. protein treatment, enzyme stabilisation in feedstuff, way of adding
biologically active materials to foodstuff.
E.g. enzyme production for pulp treatment, biocides such as a
pheromone, wood protection against fungi.
Biotech supplies &
processes
Process
Laboratory equipment
Genomics and functional
genomics
Biosensors
Transgenic animal
E.g. biomolecular production and analysis, bioseparation, DNA
sequencing, etc.
Equipment for use specifically on biological systems.
E.g. cloning, expression control, vectors, recombinant DNA techniques
E.g. biomolecules - detection and/or analysis
Animal model for helicobacter pylori infection.
Medical Technique
Tissue treatment
E.g. removing micro-organisms from tissue and cleaning tissue using
biomolecules, implant technique, dental technique, wound treatment,
blood-collecting technique.
Pharmaceuticals
Drugs and their preparation
Drug delivery systems
Diagnostics
Pharmaceuticals and vaccines for man or animal, consisting of
biomolecules or micro-organisms and their preparation.
Drug delivery systems for biopharmaceuticals
Includes biomolecular diagnostics, immunoassays, and antibodies.
To be classified as a biotechnology patent means to use, produce or analyse biological systems on a microcellular or molecular level.
128
134
BIOTECHNOLOGY-RELATED
CLASSIFICATION
Chemistry
EXPLANATION OR EXAMPLES
E.g. chemical synthesis, column material, separation and detection
New or improved chemical or
techniques, surfactants and cosmetic formulations and also probable
process
drugs and drug formulations (but not specified as such).
Environment
Environmental technique
E.g. wastewater treatment and analysis
Food
Functional food
Food technique
Quality control
Wood, pulp, and paper
Wood, pulp, or paper
treatment
Laboratory technique
Laboratory equipment
Medical Technique
Contrast agents
Nutrient solution and plasma
replacement
Wound treatment
Tissue treatment
Other
Pharmaceuticals
Drugs and their preparation
Drug delivery systems
Diagnostics
E.g. addition of trace elements to foodstuff, "health drinks", dietary
fibres, etc
E.g. milk treatment, fibre-production.
E.g. control of microflora
E.g. lignin preparation, bleaching of pulp.
Equipment for general laboratory use.
E.g. for magnetic resonance imaging or X-ray
Blood plasma substitute or blood plasma treatment method (e.g.
intravenous infusion for blood pressure control and re-administration of
treated plasma), nutrient solutions for intravenous administration, blood
material treatment and saliva substitute
E.g. sore cleansing and dressings
E.g. adhesion prevention or promotion and implant preparation
E.g. eye-surgical method, device of biocompatible material, sperm
separation, ointments and pastes for controlling micro-organisms.
New drugs and new drug compositions
Drug delivery systems and galenic pharmacy
Diagnostics not fitting the previous diagnostics description, e.g. patch
test of allergy.
135
Table C2. Number of issued patents per patent class and year
Class
Sub-class 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 TOTAL
BIOTECHNOLOGY
Agriculture
Bioprocess
Food
Wood, pulp, and
paper
Biotech supplies
& processes
Agricultural
technique
Animal food
Process
Food
technique
Functional
food
Wood, pulp,
or paper
treatment
2
2
2
3
2
1
1
1
1
3
1
1
1
1
7
5
1
4
1
5
1
7
1
11
1
1
2
4
3
1
1
1
2
1
1
Biosensor
Genomics
and
functional
genomics
Laboratory
equipment
Process
Transgenic
animal
Medical
Tissue
Technique
treatment
Drug
Pharmaceuticals delivery
systems
Diagnostics
Drugs and
their
preparation
BIOTECHNOLOGY Total
1
2
1
1
1
1
2
1
7
7
2
2
1
1
2
9
6
8
6
2
2
1
9
8
10
2
6
1
1
3
1
8
6
10
49
1
9
8
74
1
1
1
8
1
2
2
3
8
3
4
7
5
9
17
19
22
1
1
3
2
4
4
5
9
43
2
3
2
8
11
18
19
20
102
15
8
24
36
36
46
42
55
329
4
1
1
2
6
42
6
11
1
3
BIOTECHNOLOGY-RELATED
Chemistry
Environment
Food
New or
improved
chemicals
or
processes
Environmental
technique
Food
technique
Functional
food
Quality
control
3
1
1
2
2
1
6
8
1
5
4
1
2
1
1
2
1
1
1
1
136
1
7
1
5
Wood, pulp,
or paper
treatment
Laboratory
Laboratory
1
technique
equipment
Nutrient
solution
Medical
and plasma 1
Technique
replacement
Contrast
agent
Other
1
Tissue
treatment
Wound
2
treatment
Pharmaceuticals Diagnostics
Drug
delivery
6
systems
Drugs and
their
5
preparation
BIOTECHNOLOGY-RELATED
21
Total
Wood, pulp, and
paper
Total
30
1
2
2
2
1
1
1
1
2
1
2
2
2
1
2
1
1
1
1
1
1
1
1
2
1
1
15
2
3
2
1
3
10
5
8
9
28
1
1
3
8
4
10
1
12
1
1
1
3
1
1
2
3
5
7
4
4
4
7
2
6
8
17
73
16
11
12
13
24
15
9
20
21
29
51
226
26
26
33
34
38
30
28
31
39
53
96
455
43
45
55
49
46
54
64
67
85
95
151
784
137
4
Table C3. Number of issued patents per assignee and year129
BIOTECHNOLOGY
Assignee
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Total
Pharmacia AB
2
3
2
4
2
4
7
4
9
10
8
55
Astra AB
1
4
1
5
11
Symbicom AB130
1
1
1
2
1
2
2
10
P
KabiGen AB
2
3
2
1
8
P
KabiVitrum AB
1
2
2
2
7
Alfa-Laval AB
1
1
1
1
1
1
6
Biogaia AB
1
2
2
5
Ferring AB
2
3
5
Aktiebolaget Hässle
1
2
1
4
BioCarb AB
1
1
1
1
4
Cemu Bioteknik AB
1
1
1
1
4
Hightech Receptor
1
2
1
4
131
AB
Syntello AB
2
1
1
4
Chromogenix AB
2
1
3
Gambro AB
1
2
3
Probi AB
1
1
1
3
Svenska Lantmannens
2
1
3
Riksforbund
Svenska Sockerfabriks AB
1
AB Biodisk
AB Medipharm
Ake Pousette
Chemical Dynamics Development
AB
Eva Akerlof
Item Development
AB
Korsnas AB
Medivir AB
Procur AB
Skandigen AB
Trion Forskning-Och Utvecklings
Aktiebolag
A C Biotechnics AB
AB Sangtec Medical
1
Albuglobe
132
Aktiebolag
Berol Kemi AB
Berol Nobel AB
1
1
3
1
1
1
1
1
1
1
1
2
2
2
2
1
1
1
1
1
1
1
1
1
2
1
2
2
2
2
1
1
1
2
1
1
2
1
1
1
1
1
1
Astra and Pharmacia includes some of their subsidairies such as Pharmacia Biotech (now Amersham
Pharmacia Biotech)
130 Now part of AstraZeneca
P Now part of Pharmacia Corporation
131 Changed name to Active AB, 1997.
132 Changed name to Gramineer Technology, 1993.
129
138
1
1
133
1
Bifok AB
Biogaia Biologics AB
1
1
1
Bio-Instructa Labkonsult
1
1
BioInvent International AB
1
Bionative AB
Camurus AB
Carlos F. Ibanez
Charlotte ErlansonAlbertsson
Collagen Casing Einar Sjolander
AB
Ewos Aktiebolag
FOA
Gelinnovation H.B.
Got-A-Gene AB
Hans G. Boman
Karo Bio Aktiebolag
Landstingens
1
Inkopscentral LIC
Malvac Foundation
134
MonoCarb AB
1
Nobel AB
Oncholab AB
Suoma Ricard
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Syn-Tek AB
1
T&M Biopolymer Aktiebolag
ASSIGNEE
Astra AB
Pharmacia AB
Aktiebolaget Hässle
Perstorp AB
Medivir AB
Aktiebolaget Draco
1
1
11
AB Leo
P
KabiVitrum AB
Molnlycke AB
AB Ferrosan
Berol Kemi AB
Eka Nobel AB
Purac AB
1
1
11
18
9
3
12
18
20
29
25
31
194
BIOTECHNOLOGY-RELATED
1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 Total
3
3
2
2
6
2
1
2
4
7
8
29
69
1
5
3
4
1
4
3
6
5
13
21
66
3
3
2
3
8
5
3
1
28
1
1
6
2
1
3
1
1
3
19
1
1
1
1
2
4
10
2
3
1
1
2
9
Lejus Medical Aktiebolag
P
1
1
1
1
1
1
1
7
1
1
1
1
1
1
1
STFI
Thomas Ricard
BIOTECHNOLOGY
Total
1
1
1
1
2
1
2
1
2
1
2
2
2
2
2
2
2
1
1
1
1
2
1
1
1
1
2
1
2
8
2
Changed name to Foss China AB, 1999.
Changed name to Neoprobe Europe AB , 1997.
P Now part of Pharmacia Corporation
133
134
139
1
1
1
1
1
7
7
7
5
4
4
4
Item Development
AB
135
KenoGard AB
Per Arvid Emil
Carlsson
AB Erik Vinnars
Alfa-Laval AB
BioCarb AB
Conpharm AB
Excorim AB
Ferring AB
Medinvent
Michel Fockerman
Nycomed
1
1
1
1
1
1
1
1
3
1
1
2
2
1
1
1
1
1
1
Tecator AB
AB Biodisk
AB Tetra Pak
ABB
Bengt Agerup
Biacore AB
Bifok AB
Bioapatite AB
Bioglan AB
136
Biogram AB
Biolabimex AB
Bio-Tox Diagnostics
Kommanditbolag
Camurus AB
Corline Systems AB
Diffchamb AB
Drilletten AB
Duotol AB
Ellco Food AB
Ellem Bioteknik AB
Ewos Aktiebolag
Fluidcarbon International
137
AB
FOA
Four Seasons Venture Capital AB
3
3
Olle Ljungqvist Medical AB
Gacell Laboratories
138
AB
Gambro AB
GS Biochem AB
Guidor AB
1
1
2
1
1
1
1
2
2
2
2
2
2
2
2
2
1
2
2
2
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Hafslund Nycomed Innovation AB
1
Halsoprodukter Lars Karnerud AB
1
1
Changed name to Rhone-Poulenc Agro AB, 1990.
Changed name to Hydro Pharma AB 1991.
137 Changed name to Cubosome AB ,1990.
138 Changed name to Ethical Pharmaceuticals AB 1996 and then to Amarin Development AB, 1999.
135
136
140
1
Hans Jungvid Aktiebolag
1
1
Hydro Pharma AB
1
International Nutritional Research Institute AB
IRD-Biomaterial AB
Jasmine Fockerman
Jasmine Fockerman
Cederqvist
1
1
1
1
1
1
1
1
1
Karlshamns LipidTeknik AB
1
1
Karo Bio Aktiebolag
Landstingens Inkopscentral
LIC
Lief Lundblad
Ligno Tech Sweden
AB
LKB Produkter AB139
Medicarb AB
Mo och Domsjo AB
1
1
1
1
1
1
1
1
1
1
1
1
1
1
Neopharma Production AB
Probi AB
Procur AB
Rita Eberthson
SCA
Scotia LipidTeknik
AB
Solimedco
Aktiebolag
Swelab Instrument
140
AB
1
1
1
1
1
1
1
1
1
1
1
Symbicom AB
1
The Institute for Applied Biotechnology
Tricum AB
Trion Forskning-Och Utvecklings
Aktiebolag
Vertrik Bioteknik AB
BIOTECHNOLOGY15
23
RELATED Total
TOTAL
22
34
1
1
1
1
1
1
Svenska Mejeriernas Riksfoerening Ekonomi
AB
141
1
1
1
1
1
1
1
1
1
1
22
23
25
31
25
20
18
24
34
74
334
33
41
34
34
37
38
38
53
59
105
528
Now part of Pharmacia Corporation.
Changed name to Boule medical AB, 1999.
141 Changed name to Gruset I.V.G.L AB, 1999.
139
140
141
Table C4. Country/countries of assignee ownership in Biotechnology and
Biotechnology-related patents 142
BIOTECHNOLOGY
Country
SE
US
CH
SE; SE
Bioprocess (2 nf)
DK
SE
Food (2 nf)
SE
Wood, pulp, and
SE; IL; IL
paper (4 nf)
SE
DK
Biotech supplies &
SE
processes
(23 nf)
US
Class
Agriculture
JP
JP; SE
DE
FI; US
SE; FI
AU; AU
NO
DK
Medical Technique
AN
(5 nf)
NL
SE
US
Pharmaceuticals
SE
(16 nf)
US
FI
CH
SE; SE; NL
SE; SE; AN
SE; SE
US; US
NL
CA; US
DK
BIOTECHNOLOGY WITH
ASSIGNEE
Number
7
2
1
1
4
5
4
Class
BIOTECHNOLOGY-RELATED
Country
Number
Chemistry (4 nf)
2
1
1
Environment (1 nf)
68
35
4
2
2
1
1
1
1
1
1
1
1
1
96
24
1
1
1
1
1
1
1
1
1
Food (3 nf)
Wood, pulp, and
paper (2 nf)
SE
NO
FI; SE
CH
US
FI
23
5
1
3
3
1
DE
1
JP
SE
1
6
DK; SE
2
SE
12
SE
2
DK; SE
Laboratory technique SE
(2 nf)
SE; SE
US
Medical Technique
SE
NO
US
CH
DK
Pharmaceuticals
SE
US
DK
JP; JP; JP
GB
AN
SE; SE
US; SE
JP; DK
BE
CH; SE
DE
IT
278
NO
BIOTECHNOLOGY-RELATED
WITH ASSIGNEE
Total number of patents where assignee countries are indicated in the 784
patents
142
1
11
1
1
33
19
5
1
1
228
26
6
1
3
1
4
4
2
1
1
1
1
1
415
693
In parenthesis, nf means the number of patents per patentclass without an assignee. SE; SE means that two assignees from
Sweden co-owns the patent. The countries are: SE-Sweden, US-USA, NO-Norway, DK-Denmark, CH-Switzerland, CACanada, FI-Finland, GB-Great Britain, JP-Japan, NL-Netherlands, DE-Germany IL-Israel, IT-Italy, BE-Belgium, FR-France,
TW-Taiwan, IN-India, NZ-New Zeeland, AU-Australia, MX-Mexico
142
Table C5. Nationality of inventors in Biotechnology and Biotechnology-related
patents 143
BIOTECHNOLOGY
Inventor countries
Total
SE
204
SE; US
59
DK; SE
8
JP; SE
8
GB
5
US
5
FI; SE
4
NO; SE
4
CA
3
IN
3
NZ
3
US; GB; SE
2
CH; SE
2
IL
2
AU; SE
1
BE
1
US; FR; SE
1
US; GB
1
CA; SE; US
1
DE; SE
1
DE; SE; US
1
DK
1
DK; SE; US
1
FR; SE
1
GB; SE
1
IL; SE; US
1
IT; SE
1
IT; SE; US
1
MX; SE
1
MX; SE; US
1
NZ; SE
1
BIOTECHNOLOGY Total
329
% of 329
61.7
17.9
2.4
2.4
1.5
1.5
1.2
1.2
0.9
0.9
0.9
0.6
0.6
0.6
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
0.3
100.0
Total nr of patents
BIOTECHNOLOGY-RELATED
Inventor countries
Total
% of 455
SE
302
66.6
SE; US
35
7.7
NO; SE
19
4.2
DK; SE
14
3.1
US
9
2.0
CH; SE
7
1.5
CH
6
1.3
CA; SE
2
0.4
DK
5
1.1
FI
5
1.1
GB; SE
5
1.1
GB
4
0.9
JP; SE
4
0.9
CA
2
0.4
US; NO; SE
3
0.7
NL; SE
3
0.7
NL; SE; US
3
0.7
DE
2
0.4
DK; NO; SE
2
0.4
FI; SE
2
0.4
IL
2
0.4
IT
2
0.4
IT; SE; US
2
0.4
JP
2
0.4
BE; SE; US
1
0.2
US; GB; SE
1
0.2
US; IT
1
0.2
CH; FR
1
0.2
CH; GB
1
0.2
DE; SE
1
0.2
DK; NL; NO; SE
1
0.2
DK; NO
1
0.2
DK; SE; US
1
0.2
GB; TW
1
0.2
GB; US
1
0.2
IN; SE; US
1
0.2
NL
1
0.2
BIOTECHNOLOGY455
100.0
RELATED
784
143
SE; SE means that two inventors from Sweden collaborated. The countries are: The countries are SE-Sweden, US-USA,
NO-Norway, DK-Denmark, CH-Switzerland, CA-Canada, FI-Finland, GB-Great Britain, JP-Japan, NL-Netherlands, DEGermany IL-Israel, IT-Italy, BE-Belgium, FR-France, TW-Taiwan, IN-India, NZ-New Zeeland, AU-Australia, MX-Mexico
143
D.
Financing
Table D1. Funding of microbiological and biotechnological research at medical and
technical faculties, respectively, from different sources in 1997 [KSEK]
Public
Government
Other
Own
reauthorities,
General Other
Public
Swe- Research Foreign
funds
search
Swedish
municipauniver- public
founda- organisa- Other
research
dish
and
organilities, and companies
sity
R&Dtions
tions
councils foundasation /
organi144
county
funds
grants
sations
tions
type of
councils
grant
BIOTECHNOLOGY, TECHNICAL FACULTY
Uppsala
1573
0
1
44
-32
2735
7
5
1
585
Univ.
KTH
11323
0
4961
0
6132
1989
2437
750
3986
44
Chal6731
0
1917
0
4070
476
2699
72
1443
681
mers
Lund
2442
0
616
144
2835
7974
420
0
1162
121
Univ.
Total
22068
0
7495
188
13005
13174
5563
828
6592
1431
MICROBIOLOGY, MEDICAL FACULTY
Karolinska
83279 56245
24784
4087
28958
12360
37397
0
13985
4340
Institutet
Umeå
18912
6382
5778
115
2992
337
7099
3341
1242
459
Univ.
Uppsala
11317
11
3944
39
3571
716
4866
765
1920
464
Univ.
Gothenburg
16174
0
6192
0
7143
10595
4402
2438
4136
3611
Univ.
Linköping
3329
0
1186
0
784
255
573
-58
335
32
Univ.
Lund
8890
13492
4643
649
1130
2608
5253
0
2068
423
Univ.
Total
141900
76129
46527
4891
50936
26872
Source: Statistics Sweden, SCB
144
Fakultetsanslag
144
59591
6486
27486
12907
Total
4920
31622
18090
15713
70345
26543
6
46657
27613
54691
6437
39155
439
988
Table D2. Number of current investments in biotechnology companies by Swedish
venture capital companies during first half of 1999
Number of biotech Total number of Biotech share of
investments
investments
investments
HealthCap AB
Ryda Bruk AB
Industriförvaltnings AB Skandigen
Novare Kapital AB
Industrifonden
Affärsstrategerna i Sverige AB
Allmänna pensionsfonden, Sjätte
Fondstyrelsen
Visionalis AB
TUAB – Teknologiparkernas
Utvecklingsbolag AB
Start Invest AB
InnovationsKapital AB
Gesta Holding AB
Företagskapital AB
Four Seasons Venture Capital AB
Centrecourt AB
Alma Nova Industri AB
Z-invest AB
Tectelos AB
Skandia Investment
SEB Företagsinvest
Pomona-Gruppen AB
Ny Industri Venture Capital AB
Ledstiernan Partners AB
FöretagsByggarna AB
Dunross Development AB
Chalmers Invest AB
Total
15
6
6
5
3
3
3
16
6
17
21
23
13
25
94%
100%
35%
24%
13%
23%
12%
2
2
8
9
25%
22%
2
2
2
2
2
2
2
1
1
1
1
1
1
1
1
1
2
69
10
13
4
21
5
14
2
21
3
18
15
11
7
21
9
3
11
326
20%
15%
50%
10%
40%
14%
100%
5%
33%
6%
7%
9%
14%
5%
11%
33%
18%
Source: Nya förvärv och fusioner, 1999
145
Table D3. NUTEK biotechnology seed financing1 in 1997-1999, KSEK
Company
Total 1997
Bacterum AB
Bionema AB
Mexxo AB
Grants
Loans
200
600
500
300
Total 1998
Arcimboldo AB
Q-sense AB
2
Svenska Lantmännen SLR
3 177
105
1 420
252
1 400
Total 1999
Accuro Immunology AB
Anamar Diagnostics
Biosys AB
Integrum AB
Lightup Technologies AB
Mercodia AB
Pharmatrix AB
TMS Chem AB
Total
Total
1 600
9 474
200
2 500
900
744
3 000
1 125
700
130
175
810
13 441
14 251
Source: NUTEK administrative registers and programme managers
1
The figures refer to decisions on grants or loans. The money may in some cases not have been disbursed.
2
Support for a development projectin a large company
146
E.
Questionnaire
Questionnaire
Questionnaire to companies identified in the working paper (in English translation)
”The Swedish biotechnology innovation system: Forces enhancing and impeding
innovations and growth” NUTEK, May 2000.
1a. In the report your company has been categorised (see p. 67-77) in a certain way. Do you think that
the categorisation is correct?
Yes
No
❏
❏
turn to question 2
1b. If not, how should your company be categorised in accordance with the alternatives found in the report?
……………………………………………………………………….
2. Please, briefly describe your company’s main field of activity in Sweden.
………………………………………………………………………
………………………………………………………………………
………………………………………………………………………
3a. Does your company collaborate with research groups at universities and/or research institutes?
Yes
❏
No
❏
turn to question 4
3b. If yes, where are these research groups located?
Research groups at
Locally
Other parts of
Sweden
Abroad
Universities
Research institutes
3c. Can you describe the collaboration (what scientific fields, what phase in the innovation process; are there
formal contracts regulating the collaboration, do commissions occur, etc) and how the knowledge/results
achieved are transferred?
………………………………………………………………………….
………………………………………………………………………….
………………………………………………………………………….
…………………………………………………………………………..
…………………………………………………………………………..
…………………………………………………………………………..
…………………………………………………………………………..
147
4a. Does your company collaborate with or give commissions to (outsource to) other companies in its R&D
activities?
Yes
❏
No
❏
turn to question 6
4b. If yes, where are these companies located?
Company
Locally
Other parts of
Sweden
Abroad
Collaboration
Outsourcing
4c. Can you describe the collaboration (what field of activities and what phase in your R&D activities) and how
the knowledge/results achieved are transferred?
………………………………………………………………………….
………………………………………………………………………….
………………………………………………………………………….
…………………………………………………………………………..
…………………………………………………………………………..
…………………………………………………………………………..
4d. Can you describe the outsourcing (what field of activities and what phase in your R&D activities) and how
the knowledge/results achieved are transferred?
………………………………………………………………………….
………………………………………………………………………….
………………………………………………………………………….
…………………………………………………………………………..
…………………………………………………………………………..
…………………………………………………………………………..
5a. Does your company collaborate with or give commissions in its R&D activities to any of the companies
found in the report (see pp.66-77)?
Yes
No
❏
❏
turn to question 6
5b. If yes, which companies?
……………………………………………………………………………
…………………………………………………………………………….
6. What are, in your opinion, the main driving forces behind growth in the Swedish biotech industry?
……………………………………………………………………………
…………………………………………………………………………….
……………………………………………………………………………
…………………………………………………………………………….
……………………………………………………………………………
…………………………………………………………………………….
7a. Are these driving forces also the main driving forces behind growth in your company?
Yes
No
❏
❏
turn to question 8
7b. . If not, what are the main driving forces behind growth in your company?
…………………………………………………………………………….
……………………………………………………………………………
148
8. What are, in your opinion, the main obstaclesto growth in the Swedish biotech industry?
……………………………………………………………………………
…………………………………………………………………………….
……………………………………………………………………………
…………………………………………………………………………….
9a. Are these obstacles also the main obstacles to growth in your company?
Yes
No
❏
❏
turn to question 10
9b. If not, what are the main obstacles to growth in your company?
…………………………………………………………………………….
…………………………………………………………………………….
……………………………………………………………………………
10a. Do you think that the Swedish government and government agencies should do more to stimulate growth in
the Swedish biotech industry?
Yes
❏
No
❏
turn to question 11
10b. If yes, what should the Swedish government and government agencies do to stimulate growth in the
Swedish biotech industry?
……………………………………………………………………………
…………………………………………………………………………….
……………………………………………………………………………
…………………………………………………………………………….
……………………………………………………………………………
11. Do you know of any other biotech companies that are not mentioned in the report, but should have been
included, or that have appeared since 1998 (in that case please enter name and location of the company or
companies)?
……………………………………………………………………………
12. Do you have any other observations regarding the contents of the report?
…………………………………………………………………………….
……………………………………………………………………………
…………………………………………………………………………….
…………………………………………………………………………….
Thank you for your participation!
149
F. Interviews
Catharina Brooling
Monika Carlsson-Ulin
Björn Ekström
Arne Forsell
Henrik Fridén
Astrid Gräslund
Berndt Gerhardson
Anita Laser Reuterswärd
Ulf Lundqvist
Anna Nilsson
Björn O. Nilsson
Lennart Petterson
Lennart Philipson
Rickard Stankiewicz
Karl Tryggvason
Mathias Uhlén
Per Vretblad
Li Westerlund
Hans Wigzell
Staffan Normark
Bo Öberg
Bo Mattiasson
NUTEK
NUTEK
Pyrosequencing
Amersham Pharmacia Biotech
NUTEK
Stockholm University
SLU and Bioagri
The Swedish Nutrition Foundation
AproPos Research AB
Centre for Medical Innovations, Karolinska Institutet
Amersham Pharmacia Biotech
Parlamentariska bioteknikkommittén
Karolinska Institutet
Lund University
Karolinska Institutet and Biostratum
Royal Institute of Technology
The Swedish Institute for Food and Biotechnology
Stockholm University
Karolinska Institutet
Swedish Foundation for Strategic Research, SSF
Medivir
Lund University
Workshop participants, November 1999:
“Biotechnology in Sweden: Driving forces and obstacles for innovation and growth – What
should public authorities do to promote Swedish Biotech?“
Jan Brundell, Sangtec Medical AB
Monika Carlsson-Ulin, NUTEK
Sven-Gunnar Edlund, NUTEK
Thomas Edlund, Umeå University
Arne Forsell, Amersham Pharmacia Biotech
AB
Erik Forsse, Ministry of Education
Henrik Fridén, NUTEK
Christer Heinegård, NUTEK
Jens Laage-Hellman, Chalmers Technical
University
Per Lindström, Campus Uppsala
Ulf Lundkvist, Uppsala Science Park
Kaj Mårtensson, Institute for Food and
Biotechnology, SIK
Monika Mörtberg Backlund, Ministry of
Industry
Lise-Lotte Nilsson, Swedish Technical
Attachés
Staffan Normark, The Foundation for Strategic
Research, SSF
Christer Olofsson, Uppsala University
Lennart Pettersson, Parlamentariska
bioteknikkommittén
Berndt Sjöberg, Uppsala Science Park,
Innoventus Life Science
Harald Skogman, BioGaia Fermentation AB
John Skår, Centre for Medical Innovations,
Karolinska Institutet
Leif Smith, Radi Medical Systems AB
Rikard Stankiewicz, The Reasearch Policy
Institute, Lund University
Anders Thore, Novum Research Park
Mathias Uhlén, Royal Institute of Technology
150
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