Review of Patent Cases in
the English Courts in 2009
by Brian Cordery, Ewan Nettleton,
Sam Tuxford and Lorna Ballington
2
Quotation of the Year:
“An old question and answer runs as follows:
‘Where does a wise man hide a leaf? In a forest.’
It is, at least faintly, ridiculous to say that a
particular leaf has been made available to you
by telling you that it is in Sherwood Forest.
Once identified, you can of course see it. But
if not identified you know only the generality:
that Sherwood Forest has millions of leaves.”
Per Jacob LJ in Dr Reddy’s Laboratories v Eli Lilly1.
1
Decision of the Court of Appeal of 18 December, [2009] EWCA Civ 1362, paragraph 26.
© Bristows February 2010
Review of Patent Cases in the English Courts in 2009
Index
© Bristows February 2010
1
Introduction
2
Construction/Infringement
Indirect Infringement
Infringement Defences
2
4
4
Validity
Availability to the Public
Novelty
Obviousness
Insufficiency
Patentability
Added Matter
Entitlement to priority
5
5
5
6
8
9
10
10
Supplementary Protection Certificates (SPCs)
11
Employee Compensation
12
Procedural Issues
Interim Injunctions and other Interim Relief
Security for Costs
Strike Outs
Expedited Trials
Stays of English Litigation pending EPO Proceedings
13
13
14
14
14
14
Damages for Groundless Threats
15
Declaratory Relief
15
Costs
Experts / Skilled Addressee
Undertakings to the Court
Personal Liability of Directors
15
16
16
17
Community Patent / Pan-European Patent
Litigation System
18
Looking ahead – 2010 and beyond
19
The Authors
20
2
Introduction
As the global recession began to impact on the wider
legal industry at the start of 2009, the level of activity in the
English Patents Courts showed no sign of a slow-down.
In terms of numbers, there were 91 decisions in 2009
compared to 85 in 2008. It is apparent that the telecoms
and life sciences industries are continuing to dominate,
presumably because of the huge significance of the patent
system to these sectors and the fact that the term of a
patent is not altered by a challenging economic climate.
Of particular interest to patent practitioners this year were
the following developments:
• 2009 witnessed the retirement of Lord Hoffmann.
After nearly two decades of adjudicating patents cases,
it is difficult to think of an area of patent law which
has not been heavily influenced by one or more of his
seminal judgments. It will be interesting to see which of
the Judges of the newly founded Supreme Court will
don the mantle of Lord Hoffmann, particularly as Lord
Neuberger has become the Master of the Rolls and
thus may ordinarily be expected to operate in the Court
of Appeal.
• The final decision in a patent case to be handed
down by the House of Lords, Generics v Lundbeck2,
confirmed that for an invention comprising a new
product to be sufficient, the specification need only
disclose one way of making it.
• The trend towards more patents being held valid
continued. In the pharmaceutical field for example,
patents were upheld in 2009 for sustained release
formulations, novel crystalline forms and enantiomers.
• Wake Forest University v Smith & Nephew3 proceeded
from an application for an interim injunction to a
decision of the Court of Appeal on the merits on both
infringement and validity in under eight months, showing
that where the parties desire it, the English Courts can
be as quick as any system in Europe.
• The rules of “selection inventions” as laid down in IG
Farbenindustrie’s Patents4 were held to be “not part of
the living law” in the Dr Reddy’s case5.
2
Decision of the House of Lords of 25 February, [2009] UKHL 12;
[2009] RPC 13.
© Bristows February 2010
As always, the following review attempts to summarise
the most important judgments from the English Patents
Court, the Court of Appeal and the House of Lords on a
topic by topic basis. The authors have endeavoured to
ensure the summary covers all important cases but it is
of course not possible to mention every decision in this
condensed review.
Construction/Infringement
Since the seminal decision of the House of Lords in
Kirin-Amgen6, English Patents Courts at all levels have
construed claims using the so-called “bedrock” question
– namely what would the skilled person have understood
the patentee to have used the language of the claim to
mean? This question has invariably been used to the
exclusion of the ‘Protocol/Improver’ questions. Several
commentators have suggested that the bedrock question,
with its particular focus on the language of the claim,
could possibly represent a slight retrenchment to the
old law of acontextual literal analysis. However, several
mechanical patent cases from 2009 demonstrate that
such concerns are unfounded and that the Courts, whilst
still using the actual words of the claim as the touchstone,
will have full regard to their purpose and what the skilled
person would have understood from reading the claims in
the context of the specification and the relevant common
general knowledge.
The first case was the appeal in Ancon v ACS7. Here, the
Court of Appeal had to construe the claims of a patent
concerned with a fixing in a channel assembly. The
claims required that the head of the fixing should have a
“generally elliptical cone shape”. The head of the alleged
infringing fixing was flat, having no ellipse on the top.
Giving the leading judgment, Jacob LJ noted that the
issue of construction turned on the approach espoused
in Kirin-Amgen and summarised in Halliburton v Smith8.
However, rejecting a strict geometrical interpretation
of the claim, which he thought would be “something
of a nonsense”, Jacob LJ looked at the purpose of
this feature of the claim and observed that the shape
of the top of the fixing was immaterial. He considered
that the skilled person would see the patentee’s words
were directed at the cross-sections through the fixing
Decision of the Court of Appeal of 31 July, [2009] EWCA Civ 848.
(1930) 47 RPC 289.
See Footnote 1 ante.
[2005] RPC 9.
Decision of the Court of Appeal of 16 June, [2009] EWCA Civ 498.
[2006] RPC 2.
3
5
6
7
8
4
3
Review of Patent Cases in the English Courts in 2009
which had vestiges of an oval, and that the patentee had
intended a somewhat imprecise meaning. The patentee
had been faced with the problem of describing a new
shape and the Judge considered it would be wrong to
adopt a strict geometrical approach. Infringement was
therefore established and the appeal was allowed.
The second decision of interest was that of Arnold J
in Boegli-Gravures v Darsail and Pyzhov9. The claim in
question, which described an apparatus for embossing
metal foils, required the rollers to possess “pyramidal or
conical teeth … having flattened tips”. The defendants
argued that pyramidal meant that the teeth should have
a square base and four equal triangular sides forming
an apex. However the Judge rejected this approach
and found that the skilled person would assume the
term should be given its figurative meaning of generally
pyramidal in shape. Although the Judge stated that
he found it “neither necessary, nor particularly helpful”,
he went on to consider the Protocol questions for
completeness and reached the same conclusion.
However, it is also clear that the English Patents Courts
will continue to have full regard to the wording of the
claims and the need to provide a reasonable degree
of certainty for third parties. This was demonstrated in
Occlutech v AGA Medical10. The patent in suit taught
a braided metal device used for the occlusion of blood
vessels. One aspect of the description related to holding
the braided strands in place and taught that the strands
could be clamped in place to prevent unravelling.
However it went on to describe other techniques for
holding the strands in place such as soldering, brazing
and welding. Notwithstanding the breadth of this
description, Mann J found that the reference to “clamps”
in claim 1 was limited to fixing the strands of the device
together by means of an object which exerted a physical
fixing and binding force on the strands of the fabric so
that they did not unravel. Other forms of holding the ends
of the device in place, including the alternative techniques
described in the specification, were excluded11.
The construction of the terms “cylindrical” and “cylinder
surface” adopted by Peter Prescott QC sitting as a
Deputy Judge in CoreValve v Edwards Lifesciences12 also
Decision of Arnold J of 29 October, [2009] EWHC 2690 (Pat).
Decision of Mann J of 31 July, [2009] EWHC 2013 (Ch).
11
The Judge pithily observed “clamps means clamps”.
 9
10
provides an interesting contrast to the Court of Appeal’s
construction of “generally elliptical cone shape” in Ancon.
These terms were used to describe the claimed coronary
stents and the Judge held that they must therefore be
generally cylindrical in shape albeit not mathematically so.
This led to his finding that CoreValve’s product was noninfringing by virtue of its bulbous end.
Last year we reported that the Patents Court had
granted interim injunctions in respect of two pharmaceutical
patents in Leo Pharma v Sandoz13 (novel crystalline form
of calcipotriol) and Novartis v Dexcel14 (novel microemulsion
preconcentrate formulation of cyclosporin). The trial on the
merits in respect of both patents took place in 2009 and
on each occasion the patentee was successful, the former
on appeal as well (discussed below in relation to validity).
The Novartis v Dexcel15 case turned in part on a significant
legal issue regarding claim construction. Novartis’
microemulsion preconcentrate patent had been litigated
previously against another generics company, Ivax, in
respect of a different formulation before Pumfrey J at
first instance and the Court of Appeal16. Both tribunals
had made observations on the construction of certain
aspects of the claims and in particular about the miscibility
of the hydrophilic phase and the lipophilic phase. At
the interim injunction stage in the Dexcel case, Floyd J
had expressed the view that although the construction
of a patent was a matter of law, the issue was highly
dependent on the factual and technical evidence before
the Court and therefore that another Court was not bound
by the previous Court’s construction. By the time of the
trial some nine months later, Dexcel no longer argued that
the previous construction was binding, but that it was at
the very least persuasive. However Arnold J disagreed
and held that on the evidence before him, the alleged
infringing formulation did contain the hydrophilic and
lipophilic elements of the claim.
For as long as it has been a requirement for patents to
contain claims, there has been much debate over the
meaning of the ostensibly simple word “for”. The parties’
contentions in FNM Corporation v Drammock17 were
respectively whether “for” meant “for the purpose of” or
“suitable for”. The patent in issue related to a mixture of
Decision of Peter Prescott QC of 9 January, [2009] EWHC 6 (Pat);
[2009] FSR 8.
13
[2008] EWHC 541 (Pat), upheld on appeal [2008] EWCA Civ 850.
14
[2008] FSR 31.
15
Decision of Arnold J of 3 March, [2009] EWHC 336 (Pat).
16
Novartis v Ivax [2007] EWCA Civ 971, affirming [2006]
EWHC 2506 (Pat).
17
Decision of Arnold J of 15 June, [2009] EWHC 1294 (Pat).
12
4
water and dimethyl ether and related compounds for use
as a cooling spray. The reason behind the dispute lay in
the fact that some of the compositions in the prior art
were alleged to contain the claimed mixture but not for
use as cooling sprays. Having reviewed the relevant
authorities including the ancient but authoritative decision
of Adhesive Dry Mounting v Trapp18 and more modern
approaches of the EPO in Mobil/Friction Reducing
Additive19 and the English Court of Appeal in Actavis v
Merck20, Arnold J considered that it was clear that “for”
was to be construed as “suitable for”. Having reached this
conclusion, the patent was held anticipated by several
prior art citations and prior uses. Separately from the
issue of construction, the patent was also found to be
obvious. The reasoning of Arnold J was adopted by
Lewison J just over one month later in Zeno v BSM –
Bionic Solutions21. This case is also interesting because
the principal claim contained a temperature range from
“50ºC to 65ºC”. Having reviewed the very limited
authorities in this area, Lewison J concluded that the
claim required a temperature range of between 49.5ºC
to 65.4ºC.
In overturning the decision of the Patents Court and
finding Virgin’s patent for an aircraft seating system to
be valid and infringed, the Court of Appeal in Virgin v
Premium22 made some interesting findings on how much
of the law and practice of the patent system the skilled
addressee should be taken to know when he is trying to
work out what the words of a claim mean. It was held
that the skilled reader should be taken to understand at
least some basics of patent law: “We think it would be
unrealistic – indeed perverse – for the law to say that the
notional skilled reader, probably with the benefit of skilled
advice, would not know and take into account the explicit
drafting conventions by which the patent and its claims
were framed.” Particular examples were that the skilled
addressee would:
a)understand that reference numbers to drawings in
claims should not be used to limit the claim;
b)understand that the pre-characterising portion of a
claim would be expected to describe the prior art; and
20
21
18
19
(1910) 27 RPC 341.
G2/88 - [1990] EPOR 73.
[2008] RPC 26.
Decision of Lewison J of 29 July, [2009] EWHC 1829 (Pat).
© Bristows February 2010
c)upon seeing a reference to the patent being a
divisional of a parent application would say “what’s a
parent application?” and would go on to ask someone
who knows (e.g. a patent attorney).
Indirect Infringement
The issue of indirect infringement under Section 60(2)
Patents Act 1977 was considered by Lewison J in
Cranway v Playtech23. One argument made by Playtech
was that it did not indirectly infringe because it supplied
to another entity in the chain (the Tote) rather than to
end-users themselves. The Judge thought that there
was considerable force in this argument although, as the
patent was ultimately held to be invalid, the point did not
have to be decided.
Infringement Defences
CoreValve sought to rely on the experimental use defence
provided by Section 60(5)(b) Patents Act 1977 in
CoreValve v Edwards Lifesciences24. Although it was
supplying its stents for substantial remuneration, it did
so as part of a strictly controlled clinical programme
to selected hospitals in Europe with the cardiologists
involved receiving careful training. According to CoreValve
the main aims of the programme were to investigate and
confirm the safety and efficacy of its products and to
understand the effectiveness of the training programme
with a view to wider distribution of the products. There
has been much speculation in recent years over whether
the longstanding English decision in Monsanto v Stauffer25
would be followed were a similar issue to arise again, with
the Courts in other EU jurisdictions such as Germany
taking a more liberal approach. Although Peter Prescott
QC concluded that the Section 60(5)(b) defence could
not be relied upon here, it is notable that his analysis
includes more discussion of the decision of the Federal
Supreme Court of Germany in Klinische Versuche (Clinical
Trials) I26 than Monsanto. That said, the Judge felt that
the principle applied by the German Court must have
a limit, and suggested that a more complete statement
of the principle to be used involved asking whether the
immediate purpose of the transaction was (as here) to
generate revenue.
24
25
26
22
23
Decision of the Court of Appeal of 22 October, [2009] EWCA Civ 1062.
Decision of Lewison J of 7 July, [2009] EWHC 1588 (Pat); [2010] FSR 3.
See Footnote 12 ante.
[1985] RPC 515.
[1997] RPC 623.
5
Review of Patent Cases in the English Courts in 2009
Validity
Availability to the Public
Where a product enters the public domain (e.g. on free
display at a trade show) the design is made available
to the public. But what if the product was only made
available to a limited class of the public? What features
of the design are made available? These were the
issues facing Peter Prescott QC in Folding Attic Stairs
v Loft Stairs27. Before the priority date of its patent the
patentee invited the Irish Minister for Trade and Tourism
and a photographer from the Irish Times to inspect its
factory to publicise a working prototype of its new folding
attic stairway design. At the time, the patentee had not
appreciated the potentially inventive significance of its new
design. It was accepted that the photographer was given
free rein and neither the photographer nor the Minister
were under any obligations of confidence. Peter Prescott
QC noted “It is clear law that, if this test unit had been
in a public place e.g. a street, where anyone might have
stopped to examine it, its design would be considered
to have been made available to the public.” However,
the prototype was on private, not public premises, and
was only available for viewing by a small defined class of
the public (i.e. the Minister and the photographer). Peter
Prescott QC held that the published photographs did
not disclose any material features of the design and that
neither the Minister nor the photographer would be able
to describe the material features of the design. It followed
that this disclosure of the prototype did not invalidate the
patent. The Judge admitted: “I would take a very different
view if one of those present had been a person interested
in constructing folding attic ladders”.
Novelty
The most important decision on the UK law of anticipation
in 2009 was the appeal of the decision of Floyd J in the
olanzapine case28. As readers may recall, the allegation
of lack of novelty was based on an earlier British patent
application which set out a chemical structure by
reference to a so-called “Markush” formula. The formula
covered some 1019 compounds of which some 86,000
were said to be preferred. The chemical structure of
olanzapine was one of the 86,000 but was not named
specifically or described in the examples and, in rejecting
Decision of Peter Prescott QC of 9 June, [2009] EWHC 1221 (Pat); [2009]
FSR 24.
28
See Footnote 1 ante.
29
T296/87 – [1990] EPOR 337.
27
the allegation of anticipation, Floyd J found that the
compound had to be disclosed in “individualised form” in
the prior art. On appeal, Jacob LJ strongly agreed with
the trial Judge for two reasons. The first was a matter of a
priori reasoning, Jacob LJ commenting: “An old question
and answer runs as follows: ‘Where does a wise man hide
a leaf? In a forest.’ It is, at least faintly, ridiculous to say
that a particular leaf has been made available to you by
telling you that it is in Sherwood Forest. Once identified,
you can of course see it. But if not identified you know
only the generality: that Sherwood Forest has millions of
leaves.” The Judge went on to apply this reasoning to
disclosures in organic chemistry, noting that if Dr Reddy
was correct, a disclosure to, for example, “3-ringed
organic compounds” would disclose each and every
member of the class, which was plainly incorrect. The
second reason for supporting Floyd J’s decision was that
it was in conformity with the leading EPO case-law and in
particular the Hoechst Enantiomers decision of the TBA29.
The patent in Leo Pharma v Sandoz30 claimed a new
crystalline form of the known drug, calcipotriol, which
is primarily used in the treatment of acne and psoriasis.
Sandoz wished to sell a product containing this crystalline
form and therefore challenged the validity of the patent.
One attack, based on an alleged anticipation had been
rejected by the trial Judge. In roundly rejecting Sandoz’
appeal on this issue, Jacob LJ took the opportunity
to re-state the correct approach to trying to prove
anticipation by inevitable result – namely to engage the
ordinary skilled person or team, give them the prior art
and ask them to repeat it31. He noted that any departure
from this approach “inflates the costs and time, and
seldom if ever does the defendant any good.” The Judge
found that Sandoz’ experiments had two vices – namely
they had not been conducted in a seed-free environment
and that a different starting material had been used.
Following the conclusion of a partially successful EPO
opposition, the remaining valid claim of Roquette Frères
patent for “the use of maltotriitol to modify or control the
form of maltitol crystals” came under attack from Tate &
Lyle in a revocation action in the English Patents Court32.
The claim was found by Lewison J to be anticipated by
a large number of prior art documents. However it was
Decision of the Court of Appeal of 17 November, [2009] EWCA
Civ 1188.
31
This principle was first set down in Synthon’s Patent [2003]
RPC 33 at para 57.
32
Decision of Lewison J of 16 June, [2009] EWHC 1312 (Pat);
[2010] FSR 1.
30
6
held not obvious as the cited prior art did not focus on
the significance of maltotriitol to determine crystal habit.
The Judge also noted that the claim merely stated that a
known impurity in the manufacture of maltitol (maltotriitol)
could change the habit of maltitol crystals. This was
simply a property of maltotriitol discovered by Roquette,
and Lewison J therefore revoked the patent on the
further basis of being an unpatentable discovery as such.
Obviousness
The law of obviousness and in particular the issue of
whether an alleged invention was “obvious to try” was
the subject of extensive consideration by the House of
Lords in 2008 in Conor v Angiotech33. It is fair to say that
there is still some uncertainty as to the precise scope of
the law in this area, although it is clear that many fewer
patents have been held invalid for lack of inventive step,
particularly over the common general knowledge alone,
in the past two to three years. At the Court of Appeal
level, Jacob LJ made some general observations in 2009
which illustrate this slight shift in approach. For instance, in
Daiichi34, discussed in the context of SPCs below, he said:
“….it does not mean that a skilled man will pursue every
avenue relentlessly when he has only the mildest of motives
for doing so. The important point is that this passage35 only
comes into play when ‘a particular route is an obvious one
to take or try.’ And it is only obvious to try when there is at
least a fair expectation of success. Moreover it has to be a
route which would at least occur to the skilled person…”.
Later in the year, in Leo v Sandoz36, he commented that:
“The [allegation of obviousness] here is that the skilled
person would have come upon the invention [the new
crystalline form and its benefit] without any expectation
of successfully finding a better product. That sort of
obviousness attack must be scrutinised with great care.
I do not say it could not succeed but one must be very
confident that the steps said to lead to the discovery of a
new and beneficial product ‘by accident’ as it were, were
at the least, really likely, almost mandated. If you need
to do research to find an invention, then, for a finding of
obviousness, that research must be of a kind which a
skilled person would do, not which he might do.”
What is more certain is the approach which the English
Courts will take when assessing obviousness. This
[2008] RPC 28.
Decision of the Court of Appeal of 2 July, [2009] EWCA Civ 646;
[2009] RPC 23.
35
Referring to Laddie J in Brugger v Medic-Aid [1996] RPC 635 at 661, line 6.
36
See Footnote 30 ante.
37
[1985] RPC 59.
invariably involves consideration of the four Windsurfing37
steps which are now applied in the form they were
restated in Pozzoli38. Jacob LJ also commented on this in
Daiichi39, providing a clear explanation of how the “English
test” fits with the tests applied in other jurisdictions.
He explained that Windsurfing/Pozzoli is no more than
a structure by which the question, obvious or not, is to
be approached. Suggesting it is not out of step with the
EPO’s problem/solution approach, he emphasised that
there is no magic formula – obvious to try or problem/
solution – that can be used to answer the fourth Pozzoli
question of whether the differences over the prior art were
obvious. It is truly a “jury” question to be considered by
the trial Judge having heard the evidence and the
parties’ submissions.
Later in the year, Floyd J was afforded the opportunity
to comment on the state of the law of “obvious to try”
in the post-Conor era in a case concerning a patent
for the co-formulation of two drugs for the treatment
of glaucoma. Giving a typically concise overview of his
views, the Judge commented that: “a claim to a product
which does a particular job may be valid, despite the fact
that it may be obvious to make exactly such a product
to find out if it does the job.” Floyd J also noted that the
long-established authority of Hallen v Brabantia may well
have been qualified to an extent by Conor where the claim
specifies a product with a specific technical effect.
The line of cases on “selection inventions”, which can be
traced all the way back to the decision of Maugham J
in IG Farbenindustrie’s Patents40 and which was fondly
regarded by many UK patent practitioners, was held by
the Court of Appeal to be “part of legal history and not
part of the living law” in Dr Reddy’s Laboratories v Eli
Lilly41. This observation formed part of a finding that Eli
Lilly’s patent to olanzapine was not obvious over the prior
art. Jacob LJ also rejected an argument by the appellant
that the EPO jurisprudence including AgrEvo42 and
Wyeth43 had created similar rules in a separate context.
Instead the Judge observed: “The EPO jurisprudence is
founded firmly around a fundamental question: has the
patentee made a novel non-obvious technical advance
and provided sufficient justification for it to be credible?”
(in contrast to an arbitrary selection describing no real
[2007] FSR 37.
See Footnote 34 ante.
40
See Footnote 4 ante.
41
See Footnote 1 ante.
42
AgrEvo/Triazole Sulphonamides T939/92 - [1996] EPOR 171 EPO (Technical
Board of Appeal).
43
T133/01.
33
38
34
39
© Bristows February 2010
7
Review of Patent Cases in the English Courts in 2009
technical advance). Jacob LJ’s view was endorsed by
Lord Neuberger MR.
In one of his first judgments as a Patents Court Judge,
Arnold J held that many of the claims of two of Samsung’s
portfolio of vacuum cleaner patents were invalid when
challenged by Dyson44. The discussion on the law of
obviousness is interesting as it compares and contrasts
the judgment of the Court of Appeal in Pozzoli45 and the
House of Lords in Conor v Angiotech46 – the Judge
concluding that following Conor, although it was not
necessary for the patent to explain how or why the
invention did work or was practical, the disclosure in
the patent did have to at least make it plausible that
the invention would work. The case is also noteworthy
for the discussion on the approach to be taken to a prior
art document when addressing the issue of obviousness
(as opposed to novelty). Relying on the “admirable
phrase” coined by Pumfrey J in Hewlett Packard v
Waters47, Arnold J held that ambiguities which were
obvious should be resolved but that the document
should not be subjected to hermeneutical stress or to
imaginative reconstruction.
A party seeking to invalidate a patent will commonly allege
that the patent lacks inventive step over the common
general knowledge alone. Following on from previous
decisions such as Abbott v Evysio48 it is clear that the
English Patents Judges are becoming increasingly
attuned to the potential pitfalls of such attacks and in
particular that it can be relatively easy to combine parts
of the relevant background to point the skilled reader
clearly to the invention of the patent in suit. This is in
sharp contrast to an allegation based on a particular prior
art document which the skilled addressee is deemed
to read “warts and all” – i.e. there may be parts of the
document which may prompt the invention and parts
which point another way. In 2009 the cautious approach
to the common general knowledge continued to be
applied in cases such as Ratiopharm v Alza49 where
nevertheless a patent claiming a patch for the transdermal
delivery of the analgesic fentanyl was held invalid over the
common general knowledge, demonstrating that it can
still be worthwhile to run such an attack in appropriate
circumstances.
Decision of Arnold J of 22 January, [2009] EWHC 55 (Pat); [2009] FSR 15.
See Footnote 38 ante.
46
See Footnote 33 ante.
47
[2002] IP&T 5.
48
[2008] RPC 23.
49
Decision of Kitchin J of 12 February, [2009] EWHC 213 (Pat).
50
Scinopharm v Eli Lilly – Decision of Kitchin J of 27 March, [2009]
EWHC 631 (Pat).
Finding Eli Lilly’s patent to a new process for manufacturing
the anti-cancer drug, gemcitabine, to be valid, Kitchin J
re-affirmed the established principle of English law that it is
impermissible to read separate items of prior art together
for the purposes of an attack of obviousness50. In reaching
this conclusion, the Judge relied on the Court of Appeal’s
judgment in Smithkline Beecham v Apotex51 which in turn
gleaned support from the seminal decision of the House
of Lords in Technograph v Mills & Rockley52. The decision
also contains some helpful guidance on the question
of “obvious to try” and its interaction with the issue of
motivation – the Judge concluding that although motivation
was generally an important factor in the assessment of
inventive step, it was not an essential requirement.
Despite the limitations expressed by Kitchin J in the
Daiichi53 case last year, the concept of “secondary
common general knowledge” can still be of importance
in assessing inventive step. Actavis v Novartis54 is
one example where Warren J took into account the
commonly known characteristics of the cholesterol
lowering drug fluvastatin before assessing whether
a patent to a sustained release version of the drug was
obvious. In a lengthy judgment, the Judge concluded
that, on the basis of the evidence before the Court in
relation to motivation and prospects of success, the
inevitable result of his analysis was that the patent in
suit was inventive. However, he then went on to hold
that the patent was still obvious as it involved no technical
advance, drawing on the 5¼ inch plate analogy first
proposed by Laddie J in Hoechst Celanese v BP
Chemicals55.
Patentees may also consider relying on the commercial
success of their patented products to rebut an
obviousness attack. As the Court of Appeal noted in
Aerotel v Wavecrest56: “It can indeed be a powerful
indication of non-obviousness if it is shown that the
alleged invention has led to commercial success. The
question ‘why was it not done before?’ is compelling if
there is no adequate answer (e.g. that the cited prior art
is only just before the priority date, or that the success
is due to marketing).” Aerotel’s invention relating to a
telephone pre-payment business was not commercialised
until some eight years following its publication. Although
53
54
55
56
44
51
45
52
[2005] FSR 23.
[1972] RPC 346.
[2009] RPC 4.
Decision of Warren J of 16 January, [2009] EWHC 41 (Ch).
[1997] FSR 547.
Decision of the Court of Appeal of 20 May, [2009] EWCA Civ 408.
8
many competing businesses started up at this time there
was no evidence they did so riding on the coat tails of
the invention: “When the invention was made known
absolutely nothing happened. The world beat a path to
the door of Ralph Waldo Emerson’s inventor of a better
mousetrap, but the path to Aerotel’s door remained
untrodden.” Further, although Aerotel had licensed the
patent, the evidence did not establish that the licences
were anything other than so-called “nuisance” payments
to avoid the inherent risks of litigation. The Court of
Appeal upheld the Patents Court’s finding that Aerotel’s
patent was obvious.
Insufficiency
For the third year running, our discussion of the law
on insufficiency begins with Lundbeck v Generics57.
The Court of Appeal ruling we reported in 2008 was
considered last year by the House of Lords. The fact
that permission to appeal to the House of Lords had
been given surprised some practitioners because Lord
Hoffmann, who had the most experience of patents
amongst the Law Lords, had stepped down an instance
and given the leading judgment in the Court of Appeal.
In doing so, he had clarified his earlier judgment in
Biogen58, and, with the agreement of the rest of the
tribunal, including Jacob LJ, he had reversed Kitchin
J’s finding that Lundbeck’s claim to its single enantiomer
antidepressant drug, escitalopram, was insufficient. At first
instance Generics had mounted a successful challenge
to Lundbeck’s product claims59, convincing the trial
Judge that they should not stand because Lundbeck’s
contribution to the art was a process of making the single
enantiomer form of the drug (which by its very nature
everyone knew existed), and it should not be granted a
monopoly covering all such processes.
Unsurprisingly, the House of Lords unanimously agreed
with Lord Hoffmann’s ruling in the Court of Appeal. Lord
Walker considered that Generics’ case boiled down to
the allegation that the Court of Appeal’s ruling was an
unwarranted departure from Biogen. Confirming Lundbeck
was entitled to product claims for escitalopram, he stated:
“When a product claim satisfies the requirements of
Section 1 of the 1977 Act, the technical contribution to
the art is the product and not the process by which it was
57
See Footnote 2 ante.
made even if that process was the only inventive step”.
He considered that the statutory requirements and case
law60 on sufficiency, together with Articles 83 and 84
EPC spell out the need for an enabling disclosure, a
concept central to the law of patents that requires the
disclosure should enable the invention across the full
extent of the claims. Where the claims are to a single
chemical compound, this is considered to be a product
and has only one embodiment. This was the main reason
Lord Walker and his fellow Lords distinguished Biogen
where the main claim of the patent in suit covered a large
number of possible embodiments. Lord Neuberger, who
also gave a substantive judgment observed:
“it is hard to discern any statutory provision ... to support
the proposition that, once it has been established that a
product claimed in a patent is novel and non-obvious, and
the specification sufficiently explains to the person skilled
in the art how to make it, the claim can nonetheless be
rejected because there may be other ways of making the
product which owe nothing to the teaching of the patent.”
The decision also contains an interesting analysis of
the meanings of the terms “technical contribution” and
“inventive concept”. According to Lord Walker, the
inventive concept is concerned with the core or essence
of the invention and the technical contribution relates
to an evaluation of the inventive concept and how far
forward it carries the art. Lundbeck’s contribution was
the isolated enantiomer, escitalopram, even though the
inventive aspect was the process of making it.
An insufficiency attack was also considered and
ultimately rejected in CoreValve v Edwards Lifesciences61.
CoreValve’s most notable line of argument was the
suggestion that it was not sufficient for the patent to
describe how to make the physical device (the coronary
stent), and that it was necessary to explain how the
device was to be implanted clinically. Whilst Peter
Prescott QC was satisfied on the evidence that there
would be formidable problems, he did not consider that
was the standard required. As he put it, “I doubt that any
patent could be sufficient in that respect, because
it would be akin to learning to fly a helicopter by reading
the manual”.
Biogen v Medeva [1997] RPC 1.
[2007] RPC 32.
60
With reference to Asahi and Sections 14(3) and 14(5)(c) Patents
Act 1977.
61
See Footnote 12 ante.
58
59
© Bristows February 2010
9
Review of Patent Cases in the English Courts in 2009
Claims with qualitative restrictions making reference to the
results to be achieved, such as Novartis’ patent relating to
opthalmically compatible extended wear contact lenses:
“often provoke a good deal of suspicion that they are
merely an attempt to monopolise all ways of solving a
known problem. They are also inherently less clear in their
scope than claims which are defined by physical features.
At least for this latter reason, the EPO does not generally
allow such claims unless the invention can only be defined
in such terms or cannot otherwise be defined without
unduly restricting the scope of the claims.” So held
Kitchin J in Novartis v Johnson & Johnson62. Although
laying claim to a product possessing a useful activity or
desirable effect does not make the patent insufficient in
itself: “a claim to a class of products said to possess a
useful activity must be based upon the identification of a
common principle which permits a reasonable prediction
to be made that substantially all the claimed products do
indeed share that activity. Further, it is not permissible to
by-pass that requirement simply by adding a functional
limitation which restricts the scope of the claim to all the
products which do have the relevant activity.” Kitchin J
noted that Novartis’ patent did not teach such a common
principle, holding that it would involve a research
programme to identify formulations which are useful for
producing an opthalmically compatible lens suitable for
extended wear. Kitchin J’s finding of insufficiency can be
contrasted to the first instance decision in the Netherlands
where the Dutch Court rejected the insufficiency attack
and found the patent valid.
Laboratorios Almirall v Boehringer Ingelheim63 provided
confirmation that a patentee cannot use ex post facto
justification, such as post-filed experiments, to support
its patent. Sitting as a Deputy Judge of the Patents
Court, Judge Fysh QC held that sufficient justification
for the solution to a technical problem must be found in
the patent as filed. In this case, the patent was wholly
speculative, as the key ‘bonus effect’ of the claimed
invention was not particularised or evidenced in the
patent specification.
Patentability
Two co-joined appeals from the IPO in AT&T and
Decision of Kitchin J of 10 July, [2009] EWHC 1671 (Pat).
Decision of HHJ Fysh QC of 23 January, [2009] EWHC 102 (Pat); [2009]
FSR 12.
CVON64 offered Lewison J the opportunity to provide
an interesting analysis of the recent Court of Appeal
decisions on patentability in Aerotel65 and Symbian66 and
the meaning of “technical effect” in particular. Lewison J
identified “useful signposts” for practitioners to identify a
relevant technical effect:
“i) whether the claimed technical effect has a technical
effect on a process which is carried on outside the
computer;
ii) whether the claimed technical effect operates at the
level of the architecture of the computer; that is to say
whether the effect is produced irrespective of the data
being processed or the applications being run;
iii) whether the claimed technical effect results in the
computer being made to operate in a new way;
iv) whether there is an increase in the speed or reliability
of the computer;
v) whether the perceived problem is overcome by
the claimed invention as opposed to merely being
circumvented.”
AT&T’s appeal over its application relating to a “content
broker hosting system”, which acts as an intermediary
between a user wishing to buy digital content and digital
content suppliers, was rejected. Lewison J noted: “The
problem that the inventor has perceived is that digital
content suppliers supply content (e.g. music) without
knowing the functionality of the device on which it is to
be played...The problem is solved by the provision of
a ‘device profile table’ which indicates the capabilities
of the various user devices that can be connected to
the system...” Applying step 3 of the Aerotel test, the
device profile table is merely a computerised list of the
characteristics of user devices which amounts to the
mere computerisation of a method of doing business.
CVON’s appeal, concerning its application relating to a
mobile telecommunication network messaging system in
which group membership of a subscriber is authenticated
and then used as a basis for modifying text messages,
was also rejected. Lewison J explained: “The old way of
Decision of Lewison J of 3 March, [2009] EWHC 343 (Pat); [2009] FSR 19.
[2007] RPC 7.
66
[2009] RPC 1.
62
64
63
65
10
modifying messages on the basis of group membership
(where group membership records were held in a third
party database) was that the third party database
periodically transferred data to the telecommunications
network so as to update the latter’s records of group
membership. In other words the transfer of data was
initiated by the third party.” Applying step 3 of the Aerotel
test, the contribution was that it is the subscriber, rather
than the third party, who initiated the authentication
process. Lewison J agreed with the IPO’s finding that:
“...allowing a subscriber to prompt for updates to and
authentication of his group membership records is
not a technical matter, but a decision in relation to the
business of running a message modification service...
The way in which this data is then used to carry out the
authentication involves the conventional use of websites
and the Internet.”
Mann J invalidated three patents relating to electronic
programming guides in the case of Gemstar67, with two of
three patents falling for lack of patentability, being nothing
more than a computer program or the presentation of
information as such. One issue of interest in this case
was whether the patent’s “contribution” (required to be
identified in the Aerotel test) should be assessed against
the common general knowledge and the cited prior art,
or the common general knowledge alone. Mann J noted
that on the facts: “the contribution can be adequately
determined without assessing just where the baseline
is”. It is to be hoped that the referral pending before the
Enlarged Board of Appeal of the European Patent Office
concerning the patentability of software68 will cast light on
the correct approach to be taken.
Added Matter
Last year we reported that two patents belonging to Napp
teaching sustained release formulations of the pain-killing
drug, oxycodone, were held to be valid but not infringed by
a generic competitor product. The appeal of this decision
was expedited because the generic product was expected
to receive a marketing authorisation in early 2009 and, in
line with the general trend mentioned in the introduction,
the finding of non-infringement was reversed69. The
combined judgment of the three member panel including
Lord Neuberger was given by Jacob LJ and contains
69
70
67
68
Decision of Mann J of 26 November, [2009] EWHC 3068.
G03/09.
Napp v Ratiopharm and Sandoz [2009] EWCA Civ 252.
See Footnote 34 ante.
© Bristows February 2010
several important observations. Perhaps the most
interesting of these concerns the law of added matter and
in particular the issue of disclaimers. First, echoing the
comments made in Daiichi70 about obviousness, Jacob
LJ confirmed that in the Court’s view the leading EPO
authority, G1/93 Advanced Semiconductor Products71
“coincided with the principles already laid down in [the
English Courts] in Bonzel v Intervention72”.
The Court of Appeal also re-affirmed the correctness of
the “helpful elaboration” of the law in this area set out by
Kitchin J in European Central Bank v Document Security
Systems73 in 2007. Finally, the Court rejected an argument
by the generics companies that the EBA decision of
G1/03 PPG Industries74 had created an additional and
special rule of law as regards “undisclosed disclaimers”,
i.e. disclaimers which are introduced during the course of
the prosecution of the patent application to restore novelty
by cutting out otherwise anticipatory material identified
during the prior art search. Jacob LJ considered that
the trial Judge had been entirely correct to conclude
that there was only one test for added matter and that
disclaimers of accidental and deemed anticipations did
not offend because they did not add subject matter
relevant to the invention.
The Napp decision also provided the Court of Appeal with
the platform to make some unfavourable observations
regarding the practice and procedure concerning voluntary
divisional applications, concluding that the system, which
inevitably made life more complicated for third parties, was
perhaps questionable and unnecessary in light of the new
procedures for post-grant central amendment of European
patents provided for by Article 105a of the EPC. The
findings of the Court on construction and infringement
turned on specific integers of the claims and passages of
the patent specifications, and it is impossible to discern any
significant guidance from them. However it is worth noting
that the Court of Appeal respectfully but openly disagreed
with the findings of the German Courts in parallel cases.
Entitlement to priority
A case which aroused particular interest amongst the
patent attorney profession was Edwards v Cook75. In
many respects, the dispute was conventional, relating
[1995] EPOR 97.
[1991] RPC 553.
73
[2007] EWHC 600 (Pat).
74
[2004] EPOR 33.
75
Decision of Kitchin J of 12 June, [2009] EHWC 1304 (Pat);
[2009] FSR 27.
71
72
11
Review of Patent Cases in the English Courts in 2009
to the validity and infringement of a patent for an
artificial heart valve. However, Kitchin J’s judgment will
probably be cited most frequently for his interpretation
of the legislation governing entitlement to priority and
in particular his finding that the irregularities concerning
priority could not be cured after the event. Cook’s patent
in suit stemmed from a PCT patent application which was
filed on 31 January 2001 and claimed priority from a US
patent application filed on 31 January 2000. There were
three named inventors: Obermiller, Osse and Thorpe. The
priority application was filed in the names of the three
inventors and the PCT application was filed in the name
of Cook. However, at the time the PCT application was
filed, only Mr Obermiller was an employee of Cook. The
interests of the other two inventors in the PCT application
were eventually assigned to Cook in September 2002,
nearly two years after the application had been filed
but before the grant of the European Patent under
consideration. The Judge found that the factual matrix
in question did not entitle Cook to claim priority: “In my
judgment, the effect of Article 4 of the Paris Convention
and Section 5 of the [Patents] Act is clear. A person
who files a patent application for an invention is afforded
the privilege of claiming priority only if he himself filed the
earlier application from which priority is claimed or if he
is the successor in title to the person who filed the earlier
application. … Moreover his position is not improved if he
subsequently acquires title to the invention.” In the event,
the patent in suit was held to be not infringed and invalid.
The appeal is due to be heard in June 2010 and the
outcome will doubtless be eagerly awaited by the patent
attorney profession.
Supplementary Protection
Certificates (SPCs)
2009 saw a raft of decisions on SPCs. The validity of a
granted SPC was considered by the Court of Appeal
in the context of an enantiomer patent in Generics v
Daiichi76. Having upheld the first instance decision that
Daiichi’s underlying patent was inventive, the Court of
Appeal went on to consider a separate point relating
to the SPC. Generics had argued that marketing
authorisations granted to Daiichi for its racemic product
See Footnote 34 ante.
Decision of Arnold J of 31 July, [2009] EWHC 1916 (Pat).
ofloxacin should be considered the first marketing
authorisations for the single enantiomer form, levofloxacin.
If this were the case, it would have meant levofloxacin was
not ‘new’ for purposes of SPC legislation, reducing the
five year period of Daiichi’s SPC protection to nil. This was
roundly rejected with Jacob LJ stating: “from the point
of view of patent law levofloxacin was a new product.
And it was a new product as a matter of commercial
and practical reality too – no-one, without the invention,
could make it. And from the medical point of view it was
a new and better medicine. Obviously before it could
be marketed it would have to go through trials [...] So it
needed a new marketing authorisation”.
The tricky question of whether an SPC could be
granted for a product containing a combination of active
ingredients based on a patent concerned with just
one of them was considered by Arnold J in Astellas
Pharma v Comptroller77. There are two principal English
authorities on this question, Takeda78 and Gilead79
both of which were considered at length by the Judge.
Astellas had argued that its patent claims were akin to
Gilead’s (which included a claim to combinations with
other unnamed active ingredients) based on their use of
the words “comprises” and “an active ingredient” which
permitted others to be present. Whilst Arnold J accepted
this meant the claims covered products containing
additional active ingredients, he did not accept that such
combinations were ‘disclosed’ in the sense he thought
was required for the claim to protect the combination.
The Judge also rejected the broader allegations that
Takeda was wrong and that SPCs should be available
for combination products which have been granted
marketing authorisation based on patents covering just
one of the ingredients. He commented that he would have
referred the question to the European Court of Justice
to speed things up if he had been confident that was
what the Court of Appeal would do, but he did not feel
sufficiently confident and felt this was a matter best left to
the Court of Appeal.
Questions were referred on a much narrower issue by
Floyd J in Synthon v Merz80. There the point the High
Court had to consider was whether an SPC can be
obtained when the medicinal product has been placed
[2004] RPC 3.
[2008] EWHC 1902 (Pat).
80
Decision of Floyd J of 2 April, [2009] EWHC 656 (Pat).
76
78
77
79
12
on the market in the Community without the need to do
the usual prescribed safety and efficacy testing. Merz’
SPC had been granted on the basis of EU wide marketing
authorisations dating from 2002, despite having already
been on the market in Germany for a quarter of a century,
and Synthon was seeking revocation of the SPC or
a declaration it had zero term. The specific questions
referred have since been published81.
Coincidentally, a similar sort of issue arose in Generics
(UK) v Synaptech82 where earlier marketing of a product
had taken place for different indications pursuant to
marketing authorisations that were not granted in
accordance with EC Directive 65/65/EEC, the Directive
which harmonised Europe’s marketing authorisation
procedures. Here, Roger Wyand QC sitting as a Deputy
Judge felt he could decide the issue of whether the
earlier non-compliant marketing authorisations should be
considered to be the “first authorisation” for the purposes
of Article 13 of the SPC Regulation83. In his draft
judgment circulated to the parties, he concluded that they
could not and that the SPC was valid. In a strange twist of
fate, Floyd J’s judgment in Synthon v Merz84 was handed
down on exactly the same day leading Roger Wyand
to take further submissions on whether this changed
things. Rejecting Generics’ requests, he handed down
judgment in the form of his draft, albeit granting Generics
permission to appeal to seek any reference to the ECJ
from the Court of Appeal85.
Additionally, the first UK decisions were handed down
on the grant of so-called ‘paediatric extensions’ to SPCs
from the English Courts, with DuPont appealing the IPO’s
refusal of an extension for its SPC for the antihypertensive
drug, losartan. Paediatric extensions came into being
through European Regulation 1901/2006 (the Paediatric
Regulation86) which was enacted to encourage innovative
pharmaceutical companies to develop paediatric
products. This Regulation established a system of
obligations and rewards for pharmaceutical companies
with regard to testing medicines in children, including
most notably a six-month extension of their SPCs (the
‘paediatric extension’) if the required testing has been
carried out in accordance with an agreed Paediatric
Investigation Plan (or ‘PIP’) and all the required information
See OJ C 193 of 15 August 2009 at p9. The case is now pending before the
ECJ as C-195/09.
82
Decision of Roger Wyand QC of 20 May, [2009] EWHC 659 (Ch).
83
Council Regulation (EEC) No. 1768/92 concerning the creation of a
supplementary protection certificate for medicinal products.
81
© Bristows February 2010
has been submitted to the regulatory authorities.
DuPont’s request for the paediatric extension was rejected
by the IPO because, although DuPont had obtained a
positive opinion from the Paediatric Committee that its
studies were in compliance with the PIP, it was still in
the process of having its marketing authorisations to
sell losartan varied to include the paediatric indications.
The IPO had adopted a strict approach to the Paediatric
Regulation’s requirements, holding that the extension
could only be granted if the authorisations had been
varied throughout the EU. DuPont’s appeal of the rejection
went first to the High Court where John Baldwin QC
sitting as a Deputy Judge upheld the IPO’s decision87.
However, by the time the case reached the Court of
Appeal in September 200988, DuPont had managed
to put the defects in its application right, and the
key question if the IPO was right on the Regulation’s
requirements was whether it was possible for the
application to be ‘cured’.
After a thorough analysis of the EU legislation that led him
to comment “all this cross-referring and sub- and sub-sub
cross-referring begins to make the mind boggle”, Jacob
LJ, with whom the other Lord Justices agreed, decided
the application could be cured. This would be the case
in circumstances like this where the applicant, mindful of
the time limits, had filed the application before getting all
its ducks in a row unless it had behaved unreasonably.
Notably, the Court of Appeal indicated at the hearing that
DuPont’s appeal would be allowed so that the losartan
SPC could be extended before it expired. This explains
why the authors and other interested practitioners
knew from the Patents Register that DuPont had been
successful but had a frustrating time trying to get hold
of the decision until quite some time afterwards. It is
understood that the decision will lead to a change in IPO
practice to allow applicants more time to get their ducks
in a row, rather than summarily rejecting applications
which fail to comply with the strict legal requirements of
the legislation.
Employee Compensation
The first successful claim in the English Courts by
See Footnote 80 ante.
Decision of Roger Wyand QC of 20 May, [2009] EWHC 1163 (Pat).
86
Regulation (EC) No 1901/2006 of 12 December 2006 on medicinal
products for paediatric use (as amended) which amended Regulation
(EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and
Regulation (EC) No 726/2004.
87
Decision of John Baldwin QC of 22 May, [2009] EWHC 1112 (Ch).
88
Decision of the Court of Appeal of 17 September, [2009] EWCA Civ 966.
84
85
13
Review of Patent Cases in the English Courts in 2009
employee inventors claiming compensation for their
contribution to a successful patentable invention was
seen in Kelly and Chiu v GE Healthcare89. Section 40(1)
Patents Act 1977 was applied which entitles employees
named as inventors to seek compensation if the patent
has been found to be of “outstanding benefit” to the
employer. If the benefit is “outstanding” the employee is
entitled to a “fair share” of that benefit. The case involved
two former employees who were named as inventors
on two patents protecting the heart imaging product,
Myoview®. Floyd J found that the “outstanding benefit”
hurdle had been overcome and assessed the monetary
value of the patents to GE Healthcare at £50 million. The
inventors were awarded a 3% share of that benefit, to
be split between them. Floyd J said that “the benefits
[of the patents] went far beyond anything which one
could normally expect to arise from the sort of work the
employees were doing” and that “it is very important not
to underrate the contribution of the employer” in bringing
the final product to market and achieving the very high
level of global sales. The case has therefore set a high
hurdle of outstanding benefit for any potential claimant to
overcome.
While the compensation obtained by the employee
inventors appears significant, it is much less than was
originally claimed. This coupled with the specific facts
of the case and the high “outstanding benefit” hurdle
suggests the decision may not be easily applied to
modern research and development where numerous
patents often protect one product. Finally, it should be
noted that this case was decided under the law as it was
before the Patents Act 2004 came into force. Following
implementation of the 2004 Act, employee inventors are
now entitled to a fair share when the patent and/or the
invention (as opposed to the patent alone) has been of
outstanding benefit to the employer. This change was
aimed at making it easier for inventors to make claims, but
the consequences of this amendment remain to be seen.
Although not as important as Kelly, the decision of Mann J
in Shanks v Unilever90 was interesting as it related to
an apparent mistake by the legislature in the drafting of
a section of the Patents Act. The section in issue was
Section 41(2) which pertains to the assessment of the
Decision of Floyd J of 11 February, [2009] EWHC 181 (Pat); [2009] RPC 12.
Decision of Mann J of 3 December, [2009] EWHC 3164 (Ch).
91
Decision of Lewison J of 13 January, [2009] EWHC 45 (Pat); [2009] FSR 11.
92
Decision of Mann J of 31 July, [2009] EWHC 2143 (Pat).
89
90
benefit derived or expected to be derived from an employer
from an assignment of the patent in question. The section
demands that where the assignment has been made to
a connected person such as a subsidiary, the amount
of benefit is to be assessed as if “that person” were not
connected to the assignor. The question was whether
“that person” should be deemed to be an arms-length
purchaser or whether, as would be the case according to
the literal wording of the statute, the assignee is deemed
to be the same person or entity with all the same attributes
apart from the connection. The Judge ruled that the former
interpretation was arguable in the circumstances.
Procedural Issues
Interim Injunctions and other Interim Relief
Three cases, two of which were between KCI and Smith
& Nephew (“S&N”), illustrate the importance of bringing
interim injunction applications without delay. S&N
announced the launch of their new wound dressing kits
in December 2008 which were to be available in early
2009. KCI applied for an interim injunction91 within a few
days of the press announcement. Lewison J remarked
“The fact is that Smith & Nephew have not started in
any significant way to sell the potentially competing
products. Preservation of the status quo in cases where
there is real doubt about what the future might bring
is, as Lord Diplock said in the Cyanamid case, ‘a
counsel of prudence’” and granted the interim injunction.
Interestingly, on ordering the interim injunction, Lewison J
broadened the scope of the usual cross undertaking
in damages. Express provision was made for KCI’s
customers, such as the National Health Service, to apply
to the Court for compensation from KCI for any damage
suffered as a result of the injunction being in place.
On 1 April 2009, S&N launched a different product with
a new pump design. However, this time, KCI only made
its application for an interim injunction92 in late July 2009.
Acknowledging the apparent delay, KCI argued that
S&N had concealed its launch such that they had only
realised the potentially infringing activity shortly before its
application. This time it fell to Mann J, at an initial hearing
before the parties had time to complete their evidence,
14
to address the balance of convenience: “...If it is the case
that a claimant bona fide did not know of acts which
it seeks to restrain and which had been going on for
some time, and where that was because of concealment
or analogous behaviour, then that may well deprive a
defendant of the right to rely on the factual status quo at
the date of the claim form as being the status quo for the
purposes of the American Cyanamid tests.” On the facts,
Mann J found that there was no so such concealment
and KCI’s request for an interim injunction pending the
next return date of its application was refused.
Floyd J93 dismissed an application for an interim
injunction brought by Mölnlycke against BSN Medical’s
wound dressing kits finding that a delay of 6 months
between Mölnlycke knowing of BSN’s plans and
bringing the action was inconsistent with the
requirement of urgency.
Security for Costs
The procedure for security for costs serves to protect
defendants from impecunious claimants, who may be
unable to satisfy the defendant’s costs should their claim
be unsuccessful. In Mobiqa v Trinity94, although the
Claimant submitted it had sufficient funds in the bank to
meet any adverse costs award for the entire litigation,
its accounts revealed that it was operating at a loss and
dependent on support from its shareholders, as well as
other creditors. Floyd J was concerned that its investors
may be less willing to fund the claimant should it lose a
patent action against an important competitor such as the
defendant and ordered security.
Strike Outs
When the leading market research company TNS applied
to revoke a patent belonging to competitor Nielsen,
relating to a device for measuring television audience
figures, Nielsen responded by offering TNS a licence to
the patent. Having done so, it applied to strike out the
revocation proceedings on the basis that the litigation
was pointless and wasteful95. Nielsen also alleged that
the motive behind TNS’ revocation claim was to try to
obtain a favourable judgment from the English Court to
export to other jurisdictions, an allegation which TNS
accepted to be true and asserted to be unobjectionable.
Decision of Floyd J of 17 December, [2009] EWHC 3370 (Pat).
Decision of Floyd J of 23 June, [2009] EWHC 1536 (Pat).
95
Decision of Arnold J of 20 May, [2009] EWHC 1160 (Pat); [2009]
FSR 23.
96
Decision of Mann J of 7 May, [2009] EWHC 1065 (Pat).
Arnold J refused the strike out and held that it is in
principle legitimate for any party to seek to revoke a
patent regardless of the commercial value in so doing.
The Judge also held that it was not improper to seek to
gain a favourable judgment from the English Court for
use elsewhere in Europe. He also refused to stay the
proceedings pending the outcome of EPO Opposition
proceedings notwithstanding the offer of a licence.
Expedited Trials
The claimant in Intervet v Merial96 requested a speedy trial
to leapfrog other litigants but this was not allowed due to
lack of evidence on the need for it. Intervet relied on both
commercial uncertainty and public interest as evidence
for an expedited trial. Mann J stated that an extra three
months of commercial uncertainty created by the later trial
would not cause any significant impact on the claimant
and that Intervet had not provided enough evidence on
what the uncertainty was, how it would operate and how
it could justify leapfrogging. The public interest angle was
also dismissed by Mann J as Intervet presupposed that
its vaccine would be more effective than any other on
the market but had neglected to provide any evidence to
support such a claim.
Stays of English Litigation pending EPO
Proceedings
Whilst most years see at least a couple of decisions on
the question of whether English proceedings involving
European patents should be stayed pending the outcome
of opposition proceedings on validity of the patents in the
EPO, these matters are usually considered in the High
Court. Eli Lilly v HGS97 is a rare decision from the Court
of Appeal on this issue. At first instance in 2008, Kitchin
J had held HGS’ patent lacked industrial application and
was insufficient98. HGS appealed and a hearing was fixed
for July 2009. However, when Jacob LJ learned there
were parallel proceedings in the EPO with a pending
Technical Board Appeal, he called both parties’ Counsel
to see him informally. Having considered the respective
timetables, Jacob LJ decided to move the date of the
English appeal to December 2009 on the basis there was
a real prospect of a TBA decision in the interim which
would mean the English appeal did not need to be heard99.
In doing so, he emphasised the need for parties litigating
Decision of the Court of Appeal of 23 February, [2009] EWCA Civ 168.
[2008] RPC 29.
99
In the event, although the TBA decision was handed down within this
timeframe (T 0018/09 of 21 October 2009), the TBA upheld HGS’ patent
in amended form, meaning that the English Court of Appeal would need to
hear the matter.
93
97
94
98
© Bristows February 2010
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Review of Patent Cases in the English Courts in 2009
before the EPO and the English Courts to inform both
tribunals as early as possible, and ask the appropriate
tribunal to speed things up to avoid duplication.
A more conventional stay situation arose in GSK
Biologicals v Novartis100 where Novartis sought to stay
revocation proceedings in the English High Court pending
the outcome of the appeal of opposition proceedings in
the EPO. Underlining the fact that the law has moved on
from the older authorities which suggested there was a
presumption in favour of a stay101, and referring instead to
the Court of Appeal decision in Glaxo Group v Genentech
reported last year, Kitchin J refused to grant a stay.
Damages for Groundless
Threats
Most readers will already know that the UK law pertaining
to groundless threats has been somewhat softened by the
amendments introduced by the Patents Act 2004. They
will also probably know that the whole issue of unjustified
threats of infringement of intellectual property rights has
been the subject of judicial disapproval because of its
inconsistency with the “talk first” approach engendered by
the Civil Procedural Rules. The provisions can still prove to
be a trap for the unwary and should always be taken into
account by all patent holders and their advisers. There
were several “threats” cases in 2009 showing that the
provisions are far from obsolete. The decision of Arnold J
in FNM v Drammock102 was interesting for two reasons.
First, the Judge held that a letter before action and
accompanying undertakings from FNM to Drammock was
a threat because the undertakings referred to supplying
the relevant products to customers even though the letter
itself referred only to manufacture, which, together with
importation is exempt from being an actionable threat
pursuant to Section 70(4)(a) Patents Act 1977. Further,
since Drammock was not the manufacturer, the provision
in Section 70(4)(b) did not apply. Secondly, although the
correspondence sent by the patentee’s patent attorneys
was held to be a threat, it was also held that the defence
afforded by Section 70(2A)(b) applied since the patent
holder did not know and had no reason to suspect
that the patent was invalid. On the other hand, a letter
Decision of Kitchin J of 30 April, [2009] EWHC 931 (Pat).
In particular, Kimberly Clark Worldwide v P&G [2000] RPC 422.
102
See Footnote 17 ante.
103
See Footnote 21 ante.
written to a leading retailer by a firm of German patent
attorneys in respect of a device to treat acne was held to
be unjustified in Zeno v BSM – Bionic Solutions103 since a
reasonable person in the position of the recipient would
have understood the letter to have been a threat.
Declaratory Relief
Gore v Geox104 was a decision without any contested
points of law and Jacob LJ began the leading judgment
by commenting that it was unlikely to be of general
interest. However, it is perhaps notable because of
comments made regarding the product and process
descriptions of the two products for which Gore sought
declarations of non-infringement. The descriptions sought
to leave room for manoeuvre because Gore was hoping
to license its technology and the licensees might want to
make variations. This led to difficulties because the Court
was being asked to declare that everything falling within
the descriptions was non-infringing. Jacob LJ suggested
that, in future, it might be better to spell out in detail first
a particular product and process, and then itemise clearly
and separately each possible variant in relation to which
the declaration was sought.
Costs
In assessing costs, the Court continues to apply
the three-stage test which can be traced back to a
submission by one of the advocates in Actavis v Merck105;
namely: “Have you won? Have you lost a suitably
circumscribed issue, so that you should be deprived
of your costs of that issue? Is this an exceptional case
such as to lead to an adverse costs order on an issue
in favour of the overall loser?” Several cases in 2009
illustrate this issue-based approach to costs. J&J sought
their costs for successfully defending Novartis’ action
for patent infringement in Novartis v J&J106. J&J’s costs
amounted to £3,650,000 whilst Novartis’ costs were
£2,320,000. Novartis argued for no order as to costs on
the basis that it was successful on a number of issues.
Although Novartis’ patent was revoked for insufficiency,
J&J’s novelty and obviousness attacks failed. Further,
Decision of Court of Appeal of 29 July, [2009] EWCA Civ 794.
[2007] EWHC 1625.
106
Decision of Kitchin J of 29 July, [2009] EWHC 2029 (Pat).
100
104
101
105
16
J&J’s product was found to fall within the scope of some
of the claims asserted. Kitchin J noted that J&J were
“undoubtedly the commercial winners of the action” and
were entitled to their general costs. Adopting the issuebased approach, J&J’s costs were reduced by 5% for its
unsuccessful non-infringement arguments and a further
25% for its failed prior art attacks. This led to an award
of 70% of J&J’s costs to be assessed with an interim
payment of £1,250,000.
In Ratiopharm v Napp107, following the first instance
finding that the patent in suit was valid but not infringed,
the Court ordered that the generics companies should
pay to Napp 20% of its costs, notwithstanding that the
generics had, at least at that point in time, achieved the
commercial certainty that they desired. Similarly, in Actavis
v Novartis108, although the Court had found the patent
obvious over the common general knowledge, the Court
made a deduction of 5% of Actavis’ costs in relation to
the issue of infringement but, reflecting the finding that
the patent in suit was held to be valid over what the Court
termed the “Notional Project” head of obviousness and
certain pieces of prior art, the Court deducted another
50% with the result that Actavis were held entitled to just
45% of their costs. This decision is interesting as it shows
that in appropriate circumstances, the Court is in principle
willing to sub-divide issues such as obviousness where
sub-issues can be suitably circumscribed. The decision
is also of interest because Actavis claimed costs in Euros
(or in sterling equivalent at the time of the assessment),
reflecting the fact that its UK solicitors ordinarily conduct
their business in Euros and had billed their client in Euros.
Novartis argued that each invoice should be converted into
pounds sterling at the time it had been paid. The potential
additional sum payable was considerable since the pound
to Euro exchange rate had dropped from 1.49 to 1.06
during the course of the proceedings. Although ultimately
considering that this was probably a matter for the costs
assessment, Warren J stated that his strong inclination
was that Actavis was not entitled to have its costs in Euros
or the sterling equivalent at the date of assessment. This
was on the basis that the claim was in the English Court,
conducted by English solicitors and related to a UK patent.
Indemnity costs, which differ from standard costs in that
Decision of Floyd J of 10 February, [2009] EWHC 209 (Ch).
Decision of Warren J of 19 March, [2009] EWHC 502 (Ch).
109
Decision of HHJ Fysh QC of 23 January, [2009] EWHC 102 (Pat);
[2009] FSR 12.
it is the paying party and not the receiving party which
bears the burden of proof in relation to the reasonableness
of a cost or expense incurred by the paying party, are
unusual in patents cases. However the judgment in
Laboratorios Almirall v Boehringer Ingelheim109 sounds
a note of caution for parties which choose not to make
appropriate admissions thus forcing the other side to
conduct experiments. In his judgment in the main action,
Judge Fysh QC had found that Boehringer Ingelheim had
not made an admission which it “could and should have
provided” regarding the lack of activity of the S-enantiomer
of aclidinium. On the basis that this non-admission
had forced Almirall to conduct reply experiments in
inappropriate circumstances an award of indemnity costs
in respect of the costs of these experiments was made110.
The impact a party’s conduct of its case can have on
costs is also demonstrated by Cook v Edwards111.
Concluding that Edwards should recover 80% of its
costs, Kitchin J criticised Cook for, amongst other
things, persisting in seeking disclosure of development
documents despite the explanations provided suggesting
they had no relevance. Though the Judge did not order
Cook to pay the disclosure costs on an indemnity basis,
he emphasised that parties should not engage in such
futile exercises, with any disclosure needing to be both
necessary and proportionate.
Experts / Skilled Addressee
The identity of the members of the skilled team was
a pivotal issue in Schlumberger v Electromagnetic
Geoservices112. Notably, the patentee had suggested that
there could be different skilled addressees for the purposes
of obviousness and insufficiency in an effort to avoid a
squeeze argument between the two. Mann J found no
support for this suggestion in the legislation and concluded
that the skilled addressee is the same throughout.
Undertakings to the Court
The binding nature of undertakings given to the Court was
considered by the Court of Appeal in Zipher v Markem113.
Floyd J had held at first instance that Zipher had given
an undertaking in earlier proceedings that precluded it
from alleging particular claims of a family of patents were
valid and infringed. Having considered the point at issue –
Decision of HHJ Fysh QC of 27 February, [2009] EWHC 439 (Pat).
Decision of Kitchin J of 12 June, [2009] EWHC 1443 (Pat); [2009] FSR 28.
112
Decision of Mann J of 19 January, [2009] EWHC 58 (Pat); [2009] RPC 19.
113
Decision of the Court of Appeal of 10 February, [2009] EWCA Civ 44; [2009]
FSR 14.
107
110
108
111
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Review of Patent Cases in the English Courts in 2009
whether an undertaking had been given to the High Court
in circumstances where it was never committed to writing
– against the complex case history, the appeal court
concluded it had not. The undertaking offered by Zipher
had not been accepted, and it was not revived when the
earlier proceedings moved to the Court of Appeal. Whilst
emphasising the need for undertakings to be recorded in
writing, Lord Neuberger who gave the only substantive
judgment, also provided some useful guidance on the
approach the Court will take in such circumstances.
Personal Liability of Directors
In 2009, the Courts continued to apply the leading Court
of Appeal decision in MCA v Charly Records114 in relation
to the personal liability of directors for acts of companies
which they control. Each case invariably turns on its
particular facts. However in Boegli v Darsail115, one of the
Defendant’s directors, Andrei Pyzhov was found to have
exceeded his constitutional role in the company and was
thus held to be personally liable.
[2001] EWCA Civ 1441; [2002] FSR 26.
Decision of Arnold J of 29 October, [2009] EWHC 2690.
114
115
17
18
Community Patent / Pan-European Patent Litigation System
116
In 2009 we reported that achieving agreement on
the Community Patent and the pan-European Patent
Court seemed as remote a prospect as ever. We cited
difficulties in reaching agreement on the language issue
as it impacted on the Community Patent, and the difficulty
in relation to a pan-European Patent Court of achieving
consensus around a system which allowed bifurcation of
the issues of infringement and validity. Indeed, we noted
that the situation was essentially unchanged from 2008.
What we did not foresee was the monumental efforts
made by Sweden which held the EU presidency in the
second half of 2009. Regrettably, whilst the Swedes did
make some progress, it was hardly commensurate with
the huge effort; and the lack of progress despite this effort
does not bode well for 2010 and beyond.
So what did happen in 2009, and what are the prospects
for 2010?
2009 began with the Czech presidency continuing
work on the draft agreement relating to the European
Union Patent Judiciary (the then current name117 for
what was once the EPLA and before that the EPLP).
This was the proposed pan-European Patent Court
for litigating not only existing European patents, but
also future Community patents. Additionally, there
was some discussion (though not a great deal) of the
draft Regulation for the Community Patent itself. It also
occurred to someone in Brussels that it was time that the
European Court of Justice considered whether the type
of arrangements being proposed would be consistent
with European Union law. Hence, in summer 2009 a
formal request was made for an opinion by the ECJ on
“the compatibility with the EC treaty of the envisaged
agreement creating a unified patent litigation system”
(as the relevant document was entitled). The opinion of
the ECJ is expected in mid-2010.
As mentioned above, in the second half of 2009, the
Swedish presidency made a major push. At first it
continued the discussions about the precise form of the
agreement, holding a series of Working Party meetings
which dealt with sections of the draft text. However,
their attention then shifted away from negotiating a
treaty, toward reaching a political consensus on the
The authors are grateful to Bristows’ partner, Alan Johnson, for writing this
section of the review.
116
© Bristows February 2010
Court, and agreeing the text of the Community Patent
Regulation. At one stage, it appeared that the Swedes
might actually achieve their goal. Progress seemed to be
being made on a set of Council “Conclusions”. Further,
the Swedes cunningly decided that the best way of
reaching agreement on the thorny issue of language in
relation to the Community Patent was to duck the issue
altogether. The provisions about language were taken
out of the draft Regulation with a view to being decided
another day. However, with the date approaching when
the Competitiveness Council would meet, history began
to repeat itself (yet again) with the prospects of agreement
unravelling as it duly did. Not that anyone reading the
Council press release dated 4 December would think so.
The release was grandly entitled “Patents: EU achieves
political breakthrough on an enhanced patent system”
and stated that:“The Council has today unanimously adopted conclusions
on an enhanced patent system in Europe. The package
agreed covers major elements to bring about a single EU
patent and establish a new Patent Court in the EU. Both
together will make it less costly for businesses to protect
innovative technology and make litigation more accessible
and predictable. Today’s agreement will pave the way for
solving the outstanding issues to achieve a major reform
of the EU patent system in the near future.”
The EU Council’s view of the “near future” is interesting to
say the least. The most optimistic estimate as to when a
system could be up and running given by the Commission
is 2017. Other Commission estimates which have been
heard are of the order of 2020. In the authors’ opinion,
however, even such an estimate is a triumph of hope
over experience. The woolly political conclusions are
reminiscent of the March 2003 political accord brokered
by the Greek presidency, which was similarly hailed as
a breakthrough. One year later the process was dead in
the water. The reality is that the thorny issue of language
which plagues the Community Patent will not go away. It
remains inextricably linked with broader political questions
of streamlining the language regime operating within the
EU. The position now is no different than it was many
years ago. Business would prefer an English only option.
A compromise acceptable to the French and Germans
More “progress” seems to have been made in re-naming the
Court than on any other single point: the Court is now known as
the European and European Union Patents Court (EEUPC), and
prior to that was briefly known as the European and Community
Patents Court (ECPC).
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Review of Patent Cases in the English Courts in 2009
Looking ahead – 2010 and beyond
would be a three language system, as is used in the EPO.
That system, however, is unacceptable to the Spanish
in particular. A five language system including Spanish
and Italian might just be conceivable – provided that the
EPO does not have to operate in five languages! – but
what then of the smaller EU states? And in relation to the
pan-European Patent Court, similarly fundamental issues
remain such as whether national/regional panels should
have two local Judges on the panel of three, and the
thorny question of bifurcation. There are also the small
matters of how to finance the Court and where all the
Judges will come from.
Hence all that we really have is the grand announcement
from the Competitiveness Council. It now falls to the
Spanish Presidency to take matters further. Spain has
never been a fan of the proposed new system. Hence it
seems inherently unlikely that the Spanish will advance
matters much, although it is a safe bet that they may try
to use their Presidency to further their own agenda on
languages. The second half of the year sees the Belgians
taking over the Presidency, by which time the opinion
of the ECJ may also be available. In consequence, it is
possible that some further progress might then be made,
although whether the Belgians will see it as worthwhile
to invest as much time in the process as the Swedes
remains to be seen. And just to make life even more
uncertain, under the Lisbon Treaty (in force from 1 January
2010) the EU Parliament now has an increased say in
the matter – something to encourage all who followed
the “learned” debate there on computer implemented
inventions a couple of years back.
At the end of our 2008 report we speculated that the best
hope for progress would be the so-called “Emmenthal”
option, that is a system with holes in it, with an agreement
between some EU states for a system with effect in
those states alone, as used for the introduction of the
Euro. We continue to believe that this is the best hope
for agreement given that a decade of trying to reach
unanimous agreement has, in terms of concrete results,
produced absolutely zero.
The first year of the new decade already promises to be
full of interest. In particular, the Court of Appeal plainly
considers that it is important for it and the other Courts
of Europe to align closely with each other and the EPO.
It will be illuminating to see how far this objective is
implemented. Other developments in the year are likely
to include:
• Sooner or later, the newly founded Supreme Court will
hear a patents case, although the authors understand
that no cases are presently listed to be heard.
• The Court Lists continue to be full although, as noted
above, the life sciences and telecoms industries are
set to occupy most of the Courts’ time in the coming
12 months.
• 2010 is likely to witness some important decisions
from the Enlarged Board of Appeal on important
issues including diagnostic methods and possibly
even software patentability.
• It will be interesting to see if the pro-patentee trend
of the English Patents Courts continues.
• Given their enormous importance to leading
pharmaceutical companies, further litigation over the
scope of SPCs and paediatric extensions seems
inevitable.
20
The Authors
01
Brian Cordery
Partner
01
Brian specialises in contentious intellectual property
matters. His practice is divided equally between patents
and other intellectual property rights. Brian’s experience
and knowledge of patents have led him to be involved
with several leading patent cases in recent years. He
also has a strong interest in brands-related disputes
and in particular, interim relief practice and procedure.
02
Ewan Nettleton
Associate
02
Ewan Nettleton is a senior associate in the Intellectual
Property Department at Bristows. He specialises in
Intellectual Property Law with an emphasis on litigation.
He has an MA in Chemistry and a D.Phil in Protein
Chemistry and is particularly interested in matters
relating to the IT and pharmaceutical industries.
03
04
03
Sam Tuxford
Associate
Sam Tuxford is an associate in the Intellectual Property
Department at Bristows. He specialises in Intellectual
Property Law with an emphasis on litigation. He has
a masters degree in engineering and is particularly
interested in matters relating to the engineering,
technology and telecommunication industries.
04
Lorna Ballington
Senior Paralegal
Lorna Ballington is a Senior Paralegal in the Intellectual
Property Department at Bristows. Prior to joining
Bristows, Lorna studied for a BSc in Biology and an
MSc in the Management of Intellectual Property. Lorna
is presently engaged in a global lifecycle management
programme for one of the world’s best-selling drugs.
© Bristows February 2010
Review of Patent Cases in the English Courts in 2009
21
The information contained in this document
is intended for general guidance only. If you
would like further information on any subject
covered by this Bulletin, please e-mail Brian
Cordery ([email protected]),
Ewan Nettleton (ewan.nettleton@bristows.
com) or the Bristows lawyer with whom you
normally deal. Alternatively, telephone on
+ 44 (0) 20 7400 8000.
100 Victoria Embankment
London EC4Y 0DH
T +44(0)20 7400 8000
F +44(0)20 7400 8050
[email protected]
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