1
Practical Experience of
Supplementary Protection Certificate
Strategy and Prosecution
September 2015
Graham Lewis
[email protected]
www.jakemp.com
Contents
• Brief introduction
• (Very) recent news from the CJEU
• SPC Case study
• SPCs in the biotech field
• Update from the UK IPO
• Questions/discussion
(Very) Recent News from the CJEU
C-471/14 (Seattle Genetics)
Questions referred from the Austrian PTO:
1. Is the date of the first authorisation … determined under
Community law, or… the law of the respective
member state?
2. If …Community law: which is the relevant date – that of
the authorisation or that of the notification?
AG opinion issued 10 September is firmly that (1) Community law
applies and (2) that the relevant date is the date of notification
Consistent with the position adopted by the UK IPO
Answer only relevant to Article 13 (SPC term) or also Articles 3 and 7
(which MA is first, time limit to apply)?
SPC Case Study
The Product
The product is authorised for the treatment of disease x
and:
-
comprises a polypeptide with a specified amino acid
sequence;
and a methoxy(m) Polyethylene glycol (PEG) moiety;
which is attached to a specific amino acid in an external loop
of the polypeptide;
via a trisaccharide linker
trisaccharide linker
mPEG
protein
external loop
SPC Case Study
Basic Requirements
1.
The product is protected by a “basic patent” in
force in the country in question (Article 3(a))
2.
There is a valid marketing authorisation in that
country to place the product on the market as a
medicinal product (Article 3(b))
3.
The product has not already been the subject of an
SPC (Article 3(c))
4.
The marketing authorisation is the first marketing
authorisation in the country for that product (Article
3(d))
SPC Case Study
The Patent(s)
Claim 1 of parent:
A … polypeptide comprising:
the specified amino acid sequence of the product;
and a first chemical moiety which is PEG; wherein
the first chemical moiety is indirectly attached via a
second moiety to the specified external loop of the
polypeptide
Patent granted some time ago and the opposition period has expired
trisaccharide linker
protein
mPEG
external loop
SPC Case Study
The Patent(s)
Claim 1 of divisional:
A … polypeptide for use in a method of treating disease x, the
polypeptide comprising:
[definition as in parent]
[definition considered to be stronger for validity]
[definition considered to be more precise for product]
Patent granted recently and the opposition period will not expire until
after the deadline for filing an SPC application
trisaccharide linker
protein
mPEG
external loop
SPC Case Study
Article 3(c) - A Difficult Decision?
Which patent should the patentee use for the SPC
application?
General considerations:
- Term of any SPC
- Vulnerability of the patent to attack
- Suitability of the claims for an SPC
Can the claims be improved by post-grant amendment?
Not clear - C-577/13 Actavis v Boehringer
SPC Case Study
Article 3(c) - Maybe Not so Difficult….
Does the patentee actually need to make a choice?
‘The holder of more than one patent for the same product shall not
be granted more than one certificate for that product. However,
where two or more applications concerning the same product and
emanating from two or more holders of different patents are
pending, one certificate for this product may be issued to each of
these holders.’
Consider assignment of one of the patents to a separate
legal entity
File SPC applications in parallel on both patents, in the
names of different applicants. Do so openly.
SPC Case Study
Article 3(a)
trisaccharide linker
mPEG
Is the product protected
by the basic patent(s)?
protein
external loop
• Does methoxy PEG fall within “PEG” as required in claim 1 and, if yes,
does it matter that methoxy PEG is not specified in claim 1?
• Does it matter that the exact position on the external loop where the
linker joins is not specified in the claims?
• Does it matter that the nature of the linker is not defined in the claims?
Most Patent Offices raised objections under Article 3(a) in connection with
one or more of the above
SPC Case Study
Article 3(a)
trisaccharide linker
mPEG
Is the product protected
by the basic patent(s)?
protein
external loop
Not an infringement test
•
Active ingredients must be “specified in the wording of
the claims” (Medeva C-322/10)
•
For functionally defined ingredients, the
claims must relate “implicitly but
necessarily and specifically” to the active ingredient
(Eli-Lilly v HGS C-493/12)
Since applied by referring UK court in EWHC 2404:
“An antibody which specifically binds <target>” is OK
SPC Case Study
Article 3(a)
•
•
•
•
•
Argue based on understanding of “PEG” by person skilled in the
art
Argue that the exact location and exact nature of the linker are
provided at the required level of specificity because they are
encompassed by functional definitions as in Eli Lilly (C-493/12)
Argue that Medeva is concerned with combination products of A +
B - no suggestion that CJEU was seeking to impose a higher level
of specificity for a single active ingredient
Such an interpretation would lead to injustice – holder of broad
claim to pioneering (novel and inventive) generic claim in worse
position than holder of narrow claim to incremental invention
Successful in Austria, Denmark, Luxembourg, Greece and Italy
(on appeal)
How might the UKIPO have viewed this scenario?
SPC Case Study
Article 3(b) – “Squatter” SPC
Does anything in our case study change if the MA was granted to a third
party?
• Article 3 EU Regulation 469/2009 allows the holder of a patent which protects
an authorised product to apply for an SPC
• The product must be covered by MA, but patent holder need not be the
authorised party - possibility of SPCs based on MA held by unrelated third
parties endorsed in Biogen v SKB (C-181/95)
• Followed by UK High Court in Eli Lilly vs Human Genome Sciences Inc, with
the judge concluding:
“that the holder of a basic patent can make an application for an SPC in
reliance on an MA granted to a third party having no connection of any
sort with that holder. I do not consider that there is any real doubt about
this such as would justify a reference to the ECJ…”
SPC Case Study
Article 3(b) – “Squatter” SPC
• In the scenario upon which our case study is based, in general we
were able to persuade Patent Offices to follow Biogen (C-181/95) as
the leading case on this point
• J A Kemp is responsible for prosecuting series of SPC applications
where applicant does not hold marketing authorisation and the same
reasoning has usually been accepted
• The CJ-EU indicated in HGS v Eli-Lilly (C-493/12) that grant of an SPC
where the product is not specified in the claims because the applicant
“has not invested in the research leading to the invention” would
undermine the objectives of the Regulation – this could lead to more
objections from patent offices…
• However, the CJ-EU in Eli Lilly had not been asked to consider Article
3(b) and so arguably this comment does not supplant Biogen. In
addition, the CJ-EU overlooked investment HGS made in the “basic”
research which identified the antibody target.
SPC Case Study Article 3(b) – “Squatter” SPC:
Could the MA Holder have Done Anything?
July 1994
- filing
date of
A’s
patent
June 2014 – B
receives MA before
expiry of patent, so
squatter SPC
possible
July 2014
– expiry
date of
A’s
patent
August 2014 – B
receives MA after
expiry of patent, so
squatter SPC not
possible
• B could avoid risk of squatter SPC by delaying MA until after expiry date
• But if B receives MA just before expiry date and launched product just
after then:
 If A is granted a squatter SPC, then B can be sued for infringement for launching
product after expiry of patent
 If A is not granted a squatter SPC, then B’s launch of product will not infringe
– Is this outcome really the intention of the legislators?
SPC Case Study Article 3(b) – “Squatter” SPC:
Could the MA Holder have Done Anything?
• In the scenario upon which our case study is based the MA
holder did not delay the MA. What else could they do?
File third party observations
• National Patent Offices may not have explicit provisions
to deal with third party observations against an SPC
application
• BUT in our experience, most Offices will take
observations into account. The third party is not
generally made a party to proceedings.
• Position of UK IPO is clear (and recently confirmed in Case
O/552/14)
Neurim – Based Divisional Applications
Pending patent applications with filing date after 2010 could usefully be
divided into:
• A parent application with a broad claim to treating cancer (SPC expiry
2030)
• A divisional application specifically restricted to treating lymphoma
(SPC expiry up to 2035)
General Practical Tips
• Ensure, if possible, that patents grant with claims
directed specifically to clinical candidates – including
those of competitors! (post-grant amendment may be an
option)
• Applies particularly for combination products – include
claims directed to combinations of specific actives
• Consider divisionals / assignments to allow for multiple
SPC applications
• File new selection invention patent applications to
specific products covered more generally in earlier
filings
SPCs in the Biotech Field
As well as small molecules, SPCs are also available for
biotech inventions
•
–
–
–
Polynucleotides
Polypeptides, e.g. proteins, hormones, antibodies
Viruses, including inactive and attenuated viruses, e.g. vaccines
•
EU Regulatory framework allows for “biosimilar” products
to be approved by reference to an existing product via an
abbreviated pathway
•
Can an SPC be obtained which covers both the original
product and any biosimilars?
•
An SPC to a small molecule also covers generic versions,
including salts and esters (Farmitalia)
Possible Strategy for Covering Biosimilars
•
Have previously sought SPC protection for an antibody where:
–
The SPC applications define the antibody using a set of
definitions, and
–
The broadest definition specifies the antibody in terms of its
binding properties and the amino acid sequences of its CDRs
•
According to the broadest product definition, the SPCs cover
antibodies that have the same CDRs but otherwise different
sequences
•
Such an SPC, if granted, ought also to cover biosimilars
•
Some Patent Offices have granted such SPCs
•
Still possible? UK IPO view?
Enter EFTA
•
Recent SPC dispute in Norway has led to a decision from
the European Free Trade Association (EFTA) court
•
Norway is not an EU country, but as a member of the EEA
some law is harmonised with EU law, including SPC
provisions
•
EFTA decision implies only narrow protection available for
biotech products (specifically vaccines)
•
Similar effect to a CJ-EU judgement for the EU
Pharmaq v Intervet (E-16/14)
•
Patent granted to Intervet for a vaccine against viral
pancreatic disease in salmonid fish
•
Vaccine is an inactive form of a particular strain (SAV-1) of
the virus
•
Marketing Authorisation granted to Intervet in respect of
SAV-1 vaccine
•
SPCs granted to Intervet for vaccine defined as the SAV-1
strain, “or closely related strains which share similar
genotypic and/or phenotypic characteristics”
•
Competitor Pharmaq sell a vaccine against viral pancreatic
disease in salmonid fish based on SAV-3 strain
Pharmaq v Intervet
Two key questions before the Court
1
What is the scope of Intervet’s SPC?
“the scope of protection conferred by an SPC extends to a specific
strain of a virus covered by the basic patent, but not referred to in
the marketing authorisation for a virus vaccine […] only if the
specific strain constitutes the same active ingredient as the
authorised medicinal product”
2
Is Intervet’s SPC invalid insofar as it is not limited to the
specific strain authorized?
“A supplementary protection certificate is invalid to the extent it
is granted a wider scope than that set out in the relevant
marketing authorisation”
SPCs and the Unitary Patent
•
•
•
•
No provision for a unitary SPC
Most national Patent Offices appear to be comfortable
with the option to grant SPCs under the current
Regulation, with a unitary patent as the “basic patent in
force”
Industry bodies have made various proposals including
centralized examination of an SPC by a “virtual Office” of
experts, that would then result in individual national SPCs.
No official position as yet
A missed opportunity to include extension provisions
directly in the legislation for the unitary patent and/or
revise the SPC regulation?
Update from the UK IPO
•
Recent decisions relating to SPCs for medical devices
•
Product by Process claims: Icahn School of Medicine at
Mount Sinai's application (Case O/552/14)
•
Implications of Actavis v Warner-Lambert?
Any Questions?
Date
Name of Attorney
Email address of Attorney
www.jakemp.com