The Advocate General
delivers her Opinion on the requirements for grant of an SPC for a
partially patented combination product
On 13 July 2011, Advocate General
Verica Trstenjak delivered her Opinion in the joined cases of Medeva
(Case C-322/10) and Georgetown et al. (Case C-422/10) before the
European Unions Court of Justice ("CJ"). Both cases are references
for a preliminary ruling from the UK Courts on the interpretation of
Article 3 of the SPC Regulation (EC Regulation 469/2009) regarding
the requirements for grant of a supplementary protection certificate
("SPC") for a partially patented combination product.
Background
Article 3 of the SPC
Regulation sets out the conditions for the grant of an SPC. Article
3 (a) requires that the product for which the SPC is granted is
"protected by a basic patent". Article 3 (b) requires that the
product which is the subject of the SPC must have a "valid
authorisation to place the product on the market as a medicinal
product". With regard to Article 3 (a) there has been debate whether
it is sufficient for granting an SPC for a combination product that
the product infringes the basic patent ("the infringement test",
which does not require that all components are claimed) or whether
it is required that all parts of the combination are claimed in the
basic patent.
The UK courts have
submitted a number of questions to the CJ asking for clarification
regarding Art. 3 (a) and Art. 3 (b) SPC Regulation.
The Medeva and Georgetown cases
The first reference
to the CJ (C-322/10) was made by the UK Court of Appeal in
Medeva v. Comptroller-General of Patents, Designs and Trade
Marks.
The Medeva case deals
with a multi-component vaccine of which only two components are the
subject of a combination patent. An SPC for the multi-component
vaccine as authorized was refused because the patent did not claim
the additional components. An SPC for the two components of the
multi-component vaccine which were claimed in the patent was refused
in the UK, because the marketing authorisation was granted not for
the two claimed components but for the multi-component vaccine which
includes additional components. In other words, in the case of all
of Medeva's SPC applications there was a mismatch between the active
ingredient protected by the patent and the active ingredients in the
vaccine for which the relevant market authorisations had been given.
The Court of Appeal
in the Medeva case referred to the CJ the questions:
-
what in the
absence of a Community patent law, is the test is for
determining whether the "product is protected by a basic patent
in force" under Art. 3 (a) SPC Regulation, whether there may be
specific criteria for products comprising several active
ingredients and more specifically whether a vaccine containing
multiple antigens is protected by a basic patent, if the patent
protects one of the antigens;
-
whether Art. 3
(b) SPC Regulation allows grant of the SPC for a patented active
ingredient or combination of active ingredients if the marketing
authorisation was granted for a product which includes active
ingredients beyond the ingredients claimed in the patent.
The basic scenario in
the Georgetown case (C-422/10), as referred from the UK High Court
of Justice in Georgetown University et al. v.
Comptroller-General of Patents, Designs and Trade Marks, is the
same, i.e. the basic patent claims an antigen of a vaccine, whereas
the marketing authorisation is for a multi-antigen vaccine,
including additional antigens beyond the claimed ones. The SPC
applications were refused in the UK for the same reasons as set out
above for Medeva.
In the Georgetown
case the High Court referred the same question as the second Medeva
question set out above.
Summary of the Opinion
of the Attorney General
In very short summary
the opinion of the Attorney General states, that
-
it is possible to
obtain an SPC for a product containing a combination of active
ingredients if at least one of the active ingredients is
the subject matter of a basic patent, but that
-
a basic patent
can only support one SPC for a medicinal product containing the
patented active ingredient(s), which SPC must be based on the
first marketing authorisation for such product.
The Attorney General
starts out with a literal interpretation of the SPC Regulation. She
refers to Art. 1 (b) SPC Regulation defining the "product" as "the
active ingredient or combination of active ingredients of a
medicinal product", and concludes that only the combination of all
the active ingredients constitutes the "product", so that Art. 3 (a)
SPC Regulation requires that this combination is protected by a
basic patent. Further, she deduces from Art. 1 (c) SPC Regulation
(the definition of basic patent) that the decisive test for the
question whether the combination is protected by the basic patent is
the subject matter of the patent (i.e. whether the combination is
claimed by the patent) and not whether the patent's protective
effect extends to such combination (i.e. whether the combination
would infringe the patent). This leads her to conclude that based on
such literal interpretation it would not be possible to grant an SPC
in case of a medicinal product in which the combination of active
ingredients is only partially patented.
As a next step, she,
however, argues that such result would not be compatible with the
objectives of the SPC Regulation in particular taking into
consideration that manufacturers may find themselves obliged to
place active ingredients on the market in combination with other
active ingredients, but would (absent a patent on the combination)
not be able to obtain an SPC for this combination. She tries to
resolve this by way of teleological interpretation of Art. 1 (b) SPC
Regulation to the effect that the term product can include also "an"
active ingredient or "a" combination of active ingredients of the
medicinal product. Accordingly it would be sufficient under Art. 3
(a) SPC Regulation that one of the active ingredients or part of the
combination of active ingredients in the medicinal product is the
subject matter of the patent, i.e. claimed in the patent.
She then examines
whether in practice this may lead to a strategy of optimizing
protection by strategically placing different combinations on the
market with a time-lag to obtain various SPCs with different
time-lines. She concludes that this will not be possible due to the
application of Art. 3 (c) SPC Regulation according to which only one
SPC may be granted per product. She concludes that under her
teleological interpretation of Art. 1 (b) SPC Regulation, where the
product can be a single active ingredient or partial combination of
active ingredients of the medicinal product, only one certificate
can be granted for a product containing the active ingredient or
combination, so that the patentee must carefully choose for which
product containing the active ingredient or combination he wishes to
seek the SPC.
In this context the
Attorney General, further points out that the patentee cannot hold
off making this choice, as in accordance with Art. 3 (d) SPC
Regulation he must apply for the SPC based on the first marketing
authorisation for the "product", which under her interpretation of
Art. 1 (b) SPC Regulation means the first marketing authorisation
for a product containing the active ingredient or combination of
active ingredients. She concludes that this result of one SPC per
product with the same active ingredient, leads to adequate results
as the patentee can by relating the SPC application to the central
active ingredient or combination of active ingredients which can be
expected to be contained also in future medicinal products, ensure
that within the limits of the basic patent and during the term of
the SPC also these subsequent products enjoy protection.
Conclusion
If followed by the
CJ, the impact on pharma lifecycle strategies will be significant,
as the first marketing authorisation for a product containing the
patented active ingredient will determine which SPC can be obtained.
If the active ingredient is initially marketed as mono product, a
further SPC for a combination product containing this active
ingredient would not be possible. Whether the SPC for the mono
product can be enforced against the combination product is (contrary
to the Attorney General's assumption) not a foregone conclusion but
instead the subject of litigation in the various Member States.
Finally, it would be interesting to see what effect all this shall
have on already granted SPCs, where based on the same basic patent
SPCs have been granted on single active ingredients and combinations
containing this active ingredient.
For more
information on this case please feel free to contact Ina vom Feld
on ina.vom.feld@twobirds.com.
Source:
Cases C-322/10 and C 422/10, Opinion of Advocate General Trstenjak,
13 July 2011, available
here.
