The Court
of Justice of the European Union has issued new judgment interpreting Articles
1, 3, and 13 of Regulation (EC) No. 469/2009 concerning the supplementary
protection certificate (SCP) for medicinal products.
The
judgment (Case C-577/13) was issued in the context of a dispute between the
Actavis and Boehringer Ingelheim pharmaceutical companies. The question
referred to the CJEU for a preliminary ruling basically comes down to whether
an SPC may be sought for a combination of two products included in the claims
after the initial grant of the basic patent, subsequent to amendment of the
said patent. The combination was composed of: (i) an active ingredient claimed
as the sole subject matter of the invention, for which the holder had already
obtained a first SPC (telmisartan) and (ii) a second substance
(hydrochlorothiazide) within the public domain.
In response
to the questions from the referring court, the CJEU made the following
preliminary observations:
- First, the expression "as such" as used in Article 1(c) and Article 3(a) of the EU Regulation is to be interpreted autonomously in light of the objectives pursued by that Regulation and the "subject matter of the invention" covered by the basic patent.
- Second, where a patent claims several products, it may be possible to obtain several SPCs for the different products, provided that each of the said products "as such" is protected by the basic patent and constitutes the "subject matter of the invention" covered by the patent.
On that
basis, the CJEU ruled that a second SPC may not be obtained for a product
comprising a combined product composed of an active ingredient that is the sole
"subject matter of the invention" for which an SPC has already been
obtained in combination with another substance. In the CJEU's view, in the case
that concerns us here the combination of the active ingredients telmisartan and
hydrochlorothiazide, the latter being in the public domain, is not the true
"subject matter of the invention" covered by the basic patent.
The CJEU
based its decision in this case on the requirement to balance the interests of
the pharmaceutical industry and those of public health, since unlimited
entitlement to multiple SPCs for subsequent marketing of an active ingredient
by combining it with another ingredient or substance that is not the subject
matter of the invention as originally protected would tip the balance in favour
of the former.
The CJEU
thereby upheld previous case law set forth in earlier judgments concerning SPCs
for combinations of products (see cases Actavis vs Sanofi – C-443/12 – and
Georgetown University II – C-484/12). The judgment leaves undecided the
question as to whether a patent may be amended after grant so as to insert
claims for a combination of products that could comply with the requirements
for obtaining an SPC. However, while this question was not expressly addressed,
the CJEU appears to be implicitly opposed to that possibility.
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