SPCs For Combination Products Conditionally Possible

Author:Mr Gertjan Kuipers
Profession:De Brauw Blackstone Westbroek N.V.

The Court of Justice of the European Union ("CJ") ruled on 24 November 2011 that a marketing authorisation ("MA") granted for a multi-disease vaccine of which not all active ingredients fall within the basic patent, does not prevent the granting of a supplementary protection certificate ("SPC") for an active ingredient specified in the wording of the claims of the basic patent. Disharmony existed in Europe regarding the applicability of Regulation 469/2009 (the "SPC Regulation"') to "combination products". This ruling now means that innovative pharmaceutical companies can benefit from SPCs even when the patent does not protect the combination product for which an MA was granted. However, an SPC cannot be granted for the combination product as such but only for the patented part of the combination product.

Background: what are the conditions for obtaining an SPC?

SPCs are intended to compensate pharmaceutical companies for the loss of effective patent term caused by the delay in getting regulatory approval for medicinal products. An SPC follows and replaces the basic patent after the end of the general protection term and provides a maximum of five years of supplementary protection. The conditions for obtaining an SPC, as set out in art. 3 of the SPC Regulation, include that at the time of the application

(a) the product is protected by a basic patent in force (b) a valid authorisation to place the product on the market as a medicinal product has been granted. Additional conditions are: (c) the product has not already been the subject of an SPC (d) the MA referred to in (b) is the first authorisation to place the product on the market as a medicinal product.

What is the issue with combination products such as multi-disease vaccines and the SPC Regulation?

The SPC Regulation defines a 'product' as the active ingredient or combination of active ingredients of a medicinal product. If the (combination) product is (i) fully specified in a patent, and (ii) the MA was granted for the same (combination) product, no issue arises. However, a mismatch may occur between the 'product' that is patented and the 'product' for which an MA was granted. This issue is especially significant for multi-disease vaccines as is the case in both Medeva (C-322/10) and Georgetown (C-422/10). Due to public health policy, vaccines frequently contain a combination of active ingredients directed at a number of different diseases, so that only one injection is needed to...

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