ECJ Clarifies Requirements For Award Of Supplementary Protection Certificate For Medicinal Product

Author:Van Bael Bellis
Profession:Van Bael & Bellis

On 24 November 2011, the Court of Justice of the European Union ("ECJ") delivered its judgments in case C-322/10 Medeva BV ("Medeva") v. Comptroller General of Patents, Designs and Trade Marks and case C-422/10 Georgetown University, University of Rochester, Loyola University of Chicago v. Comptroller General of Patents, Designs and Trade Marks. The ECJ judgments address the requirements for granting a Supplementary Protection Certificate ("SPC") to medicinal products. In particular, the judgments clarify the requirement for the relevant active ingredient or combination of active ingredients to be found in the wording of the claims of the basic patent relied on. The judgments of the ECJ are likely to affect how SPCs will be granted in the future and may even open the door for invalidation procedures against existing SPCs.

Under Regulation (EC) No 469/2009 of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the "SPC Regulation"), SPCs are granted for medicinal products for which the period that elapses between the filing of an application for a patent for a new medicinal product and the authorisation to place the medicinal product on the market makes the period of effective protection under the patent insufficient to recover the investment that went into the research of the product. Article 13 of the SPC Regulation allows for a single extension of the period of exclusivity afforded by the patent for a maximum period of five years. However, the subject matter of the SPC is different to the subject matter of the patent. Whereas a patent can be granted for any invention, an SPC is granted specifically for a medicine for which a marketing authorisation was obtained.

The cases at hand relate to the application for SPCs for vaccines. Patents underlying these vaccines are often granted for a single vaccine, with a specific combination of active ingredients. However, vaccines put on the market by the applicants for the SPC are often based on a market authorisation for a multi-disease vaccine, including a number of active ingredients that are not mentioned in the basic patent.

In the first case, case C-322/10, Medeva filed five applications for SPCs which were refused by the UK Patent Office. Four of the five applications were rejected because the SPC application mentioned more active ingredients than the basic patent, and the fifth application was refused because the marketing authorisation to which it referred...

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