On 24 November 2011, the Court of Justice of the European Union (CJEU) delivered its judgement in two seminal cases relating to Supplementary Protection Certificates (SPCs). Potter Clarkson represented Georgetown University, University of Rochester and Loyola University of Chicago in one case and the party in the other case was Medeva. Our IP Update No 155 discusses the corresponding Advocate General's opinion, which opinion is superseded by the present judgement. The ruling provides significant clarity and is binding on all EU national patent offices and courts.
SPCs and their availability
SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.
Under Regulation (EC) No 469/2009, any "product" that is protected by a basic patent in force and that is validly authorised to be placed on the market as a medicinal product, is eligible for SPC protection, provided that it is new to the market and has not previously been protected by an SPC. The term "product" is defined as: "the active ingredient or combination of active ingredients of a medicinal product".
Cases concerning authorised medicinal products that contain a combination of active ingredients (e.g. A+B) have now brought two issues into sharp relief:
What are the criteria for determining whether a Product is 'protected' by a basic patent in force? What is a 'valid authorisation' to place the Product on the market as a medicinal product? Medeva and Georgetown University et al references
These issues have now been considered by the CJEU upon referral from the UK Courts in appeals lodged by Medeva and Georgetown University et al (cases C-322/10 and C-422/10, respectively).
Both Medeva's and Georgetown University et al's SPC applications relate to vaccines containing multiple antigens authorised in combination. The allowability of the Georgetown University et al and one of the Medeva applications hinges on whether a marketing authorisation for a combination vaccine is a 'valid authorisation' for Products defined as just one of the antigens, or a sub-combination of antigens, present in the vaccine. The allowability of Medeva's other applications depends upon whether a patent that discloses some, but not all, of the antigens in an approved vaccine nevertheless 'protects' the entire combination of antigens for the purpose of securing an SPC.
The CJEU has decided the following.
For an SPC to...