Short Summary of the Medeva/Georgetown CJEU Hearing

Many thanks to Hugh Goodfellow (Carpmaels & Ransford) and Brian Cordery (Bristows) for submitting the report below on the Medeva/Georgetown hearing before the CJEU on 12 May 2011.

"On 12 May 2011, the Court of Justice of the European Union (CJEU) heard the joined cases of Medeva (Case C-322/10) and Georgetown (Case C-422/10) - both references from the UK Courts on the interpretation of certain provisions of Article 3 of the SPC Regulation (EC Regulation 469/2009).

For those readers who are not intimately familiar with the issues referred (and thus may have inadvertently stumbled across this blog), Article 3 of the SPC Regulation sets out certain conditions for an SPC to be obtained. Article 3(a) requires that at the time the SPC application is made, the product which is the subject of that SPC must be “protected by a basic patent in force”. Article 3(b) requires that “a valid authorisation to place the product on the market as a medicinal product” has been granted at the time that the application for the SPC is made.

Representatives for Medeva, Georgetown, the UK and Portuguese Governments, and the Commission gave oral submissions to a panel of five judges: (Jean-Claude Bonichot (France), Lars Bay Larsen (Denmark), Camelia Toader (Romania), Alexandra Prechal (The Netherlands), and Egidijus Jarašiunas (Lithuania)).

Medeva and the UK Government advocated applying a so-called “infringement test” when considering Article 3(a), such that a combination of A+B would be protected by a patent for A because the patent would be infringed by the combination. For the UK Government, this represents a complete shift in thinking from the position previously adopted by the UK IPO on this issue. From the oral submissions made to the Court at the hearing, it was unclear what approach the Commission would prefer.

On Article 3(b), Georgetown and the Commission both considered that this should be interpreted so that a marketing authorisation (MA) for A+B could be specified as a valid authorisation to obtain an SPC for A, if the MA for A+B represents the first approval for A. The UK Government was opposed to this idea.

At the hearing, reference was made to questions submitted by the Court to the parties and the other bodies represented at the hearing on Article 4 (Subject Matter of Protection) and the Biogen decision (C-181/95). Those questions and the answers submitted to the Court have not been made public. However the representative for the Commission stated that an analysis of Article 4 was not necessary in order to be able to interpret Article 3.

The opinion in these cases will be delivered on 13 July 2011 by Advocate-General Verica Trstenjak of Slovenia. The actual decision of the Court – which of course may follow the AG’s opinion or deviate from it - will follow several months later."