13 July 2011

SPCs on Combination Products – Advocate General Gives with One Hand and Takes With Another

SPCs on Combination Products – Advocate General Gives with One Hand and Takes With Another

The Advocate General (AG) of the Court of Justice of the European Union has issued his opinion on 13 July 2011, on two of a series of four referrals (Medeva and Georgetown University). These referrals relate to Supplementary Protection Certificates (SPCs) for medicinal products comprising a combination of active ingredients.

The AG considered that a valid marketing authorisation exists for a single active ingredient (A) even if that authorisation relates to a medicinal product which is a combination of active ingredients (A + B). If followed by the full Court, this would permit grant of an SPC for a medicinal product containing only A even when the authorisation relates to A + B.

The AG also considered that national patent law should be followed when deciding whether a product is protected by a basic patent in force. However, he specifically rejected the 'infringement test' (whether the product would infringe the basic patent) for the purposes of answering this question. If followed by the full Court, this could prevent grant of an SPC for a medicinal product containing A + B when the basic patent relates only to A.

The AG's opinion on the other two referrals on this topic (Yeda and University of Queensland) is still awaited – we will update you on these opinions as soon as they are available.