BioCentury
ARTICLE | Politics & Policy

EU court ruling clarifies SPCs for combo products

December 2, 2011 1:17 AM UTC

The EU Court of Justice issued a ruling clarifying the conditions for obtaining additional patent life for products comprising more than one active ingredient or for vaccines against multiple diseases. The case was referred to the ECJ by the Court of Appeals of England and Wales, which sought a ruling on the interpretation of Article 3 of Regulation No. 469/2009 covering supplementary protection certificates (SPCs) before ruling in a suit related to SPC applications from Medeva BV.

Medeva is appealing the European Patents Office (EPO) 2009 rejection of its SPC applications for multivalent vaccines. EPO ruled that four of Medeva's SPC applications contained more active ingredients than were identified in the supporting patent. EPO rejected a fifth application for two active ingredients, saying that although the supporting patent identified both ingredients, the supporting marketing authorization covered a product with nine ingredients. Medeva was acquired in 2000 by Celltech Group, which UCB Group (Euronext:UCB) acquired in 2004. ...