Janssen HIV Drug U.K. Patent Extension Case to Go to EU Top Court

摘要

Sandoz Ltd.'s lawsuit to clear the way for its generic version of the Prezista HIV drug will now go to the Court of Justice of the European Union. The England and Wales Court of Appeal (Civil) Jan. 25 referred the dispute to the EU's top court, to clarify how to determine whether a particular product is covered by a supplementary protection certificate (SPC), which extends the protection term for certain patent rights for drugs. SPCs are governed by EU law and are designed to make up for some of the patent protection term lost to the market approval process.