3 September 2010

ECJ Rules on SPC Application Time-Limits - Case C-66/09

ECJ Rules on SPC Application Time-Limits - Case C-66/09

Questions concerning Supplementary Protection Certificate (SPC) applications filed in new member states of the European Union were referred to the European Court of Justice (ECJ) by the Supreme Court of Lithuania in February 2009. The ECJ has now handed down its decision, effectively ending the SPC applicant's request for an SPC in Lithuania relating to Aranesp (treatment of anaemia).

The ECJ ruled that for the purpose of calculating the time-limit for filing an SPC application, the date on which Lithuania acceded to the European Union should not be understood as the date on which the Community market authorisation was granted for this product in Lithuania. Amgen's marketing approval was granted prior to six months before Lithuania's ascension to the EU, and they had therefore tried to obtain an SPC based on the date of ascension.

A full report of the ECJ judgment will follow shortly.