ES - Cinfa v. Pfizer / Amlodipine / Cassation Appeal

Laboratorios Cinfa, S.A. v. Pfizer Ltd., Pfizer Corporation & Pfizer, S.A., Supreme Court, Spain, 30 June 2010, Docket No. 1785/2006.

On 30 June 2010, the Supreme Court rendered a decision putting an end to the long-lasting proceedings in which Pfizer and Laboratiorios Cinfa (Cinfa) have been confronted for 8 years in relation to the marketing in Spain of generic drugs of amlodipine besylate. Contrary to what both the First Instance Court and the Court of Appeals had previously declared, the Supreme Court understood that Cinfa could not take advantage of the experimental use exception to patent rights -as drafted subsequent to the insertion of the “Bolar Provision” in the Spanish Patents Act- to elude the infringement of Pfizer’s patents ES 2012803 (EP 244944) and ES 520389 with respect to the activities carried out aimed at obtaining the corresponding marketing authorization from the Spanish Medicines Agency, thus declaring the Supreme Court the infringement of Pfizer’s patents.