Pfizer Inc said today (In a press release) that the Court of Appeal of Barcelona has upheld the company's enantiomer patent (ES2153332) covering the calcium salt of atorvastatin, the active ingredient in Lipitor, reversing the lower court decision. The enantiomer patent expires in July 2010.
The patent was challenged jointly by generic companies Laboratorios Cinfa S.A., Kern Pharma S.L., Laboratorios Alter S.A. and Laboratorios Belmac S.A., and is one of four separate challenges to the enantiomer patent by generic companies in Spain. Lipitor is sold in Spain under the brand names Zarator and Cardyl. "This is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries and for the patients who benefit from those discoveries," said Pfizer Senior Vice President and Associate General Counsel Peter C. Richardson. Cinfa, Kern, Alter and Belmac can seek to appeal the decision to the Supreme Court of Spain.
Earlier Pfizer has asserted that it intends to litigate aggressively in order to defend its products. ( pfizer press release)
Earlier Decision in Spain
1) In December 2005 Madrid Court of First Instance finds enantiomer patent valid and enforceable.
2) In September 2006 Barcelona Mercantile Court finds some claims of the Basic patent invalid in two separate decisions against generic companies like Lek and Laboratorios Cinfa
3) In October 2006 Madrid Court of Appeal rejects appeal in relation to enantiomer patent. however At the request of Barcelona Mercantile Court, the European Patent Office (EPO) provides an advisory opinion (news-medical) holding the Basic patent valid. Ranbaxy issues statement to investors referring to the earlier Barcelona Mercantile Court decisions and announced that the EPO opinion is not legally enforceable.
4) On 25 July 2007 The Commercial Court of First Instance in Barcelona, has upheld the enantiomer patent covering the calcium salt of atorvastatin. However Stabilized formulation patent ES2133158 (Expiry: December 2013) for Atorvastatin was held invalid and unenforceable.
5) on 23 October 2007 Court of Appeal of Barcelona upheld Pfizer's Enantiomer patent covering the calcium salt of atorvastatin reversing the lower court decision. The calcium salt patent expires in July 2010. Generic manufacturer Lek Pharmaceuticals challenged the patent
