Pfizer to appeal Lipitor ruling

Pfizer has announced that it intends to appeal the decision of a German court published this week regarding its patent of the active ingredient in its cholesterol-lowering drug, Lipitor.

The Federal Patent Court in Munich revoked the company’s patent over atorvastatin calcium, which is due to expire in July 2010, following a legal challenge by Ranbaxy Laboratories and Basics, two generic pharmaceuticals manufacturers.

Pfizer maintains that this court decision has no commercial impact on the firm, as neither Ranbaxy nor Basics have secured regulatory approval to supply a generic atorvastatin-containing drug in Germany, while Pfizer’s basic patent over atorvastatin expires after the enantiomer patent.

“Pfizer said it will appeal the decision, a process expected to take two to three years,” the company reports.

“The ruling will have no effect on a pending challenge to the basic atorvastatin patent in Germany by the same two companies.”

The company also notes that the federal court decision will have no impact on other patent litigation regarding Lipitor being conducted in other countries worldwide.

In July 2007, Pfizer announced that a high court in Dublin awarded in its favour regarding its patent over atorvastatin, ruling that a competing product from Ranbaxy would infringe the company’s Lipitor patent, which is due to expire in Ireland in November 2011.