Pfizer Inc said that the Federal Patent Court in Munich, Germany has revoked the companyâs patent covering atorvastatin calcium, the active ingredient in Lipitor. The patent at issue in the lawsuit (EP 409,281) expires in July 2010. The decision - which resulted from a patent challenge by generic manufacturers Ranbaxy Laboratories Limited and Basics GmbH - has no immediate commercial impact because neither company has regulatory approval to sell a generic atorvastatin product in Germany, and because Pfizer's basic patent covering atorvastatin remains in force, and expires after the enantiomer patent. That patent expires in November, 2011. Lipitor is sold in Germany under the brand name Sortis.
Pfizer said it will appeal the decision, a process expected to take two to three years. The ruling will have no effect on a pending challenge to the basic atorvastatin patent in Germany by the same two companies. Pfizer also noted that the decision will have no impact on patent litigation involving Lipitor in other jurisdictions around the world.
For further information, visit www.pfizer.com.