Ranbaxy Challenges Pfizer’s Lipitor Patent — and Wins

PharmaManufacturing.com
08/03/2006

Ranbaxy Laboratories Ltd. (Gurgaon, India) announced Aug. 3 that the U.S. Court of Appeals for the Federal Circuit (CAFC) handed down a judgment in its case challenging two key atorvastatin patents held by Pfizer. Atorvastatin is a cholesterol-lowering drug, marketed by Pfizer as Lipitor, and is the largest-selling drug in the world, with estimated annual sales in the U.S. of $8.5 billion.

CAFC sided with Ranbaxy by invalidating one of Pfizer’s atorvastatin patents, U.S. Patent No. 5,273,995 (‘995) and overturning Delaware District Court judgement in that regard. However, it affirmed the portion of the judgement, which held that Ranbaxy’s product infringes Pfizer’s U.S. Patent No. 4,681,893 (‘893). The ruling followed a hearing in the U.S. CAFC, which took place May 4, 2006.

Commenting on the decision, Jay R. Deshmukh, Senior Vice President, Global Intellectual Property for Ranbaxy said, “We are pleased by the Courts decision on the ‘995 patent and are evaluating our options with respect to the ‘893 patent.”

Subject to the appellate process and market authorization by the U.S. FDA, Ranbaxy now has the opportunity to bring the launch date forward to March, 2010 from June, 2011 with 180-day exclusivity in the U.S. market.

Ranbaxy Laboratories Ltd. serves customers in more than 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in eight countries. For more information, visit www.ranbaxy.com.