Biopharmaceuticals Cardiology Generics Litigation

 News Release - August 2, 2006

Ranbaxy Invalidates Pfizer's '995 Lipitor U.S. Patent

CAFC overturns earlier District Court ruling on the same patent

PRINCETON, N.J., Aug. 2 (HSMN NewsFeed) -- Ranbaxy Laboratories Limited (Ranbaxy) announced today 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 USD 8.5 Bn (IMS - MAT: March 2006).

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 Limited, headquartered in India, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. The Company's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies", resulting in a number of products under development. The Company is serving its customers in over 125 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 49 countries and manufacturing operations in 8 countries.

Source: Ranbaxy Laboratories

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