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(R), 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.
Ranbaxy Laboratories Limited
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