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Ranbaxy one up against Pfizer of the two patent cases
By agencies
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Thursday, 03 August 2006, 19:30 IST
NEW DELHI: Ranbaxy Laboratories Limited has stated that the US Court of Appeals for the Federal Circuit (CAFC) handed down a judgment in its case challenging two key atorvastatin patents held by Pfizer.
"CAFC sided with Ranbaxy by invalidating one of Pfizer's atorvastatin patents U.S. Patent No 5,273,995 and overturning Delaware District Court judgment in that regard," Ranbaxy Laboratories Ltd said in a statement on Thursday.
Atorvastatin is a cholesterol-lowering drug, marketed by U.S.-based Pfizer as Lipitor. It is the largest-selling drug in the world with estimated annual sales in the US of $8.5 billion.
"We are pleased by the court's decision on the '995 patent and are evaluating our options with respect to the '893 patent," said Jay R Deshmukh, senior vice president of global intellectual property for Ranbaxy, who is now weighing the options for fresh appeal as it is keen to tap the U.S. market with its own cheaper generic drug.
However, it affirmed the portion of the judgment, which held that Ranbaxy's product infringes Pfizer's U.S. Patent No. 4,681,893 (893). The ruling followed a hearing in the US CAFC, which took place May 4, 2006.
Subject to the appellate process and market authorization by the US 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.