August 08, 2006
Appeals court: Ranbaxy can bring forward generic Lipitor launch date
A federal appeals court deemed one Lipitor patent invalid, reversing a lower court’s decision, and upheld another, decreasing by a year Pfizer’s patent exclusivity on the anti-cholesterol drug.
The decision by the Court of Appeals for the Federal Circuit in Washington means Lipitor remains under patent until March 2010. The patent that the court reversed would have staved off generic competition until June 2011.
The original lawsuit was brought by Pfizer in 2003 against generic manufacturer Ranbaxy, which is attempting to sell a generic version of atorvastatin.
Peter Richardson, Pfizer associate general counsel, said in a statement that Pfizer was “disappointed” by the ruling on the 2011 patent. “The decision turned on a technical defect in the patent. There is a process for correcting such defects in the U.S. Patent and Trademark Office, and Pfizer plans to pursue that option.”
Jay Deshmukh, Ranbaxy senior VP, global intellectual property, said the firm was pleased by the court’s decision on the 2011 patent and that Ranbaxy is evaluating its options with respect to the 2010 patent. The firm has 180-day exclusivity of a generic version in the US market.
In December a Delaware federal court ruled in favor of Pfizer on both Lipitor patents, saying Ranbaxy’s planned generic infringed upon them. That court then enjoined Ranbaxy against selling generic atorvastatin before June 2011. Ranbaxy appealed, leading to the recent decision.
Global sales for Lipitor were $12.2 billion last year, making it the best-selling drug in the world.