Lipitor Worldwide Patent Infrinement Litigation Update

Ranbaxy announced in a press release yesterday that it won a court decision in Norway that Ranbaxy does not infringe two of Pfizer's Norwegian patents on Lipitor.  Pfizer responded with its own press release, announcing that the ruling "has no practical effect on Pfizer's ability to protect Lipitor" from generic competition in Norway because a different Norwegian Lipitor patent was held valid and infringed last year.  Lipitor is the world's best-selling drug, with $12.2 billion in sales last year.

Earlier this month, the U.S. Court of Appeals for the Federal Circuit partially reversed a district court decision that held two Pfizer patents on Lipitor valid and infringed.  The CAFC upheld the ruling as to one of Pfizer's patents, but reversed as to the other, finding a dependent claim of the second patent invalid due to incorrect claim structure.  Pfizer has indicated that it is seeking a reissue of that second patent to correct the claim defect.  If the CAFC's ruling holds up and Pfizer fails in its bid for a reissue patent, generic Lipitor could be launched on the U.S. market in March 2010 rather than June 2011.

MarketWatch.com has a nice article summarizing the state of the Lipitor patent infringement cases between Pfizer and Ranbaxy worldwide.

UPDATE:

• Pfizer announced on Sept. 13 that a court in the Netherlands upheld Pfizer's basic patent on atorvastatin (the active ingredient in Lipitor) and ruled that it would be infringed by Ranbaxy's generic atorvastatin.  According to Pfizer, the patent will not expire until November, 2011.