Ranbaxy wins Lipitor patent war in Norway

A Norway court today ruled that Pfizer Inc's process patent for atorvastatin in Norway was not infringed by Ranbaxy Laboratories' generic version of the cholesterol lowering drug.

However, the court has ruled that the Indian drug maker's product would infringe Pfizer's Norwegian patent on one of the intermediate compounds that go into the making of atorvastatin.

Atorvastatin, sold under the Lipitor brand by Pfizer, earns about $12 billion a year in global sales, making it the highest earning prescription drug in the world.

Two other Lipitor patents were at issue but were not ruled upon by the court. "The judgement is not fully as anticipated. It is a good victory but not a complete victory," said Malvinder Singh, President (Pharmaceuticals), Ranbaxy.

The Norwegian market for the drug is $50 million and growing at 8-10 per cent. The patent on which non-infringement has been declared was expiring in 2016 while the one on intermediate was due to lapse in 2009.

Pfizer on its part, is counting the ruling on intermediate patent as a victory. Ranbaxy can appeal the decision, but it will not be able to market a product made using the patented intermediate compounds unless it prevails on appeal, stated a release on Pfizer's website.

Jeffrey B. Kindler, Pfizer's vice chairman and general counsel, said, "We are pleased with the court's decision, which is a victory not only for Pfizer, but for all innovators pursuing high-risk medical discoveries." Explaining his strategy for launch in Norway, Singh said, "If our appeal is successful and all the regulatory approvals come by as anticipated, we should be able to launch by late 2006 or early 2007. However, even in the worst case scenario, we can launch it in 2009 as the patent in question would expire then."

Ranbaxy plans to appeal immediately to the Norwegian Court of Appeals against the latter judgment (..on infringement of intermediate compound). In addition it plans to file an invalidity action in the Oslo City Court against the intermediate patent, according to a company release.

Atovastatin litigation, which is going on in several countries like US, UK and Austria, is one of the most keenly observed battles between innovator and generic companies. While Ranbaxy won lawsuit in Austria, it faced reverses in the UK recently. The case is due for hearing by the end of this year.