Novartis sues Ranbaxy on hypertension drug copy

Novartis, Europe's third-biggest drugmaker, has sued Ranbaxy Laboratories to block sales of a generic version of the blood-pressure medicine, Diovan, in the US.

Ranbaxy, India's second-biggest drugmaker, is seeking US Food and Drug Administration (USFDA) approval to sell a low-cost version of the drug, whose key ingredient is valsartan. Novartis contends that the drug is protected by a patent which expires in 2012.

Diovan is the biggest seller for Novartis, with sales of $1.2 billion in the second quarter.

The company last month cut its 2007 sales-growth forecast because of generic competition to its heart drug Lotrel and Lamisil for nail fungus.

Ranbaxy, based in Gurgaon, originally agreed not to sell the drug until the patent expired. In June, it amended its application to say the patent is invalid, Novartis said in a complaint in the federal court in Newark, New Jersey. Novartis, based in Basel, Switzerland, said Ranbaxy "lacked a good faith basis'' for its claim.

Such lawsuits are frequently filed over prescription drugs to clarify patent rights while the FDA application proceeds.

"This is part of our overall effort to market generic products in a timely fashion, to make them accessible and affordable to the US healthcare system,'' Ranbaxy spokesman Chuck Caprariello said.

The FDA last week gave Diovan an extra six months of protection after its patent expires. The extension through September 2012 was granted as a routine incentive because Novartis tested the drug's effects on children.