Pharma Companies Sparring Over Discount Drug

Valsartan, an angiotensin receptor blocker and important drug for the treatment of high blood pressure, has become the focal point of recent tensions between two rival drug companies. Novartis, who manufactures and sells the drug under the brand name Diovan, has sued rival Ranbaxy to block the production of a cheaper, generic alternative.

Ranbaxy has petitioned the FDA for permission to manufacture and sell the drug, saying that its effectiveness as a hypertension treatment is being limited by price inflation from patent protection that gives Novartis the exclusive right to make and market the drug.

While the two companies had earlier reached a deal by which Ranbaxy would begin production of a generic version of valsartan in 2012, new documents filed in federal court, and submitted to the FDA, show that Ranbaxy is now challenging the Novartis patent as "invalid," claiming that Novartis was inappropriately granted a patent extension. The FDA is reviewing the matter but says that patent extensions are standard practice in cases where drug companies pay to expand the testing of drugs on different patient populations.

While a long legal battle is likely to result, the disagreements bring the drug patent process, which many have criticized as being too focused on companies instead of patients, to the forefront.