Aurobindo Pharma in patent litigation cases in US

Hyderabad: Three multinational drug makers—The Medicines C., Hospira and Kowa Co. Ltd, in separate cases—have dragged Indian firm Aurobindo Pharma to court on allegations of patent infringement.

According to the petition copies, Hospira has alleged that Aurobindo’s abbreviated new drug application (ANDA) to make a generic version of a dexmedetomidine hydrochloride injection would infringe its patented drug Precedex. Aurobindo officials were unavailable for comments. However, a market analyst said that “these patent infringement cases are not uncommon for generic drug maker. The product launch will depend on the outcome of the court and US FDA (Food and Drug Administration) approvals”.

Hospira filed the petition in the US district court of Delaware. The drug is used for the sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. Similarly, the Medicines Co. in a separate petition filed in the district court of New Jersey alleged that the Indian drug maker’s ANDA would infringe on it’s drug—Angiomax—on two counts. Angiomax (bivalirudin) is used as an anticoagulant in patients with unstable angina undergoing percutaneous translurninal coronary angioplasty. Kowa in its petition filed in Ddstrict court of the Southern District of New York alleged that Aurobindo’s recent ANDA with US FDA would infringe on its patented drug Livalo (Pitavastatin) on four counts. Pitavastatin is used as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides, and to increase high-density lipoprotein cholesterol.

“Plaintiff request the following relief...a permanent injunction restraining and enjoining against any infringement by defendants...of the Livalo patents, through the commercial manufacture, use, sale, offer for sale or importation into the United States of Aurobindo’s pitavastatin drug product or any drug product containing Pitavastatin,” Kowa prayed the court in its petition. Kowa also filed a similar petition against another Indian drug maker Zydus Pharmaceuticals on the same drug.