In a morale booster for the Indian pharmaceuticals industry, reeling under a flood of patent infringement litigations, the world?s largest generic drug manufacturer, Teva, has withdrawn a case filed against Mumbai-based USV Ltd. Teva had accused USV of infringing the patent of Teva?s carvedilol active pharmaceutical ingredient (API), the major ingredient in GlaxoSmithkline?s (GSK?s) cardiac drug, Coreg.
Meanwhile, the US Food & Drug Administration gave its approval for generic versions of Coreg to Aurobindo Pharma, Caraco Pharma, Dr Reddy?s Laboratories, Glenmark Pharmaceuticals, Lupin, Ranbaxy Laboratories and Zydus Pharmaceuticals on September 5, the same day of its patent expiry.
Last month, a lawsuit against USV was dismissed ?without prejudice? by Judge John Hughes of the US district court for the district of New Jersey at Teva?s request. The judge also ruled that USV has the right to import carvedilol into the US. The verdict makes USV free to re-file a drug master file for carvedilol (base or phosphate). The current US sale of Coreg stands at $1,555.4 million, with global sales of $2,211 million.
On July 3, FE had reported Teva?s filing of suits against Ranbaxy, Dr Reddy?s Labs, Lupin, Orchid, Cadila Pharmaceuticals, USV Ltd and Wanbury Ltd alleging the firms infringed the patent that Teva has been granted for carvedilol API.
K Rajendran, head, knowledge cell, USV, said, ?This move by Teva may be interpreted as a market protection move aimed at stopping these future generic players as long as it can and reaping a financial windfall while it lasts.?
Mark Pohl, the US pharmaceutical patent attorney who represented USV, said, ?We informed Teva that USV would seek a hefty fine against them, as Teva?s action is an attempted monopolisation which is a federal antitrust violation. In this way, USV was not looking either to file a counter suit or ask for a simple dismissal of the case.? Later, in court, Teva?s lawyers said the suit against USV had no basis, and that it should be dismissed, he added.