AstraZeneca files patent suit against Indian partner Torrent over blockbuster cholesterol drug Crestor; Eli Lilly loses Gemzar patent appeal

Anglo-Swedish drug major AstraZeneca has filed a Para IV patent infringement law suit against the Gujarat-based Torrent Pharmaceuticals and its US subsidiary for its alleged move to manufacture and sell a generic version of its blockbuster cholesterol-lowering drug Crestor (rosuvastatin), before its patent expiry.

Torrent's patent infringement comes as a surprise, as earlier this year AstraZeneca entered into a partnering deal with the Indian firm to buy the licenses and market authorizations for 18 generic products in nine countries, with possibly more products and markets to be agreed (The Pharma Letter March 11).

According to Indian news service PharmaBiz.com, the complaint against Torrent Pharma filed with the District Court of Delaware, USA, is based on US Patents 6,858,618 ('618 patent) and 7,030,152 ('152 patent) for uses of rosuvastatin calcium for pediatric treatment of heterozygous familial hypercholesterolemia (HeFH) and for primary prevention of cardiovascular disease. AstraZeneca contends that the exclusivity rights provided by the `618 patent, as extended by applicable regulatory exclusivities, will expire on June 17, 2022, while the exclusive rights provided by the `152 patent will lapse on April 2, 2018.