US Appeals Court's Ruling Delays Generic Prevacid

Japanese drug major, Takeda Pharmaceuticals Co. has won a US appeals court ruling that delays Teva Pharmaceutical Industries Ltd. from selling a generic version of the heartburn drug Prevacid, generically Lansoprazole until next year. The US Court of Appeals for the Federal Circuit, without issuing an opinion upheld a district court’s decision that US Patent No. 4,628,098 is both valid and enforceable. Post ruling, Teva said it will launch its generic versions no later than November 10, 2009.

Earlier in March 2008, the US District Court for the District of Delaware in its opinion ruled that Takeda’s patents on Prevacid are valid and that Teva’s ANDA for a generic version of Prevacid capsules infringes one of the patents. During litigation Takeda asserted US Patent Nos. 4,628,098 and 5,045,321 against Teva. Teva conceded that its ANDA product infringes the ‘098 patent but still contested infringement of the ‘321 patent. Moreover, Teva argued that ‘098 and ‘321 patents are invalid for obviousness and unenforceable due to inequitable conduct.

During trial, the district court rejected Teva’s arguments that ‘098 and ‘321 patents would have been obvious but found that Teva’s ANDA product does not infringe the ‘321 patent. The court also found Teva’s inequitable conduct arguments to be meritless. Teva subsequently appealed the district court decision. Prevacid is a blockbuster drug with US annual sales more than USD 2.5 billion.