Tuesday, July 10, 2007

Daiichi Sues Mylan for Patent Infringement

Daiichi Sankyo Company Ltd. et al. v. Mylan Pharmaceuticals Inc. et al. 2:07-cv-03039 filed June 22, 2007 in the District Court of New Jersey Daiichi Sankyo has filed a civil action for patent infringement in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. alleging infringement of the US 5,616,599 (the ‘599 patent) covering chemical compound Olmesartan Medoxomil, one of the active ingredients of Sankyo’s antihypertension drug Benicar HCT tablets. The complaint is in response to Mylan’s submission of an Abbreviated New Drug Application (ANDA) No. 78-827 to the US FDA under Para IV certification seeking approval to market and sell generic Olmesartan Medoxomil and Hydrochlorothiazide tablets before the expiration of the ‘599 patent. In its complaint, Sankyo alleged that Mylan ANDA product would infringe one or more claims of the ‘599 patent under 35 USC § 271 (e)(2).

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