On Wednesday, July 1, 2009, counsel for Bayer Schering Pharma AG, Bayer Healthcare Pharmaceuticals, Inc. and Schering Corporation filed a complaint in the United States District Court for the District of Delaware against Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals USA, Inc. In the complaint Bayer claims that Teva has infringed their Patent No. 6,362,178 for “2-Phenyl Substituted Imidazotriazinones As Phosphodiesterase Inhibitors” also known as LEVITRA, a drug approved by the U.S. Food and Drug Administration for the treatment of erectile dysfunction. Schering Corporation currently has exclusive rights through a license to market and sell LEVITRA across the United States.
According to the complaint, Teva notified Bayer of their knowledge of Patent ‘178 through a letter dated May 19, 2009, and that they did not believe it to be a valid and enforceable patent though a reason was not provided. The letter also notified Bayer that Teva filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration for Vardenafil Hydrochloride Tablets, a generic version of LEVITRA, which uses the same active ingredient, vardenafil HCl.
Bayer claims that Teva had prior knowledge of Patent ‘178 before filing for approval from the U.S. Food and Drug Administration to manufacture and sell the generic version and because vardenafil HCl is contained in the generic version, this action infringes Patent ‘178. Bayer is seeking a judgment ordering that the effective date of any FDA approval for Teva to make, use, offer for sale, sell, market, distribute, or import Teva’s product be no earlier than the expiration date of Patent ‘178; a judgment declaring that making, using, selling, offering for sale, marketing, distributing, or importing Teva’s product prior to the expiration date of Patent ‘178 will infringe Patent ‘178; and an award of attorneys’ fees and Plaintiffs’ costs and expenses in this action.
Counsel for Teva has not yet filed a response.