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Alcon Laboratories Inc., Alcon Research Ltd., and Kyowa Hakko Kirin Co. Ltd. have won a patent infringement lawsuit against Apotex, Inc. and Apotex Corp. in the U.S. District Court for the Southern District of Indiana.
Indianapolis-Alcon Laboratories Inc., Alcon Research Ltd., and Kyowa Hakko Kirin Co. Ltd. have won a patent infringement lawsuit against Apotex, Inc. and Apotex Corp. in the U.S. District Court for the Southern District of Indiana.
Alcon filed the lawsuit after Apotex submitted an abbreviated new drug application to the FDA requesting approval to manufacture and sell a generic version of Alcon’s olopatadine hydrochloride ophthalmic solution (Patanol) before its patent had expired. The patent is jointly owned by Alcon and Kyowa.
The court’s decision, which is subject to appeal, would prevent Apotex from bringing its generic version of the drug to market before the drug’s patent expires in 2015.
“We are pleased with the court’s decision affirming the validity and enforceability of the . . . patent,” said Stuart Raetzman, Alcon’s area president, United States, and vice president of global marketing. “Alcon invested many years and millions of dollars in the discovery and development of an ocular allergy product that would stabilize mast cells in the eye and provide long-term relief of the signs and symptoms of ocular allergies.”
According to Alcon, the proprietary olopatadine solution is the world’s leading prescription eye drop used to treat the signs and symptoms of allergic conjunctivitis, and the family of products to which it belongs accounts for more than 75% of prescriptions written for ocular allergies in the United States.