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Novartis has announced that two affiliates of its Alcon Division, Alcon Laboratories, Inc. and Alcon Research, Ltd. have prevailed in a US patent infringement lawsuit filed along with Kyowa Hakko Kirin Co. Ltd. (“Kyowa”) against Apotex, Inc. and Apotex Corp. (collectively, “Apotex”) in the US District Court for the Southern District of Indiana.
Alcon’s lawsuit was filed in response to Apotex’s submission of an Abbreviated New Drug Application (“ANDA”) to the US Food and Drug Administration (“FDA”) requesting approval to manufacture and sell a generic version of Alcon’s Patanol® (olopatadine hydrochloride ophthalmic solution) prior to the expiration of US patent number 5,641,805, which 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 prior to the Patanol patent expiration in 2015.
“We are pleased with the court’s decision affirming the validity and enforceability of the Patanol patent,” said Stuart Raetzman, Area President US and Vice President Global Marketing, Alcon. “Alcon invested many years and millions of dollars in the discovery and development of an ocular allergy product that would stabilise mast cells in the eye and provide long-term relief of the signs and symptoms of ocular allergies. Patanol was the result of this R&D effort and today’s court decision is an important milestone to defend Alcon’s intellectual property rights.”
Patanol, also known in many countries as Opantanol® solution, is the world’s leading prescription eye drop used to treat the signs and symptoms of allergic conjunctivitis, including itching, redness, chemosis, tearing, and lid swelling. Today, the Patanol family of products account for more than three out of every four prescriptions written for ocular allergies in the US.
The case is referred to as Alcon Research, Ltd. et al. v. Apotex, Inc. et al., case number 1:06-cv-1642-RLY-TAB in the US District Court for the Southern District of Indiana -Indianapolis Division.