Novartis 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 stabilize 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.
Alcon, the global leader in eye care, is the second largest division of the Novartis Group with combined pro forma sales of more than USD 9.4 billion in 2010. Alcon has more than 22,000 employees with headquarters in Fort Worth, Texas, USA.
Novartis provides healthcare solutions that address the evolving needs of patients and societies and focused solely on healthcare, it offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, consumer health products, preventive vaccines and diagnostic tools.