Alcon, Inc.
Patanol® is the world's leading prescription eye drop used to treat the signs and symptoms of allergic conjunctivitis
US court decision is an important milestone to defend Alcon´s intellectual property rights until the Patanol patent expires in 2015
Basel, May 24, 2011 – Novartis announced today, 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 Opatanol®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.
About Alcon
Building on its heritage of more than 65 years, 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. Alcon's three businesses - Surgical, Pharmaceutical and Vision Care - meet the diverse needs of eye care professionals and patients offering the widest spectrum of eye care products with operations in 75 countries and products available in 180 markets. For more information, visit www.alcon.com.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of patients and societies. Focused solely on healthcare, Novartis 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. Novartis is the only company with leading positions in these areas. In 2010, the Group's continuing operations achieved net sales of USD 50.6 billion, while approximately USD 9.1 billion (USD 8.1 billion excluding impairment and amortization charges) was invested in R&D throughout the Group. Headquartered in Basel, Switzerland, Novartis Group companies employ approximately 119,000 full-time-equivalent associates and operate in more than 140 countries around the world. For more information, please visit http://www.novartis.com.
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