Healthcare Industry News: ketorolac tromethamine
News Release - April 12, 2007
U.S. Federal Circuit Court Affirms Judgment for Allergan, Inc. and Roche Palo Alto, LLC against Apotex, Inc., Apotex Corp., and Novex Pharma in Ketorolac Patent Infringement LawsuitIRVINE, Calif.--(HSMN NewsFeed)--Allergan, Inc. (NYSE:AGN ) announced today that the United States Court of Appeals for the Federal Circuit has affirmed a favorable ruling for Allergan and Roche Palo Alto, LLC, formerly known as Syntex (U.S.A.) LLC, in a patent infringement lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma (the "Defendants") preventing the Defendants from obtaining U.S. Food and Drug Administration approval to market a generic version of Allergan's product ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5% and enjoining the Defendants from manufacturing or selling the same.
In 2006, the Defendants appealed a ruling by the United States District Court for the Northern District of California that the Defendants' proposed generic product infringed a valid and enforceable patent owned by Roche Palo Alto, LLC and licensed to Allergan. The District Court's ruling provided that the effective date of any approval of the Defendants' Abbreviated New Drug Application may not occur before U.S. Patent No. 5,110,493 expires in 2009 and that the Defendants, together with all persons and entities acting in concert with the Defendants, are enjoined from making any preparations that make, use, sell, or offer for sale ketorolac tromethamine ophthalmic solution 0.5% in the United States. The Federal Circuit affirmed the District Court's ruling in all regards.
"This ruling is a triumph for the value of intellectual property rights and their protection," said Douglas S. Ingram, Allergan's Executive Vice President, Chief Administrative Officer, General Counsel and Secretary. "It is only through continuing innovation that new and improved medicines are made available to health care providers and their patients. The development of, and equally importantly the respect for, intellectual property are essential for life-enhancing innovation. As we have repeatedly stated, Allergan will fiercely defend its intellectual property rights against those who would trade on the hard work and creativity of our scientists and R&D professionals."
ACULAR® is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis and the treatment of post-operative inflammation in patients who have undergone cataract surgery. The most frequently reported adverse event is transient burning and stinging upon instillation. Full prescribing information for ACULAR® is available at www.allergan.com.
About Allergan, Inc.
With more than 55 years of experience providing high-quality, science-based products, Allergan, Inc., with headquarters in Irvine, California, discovers, develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics, obesity intervention and other specialty markets that deliver value to its customers, satisfy unmet medical needs, and improve patients' lives.
This press release contains "forward-looking statements" including, but not limited to, the statements by Mr. Ingram and statements regarding litigation outcomes and the timing of generic versions of Allergan's products. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Allergan's expectations and projections. Risks and uncertainties include, among other things, the uncertainties associated with the litigation and appeal process; general industry and pharmaceutical market conditions; general domestic and international economic conditions, such as interest rate and currency exchange rate fluctuations; technological advances and patents obtained by competitors; challenges inherent in product marketing such as the unpredictability of market acceptance for new pharmaceutical and biologic products and/or the acceptance of new indications for such products; domestic and foreign health care reforms; the timing and uncertainty of the research and development and regulatory processes; trends toward managed care and health care cost containment; and governmental laws and regulations affecting domestic and foreign operations. Allergan expressly disclaims any intent or obligation to update these forward-looking statements except as required to do so by law. Additional information concerning these and other risk factors can be found in press releases issued by Allergan, as well as Allergan's public periodic filings with the Securities and Exchange Commission, including the discussion under the heading "Risk Factors" in Allergan's 2006 Form 10-K. Copies of Allergan's press releases and additional information about Allergan is available on the World Wide Web at www.allergan.com or you can contact the Allergan Investor Relations Department by calling 1-714-246-4636.
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