Healthcare Industry News: cataract
News Release - June 5, 2006
Allergan Wins ACULAR(R) Patent Infringement Lawsuit Against Apotex, Inc., Apotex Corp., and Novex PharmaIRVINE, Calif.--(HSMN NewsFeed)--June 5, 2006--Allergan, Inc. (NYSE: AGN ) announced today that the United States District Court for the Northern District of California has ruled in favor of Allergan, Inc. and Syntex (USA) LLC in a patent infringement lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma (the "Defendants").
In 2004, Allergan and Syntex won a patent infringement trial against the Defendants, who had filed an Abbreviated New Drug Application (ANDA) to market a copy of Allergan's non-steroidal anti-inflammatory drug, ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5%. After remand from the Court of Appeals for the Federal Circuit, and after a rehearing of the matter, the Court issued its opinion on June 2, 2006, finding that the Defendants' ANDA infringes U.S. Patent No. 5,110,493 -- owned by Syntex and licensed by Allergan -- and that the patent is valid and enforceable.
Accordingly, the Court ruled on June 2, 2006, that the effective date of any approval of the Defendants' ANDA may not occur before the patent expires in 2009 and that the Defendants, and all persons and entities acting in concert with them, are enjoined from making any preparations to make, use, sell, or offer for sale ketorolac tromethamine ophthalmic solution 0.5% in the United States.
"We are pleased with the Court's decision, after trial and separate rehearing, that the Defendants' attempted copy of our product infringed Syntex's and Allergan's valid and enforceable intellectual property rights," said Douglas S. Ingram, Allergan's Executive Vice President, General Counsel and Secretary. "Respect for the hard work and ingenuity that goes into the development of intellectual property is critical to the kind of drug innovation that will enable companies such as Allergan to discover and develop better medicines that benefit patients."
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, 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 outcomes of the litigation, the appeal process 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; the uncertainties regarding the regulatory approval process and the timing associated therewith; 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 2005 Form 10-K and Allergan's Form 10-Q for the quarter ended March 31, 2006. 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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