Healthcare Industry News: Novex Pharma
News Release - January 3, 2006
Allergan Granted Temporary Restraining Order in ACULAR(R) Patent Infringement CaseIRVINE, Calif.--(HSMN NewsFeed)--Jan. 3, 2006--Allergan, Inc. (NYSE:AGN ) announced today that on December 29, 2005, in its patent infringement lawsuit against Apotex, Inc., Apotex Corp., and Novex Pharma (collectively the "Defendants"), the United District Court for the Northern District of California granted Allergan's and Syntex (USA) LLC's application for a temporary restraining order against the Defendants. In its ruling, the District Court ordered that the Defendants "are restrained and enjoined, pending the Court's decision as to whether a preliminary injunction should issue, from commercially manufacturing, using, offering to sell, or selling within the United States or importing into the United States" the generic version of ACULAR® (ketorolac tromethamine ophthalmic solution) 0.5% for which the Defendants have sought FDA approval via an abbreviated new drug application.
The patent infringement lawsuit was tried in June 2003, and on January 27, 2004, the District Court entered a judgment in Allergan's and Syntex's favor and against the Defendants, finding that Defendants' proposed generic ketorolac tromethamine ophthalmic solution infringed U.S. Patent No. 5,110,493 ("the '493 patent"). The matter was appealed by the Defendants to the Federal Circuit Court of Appeals, which upheld the District Court's finding of infringement but remanded the matter to the District Court for the District Court's reconsideration of the Defendants' claim that the '493 patent is "obvious" and thus invalid. In granting Allergan's and Syntex's application for a temporary restraining order, the District Court ruled that Allergan and Syntex "have a strong likelihood of success on the merits in defending against Defendants' claim that the U.S. Patent No. 5,110,493 is obvious" and noted that "the public interest strongly favors the enforcement of patent rights and encouraging innovation."
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.
About Allergan, Inc.
Allergan, Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing specialty pharmaceutical products worldwide. Allergan develops and commercializes products in the ophthalmology, neurosciences, medical dermatology, medical aesthetics 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, statements regarding possible outcomes of the litigation and the timing of generic versions of the Company'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 "Certain Factors and Trends Affecting Allergan and its Businesses" in Allergan's 2004 Form 10-K and Allergan's Form 10-Q for the quarter ended September 30, 2005. 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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