CORONA, Calif., Aug. 13 /PRNewswire-FirstCall/ -- Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that the United States District Court for the Southern District of Florida ruled today that Watson's Naproxen Sodium ER tablets, the generic version of Naprelan(R), infringes Elan's U.S. Patent No. 5,637,320 (the "'320 Patent"). The action, Elan Corporation Plc v. Andrx Pharmaceuticals, Inc., was initially brought by Elan in October 1998 following Andrx's filing of a paragraph IV Abbreviated New Drug Application for its product. In March 2002, the District Court ruled that Elan's '320 Patent was invalid. Subsequently, in May 2004, the United States Court of Appeals for the Federal Circuit reversed the District Court's finding of invalidity and remanded the case for further proceedings. In January 2005, Elan filed a related case against Andrx in the United States District Court for the Southern District of Florida alleging that Andrx's Naproxen Sodium ER tablets infringe the '320 Patent, and seeking damages for willful infringement. In late 2005 the parties completed briefing the District Court on the validity of the '320 Patent and whether Andrx's product infringes the '320 Patent. The matter has been under submission to the District Court since late 2005. In today's ruling, the District Court held that Andrx's Naproxen Sodium ER tablets infringe the '320 Patent and that Andrx's infringement was willful. The District Court has set a further hearing on the matter for September 19, 2008, to address issues related to a damages phase of the trial and the possibility of injunctive relief. The Company intends to appeal today's ruling.
"We are disappointed and disagree with the court's ruling today and believe we have substantial meritorious issues to raise on appeal," stated Paul M. Bisaro, Watson's President and Chief Executive Officer. "We will continue to vigorously defend our position that our product does not infringe the '320 Patent," concluded Mr. Bisaro. Andrx launched its 500 mg Naproxen Sodium ER tablets in September 2002. For the twelve months ended December 31, 2001, Elan's 500 mg Naprelan(R) product had sales of approximately $27 million, according to IMS Health Data. For the twelve months ending June 30, 2008, Watson's 500 mg Naproxen Sodium ER tablets had sales of approximately $4 million, according to IMS Health Data.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc., headquartered in Corona, CA, is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes brand and generic pharmaceutical products. Watson pursues a growth strategy combining internal product development, strategic alliances and collaborations and synergistic acquisitions of products and businesses.
For press releases and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
Forward-Looking Statement
Any statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect Watson's current perspective of existing trends and information as of the date of this release. These forward looking statements include, but are not limited to, statements concerning the potential of being successful in the appeal of today's District Court ruling concerning the '320 Patent. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements. Actual results may differ materially from Watson's current expectations depending upon a number of factors affecting Watson's business. These factors include, among others, the difficulty of predicting the timing or outcome of litigation, including the appeal of today's District Court ruling concerning the '320 Patent; the inherent uncertainty of litigation; the potentially material adverse effects on the Company's results of operations, financial condition and cash flows of a final decision that the Company infringes the '320 Patent; market acceptance of and continued demand for Watson's products; patents and other intellectual property rights held by competitors and other third parties; and other risks and uncertainties detailed in Watson's periodic public filings with the Securities and Exchange Commission, including but not limited to Watson's Annual Report on Form 10-K for the year ended December 31, 2007.
Naprelan(R) is a registered trademark of Elan Corporation plc.
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CONTACT: Investor Relations, Patty Eisenhaur of Watson Pharmaceuticals,
Inc., +1-951-493-5611
Web site: http://www.watsonpharm.com/
