|Watson Says Appeals Court Affirms Concerta(R) Patent Invalid|
MORRISTOWN, N.J., April 26, 2010 /PRNewswire via COMTEX/ --Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that the U.S. Court of Appeals for the Federal Circuit Court has affirmed a March 31, 2009 District Court decision that the asserted claims of ALZA's United States Patent No. 6,919,373 "the '373 Patent" are invalid. The original suit by ALZA Corporation and McNeil-PPC, Inc. alleged that Watson's generic versions of Concerta(R) (methylphenidate hydrochloride extended-release tablets), developed by Watson's subsidiaries, Andrx Corporation and Andrx Pharmaceuticals LLC, infringed the '373 Patent. The opinion, dated April 26, 2010, applies to Watson's generic versions of Concerta(R) in the 18 mg, 27 mg, 36 mg and 54 mg strengths.
Watson noted that the Appeals Court decision addresses patent infringement questions concerning its methylphenidate ER tablets, a generic version of Concerta(R). FDA must resolve a Citizen Petition, and approve Watson's pending Abbreviated New Drug Application (ANDA), prior to launch of its generic. Concerta(R) has annual brand sales of approximately $1.2 billion.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading global specialty pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.
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Statements contained in this press release that refer to non-historical facts are forward-looking statements that reflect Watson's current perspective of existing information as of the date of this release. It is important to note that Watson's goals and expectations are not predictions of actual performance. 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 product development efforts and FDA approvals or actions, if any; the difficulty of predicting the timing or outcome of litigation; the impact of competitive products and pricing; the timing and success of product launches; difficulties or delays in manufacturing; the availability and pricing of third party sourced products and materials; successful compliance with FDA and other governmental regulations applicable to Watson and its third party manufacturers' facilities, products and/or businesses; and such 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 31,2009. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Concerta(R) is a registered trademark of ALZA Corporation.
SOURCE Watson Pharmaceuticals, Inc.