SOURCE: Watson Pharmaceuticals

 

CORONA, CA--(Marketwire - October 24, 2008) - Watson Pharmaceuticals, Inc. (NYSE: WPI), a leading specialty pharmaceutical company, today announced that its subsidiary Watson Laboratories, Inc. has filed a lawsuit in the U.S. District Court of Delaware against Barr Pharmaceuticals, Inc. and its subsidiary Barr Laboratories, Inc. for infringement of patents listed in the Orange Book for Watson's product OXYTROL® (Oxybutynin Transdermal System).

The lawsuit is based upon an Abbreviated New Drug Application (ANDA) filed by Barr requesting approval to market and sell a generic version of OXYTROL® to be sold in the United States prior to the expiration of the Orange Book listed patents. In its Notice Letter to Watson, Barr alleges that patents covering OXYTROL® are invalid, unenforceable and/or will not be infringed by Barr's manufacture, use or sale of the product described in its ANDA.

The filing of this lawsuit is provided for by the Hatch-Waxman Act, a federal statute governing certain aspects of generic drug approvals. Under that statute, the filing of the lawsuit stays any FDA approval of the Barr ANDA until the earlier of a district court judgment in favor of Barr or 30 months from Watson's receipt of Barr's Notice Letter.

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. 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, patents and other intellectual property rights held by Watson and the uncertainty of the outcome of litigation related to such patents and intellectual property rights; the difficulty of predicting the timing or outcome of product development efforts and FDA or other regulatory agency approvals or actions; the impact of competitive products and pricing; market acceptance of and continued demand for Watson's products; difficulties or delays in manufacturing; 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.