Healthcare Industry News: Solvay Pharmaceuticals
News Release - February 2, 2009
Watson Acknowledges Federal Trade Commission Action Regarding AndroGel Patent SettlementCORONA, Calif., Feb. 2 (Healthcare Sales & Marketing Network) -- Watson Pharmaceuticals, Inc. (NYSE: WPI ), a leading specialty pharmaceutical company, announced today that the U.S. Federal Trade Commission (FTC) and the State of California have filed a lawsuit in the United States District Court for the Central District of California alleging that the Company's 2006 patent lawsuit settlement with Solvay Pharmaceuticals Inc. related to AndroGel® 1% (testosterone gel) CIII is unlawful.
"We are disappointed that the FTC has decided to challenge our patent settlement, as we believe the agreement fully complies with both the spirit and letter of the antitrust and consumer protection laws, as interpreted by numerous appellate courts throughout the U.S.," said Paul Bisaro, Watson's President and Chief Executive Officer. "Importantly, our settlement promotes competition and confers a meaningful benefit to U.S. consumers by providing for, among other things, the entry of a generic version of AndroGel® five years prior to the expiration of the AndroGel® patents. We intend to vigorously defend ourselves in this matter."
In 2003, Watson submitted an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of AndroGel. Solvay initiated litigation against Watson alleging that its product infringed Solvay's patent. Under terms of a 2006 settlement agreement, Solvay granted Watson a non-exclusive license to the U.S. patents covering AndroGel. Watson agreed not to commence marketing its generic equivalent product until August 31, 2015 or the date on which another generic product enters the U.S. market, whichever occurs first. Additionally, Watson agreed to forfeit its 180-day marketing exclusivity on the product awarded under the Hatch-Waxman Act.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading specialty pharmaceutical company that develops, manufactures, markets, sells and distributes generic and specialty brand 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.
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, the difficulty of predicting the timing and outcome of litigation, including the ultimate outcome of the FTC and State of California litigation related to AndroGel® or the amount of time it will take for the FTC litigation to be resolved; the impact of competitive products and pricing; 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.
Source: Watson Pharmaceuticals
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