Watson Pharmaceuticals, Inc., a leading specialty pharmaceutical company, announced that the US 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 per cent (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 US 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 US 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.

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.