MORRISTOWN, N.J., March 25, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE :WPI ), a leading integrated global pharmaceutical company, today confirmed that it has received a favorable decision from the U.S. Court of Appeals for the Federal Circuit related to its ongoing patent challenge in connection with Watson's Abbreviated New Drug Application (ANDA) seeking FDA approval to market a generic version of Teva Women's Health, Inc.'s SEASONIQUE® (levonorgestrel/ethinyl estradiol (0.15 mg/0.03 mg) and ethinyl estradiol (0.01 mg)).
The Appeals Court reversed and remanded for trial a March 31, 2010 summary judgment order from the United States District Court for the District of Nevada regarding United States Patent No. 7,320,969 (the '969 patent). On January 22, 2008, Watson notified Teva Women's Health that Watson's ANDA contained a paragraph IV certification asserting that the '969 patent is invalid, unenforceable and/or not infringed. Based on available information, Watson believes it may be the "first applicant" for a generic version of SEASONIQUE® and, should its product be approved, it may be entitled to 180 days of generic market exclusivity.
SEASONIQUE® is indicated for the prevention of pregnancy.
About Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc. is a leading integrated global 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.
For press release and other company information, visit Watson Pharmaceuticals' Web site at http://www.watson.com.
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, risks and uncertainties affecting Watson's business. These factors include, among others, the difficulty of predicting the timing and outcome of the pending patent litigation; the difficulty of predicting the timing or outcome of product development efforts, including FDA and other regulatory agency approvals and actions, if any; 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; changes in the laws and regulations; 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 31,2010. Except as expressly required by law, Watson disclaims any intent or obligation to update these forward-looking statements.
Seasonique® is a registered trademark of Teva Women's Health, Inc.
Watson Pharmaceuticals, Inc.
Watson Pharmaceuticals, Inc.
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