Watson Pharmaceuticals, Inc., a leading integrated global pharmaceutical company, confirmed that it has received a favourable decision from the US 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.
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.