Barr Pharmaceuticals' wholly-owned subsidiary, Duramed Pharmaceuticals, Inc, has filed suit against Watson Pharmaceuticals and its subsidiary, Watson Laboratories, Inc., for infringement of the patent protecting Duramed's Seasonique extended-cycle oral contraceptive product. The company's Seasonique Patent No. 7,320,969 is due to expire on January 30, 2024. In addition to the patent, the company also has 3-year New Product Exclusivity for its Seasonique product until May 25, 2009.

"We remain committed to enforcing our patent on our Seasonique extended-cycle oral contraceptive product and will pursue all legal means necessary to prevent Watson from launching a generic product prior to patent expiry in 2024," said Bruce L. Downey, Barr's chairman and CEO.

On January 22, 2008, the US Patent and Trademark Office issued the patent for the company's Seasonique extended-cycle oral contraceptive. The company immediately submitted the patent to the US Food and Drug Administration (FDA) for listing in the Orange Book. On January 22, 2008, Watson notified the company pursuant to the Hatch-Waxman Act that Watson had filed an Abbreviated New Drug Application (ANDA) with the FDA for Seasonique and that Watson had amended its application to include a paragraph IV certification asserting that the Seasonique patent is invalid, unenforceable or not infringed by Watson's ANDA product. Barr has filed to enforce the patent and prevent Watson from marketing a competing product prior to patent expiry in 2024. If Barr is unsuccessful in this litigation, the company may face generic competition for Seasonique as early as May 25, 2009, the date of expiration of our existing new product regulatory exclusivity for Seasonique.

Barr Pharmaceuticals, Inc. is a global specialty pharmaceutical company that operates in more than 30 countries worldwide and is engaged in the development, manufacture and marketing of generic and proprietary pharmaceuticals, biopharmaceuticals and active pharmaceutical ingredients. A holding company, Barr operates through its principal subsidiaries: Barr Laboratories, Inc., Duramed Pharmaceuticals, Inc. and PLIVA d.d. and its subsidiaries.