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Barr and Wyeth in Patent Lawsuit against Watson PharmaceuticalsRonald Maldonado Rodriguez, PhD MSc , Analyst, Lifescience Consulting SA, 18/04/2008 Last December, Barr Pharmaceuticals announced that its wholly-owned subsidiary, Duramed Pharmaceuticals, filed a patent lawsuit in the Federal Court in Trenton, New Jersey, against Watson Pharmaceuticals and certain of its subsidiaries. The complaint is related to Quasense(TM) ( levonorgestrel/ethinyl estradiol tablets USP), Watson's generic version of the oral contraceptive Seasonale(R). The lawsuit asserted that Watson's Quasense(TM) product infringes Duramed's U.S. Patent 5,895,032. On March 5, 2008, Duramed filed a new lawsuit against Watson Pharmaceuticals and its subsidiary, Watson Laboratories, 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 status for its Seasonique product until May 25, 2009. Following the Barr lawsuit affair, Wyeth also filed a patent lawsuit against Watson on March 12, 2008 in the U.S. District Court of Delaware, seeking to prevent Watson from commercializing its generic LYBREL(R) (levonorgestrel ethinyl estradiol tablets) prior to the expiration of U.S. patent number 6,500,814. In March 13, 2008, Watson Pharmaceuticals recognized that it filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its contraceptive generic levonorgestrel ethinyl estradiol product prior to the expiration of patents owned by Wyeth on LYBREL Watson believes it may be the first applicant to file an ANDA for a generic of LYBREL(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity. Copyright 2008 lifescience-online.com - All rights Reserved
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