On February 27, a federal judge in the U.S. District Court for the Western District of Pennsylvania held that Pfizer Inc.'s patent for the compound amlodipine besylate is valid, enforceable and would be infringed by Mylan Laboratories Inc.'s generic version of Pfizer's blockbuster hypertension drug Norvasc®. The judge also enjoined Mylan from selling and marketing a generic version until the pediatric exclusivity period for the patent expires in September 2007. Mylan has filed a notice of appeal.
This is the third time Kaye Scholer has successfully enforced the amlodipine besylate patent for Pfizer against generic companies in the past year, by prevailing in three separate bench trials. In January 2006, a federal judge in the U.S. District Court for the Northern District of Illinois held that generic manufacturer Apotex infringed the patent and that it is valid and enforceable. In August 2006, the U.S. District Court for the Middle District of North Carolina upheld Pfizer's patent against generic manufacturer Synthon Pharmaceuticals. Both judgments have been appealed.
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