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US court upholds patent on Otsuka, Bristol-Myers Squibb's Abilify

09 May 12

Otsuka Pharmaceutical Co., Ltd. and Otsuka Holdings, Co., Ltd., the parent company of Otsuka Pharmaceutical Co., Ltd., announced today that the U.S. Court of Appeals for the Federal Circuit issued its judgment dated May 7, 2012 in favor of Otsuka Pharmaceutical Co., Ltd. in its patent litigation against several companies seeking FDA approval to market generic copies of ABILIFY®

The Federal Circuit affirmed the only issue on appeal from the district court’s decision, holding that the asserted claims of U.S. Patent No. 5,006,528 covering aripiprazole, the active ingredient in ABILIFY®, are valid, thus maintaining patent and regulatory protection for ABILIFY® in the United States until at least April 20, 2015.

The validity of a patent covering the schizophrenia therapy's active ingredient had been challenged by Teva and Apotex. Although the companies conceded that their proposed generic versions of Abilify would infringe the patent, Teva and Apotex contended that the drug was already covered by a patent that expired in 2005.