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Otsuka Prevails in U.S. Abilify® Patent Appeal

May 7, 2012

Related Professionals: Browning Ph.D., Paul W., Flibbert, Michael J., Monroe, James B., Main Ph.D., Denise

Press Release

May 7, 2012

Contact:    James B. Monroe, 202.408.4159

Otsuka Prevails in U.S. Abilify® Patent Appeal


WASHINGTON, DC - The U.S. Court of Appeals for the Federal Circuit ruled today (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 a decision of the U.S. District Court for the District of New Jersey 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 U.S. until at least April 20, 2015. The District Court also had held that the patent was enforceable and infringed by the proposed generic products, which issues were not appealed to the Federal Circuit. As a result of these holdings, the FDA is precluded from approving, and the respective companies are enjoined from marketing, these products in the U.S. until at least April 20, 2015. Abilify® is prescribed for schizophrenia and other mental disorders and is one of the largest selling pharmaceutical in the U.S., with over $5.2 billion in sales in 2011. Otsuka co-markets this product in the U.S. with BMS. BMS was not a party to these litigations.

The Defendants included Teva Pharmaceuticals, Barr Pharmaceuticals (now part of Teva), Sandoz, Synthon Laboratories, Sun Pharmaceuticals, Zydus Pharmaceuticals and Apotex. Finnegan's co-counsel on the case was Fitzpatrick, Cella, Harper & Scinto.

About Finnegan
With more than 375 intellectual property lawyers, Finnegan is one of the largest IP law firms in the world. From offices in Washington, DC; Atlanta, Georgia; Cambridge, Massachusetts; Palo Alto, California; Reston, Virginia; Brussels, Belgium; Shanghai, China; Taipei, Taiwan; and Tokyo, Japan, the firm practices all aspects of patent, trademark, copyright, and trade secret law, including counseling, prosecution, licensing, and litigation. Finnegan also represents clients on IP issues related to international trade, portfolio management, the Internet, e-commerce, government contracts, antitrust, and unfair competition. For additional information on the firm, please visit