ACTOS (Pioglitazone) Takeda Wins Patent Infringement Litigation on Appeal Against ANDA Filers for Generic Actos

OSAKA, Japan and LINCOLNSHIRE, Ill., July 2, 2007 – Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc. (“TPNA”) announced today that a panel of the U.S. Court of Appeals for the Federal Circuit has upheld the validity and enforceability of Takeda’s U.S. Patent No. 4,687,777 (“‘777″) covering pioglitazone hydrochloride, the active ingredient in ACTOS”, on June 28 2007. The decision confirms patent protection for this widely prescribed drug until 2011 in the United States.

The Appeals Court ruling affirmed the February 2006 decision upholding the ‘777 patent’s validity by the U.S. District Court for the Southern District of New York in a lawsuit brought by Takeda against the generic manufacturers Mylan Pharmaceuticals1 and Alphapharm Pty Ltd2.

Other U.S. patents covering certain methods of treatment using ACTOS® and certain compositions that include ACTOS® will expire in 2016.

“Takeda has always confidence in its patents,” said Mr. Seiji Hakoda, General Manager of Intellectual Property Dept. of Takeda. “Because innovation is critical to our company, we have a profound respect for the protection of intellectual property rights. We are very pleased with the ruling.”

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More information about ACTOS (Pioglitazone):

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ACTOS (Pioglitazone) Combination Therapy

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