Takeda wins patent infringement case

Feb 24 2006

Takeda Pharmaceutical Company Limited and its wholly owned subsidiary, Takeda Pharmaceuticals North America, Inc. have announced that Takeda's intellectual property rights have been successfully asserted against generic manufacturers seeking to challenge Takeda's patent rights to ACTOS (pioglitazone HCl).

A federal judge of the U.S. District Court for the Southern District of New York ruled on February 21, 2006 that a patent covering the active ingredient of ACTOS is valid and enforceable.

Takeda filed patent infringement actions against Mylan Pharmaceuticals, Ranbaxy Laboratories, and Watson Pharmaceuticals, in October 2003, and against Alphapharm Pty in March 2004, in response to the filing of Abbreviated New Drug Applications (ANDAs) with the FDA under provisions of the Hatch-Waxman Act, challenging certain of Takeda's listed patents, including U.S. Patent No. 4,687,777 (the "'777 patent"), which covers the active ingredient of ACTOS, pioglitazone hydrochloride. Alphapharm and Mylan were the only defendants to challenge the '777 patent. Trial of the challenges by Alphapharm and Mylan to the validity and enforceability of the '777 patent took place from January 17, 2006 to January 30, 2006.

The Court's ruling prevents the FDA from approving the ANDAs filed by Alphapharm and Mylan, and thus prevents those generic manufacturers from selling pioglitazone tablets until the '777 patent expires, in 2011. Other U.S. patents covering certain methods of treatment using ACTOS and certain compositions that include ACTOS will expire in 2016.