Takeda wins patent infringement litigation against ANDA filers for generic Actos

By Elaine Rigoli

Tampa, Fla., Feb. 22 - Takeda Pharmaceutical Co. Ltd. and subsidiary Takeda Pharmaceuticals North America, Inc. announced Wednesday that Takeda's intellectual property rights have been successfully asserted against generic manufacturers seeking to challenge Takeda's patent rights to Actos.

A federal judge of the U.S. District Court for the Southern District of New York ruled on Feb. 21 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 Oct. 2003, and against Alphapharm Pty in March 2004, according to a company news release.

The suit was 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 Jan. 17 to Jan. 30, the release said.

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.

"Takeda has confidence in its patents," said Seiji Hakoda, general manager of Takeda's intellectual property department, in a company statement.

"Because innovation is critical to our company, we have a profound respect for the protection of intellectual property rights. We are pleased with the ruling."

Takeda, located in Osaka, Japan, is a research-based global company with its main focus on pharmaceuticals.

Based in Lincolnshire, Ill., Takeda Pharmaceuticals North America is a wholly owned subsidiary of Takeda.

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