Takeda wins patent infringement case

NewsGuard 100/100 Score

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.


The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
Dupilumab shows promising results in Phase 3 trial for COPD with type 2 inflammation