Sunday, April 6, 2008

Takeda Wins Definitive Decision in Patent Infringement Litigation on Appeal against an ANDA Filer for Generic Actos

Takeda Pharmaceutical Company Limited announced today that, on March 31, 2008, the U.S. Supreme Court denied the Petition for a Writ of Certiorari by Alphapharm Pty Ltd.

The Supreme Court decision finally affirms the Appeals Court decision upholding the validity of Takeda’s U.S. Patent No. 4,687,777 (“777”) covering pioglitazone hydrochloride, the active ingredient in ACTOS®. The decision arises from a lawsuit brought by Takeda and TPNA in March 2004 in order to oppose an Abbreviated New Drug Application (ANDA) filed by Alphapharm Pty Ltd.

Based on this final decision, the FDA will not approve and Alpharpharm Pty Ltd. may not launch a generic version of pioglitazone until the “777” patent expires in 2011.

Takeda owns other U.S. patents covering certain methods of treatment using pioglitazone hydrochloride and certain compositions that include pioglitazone hydrochloride.

“We are very pleased that the fair and appropriate ruling regarding this litigation was confirmed by the Supreme Court,” said Mr. Yoichi Okumura, General Manager of Intellectual Property Dept. of Takeda. “We have profound respect for the protection of intellectual property rights because innovation is critical to us as an R&D-oriented pharmaceutical company.”

No comments: