Takeda Pharmaceutical Company Limited (Takeda) announced that the US Court of Appeals for the Federal Circuit affirmed Takeda's award of attorneys' fees against generic drug manufacturers, Mylan Inc and Alphapharm Pty, Ltd, arising out of Takeda's successful enforcement of its patent covering the active ingredient in ACTOS (pioglitazone hydrochloride). Mylan Inc must pay Takeda and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc (TPNA) $11.4 million plus interest, and Alphapharm Pty, Ltd. must pay $5.4 million plus interest.

Takeda and TPNA sued Mylan and Alphapharm for patent infringement as a result of their filing of Abbreviated New Drug Applications (ANDAs) seeking FDA approval to market a generic version of Takeda's ACTOS. Mylan and Alphapharm challenged the validity and enforceability of US Patent No. 4,687,777 which covers pioglitazone, the active ingredient in ACTOS. The US District Court for the Southern District of New York held that the Mylan and Alphapharm challenges to the '777 patent were not certified in good faith, as required by the Hatch-Waxman Act. The Court also found that both Mylan and Alphapharm had engaged in litigation misconduct. The court awarded Takeda its full amount of attorneys' fees claimed against both Mylan and Alphapharm. That decision was affirmed by the US Court of Appeals for the Federal Circuit on December 8, 2008.