Takeda Chemical Industries Ltd (TCI) and Takeda Pharmaceuticals North America Inc (TPNA) filed lawsuits on October 17, 2003 against Mylan Pharmaceuticals, Watson Pharmaceuticals and Ranbaxy Laboratories for patent infringement. The patent infringement actions were filed in the U.S. District Court for the Southern District of New York.

Under provisions of the Hatch-Waxman Act, this action was taken in response to Abbreviated New Drug Applications (ANDA) filings with the U.S. Food and Drug Administration by Mylan, Watson and Ranbaxy for pioglitazone tablets, generic versions of TPNA's ACTOS (pioglitazone HCl). Takeda has asserted several U.S. patents relating to the composition of pioglitazone and methods of treatment using the compound.

TCI and TPNA have full confidence in the validity and enforceability of these patents and, as demonstrated by the legal action, will take appropriate steps to vigorously protect their patent rights.

ACTOS is an effective therapy option for type 2 diabetes and acts by reducing insulin resistance, a core metabolic defect.