I am always entertained by Pioglitazone news items appearing every now & then. It is an ancient molecule. I made it in 1990 while at BootsPharmaceuticals. Dr. Lokhande & Mr. Joshi were the fine chemists in my group who synthesised it. We needed it along side Ciglitazone and asankyo compound CS 045 for comparing the activities of compounds inour Antidiabetic screening programme.
Pioglitazone still lives on in the Actos. Year 2010 expiry whichappeared distant is now nearing rapidly. Thanks to Hatch & Waxman.------------------------------------------------------------------------------------ Quoting from Pharmabiz.com
US court upholds Takeda's award of attorney's fees on Actos patent caseSaturday, December 13, 2008 15:00 ISTOsaka, Japan
Takeda Pharmaceutical Company Limited (Takeda) announced that the USCourt of Appeals for the Federal Circuit affirmed Takeda's award ofattorneys' fees against generic drug manufacturers, Mylan Inc andAlphapharm Pty, Ltd, arising out of Takeda's successful enforcement ofits patent covering the active ingredient in ACTOS (pioglitazonehydrochloride). Mylan Inc must pay Takeda and its wholly-ownedsubsidiary, Takeda Pharmaceuticals North America, Inc (TPNA) $11.4million plus interest, and Alphapharm Pty, Ltd. must pay $5.4 millionplus interest.
Takeda and TPNA sued Mylan and Alphapharm for patent infringement as aresult 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 USPatent No. 4,687,777 which covers pioglitazone, the active ingredientin ACTOS. The US District Court for the Southern District of New Yorkheld that the Mylan and Alphapharm challenges to the '777 patent werenot certified in good faith, as required by the Hatch-Waxman Act. TheCourt also found that both Mylan and Alphapharm had engaged inlitigation misconduct. The court awarded Takeda its full amount ofattorneys' fees claimed against both Mylan and Alphapharm. Thatdecision was affirmed by the US Court of Appeals for the FederalCircuit on December 8, 2008
