Takeda Must Face Antitrust Suit Over Actos Patent Gamesmanship

Takeda Pharmaceutical Co. Ltd. must face claims it delayed generic competition for the diabetes drug Actos by misrepresenting its patents to regulators, a Southern District of New York judge ruled.

The proposed antitrust class action accuses the pharmaceutical company of gaming the Hatch-Waxman Act’s patent litigation regime by mischaracterizing two patents covering only drug delivery methods, not chemical substances.

Based on those representations, the Food and Drug Administration forced other drugmakers seeking generic approval to challenge the patents, rather than letting them “carve out” non-infringing methods of use, the suit says.

That allegedly led to a regulatory process strewn with ...