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 ...