Generic, Biosimilar Makers’ Dual Patent Contests Still Safe

Generic and biosimilar drug makers such as Teva Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd. will continue challenging name-brand drug products both in court and administrative proceedings for the foreseeable future as congressional efforts to eliminate this dual-track option falter.

Hatch-Waxman Act namesake Sen. Orrin Hatch (R-Utah) and others have introduced bills in recent months that would preclude generic and biosimilar drug sponsors from availing themselves of the Patent and Trademark Office’s Patent Trial and Appeal Board while also fighting it out in district court. There doesn’t seem to be enough support to pass them, even though many observers ...