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Category: IPR

Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers

Generics and biosimilar makers have increasingly used inter partes reviews, proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines.  Senator Orrin Hatch, co-author of the Hatch-Waxman Act, has introduced an amendment that would require these manufacturers either to take advantage of the abbreviated regulatory approval pathways provided by the Hatch-Waxman Act and BPCIA and challenge innovator patents in district court or to challenge innovator patents in IPRs before the PTAB, but not both.  Senator Hatch explains that while he strongly supports IPRs and the America Invents Act and that IPRs are of particular importance to the tech community to fight “patent trolls,” they are also “producing unintended consequences in the Hatch-Waxman context” and “threaten[] to upend the careful Hatch-Waxman balance by enabling two separate paths to attack a brand patent.”  If enacted, generics and biosimilar makers that choose to take advantage of the abbreviated regulatory process will challenge innovator patents in court rather than in IPRs before the PTAB.

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