Double Jeopardy at the PTO Threatens Healthcare Innovation

Double Jeopardy at the PTO Threatens Healthcare Innovation

There has been no shortage of commentary related to the efforts of Allergan to shield itself from the un-American threat of double jeopardy they have repeatedly faced through gamesmanship of the PTO’s Inter Partes Review (IPR) process.

An op-ed by Allergan CEO Brent Saunders today in The Wall Street Journal demonstrates the unconventional steps the company has taken to protect itself from the flaws of IPR that are being “exploited by generic manufacturers and a new breed of reverse trolls.”

Generic pharmaceutical manufacturers, who already have full opportunities to challenge innovator patents in federal court, are using these flaws within IPR to initiate duplicative patent reviews until a sympathetic panel of PTO Administrative Patent Judges renders a decision to invalidate. In the process, they – not Allergan – are undermining the carefully balanced, Congressionally-mandated system that has successfully spurred both innovation and generic drug entry for decades.

IPR undermines the long-established, bi-partisan Hatch-Waxman framework that allows for legitimate patent questions to be litigated in the open in federal court.

To remedy the abuses of IPR, BIO has been calling on Congress for several years to harmonize the legal standards used in IPR and in the federal courts, and provide assurance that patent owners will be free of repeated threats to their intellectual property following a court ruling.

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