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6 September 2022AmericasMuireann Bolger

Vidal steps up scrutiny of Fintiv rule-based decisions

Mylan and Edwards Lifesciences argue that the controversial rule safeguards poor-quality patents | US v Arthrex conferred increased authority to Vidal over PTAB decisions.

The director of the US Patent and Trademark Office, Kathi Vidal, will review another decision not to assess a patent under the guidelines set out by the controversial NHK-Fintiv rule.

Vidal issued the order confirming that she had initiated the review on Friday, September 2, following mounting speculation that she would address the issues created by the rule since she took up her role last April.

Instituted by her predecessor Andrei Iancu, the rule holds that the existence of a parallel district court lawsuit or any overlap between the issues in both proceedings should preclude an inter partes review (IPR) of a patent by the US Patent Trial and Appeal Board (PTAB).

While this latest review concerns a decision not to assess a gaming patent under NHK-Fintiv, generic drug makers have long criticised the controversial rule and its effect on inter partes reviews (IPRs). For example, companies such as Mylan (now part of Viatris) and Edwards Lifesciences have put forward criticisms in amicus briefs before the US Supreme Court.

They argue that the rule compromises the integrity of the US patent system by protecting poor-quality patents.

In September 2021, Senators Patrick Leahy and Republican Senator John Cornyn introduced a new bill, the Restoring the America Invents Act, arguing against the use of discretionary denials.

Vidal’s decision is a use of the USPTO director’s authority bestowed by the US Supreme Court in its landmark US v Arthrex ruling, which held that the PTAB’s administrative judges are unconstitutionally appointed.

This order confirming the review of the PTAB’s August 9 ruling comes after Vidal announced earlier this month that she would review another decision not to take up the challenge of reviewing a pig virus vaccine patent.

In June, Vidal unveiled long-anticipated guidance for the procedures governing the discretionary denials that can be handed down by the PTAB when declining to review a patent’s validity.

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