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14 November 2023AmericasMuireann Bolger

USPTO aims to fend off Fintiv challenge at SCOTUS

Controversial rule precludes a patent review if there is parallel litigation | Big pharma and tech companies insist the rule is “arbitrary and capricious” | US agency backs Vidal’s authority, calling a proposed intervention “unnecessary”.

The  US Patent and Trademark Office has urged the  US Supreme Court to reject calls by  Edward Lifesciences and others to review the  Fintiv rule.

The rule, which has stoked controversy ever since its introduction in 2018, permits a Patent Trial and Appeal Board tribunal to decline a patent review if there is parallel litigation in  a district court.

The medical device maker, along with Intel,  alleges that such factors “are arbitrary and capricious or inconsistent with statutory provisions” governing the requested review of a patent.

In its  amicus brief, filed on November 9, the USPTO counters that a SCOTUS review would be unnecessary because of USPTO director Kathi Vidal’s  own ability to evaluate and revisit the Fintiv factors in a contested decision.

Vidal, it continues, announced  “several clarifications” to the board’s current application of Fintiv in June 2022, and later issued an  Advance Notice of Proposed Rulemaking addressing (among other things) the effect of parallel district-court litigation on institution decisions in 2023.

The agency points out that during 2022, SCOTUS denied three petitions for writs of certiorari raising challenges to the Fintiv factors, namely Corp v VLSI Tech, Mylan Labs v Janssen Pharmaceuticals, and Apple v Optis Cellular Tech.

The petitioners in those cases all challenged individual decisions in which the board declined to institute inter partes review, adds the USPTO.

SCOTUS should consequently reject the artificial valve manufacturer’s attempt to obtain a different result by raising the same basic arguments in a freestanding challenge to the director’s guidance, it explains.

The brief also notes that to preserve her effective control over the agency in circumstances where delegation is a practical necessity, “the director must be able to give guidance in the form of instructions to her delegatee(s)—the board (or board panels)—about how to make the institution determinations on her behalf”.

The USPTO concludes by arguing that a SCOTUS review is unwarranted “in light of the agency’s continuing evaluation of such issues” and “that the petitioners’ disapproval of the USPTO’s current approach cannot justify this court’s intervention here”.


More on this story

Americas
14 March 2023   Medtech company wins reversal of earlier ruling | Door opens to mount a challenge of controversial rule | USPTO director‘s updated guidelines influence court’s reasoning.
Americas
31 August 2021   Mylan Pharmaceutical and Edwards Lifesciences have joined a petition urging the US Supreme Court to order the US Court of Appeals for the Federal Circuit to reconsider inter partes review petitions that have been denied due to the NHK-Fintiv rule.
Big Pharma
2 January 2024   Life science attorneys should see some notable developments relating to artificial intelligence, patent eligibility and the Fintiv rule, write Manita Rawat and Alexander Stein of Morgan Lewis.

More on this story

Americas
14 March 2023   Medtech company wins reversal of earlier ruling | Door opens to mount a challenge of controversial rule | USPTO director‘s updated guidelines influence court’s reasoning.
Americas
31 August 2021   Mylan Pharmaceutical and Edwards Lifesciences have joined a petition urging the US Supreme Court to order the US Court of Appeals for the Federal Circuit to reconsider inter partes review petitions that have been denied due to the NHK-Fintiv rule.
Big Pharma
2 January 2024   Life science attorneys should see some notable developments relating to artificial intelligence, patent eligibility and the Fintiv rule, write Manita Rawat and Alexander Stein of Morgan Lewis.