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9 January 2024Big PharmaMuireann Bolger

SCOTUS rejects big pharma’s challenge to USPTO power

Generics companies have often inveighed against the “arbitrary and capricious” rule | Judicial immunity granted to Vidal’s decisions at odds with Congress and SCOTUS precedent, say generics and big tech.

The US Supreme Court has knocked back the latest attempt by Edwards Lifesciences and others to undermine or dismantle the controversial Fintiv  Rule yesterday, January 8.

In November, the pharma company, along with Intel,  filed a writ of certiorari, asking the US’ highest court to scrutinise the rule, which has long been a bone of contention for tech companies and generic drug makers.

Introduced by former US Patent and Trademark Office ( USPTO) director Andrei Iancu in 2020, the rule permits a Patent Trial and Appeal Board ( PTAB) tribunal to decline a patent review if there is parallel litigation in a district court.

Edwards, along with Apple, Google, Mylan and Cisco Systems have frequently argued that the Fintiv rule is an “arbitrary and capricious” one that stifles competition and helps to uphold patents of “dubious validity”.

Judicial immunity

In its November brief to SCOTUS, Edwards argued that an earlier judgment delivered in March by the US Court of Appeals by the Federal Circuit had gone too far in holding that USPTO rules were “immune from judicial review”.

In Apple v Vidal, the Federal Circuit affirmed a lower court’s judgment dismissing challenges to the USPTO director’s instructions because they were “substantively contrary to statute and..arbitrary and capricious”. The appeals court also remanded “any further exploration of the effect of the post-Fintiv clarifications" to a federal court in Northern California.

Such a decision, argued the brief, gives the USPTO “free rein to adopt unlawful institution standards that undermine the patent system with no judicial oversight, in sharp conflict with SCOTUS’ precedent”.

“That decision risks foreclosing judicial oversight of any USPTO rule governing the institution of IPR—a procedure Congress saw as vital to the strength of the patent system,” added the filing.

The USPTO countered in its own brief, also filed in November, 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”.

Edwards was represented by Knobbe Martens Olson & Bear.

The USPTO’s solicitor’s office represents the US government.

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