Mylan’s NHK-Fintiv challenge denied by SCOTUS

The US Supreme Court has rejected a bid from generic drugmaker Mylan (now part of Viatris) to overturn the NHK-Fintiv rule.

The court handed down its decision on Tuesday, January 18, denying challenges from both Mylan and Apple to secure a reversal of the Patent Trial and Appeal Board’s (PTAB) refusal to review patents owned by Janssen Pharmaceutica and Optis Cellular Technology.

The NHK-Fintiv rule dictates that the existence of a parallel district court lawsuit should preclude an inter partes review (IPR). This has led to a sharp rise in denials of IPR petitions of patents over the past two years.

These two challenges were some of the most high-profile of several lawsuits aimed at overturning the rule.

Mylan submitted its petition for writ of certiorari in August 2021, following a decision from the Federal Circuit to refuse to hear an appeal in a patent lawsuit it was embroiled in with Janssen Pharmaceuticals.

The petition asked the Supreme Court to consider whether the America Invents Act provision 35 USC § 314(d) “categorically precluded” appeal of all decisions not to institute IPR review and whether the NHK-Fintiv rule could be deemed “unlawful”.

Mylan said that, despite the rules short life, it had “resulted in chaos” in patent litigation, with numerous “timely” filed IPR petitions being denied due to “aggressive” district court scheduling.

It also claimed that the rule was not the “product of formal rulemaking” as it was created in light of two precedential PTAB decisions and “never faced public comment”.

The rule was established by former USPTO director Andrei Iancu following NHK Spring v Intri-Plex in 2018, in which the PTAB held that the existence of a parallel district court lawsuit should preclude an IPR review.

Apple v Fintiv (2020) then outlined six scenarios for the PTAB to consider before instituting a review of a patent, including the trial date in the parallel case, whether the court has stalled its case for the PTAB review, and any overlap between the issues in both proceedings.

Prior efforts

Before it filed its own petition, Mylan joined Edwards Lifesciences and 10 others including internet service providers Verizon and Comcast in filing an earlier  amicus  brief in support of Apple’s petition against the rule in October 2021.

That brief highlighted several life science IPR petitions that were denied due to the NHK-Fintiv rule, including Edwards Lifesciences v Boston, Edwards Lifesciences v Evalve, and Mylan Labs v Janssen Pharm.

The brief asked that the Circuit “correct institution denials” based on the “unlawful” rule and that the Supreme Court should grant Apple’s petition for a writ of certiorari.

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