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31 August 2021AmericasAlex Baldwin

Mylan, Edwards back NHK-Fintiv challenge

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 (IPR) petitions that have been denied due to the NHK-Fintiv rule.

The rule allows the Patent Trial and Appeal Board (PTAB) to refuse to institute an IPR of a patent or patents also subject to parallel litigation in US district courts.

Mylan and Edwards joined 10 others, including tech leaders Verizon and Comcast and three associations representing the software, automotive, high tech industries, in an amicus  brief submitted to the Supreme Court on Friday, August 27, in support of Apple’s earlier petition against the rule.

The brief highlights 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 amici know firsthand how the binding NHK-Fintiv rule, and the Federal Circuit’s refusal to question it, have hobbled IPR,” the brief stated.

The brief asks 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.

Amici concerns

The brief claims that the rule presents a “significant” threat to the essentiality of IPR by severely restricting the availability to companies accused of infringement.

It claims that Congress failed to address the issues “plaguing” the patent system as a result of NHK-Fintiv, arguing against the US Patent and Trademark Office’s (USPTO) argument that the rule improves the efficiency of infringement disputes.

The rule also “exceeds statutory limits” imposed by the America Invents Act (AIA), alleging that Congress did not mean for the existence of parallel district court action to foreclose the availability of IPR.

Making the rules

The NHK-Fintiv 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.

The rule has been subject to much criticism from regular petitioners to the PTAB, with several petitions to the Supreme Court asking for the rule to be overturned, including one submitted by Mylan earlier in August.

Brenton Babcock and Tyler Train of Womble Bond Dickinson called the rule a “powerful procedural weapon” for patent owners.

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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.

More on this story

Americas
16 September 2021   Intel has backed Mylan's bid to convince the US Supreme Court to remove the controversial NHK-Fintiv rule, on the basis that it is “unlawful”.
Generics
21 September 2021   Several US lawmakers have called upon the US Patent and Trademark Office to curb the increase in inter partes review denials to combat the “soaring cost” of prescription drugs.
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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.