PTAB: Roche patent can’t evade IPR under Fintiv

Roche unit Chugai failed to persuade the  US Patent Trial and Appeal Board (PTAB) that it should not institute inter partes reviews (IPRs) of a patent covering Actemra (Atlizumab), a treatment for arthritis under the NHK/Fintiv rule.

The dispute began last year when Fresenius filed a petition for the IPR of the US patent number 7,521,052 in a bid to market a generic version of the treatment.

The patent covers methods of treating rheumatoid arthritis, which Fresenius argued is invalid because it is anticipated or obvious.

Chugai countered that the PTAB should decline to institute under NHK Spring/Fintiv rule.

Established under former USPTO director Andrei Iancu, the rule derived from NHK Spring v Intri-Plex (2018) in which the PTAB held that the existence of a parallel district court lawsuit should preclude an IPR.

In May 2020, Apple v Fintiv outlined six scenarios for PTAB to consider before instituting a review, 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.

This prompted Apple, Google, Cisco, Intel and Edwards Lifesciences to file the lawsuit against the USPTO, after the PTAB declared its 2018 decision in NHK and its March 2020 decision in Fintiv to be precedential.

But Chugai scuppered its chances of applying the rule when it conceded before the PTAB that there was no pending litigation between the parties. The board remained unconvinced by its insistence that the institution under Fintiv could still be applied “because of the near-certainty of parallel, duplicative proceedings”.

Chugai also asserted that: “[t]he absence of any pending litigation between the parties does not mean they do not have a dispute.”

The company argued that: “once petitioners seek approval from FDA for their copy of Actemra, the parties’ patent disputes are likely to explode into full-blown district court litigation, including, potentially, preliminary injunction proceedings on patents like the ’052 patent.

According to Chugai, in refusing to hold off serving its notice of intent to market until this proceeding concludes, “petitioners virtually guarantee that the trial court and the board will be addressing the ’052 patent in parallel”.

But the board rejected this argument, holding that Chugai had identified, “at best, a hypothetical future district court litigation”. It further concluded: “Because the patent owner has not identified an existing parallel proceeding to consider, we decline the patent owner’s invitation for us to consider discretionary denial of the institution under Fintiv.”

Fresenius was found to have established a reasonable likelihood of prevailing in its assertion that claim 1 of the ’052 patent is unpatentable, and the board instituted an IPR of the challenged claim on all asserted grounds.

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