On February 28, 2025, the USPTO rescinded its previous June 22, 2022 ("Rescission"), guidance on an Interim Procedure for Discretionary Denials ("2022 Guidance"). On March 24, 2025, the USPTO issued further guidance on the intended impact of this Recission ("2025 Guidance).
As we wrote at the time, the 2022 Guidance clarified that the "PTAB will not deny institution of an IPR or PGR under Fintiv" in three scenarios: where (1) unpatentability is compelling, (2) a parallel case is before the ITC, or (3) a Sotera Stipulation is made.2022 Guidance. at 9. The 2022 Guidance also clarified that the median time-to-trial evidence for consideration of interactions with parallel district court proceedings, rather than relying solely on scheduled trial dates. Id. at 9.
While the Rescission stated the 2022 Guidance was no longer in effect, substantial questions have lingered regarding the intended impact of this action, including to what proceedings it applies, and what weights these considerations have going forward. The 2025 Guidance provides answers. First, the guidance makes clear it applies to institution decisions for pending petitions, but not for instituted proceedings. 2025 Guidance at 2. Second, while all factors remain an important part of a full Fintiv analysis, the USPTO will no longer consider any dispositive on their own. Id. at 2-3. And third, evidence of time-to-trial statistics may still be considered. Id. at 3.
2025 Guidance Applies if Institution is Still Under Consideration
The 2025 Guidance clarifies that the Interim Procedure's recission applies only prospectively, "to any case in which the Board has not issued an institution decision, or where a request for rehearing or Director Review of an institution decision was filed and remains pending." 2025 Guidance at 2. If a decision on institution is already final, the Board will not revisit the previous decision "absent extraordinary circumstances." Id. So, while the 2025 Guidance will apply to all cases going forward, including those filed before the Rescission, it will not be a basis to overturn past institution decisions.
Fintiv Applies to ITC Investigations, with a Focus on the ITC Target Date
In what is likely to be the most impactful change, the 2025 Guidance's reverses the 2022 Guidance that Fintiv will not apply to ITC investigations. Reasoning that "although an ITC final invalidity determination does not have preclusive effect, it is difficult as a practical matter to assert patent claims that the ITC has determined are invalid," the 2025 Guidance indicates that the Fintiv analysis must still take place. Id.
The 2025 Guidance further particularly calls out the impact of the relative timing of the IPR Final Written Decision, and the ITC target date (which as the 2025 Guidance notes is the commission decision date, not the ALJ initial determination date). Specifically, "the Board is more likely to deny institution where the ITC's projected final determination date is earlier than the Board's deadline to issue a final written decision, and the Board is less likely to deny institution under Fintiv where the ITC projected final determination date is after the Board's deadline to issue a final written decision." Id.
Sotera Stipulations and Compelling Merits Remain Important Factors, but Not Dispositive
The 2025 Guidance further clarifies that while the 2022 Guidance's instruction that the Board will not discretionarily deny cases with Sotera stipulations and compelling merits has been rescinded, Sotera stipulations and compelling merits remain important considerations. The 2025 Guidance states that "a timely-filed Sotera stipulation" is "highly relevant," and that the strength of the merits is "part of a balanced assessment of all the relevant circumstances in the case." Id. at 2-3. But neither, by themselves, will be "dispositive" going forward. Id.
Median Time-to-Trial Statistics Remain Relevant
Finally, the 2025 Guidance clarifies that at least one portion of the 2022 Guidance remains in effect, the availability of evidence regarding median time-to-trial statistics to put scheduled trial dates in context. The 2025 Guidance states, "the Board may consider any evidence that the parties make of record that bears on the proximity of the district court's trial date or the ITC's final determination target date, including median time-to-trial statistics for civil actions in the district court in which the parallel litigation resides." Id.at 3.
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