On October 17, 2025, the United States Patent and Trademark Office (“PTO”) took several actions designed to provide guidance for Inter Partes Review (“IPR”) proceedings. The PTO withdrew proposed rules issued in April 2024, announced that all institution decisions would be made by the PTO Director, and published a new set of proposed rules governing the institution of IPR proceedings.
An IPR proceeding is a trial that occurs in the Patent Office to adjudicate the validity of an already issued patent. When a petition for IPR is filed with the PTO, the PTO initially decides whether to institute a trial to determine the validity of the challenged patent.
PTO Director John Squires’s announcement modifies the March 2025 interim process on institution. Earlier this year, the PTO put into place an interim process, which bifurcated the institution decision into two steps. Initially, the Director determined whether any discretionary considerations would bar institution. If not, then an institution decision based on the technical merits of the petitioned prior art grounds was delegated to a Board panel. Now, the PTO Director will personally determine whether to institute trial based on review of discretionary considerations, the merits, and non-discretionary considerations—without delegating any decisions to the Board that conducts the trial proceeding.
The PTO’s new proposed rules seek to “draw clearer lines around the circumstances when IPRs should or should not be instituted.” 90 Fed. Reg. 48338. They are designed to focus IPR proceedings “on patent claims that have not previously been challenged in litigation or where prior litigation was resolved at an early stage.” In general, the proposed rules identify circumstances where institution will be denied except under “extraordinary circumstances”:
- No IPR Where Pending Proceedings with Validity Challenges under 35 U.S.C. § 102 or 103 Exist. Proposed Section 42.108(d) makes clear that the PTO will not institute an IPR when a petitioner intends to pursue invalidity challenges under 35 U.S.C. §§ 102 or 103 in another venue (e.g., district court, the U.S. International Trade Commission (ITC)). The petitioner must file a stipulation that it will not pursue such challenges with the PTO and any other venue where litigation is pending. Notably, the required stipulation forecloses even invalidity challenges in other venues that could not have been brought as a grounds for an IPR (e.g., prior sale, public use, and prior art systems).
- No IPR where Prior Post-Issuance Adjudication of Invalidity Has Failed. Proposed Section 42.108(e) describes circumstances where an IPR will not be instituted or maintained due to a prior finding that the patent is not invalid by a district court (42.108(e)(1)-(2)), the ITC (42.108(e)(3)), or a PTO post-grant review (42.108(e)(4)-(5)). The Section further states that an IPR will not be instituted where a determination of invalidity at the district court has been reversed by the Federal Circuit (42.108(e)(6)). Under the proposed rule, any determinations on an independent claim automatically extend to its dependent claims.
- No IPR where a Decision in Parallel Litigation will occur before the final written decision. Proposed Section 42.108(f) makes clear that no IPR will be instituted or maintained where a parallel proceeding in U.S. district court, the ITC, or the PTAB is “more likely than not” to reach a decision before the final written decision in the IPR. Under the proposed rule, any decisions on an independent claim automatically extend to its dependent claims.
- Discretion Reserved to Institute IPR in “Extraordinary Circumstances.” Proposed Section 42.108(g) allows the PTO to institute an IPR in circumstances where institution would otherwise be denied when “unusual or extraordinary circumstances” are present. Two examples of “extraordinary circumstances” are provided: (1) a prior challenge instituted in bad faith to prevent future challenges and (2) where a prior challenge is rendered irrelevant in view of change in a statute or Supreme Court precedent. The rule also identifies several situations that do not constitute “extraordinary circumstances,” including “new or additional prior art” or new case law if from a court that is not the Supreme Court (e.g., the Federal Circuit).
Comments on the Proposed Rules are Due by December 2, 2025. If you have questions or concerns or would like to consider filing proposed comments, please reach out to Mikaela Stone at mikaela.stone@KSLAW.com or Jeff Mills at jmills@kslaw.com.