USPTO’s Proposed IPR Institution Rule Advances to Final Review

Need to know

On July 22, 2026, the U.S. Patent and Trademark Office (USPTO) submitted its final rule, Revision to Rules of Practice before the Patent Trial and Appeal Board (RIN 0651-AD89), to the Office of Information and Regulatory Affairs (OIRA) within the Office of Management and Budget (OMB) for review. The rule is currently listed as pending OIRA review and has been categorized as not economically significant. 

The submission signals that the USPTO has completed its review of public comments and that publication of the final rule may be near, although the final rule text has not yet been made public. 

Background

The rule originates from a Notice of Proposed Rulemaking published October 17, 2025 (90 Fed. Reg. 48335), which proposed amendments to 37 C.F.R. Part 42 governing institution of inter partes review (IPR) proceedings before the Patent Trial and Appeal Board (PTAB). As we previously reported, the rule would create several categorical bars on institution, including:

• Prior validity determinations. The PTAB would not institute IPR where the challenged claims (or substantially similar claims) have already been upheld against invalidity under §§ 102 or 103 in another forum, including a district court, the International Trade Commission (ITC), a prior PTAB proceeding, or ex parte reexamination.
• Parallel litigation (§ 42.108(f)). The PTAB would not institute IPR where parallel district court or ITC litigation is likely to resolve validity before the PTAB would reach a final written decision — effectively converting what was previously one discretionary Fintiv factor into a dispositive bar.
• Enhanced stipulation requirement. Institution and continued maintenance of an IPR would be conditioned on the petitioner filing a stipulation forgoing §§ 102/103 invalidity challenges in other forums.
• Narrow “extraordinary circumstances” exception (§ 42.108(g)). The PTAB may institute IPR notwithstanding certain categorical bars if the Director finds that extraordinary circumstances warrant institution.  

The public comment period closed December 2, 2025 (extended from the original November 17, 2025 deadline). The USPTO received more than 11,000 comments from the public, reflecting significant stakeholder interest in the proposed changes. It is not yet apparent whether, or how, the Office revised the final rule in response to those comments.  

What it means

If finalized substantially as proposed, the rule would restrict the availability of IPR as a vehicle for challenging patent validity — potentially leaving more validity disputes to be resolved in district court and ITC proceedings. Petitioners may need to account for these restrictions earlier when developing parallel PTAB and litigation strategies.

Next steps  

• OIRA review. OIRA review is the final significant procedural step before publication of the rule in the Federal Register. There is no fixed statutory deadline. For a rule designated not economically significant, review may conclude within days to a few weeks, although it can extend toward 90 days. OMB may clear the rule or return it to the agency. Alternatively, the agency may withdraw the rule from review or resubmit it after further consideration during the review process.
• A window to be heard. While the rule remains under review, interested parties may request an “E.O. 12866” meeting with OIRA to provide views on the rule. OIRA’s meeting-request page states that, under Executive Order 12866, OIRA meets on regulatory actions with any interested party to discuss issues on a rule under review. OIRA’s guidance also states that any member of the public may request a meeting while OIRA is reviewing a draft regulatory action, but that OIRA may complete review before a scheduled meeting, in which case the meeting may be canceled.
  
  To request a meeting, interested partes may enter RIN number 0651-AD89 on OIRA’s meeting-request page. OIRA also provides a how-to-guide for E.O. 12866 meetings. If OIRA holds a meeting with outside parties, then the subject, date, and participants of the meeting — along with any written materials submitted — are publicly disclosed on Reginfo.gov.  
• Publication. Once OIRA review concludes, the final rule may publish in the Federal Register with a stated effective date (commonly 30–60 days out), at which point it amends 37 C.F.R. Part 42.

How we can help

OIRA review is the last major step before the final rule may be published. Fish & Richardson’s post-grant team is monitoring the rule’s status and can help clients:

1. Engage before finalization: assess whether an E.O. 12866 meeting with OIRA may be appropriate and help prepare targeted messaging and materials
2. Plan for implementation: evaluate how the final rule could affect coordinated IPR, district court, ITC, and ex parte reexamination strategies to maximize available remedies and defenses, accounting for all aspects of the ever-evolving legal landscape
3. Adjust filing strategy: consider how potential categorical bars, timing issues, and stipulation requirements may affect future validity challenges.