notice of proposed rulemaking Archives

Double trouble: Proposed IPR institution changes would limit duplicative proceedings

by Rick Evans | Oct 23, 2025 | America Invents Act, Patents

The United States Patent and Trademark Office (USPTO) proposed changes to the rules governing inter partes reviews (IPRs) before the Patent Trial & Appeal Board, including setting limits on use of IPR proceedings for patent claims that have already been challenged in a prior proceeding. According to the USPTO, the proposal is aimed at preventing duplicative litigation against patent holders and promoting fairness, efficiency, and predictability in patent disputes.

The Notice of Proposed Rulemaking introduces changes to 37 C.F.R. § 42.108 that would bar the institution of IPRs in cases where:

A petitioner refuses to stipulate that it won’t pursue invalidity challenges under §§ 102 or 103 in other venues, such as a district court or the US International Trade Commission (ITC).
The challenged claims were found not invalid or not unpatentable in a prior district court, ITC, Board reexamination, or Federal Circuit proceeding.
Parallel litigation involving the patent will likely reach a decision before the final IPR written decision.

The proposed rule would provide an exception to the proposed IPR limitations in “extraordinary circumstances,” such as a bad faith institution of a previous IPR or a substantial change in law that renders a prior challenge irrelevant.

The USPTO explained that the proposed changes will offer greater certainty for patent owners by reducing serial validity challenges, improving judicial efficiency by minimizing duplicative proceedings, and facilitating lower litigation costs and stronger investment incentives. The USPTO noted that the changes would benefit smaller technology companies, which often lack the litigation resources of larger companies and are more vulnerable to the effects of weaker patent rights.

The proposed changes would represent a significant shift in the availability of IPR for petitioners and would alter the timing and strategy of decisions about whether to pursue an IPR. Comments on the proposed rule changes are due by November 17, 2025, and can be submitted via the federal eRulemaking portal.

PTO Withdraws Proposed Rule on Terminal Disclaimer Changes

by Amol Parikh | Dec 12, 2024 | Patents

The US Patent & Trademark Office (PTO) withdrew its proposed rule that suggested major changes to its terminal disclaimer practice. 89 Fed. Reg. 96152 (Dec. 4, 2024).

In May 2024, the PTO issued a Notice of Proposed Rulemaking that would have required a terminal disclaimer to include an agreement that a patent would be unenforceable if it was tied directly or indirectly to another patent having any claim invalidated or cancelled based on prior art. During the proposed rule’s 60-day comment period, the PTO received more than 300 comments from a variety of stakeholders that both supported and opposed the proposal.

The PTO issued a notice withdrawing the proposal, explaining that in light of resource constraints, it decided not to move forward.

Patent Thicket Avoidance: PTO Proposes Changes to Terminal Disclaimer Practice

by Peter Brunovskis, PhD | May 23, 2024 | Patents

On May 10, 2024, the US Patent & Trademark Office (PTO) issued a notice of proposed rulemaking (Notice) concerning major changes to the terminal disclaimer (TD) practice, which may lead to a sea change in patent prosecution strategies. The proposed change would require a TD to include an agreement from the patent owner that the patent will be unenforceable if it’s tied directly or indirectly to another patent having any patent claim invalidated or canceled based on prior art. 89 Fed. Reg. 40439 (May 10, 2024).

The rule change is a potential boon for patent challengers and is intended to promote innovation and competition by allowing a competitor to avoid enforcement of patents tied by TDs to patents with claims finally held unpatentable or invalid. Under current practice, invalidation of a patent tied to another patent by a TD does not directly affect the patentability of the other patent. Under the new rule, a competitor could target a single patent in a validity dispute in a post-grant challenge without the need to seek review and invalidation of other related patents. As a result, invalidating one claim in a patent tied to other patents by TDs would render all other tied patents unenforceable.

According to the Notice, the proposed change aligns with the US government’s intent to reduce drug costs and promote competition by reducing barriers to market entry in accordance with President Biden’s Executive Order 14036 on “Promoting Competition in the American Economy.” Part of the reduced costs are said to come from bringing down the cost of challenging large “patent thickets” of multiple patents covering a single product or minor variations of the product tied by TDs.

The proposed rule change would represent a paradigm shift for TD practice. Current TD practice under 37 CFR 1.321(c) or (d) allows applicants to file multiple patents with claims varying in only minor ways from one another by filing TDs to obviate obviousness-type double patenting (ODP) rejections over closely related patent claims issued or pending in applications commonly owned or commonly owned on the basis of a joint research agreement. In filing a TD, the applicant agrees to disclaim any patent term extending beyond the term of the prior patent having similar patent claims.

The proposed rule seeks “to revise 37 CFR 1.321 (c) and (d) to require that a terminal disclaimer filed to obviate nonstatutory double patenting include an agreement by the disclaimant that the subject patent or any patent granted on the subject application shall be enforceable only if the patent is not tied and has never been tied directly or indirectly to a patent by one or more terminal disclaimers filed to obviate nonstatutory double patenting in which:

(1) any claim has been finally held unpatentable or invalid under 35 U.S.C. 102 or 103 . . . by a Federal court in a civil action or by the PTO, and all appeal rights have been exhausted; or

(2) a [...]

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