Current and Former Lawmakers Lock Horns in Comments on USPTO’s Proposed PTAB Changes

The deadline for comments on the U.S. Patent and Trademark Office’s (USPTO’s) Notice of Proposed Rulemaking (NPRM) issued in October, titled “Revision to Rules of Practice before the Patent Trial and Appeal Board,” was yesterday, December 2. As of today, the Office has received 10,783 comments and has published just over 1,000 of them. [Update: as of December 4, the Office has received 11,439 comments and has now posted more than 2,000 of them].

The NPRM modifies the rules of practice for inter partes reviews (IPRs) before the Patent Trial and Appeal Board (PTAB), with the stated goal being “to focus inter partes review proceedings on patent claims that have not previously been challenged in litigation or where prior litigation was resolved at an early stage.”

It was issued on the same day that the Office officially withdrew a 2024 NPRM published by former USPTO Director Kathi Vidal, which proposed to codify several changes around serial and parallel petitions practices; rules for briefing on discretionary denial requests; termination and settlement agreements; and the factors for consideration of discretionary denials.

The proposed rule would expand upon USPTO Director John Squires’ emphasis on “born-strong” patents and quiet title. A press release issued on the NPRM in October said that, under current practice, “the Office is concerned that even extremely strong patents become unreliable when subject to serial or parallel challenges.”

The NPRM noted that “hindsight bias” and the fact that “reasonable minds may, and frequently do, disagree about whether a particular patent claim meets the statutory requirements” result in even very strong patents being at risk of invalidation throughout their lifetime when there is an ability to challenge them repeatedly in different forums.

Under the proposal, when a claim has been found valid via both examination at the USPTO and in another forum, such as a district court, the International Trade Commission, or another USPTO proceeding, IPR may be unwarranted. It would require IPR petitioners to stipulate that they will not be pursuing invalidity challenges in other venues and “would further require the Petitioner to file the stipulation in any other venue where it is litigating with the patent owner.”

The rules have been broadly welcomed by IP holders and practitioners, and broadly opposed by those who want to preserve the option to easily challenge patents. Below, we summarize several submissions from individuals and organizations on both sides. Additional comments will be featured as they become available.

Bipartisan, Bicameral Support from Current Members of Congress

Senators Thom Tillis (R-NC) and Chris Coons (D-DE), along with Representatives Nathaniel Moran (R-TX) and Deborah Ross (D-NC), submitted comments urging the USPTO to finalize the proposed rule, but also to support the Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act.

The letter explained:

“Congress made clear in enacting the AIA [America Invents Act] that the PTAB should not be used ‘for harassment or a means to prevent market entry through repeated litigation and administrative attacks’ and that ‘[d]oing so would frustrate the purpose of the [PTAB] as providing quick and cost effective alternatives to litigation’ and ultimately undermine innovation by ‘divert[ing] resources from the research and development of inventions.’”

Because the PTAB has become merely an additional forum in which to challenge patents, the rule as well as the PREVAIL Act are needed to help restore it to its “core purpose” as an alternative to district court litigation, said the authors. The letter also emphasized that a USPTO rule can be repealed or altered by future administrations, and so the PREVAIL Act is crucial to codify key changes. It added:

“Although the NPRM and the PREVAIL Act take slightly different approaches, both the bill and the Proposed Rule would:

• • Eliminate repetitive challenges by the same party on the same patents;
  • End duplicative challenges and parallel proceedings in multiple tribunals, requiring a party to choose whether to bring a challenge in the PTAB or another forum, like federal district court or the ITC; and
  • Reduce inconsistency between tribunals and improve efficiency by providing an inventor ‘quiet title’ when a final judgment has been entered on the validity of a patent claim.”

Leahy and Other Former Lawmakers Urge Withdrawal

Taking the opposite position to Tillis, Coons, Moran and Ross, 14 former lawmakers—including the author of the AIA, former Senator Patrick Leahy (D-VT)—warned the USPTO that the proposed rule “runs afoul of the AIA on multiple fronts.”

Specifically, the letter charges that the USPTO does not have authority to revise the AIA by requiring that parties waive defenses in district court beyond those they “raised or reasonably could have raised” at the PTAB or by “binding PTAB petitioners to any prior litigation regarding the patent in question, regardless of whether the petitioner was a ‘real party in interest’ or ‘in privy’ in those cases.” Furthermore, said the letter, the proposal to bar petitioners from filing IPRs within the one-year timeframe set forth in the AIA if there is parallel litigation that is likely to conclude prior to a final written decision constitutes “a nonstatutory barrier to PTAB access and violates the AIA’s intent.”

The lawmakers also challenged the USPTO’s assertion that the rule would not have “a significant economic impact on a substantial number of small entities,” arguing that the PTAB is often the best way for small entities to address mass litigation by patent assertion entities (PAEs). “Reducing the circumstances in which patent validity review is viable, as this NPRM does, will undoubtedly embolden assertion entities to target more vulnerable small- and medium-sized businesses,” charged the letter.

The lawmakers also claimed that the rule will have a “significant and detrimental” economic impact and asked that it be withdrawn in its entirety.

Leahy and fellow signatory to the comment, former Rep. Bob Goodlatte (R-VA), also submitted a letter in November to Director of the Office for Management and Budget, Russel Vought, slamming the rule as flouting administrative law and arguing it should be rescinded. At a minimum, however, Leahy and Goodlatte said the OMB must conduct a mandatory regulatory evaluation.

Inventor Defense Alliance: Foreign Users of PTAB Are Not Inherently Bad

A group launched late last year, the Inventor Defense Alliance (IDA), told Squires the proposed rule would be “an important step toward restoring balance and fairness in the post-grant review process,” but also urged the Office to “strike a careful balance” that will not undermine the process outlined by the AIA.

The IDA’s comment also focused on the concerns highlighted by the NPRM surrounding foreign users of the PTAB, particularly from China, which it claimed are overblown. It noted that only two of the top ten users of the PTAB between 2012 and 2024 were Chinese companies (ZTE and Huawei) and said that “it is worth emphasizing that foreign participation in the U.S. patent system is not inherently harmful.” Specifically, disclosure of foreign technology via the U.S. patent system gives American researchers and startups an edge and helps to ensure that U.S. companies will enjoy the same protections in other jurisdictions. “Strong, mutual IP recognition is a cornerstone of continued technological leadership,” said the IDA.

US Inventor Offers Sample Comment Language 

US Inventor is urging inventors to submit comments via an AI tool it offers on its website, the AI Comment Assistant. As part of the campaign, it has provided sample language for submissions, which urges the USPTO to adopt a rule that will ensure predictability; impose a limit of one petition/ AIA trial per patent; deny petitions where there are parallel proceedings pending; interpret the definition of a “privy” to “include a party to an agreement with the petitioner or real party of interest related to the validity or infringement of the patent where at least one of the parties to the agreement would benefit from a finding of unpatentability”; and consider the greater economic impact of AIA trial institutions on independent inventors and small businesses.

One Inventor/ Entrepreneur’s View: Substantial License Activity Should Count

Jeff Hardin of InventorRights.com, a business owner and entrepreneur,supports the NPRM’s bar on duplication of agency work via institution of an IPR in which the challenged claims have already been found valid or not invalid in another judicial or administrative proceeding, but wants the Office to take it further. According to Hardin, if the standard is that where “adequate scrutiny” has been “demonstrated, post-issuance, on the merits by an expert or a constitutionally authorized tribunal,” then that logic should extend to situations in which the claims at issue are already “subject to substantial, arms-length license agreements.”

Hardin noted that the U.S. Court of Appeals for the Federal Circuit has recognized that licensing activity “constitutes an authoritative, objective measure of patent validity and nonobviousness” in Ancora Technologies, Inc. v. Roku, Inc., 140 F.4th 1351 (Fed. Cir. 2025). “If the USPTO’s goal is to focus its limited adjudicatory capacity on ‘the most appropriate disputes,’ then evidence of real-world licensing should preclude institution just as surely as a district-court verdict or ITC determination,” Hardin said. The comment added that a “substantial license” can be defined as one where the “economic value equals or exceeds the expected cost of defending a patent infringement suit through the discovery stage” as measured using industry data such as the American Intellectual Property Law Association (AIPLA) Economic Survey, for example.

Patient Advocates Oppose Changes

Patients For Affordable Drugs (P4AD)“strongly oppose[s]” the proposed rule because, according to their submission, the PTAB “allows for more efficient, accessible, and affordable challenges to invalid patents,” particularly in the context of pharmaceutical patents. Prior to the American Invents Act (AIA), said P4AD, invalidating pharma patents “cost millions of dollars in district courts, harmed many communities, and led to patients, patient advocacy organizations, and researchers often lacking standing. The PTAB and Inter Partes Review (IPR) created a much-needed pathway for curbing Big Pharma’s patent abuse and bringing lower-cost generic and biosimilars to market.”

P4AD’s comment claimed that cardiovascular drug prices after IPR challenges fell 97%, cancer drugs by 80-98% and opioid addiction treatments became 50% more affordable. The comment cited a paper published by Charles Duan, “On the Appeal of Drug Patent Challenges”, 72 Am. U. L. Rev. 1177 (2023), to support this proposition. The comment also noted that many of the pharmaceutical patents that have been invalidated at the PTAB would not have been under the proposed rule because they are largely more than six years old, and would have been rejected under the Office’s recent “settled expectations” doctrine, which is separately being challenged at the Federal Circuit.

C4IP Weighs In

Like the current members of congress who submitted comments, the Council for Innovation Promotion (C4IP) emphasized the importance of the Office vocally supporting the PREVAIL Act in order to ensure a solution “that is less subject to revision under successive USPTO leadership.” While C4IP supports the rules package and commended Squires and then-Acting Director Coke Morgan Stewart for their decisive leadership in introducing changes to PTAB practice, the comment underscored that there should still be a clear path to challenging a patent at the PTAB and warned the Office against “inadvertently disincentivizing use of inter partes reviews (IPRs) altogether, which would undermine congressional intent in a different way.”

While C4IP is generally supportive of the rule, it expressed concern that as written it could discourage use of the PTAB altogether  According to C4IP, the final rule should make it clearer that the PTAB is still a viable option for review of a patent “once where such review would not duplicate validity proceedings of a district court or the ITC on behalf of the same party.” The goal should be balance, said the comment, which specifically asked the Office to clarify how Section 42.108(d) of the rule, which deals with stipulations, would interact with Section 42.108(f), which bars institution where there is parallel litigation. The comment explained:

“C4IP suggests making clear that if a petitioner is willing to submit this stipulation, the proposed bar in § 42.108(f) should not preclude the petitioner from proceeding in the PTAB. In other words, where the petitioner is both attempting to challenge a patent in an IPR and is the same party in a district court or ITC proceeding, the fact that the district court or ITC proceeding might issue a decision first should not preclude institution if the petitioner is willing to submit a stipulation.”

The comment also suggests modifying proposed Section 42.108(d) “so that it operates on a claim-by-claim (rather than patent-by-patent) basis and so that it extends only to §§ 102–103 invalidity arguments based on patents and printed publications, in line with the scope of the PTAB’s jurisdiction in IPRs.” Other revisions to the final rule C4IP proposed include:

• Reconsideration of proposed Section 42.108(e), which would automatically block IPRs where an ex parte reexamination Office Action upheld a patent claim’s validity, since this is “already appropriately accounted for under 35 U.S.C. § 325(d) and existing PTAB precedent, such as Advanced Bionics”;
• Broadening of Section 42.108(g) to allow for more Director discretion to institute proceedings in “extraordinary circumstances”;
• Clarification of the wording of Section 42.108(g) to indicate whether “a panel of three administrative patent judges will resume initial consideration of IPR institution
  decisions on their own instead of in conjunction with the Director,” which would rescind the Director’s memo issued on October 17, and which C4IP would support; and
• Clarification of whether the final rule will codify the various other changes that have been introduced under the current administration since Acting Director Stewart took over.

IPWatchdog also received a packet of 14 comments that are generally supportive of the proposed rule, including some of those outlined here, as well as comments from AIA co-author Lamar Smith (R-TX); The Alliance of U.S. Startups and Inventors for Jobs (USIJ); the Innovation Alliance; and more.

This article was updated after publication to include C4IP’s and other comments.