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There is pending legislation before Congress that, if passed, would shift the current patent landscape in favor of patent owners. The following three bills have been introduced in Congress with bipartisan sponsorship and support: the PERA Act (co-sponsored by Senators Thom Tillis (R-NC) and Chris Coons (D-DE), and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA)),1 the PREVAIL Act (co-sponsored by Senators Coons, Tillis, Dick Durbin (D-IL) and Mazie Hirono (D-HI), and Representatives Nathaniel Moran (R-TX) and Deborah Ross (D-NC)),2 and the RESTORE Act (co-sponsored by Senators Coons and Tom Cotton (R-AR), and Representatives Moran and Madeleine Dean(D-PA)).3 All three bills aim to strengthen patent holders’ rights.4
This article provides a brief overview of the pending legislation, their current status, and their impact if they were to pass.
The Patent Eligibility and Restoration Act (PERA) aims to modify and clarify patent subject matter eligibility requirements under 35 U.S.C. §101.
Ever since the Supreme Court’s decisions in Mayo5 and Alice6—which reaffirmed that there are certain implicit exceptions to the scope of patentable subject matter (such as laws of nature, natural phenomena, and abstract ideas)—courts have struggled with how to define and apply these judicially-created exceptions. Stakeholders across industries,7 the USPTO,8 the Solicitor General,9 and even judges on the Court of Appeals for the Federal Circuit have looked to the Supreme Court for further guidance on the test for patent eligibility,10 but the Supreme Court to date has declined to grant certiorari.11
The U.S. Patent & Trademark Office has issued its own guidelines for how to evaluate patent eligibility in view of Supreme Court precedent,12 and newly-confirmed Director Squires appears to be a proponent of broader patent eligibility standards.13 But, the Federal Circuit does not consider itself bound by the agency’s views and guidelines,14 demonstrating the need for either further Supreme Court guidance or legislative action. In the interim, there has been increased scrutiny of patents directed to medical diagnostics, software, biotechnology, and the like.
On the legislative front, most recently with the reintroduction of the PERA bill, Congress has taken some action in an attempt to bring more clarity into this area of law and to “restore patent eligibility to important inventions across many fields while also resolving legitimate concerns over the patenting of mere ideas, the mere discovery of what already exists in nature, and social and cultural content that everyone agrees is beyond the scope of the patent system.”15 Senator Tillis, one of the sponsors of the PERA bill, has stated that Supreme Court decisions have “rendered patent eligibility law unclear, unreliable and unpredictable,” and that judicially-created exceptions to §101 have rendered an increasing number of inventions ineligible for patent protection.16 Senator Coons, another co-sponsor, has stated that “PERA restores clarity to the law on what can be patented and what cannot – guidance that federal courts have been requesting for years and that the Supreme Court has refused to provide.”17 The goal of PERA is to restore patent protection to inventions, especially in areas where other countries offer patent protection, and to “affirm[] the basic principle that the patent system is central to promoting technology-based innovation.”18
To do so, the PERA Act will maintain the four statutory categories codified in §101 (process, machine, manufacture and composition of matter), which states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”19
The PERA Act would eliminate all judicially-created exceptions, and instead replace them with the following statutory exclusions:
For the first two categories, the 2025 version of the bill states that a claimed invention will not be excluded from patent eligibility “if the invention cannot practically be performed without the use of a machine or manufacture.” A prior version of the bill included this same “practically be performed” language for process category 2, but not for category 1. The 2025 version of the bill further states that “the inclusion of pre- or post-solution activity by a computer (or other machine or manufacture) in claim language shall not be sufficient to confer patent eligibility on the claim if that computer (or other machine or manufacture) is not necessary to practically perform the invention.”
For the last two categories, additional clarifications are provided. A human gene will not be considered “unmodified” if it is “purified, enriched, or otherwise altered by human activity” or “otherwise employed in a useful invention or discovery”; although a previous version of the bill also included the word “isolated” in its definition of “unmodified” genes, the word “isolated” has been removed from the 2025 version of the bill. Accordingly, “isolated” human genes presumably would remain patent-ineligible, consistent with the Supreme Court’s decision in Myriad,21 at least unless claimed in a manner where such isolated genes are “otherwise employed in a useful invention or discovery.” Under the 2025 bill, a “natural material” will not be considered “unmodified” if it is “isolated, purified, enriched, or otherwise altered by human activity” or “otherwise employed in a useful invention or discovery.” It is unclear the extent to which the “human genes” category is intended to overlap with the “natural materials” category, or if the two are meant to be mutually exclusive.
According to the bill’s sponsors, these defined statutory exceptions will provide clarity on patent eligible subject matter, allowing for growth and development in areas such as technology and innovation, biotechnology, and AI.22
Opponents of the bill fear that it would stifle innovation by creating monopolies on fundamental scientific ideas and biological materials, thereby hampering innovations in fields such as diagnostic testing and personalized medicine, and also make it easier to empower entities owning vaguely-defined patents to extract settlements.23 This echoes the concerns expressed by the Supreme Court that judicially-created exceptions are “basic tools of scientific and technological work” and “monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.”24 The concern driving such judicial exceptions is one of pre-emption, and potentially inhibiting “further discovery by improperly tying up the future use of . . . building blocks of human ingenuity.”25 Opponents of the bill have also expressed concern that the proposed “practically be performed” standard would unduly extend eligibility and that the standard is not any clearer than the current eligibility test as promulgated by the Supreme Court. 26
On October 8, 2025, a hearing took place before the Senate Intellectual Property Subcommittee on the 2025 version of the PERA bill, with proponents of the bill once again speaking in its favor, and opponents reiterating concerns that the bill does not strike the right balance. Former USPTO Directors Iancu and Kappos, and others who support the bill, believe it provides stability and coherent decision making into what is and isn’t patent eligible. In their view, it suffices that patent eligible inventions would still have to go through novelty, non-obviousness and disclosure tests, and that §101 should be a “broadly welcoming gate, not a guillotine”.27
Opponents worry that the bill would “massively increase rather than decrease uncertainty” for main street businesses who would once again have to grapple with non-practicing entities that assert overly broad patents on well-known business practices using technologies others had invented (as had been done with computers, the internet, and smartphones, and as will be done with AI).28 They expressed concern about the bill not only reversing a decade of precedent under Alice, but also sweeping away guardrails against the patenting of mere ideas that date back to Supreme Court decisions in the 1800s.29 On the life sciences side, opponents argued that the bill would cause substantial harm to the research and clinical community as it relates to genetic testing, including because it would “permit the privatization of natural law in the form of knowledge of new biomarkers and their clinical relevance.”30
If the PERA bill were to pass in its current form, and notwithstanding the sponsors’ stated goal of clarity, there will undoubtedly be ensuing litigation over how to interpret the various provisions of the Act, including but not limited to what constitutes “unmodified” as it relates to human genes and natural materials, how broadly the “otherwise employed in a useful invention or discovery” exception will be applied, what constitutes “substantially economic, financial, business, social, cultural, or artistic,” and where the line is to be drawn between inventions that cannot “practically be performed” without the use of a machine, and those that can be.
Since 2019, various attempts have been made to pass subject matter eligibility reform legislation, but none have yet succeeded. A 2023 version of the PERA bill was referred to the Senate Judiciary Committee and hearings were held in January 2024 before the Subcommittee on Intellectual Property, but no further progress was made at that time. The 2025 version of PERA was introduced on May 1, 2025 in the Senate as S.1546 and referred to the Senate Committee on the Judiciary, and as H.R.3152 in the House where it was referred to the House Committee on the Judiciary. Currently, the prospects of the bill passing remain uncertain.
The Promoting and Respecting Economically Vital American Innovation Leadership (PREVAIL) Act focuses on reforming rules and procedures at the Patent Trial and Appeal Board (PTAB), which adjudicates the inter partes review (“IPR”) and post-grant review (“PGR”) proceedings established under the Leahy-Smith America Invents Act.
IPR and PGR proceedings were intended to help reduce the costs of patent litigation and to maintain the integrity of the patent system by allowing a streamlined Patent Office review of issued patents.31 Currently, there is no standing requirement for PTAB proceedings and a “preponderance of the evidence” standard applies (instead of the “clear and convincing evidence” standard that would be applied in court based on a presumption of validity). Critics of the system have argued that IPR and PGR proceedings, especially when repetitive and serial petitions are filed, have had the effect of harassing patent owners and unnecessary duplication of work between the USPTO and the courts.
The USPTO itself has sought to reduce serial petitions and duplication of work through application of certain discretionary factors when determining whether an IPR or PGR ought to be instituted before the PTAB,32 and has faced several challenges to its discretionary procedures over the years,33 with critics arguing that the USPTO’s practices undermine the AIA’s goal of providing a just, speedy, and inexpensive alternative to litigation. Discretionary denials increased under USPTO Director Iancu’s tenure from 2018-2021, were curtailed under Director Vidal’s tenure, and increased again pursuant to then-Acting Director Stewart’s March 2025 memorandum for managing the PTAB’s workload that established a bifurcated process for institution decisions separating discretionary considerations and merits/non-discretionary considerations.34 Director Squires has left that bifurcated process undisturbed, and has delegated responsibility for discretionary denial decisions to now Deputy Director Stewart.35
The PREVAIL bill aims to statutorily “reduce the number of serial or repetitive petitions for inter partes and post-grant reviews, and the duplicative work faced by the district courts and the PTAB” and thus “promote fair treatment for inventors, improve efficiency and ensures the USPTO has the resources it needs”.36 To do so, the bill includes the following provisions:
The bill was originally introduced in the Senate in 2023, and passed out of the Senate Judiciary Committee by a narrow vote in late 2024. 38 A manager’s amendment regarding the definition of non-profit was added to the bill to appease concerns about the impact of the new standing requirement on patient advocacy groups and their ability to challenge drug patents, 39 but no further action was taken at that time.
On May 1, 2025, the PREVAIL Act was reintroduced in the Senate, with the 2024 amendment, as S.1553 and referred to the Senate Judiciary Committee, and introduced in the House as H.R. 3160 and referred to the House Judiciary Committee. No further action has yet been taken.
The Realizing Engineering, Science and Technology Opportunities by Realizing Exclusive (RESTORE) Patent Rights Act aims to restore the presumption that courts can issue injunctions if patent infringement is found.
Historically, upon a finding of infringement, courts would presume that an injunction should be granted. 40 That practice changed in 2006 with the Supreme Court decision in eBay v. MercExchange, 41 which created a four-factor test to determine whether an injunction should issue. Under eBay, a plaintiff seeking a permanent injunction must prove: (1) irreparable injury, (2) inadequate remedies at law (such as monetary damages), (3) balance of hardships between the plaintiff and defendant warrants a remedy in equity, and (4) the interests of the public would not be disserved by issuance of an injunction. The eBay court explained that “the decision to grant or deny permanent injunctive relief is an act of equitable discretion by the district court” and that neither the Patent Act nor Congress intended any departure from this general practice. 42
According to the bill’s sponsors, removing the presumption that an injunction should issue has substantially reduced the ability of patent owners to obtain injunctions and has created incentives for large, multinational companies to commit predatory acts of infringement. 43 Reportedly, after eBay, requests for permanent injunctions in patent cases dropped by 65% and grants of permanent injunctions fell even further. 44
The bill proposes to add to §283 of 35 U.S.C. the following language:
“If, in the case under this title, the court enters a final judgment finding infringement of a right secured by patent, the patent owner shall be entitled to a rebuttable presumption that the court should grant a permanent injunction with respect to that infringing conduct.” 45
Opponents of the bill reiterate the positive impact that the eBay decision has had on investment in research and development and innovation ecosystem as a whole. They argue that patent assertion entities (who would not be able to demonstrate irreparable harm under eBay) would be the biggest beneficiaries and would gain undue bargaining leverage with which to extract royalties. They cite the continued prevalence of injunctions being granted in today’s patent cases, with one study finding that permanent injunctions were granted in approximately 75% of cases. 46 They further argue that the eBay decision brought patent cases in line with longstanding, historical precedent that an injunction is discretionary, equitable relief, not something that ought to be automatically granted, and that the bill would have the impact of disincentivizing U.S manufacturing. 47
The bill was first introduced on July 30, 2024 to the Senate Judiciary Committee and a hearing was held, but the bill was never voted on. The bill was reintroduced on February 2, 2025 in the Senate as S.480 and in the House as H.R. 1574, and is identical to the 2024 version. The bill has not yet made any further progress.
If any of these bills were to pass, there would be a shift in the patent landscape in favor of patent owners. Newly-confirmed Director Squires appears to be in favor of at least broadening patent eligibility, especially as it relates to AI, 48 and depending on the political will for patent reform and the priorities of the current administration, we may see an increased focus on the pending patent legislation in the near future. It will be imperative to monitor these bills and any related developments, and to monitor how Squires as the new USPTO Director may implement his own changes in these areas.