Almost every patent attorney has heard some version of this question from a new client: “So if I invent something, you can patent it, right?” The truthful answer is that patent eligibility, the threshold question of whether an invention is even the kind of thing that can be patented, is far from simple.
The patent eligibility doctrine as it stands has faced significant criticism for its many twists and turns, and the judiciary’s own divisions run deep. As the Chief Judge of the Federal Circuit observed in 2020: “What we have here is worse than a circuit split—it is a court bitterly divided. [T]here is very little about which all twelve of us are unanimous, especially when it comes to § 101. We were unanimous in our unprecedented plea for guidance.”[1] That guidance has not come. Instead, the Chief Judge’s warning has only grown more prescient: “I grow more concerned with each passing decision that we are, piece by piece, allowing the judicial exception to patent eligibility to ‘swallow all of patent law.’”[2]
Against this backdrop of widespread disagreement and persistent uncertainty, the Patent Eligibility Restoration Act of 2025 (“PERA”), a revised version of a 2023 predecessor bill, seeks to remedy the confusion. The Bill is sponsored by Senators Chris Coons and Thom Tillis, as well as Representatives Kevin Kiley and Scott Peters.
At its core, PERA would eliminate the Alice/Mayo framework and replace it with a statutory list of what is, and is not, patent eligible. Here is what that means in practice.
The Current Framework: Alice and Mayo
35 U.S.C. § 101 is brief and broadly worded. It sets out four categories of patent-eligible subject matter: processes, machines, manufactures, and compositions of matter.[3] From those categories, courts have carved out three judicial exceptions: laws of nature, natural phenomena, and abstract ideas. The Supreme Court’s decisions in Alice Corp. v. CLS Bank International and Mayo Collaborative Services v. Prometheus Laboratories established a two-step framework for analyzing patent eligibility.[4] Step one asks whether an invention is directed to one of the three judicial exceptions. If not, the inquiry ends and the patent moves on to the usual analyses for novelty, non-obviousness, and disclosure. If the answer is yes, step two asks whether the invention nevertheless contains an “inventive concept”—something sufficient to ensure that the patent amounts to significantly more than a patent on the ineligible concept itself.[5]
In practice, however, this two-step test has proven far easier to describe than to apply.Practitioners have criticized the Alice/Mayo framework as difficult to implement, with Federal Circuit opinions sometimes providing only cursory reasoning in their eligibility analyses.[6] Alice was met with criticism by proponents of software patents,[7] while Mayo was criticized by those in the medical field as potentially making it more difficult for diagnostic methods to be patented, thereby reducing the likelihood of research funding in the space.[8] Perhaps the most significant practical criticism is that the two-step framework frequently collapses into a one-step inquiry—the Federal Circuit essentially using step two to rerun step one, which further narrows the scope of what gets patent protection.[9]
Despite the controversy, Alice and Mayo remain the governing law on patent eligibility. Whether they are here to stay is the central question PERA seeks to answer.
Enter PERA: The Patent Eligibility Restoration Act of 2025
PERA would fundamentally restructure the patent eligibility inquiry.[10] Rather than relying on judicially created exceptions applied through the Alice/Mayo two-step framework, the Bill would establish a statutory regime that expressly defines what is, and what is not, eligible for patent protection.[11] The Bill is sponsored by Senators Chris Coons and Thom Tillis, as well as Representatives Kevin Kiley and Scott Peters.
What PERA Would Prohibit
Under PERA, the following subject matter would be per se unpatentable: mathematical formulas; processes that are substantially economic, financial, business, social, cultural, or artistic; mental processes performed solely in the human mind; unmodified human genes as they exist in the human body (including genes that are merely isolated); and unmodified natural materials as they exist in nature.[12]
PERA also takes direct aim at business method patents. The Bill specifies that “process claims drawn solely to the steps undertaken by human beings in methods of doing business, performing dance moves, offering marriage proposals, and the like shall not be eligible for patent coverage.”[13] This represents a significant limitation on business method patents, a category that had already faced challenges under the America Invents Act, which created inter partes mechanisms for third-party invalidation of covered business method patents.[14] But PERA does not stop there.
Computer-Implemented Inventions
One of the most practically significant features of PERA is how it handles computer-implemented inventions—a subject that has generated enormous litigation since Alice. Alice held that processes directed to an abstract idea are patent-ineligible even if they are performed on a generic computer.[15] PERA addresses this directly: it specifies that an abstract business method does not become patentable simply by adding a reference to doing it “on a computer.”[16] But—and this is the key departure—PERA would preserve patent eligibility for processes that cannot practically be performed without the use of a machine (including a computer).[17] Unlike Alice, PERA protects inventions where a computer is genuinely necessary to perform the claimed process, whether or not that computer is “generic.” In other words: the mere mention of a computer does not save an otherwise ineligible process. But if the computer is truly integral, the invention may remain eligible.[18]PERA’s provision that “any process that cannot be practically performed without the use of a machine (including a computer) or manufacture shall be eligible for patent coverage” would appear to render eligible many computer-implemented processes, effectively overriding the central holding of Alice.[19]
Biotech Inventions
The stakes here are particularly high for the biotech and personalized medicine industries. The inclusion of naturally occurring processes would expand patent eligibility, particularly in the diagnostics space. Following Mayo, funding for diagnostics research reportedly dropped by billions[20] of dollars, and the field shifted toward reliance on laboratory-developed tests to sidestep patentability concerns.[21] A 2021 BioWorld analysis published on October 20, 2021, reported that VC investment in in vitro diagnostics would have been $9.3 billion higher over the four years following Mayo had that decision not been issued, findings the study’s author said demand Congress’s immediate attention.[22] PERA’s expansion could also mean a return to the pre-Myriad landscape in the DNA space. Where Myriad held that DNA sequences isolated from the human body are not patent-eligible,[23] PERA could open the door to patents on isolated DNA sequences that did not originate in the human body. This is a significant expansion beyond the current limit of artificially created cDNA.
PERA’s language will almost certainly require judicial interpretation. For instance, what does it mean for a process to be “substantially economic, financial, business, social, cultural, or artistic?”[24] What makes a process substantially artistic? What makes one substantially cultural? The goal of PERA is clarity, but in solving old ambiguities, the Bill would create new ones.
Commentary on PERA
The debate over PERA is vigorous, and the dividing lines are not always intuitive.
Supporters argue that rewriting the current eligibility framework would clear the path for industries like artificial intelligence to grow.[25] Two former USPTO Directors, Andrei Iancu and David Kappos, have been vocal proponents of PERA, blaming the current doctrine for stifling “innovation and investment.”[26] Even some Federal Circuit judges have expressed frustration with the current state of § 101, indicating that the doctrine sometimes compels them to deny patent protection to legitimate advances in medicine and computer-implemented technology—inventions that would have been protected under the pre-Alice/Mayo framework. Some proponents also point to the inventors the United States has lost to competing countries—including China and nations across Europe—which offer more robust patent protection for inventions that U.S. courts have found ineligible. For supporters of PERA, American technological leadership depends in part on closing that gap.[27]
Opponents of PERA raise a number of concerns. For example, critics argue that PERA would enable patent assertion entities (PAEs)—so-called “patent trolls”—to obtain low-quality or vague patents and use them to threaten legitimate businesses.[28] According to these critics, PERA would be a step back in the fight against what one commentator has called “a rogue’s gallery of terrible software patents.”[29]
A related concern is monopoly.[30] Critics worry that PERA would allow inventors to effectively monopolize fields such as genetic information and medical testing, with downstream harm for patients, small businesses, and market competition more broadly. [31] Retail industry voices have been particularly pointed, “arguing that PERA could revive vague business method patents and increase litigation risk for businesses.”[32]
Voices at the Senate Hearing
On July 14, 2026, the U.S. Senate Committee on the Judiciary held a full committee hearing titled “From Genes to Machines: The Patent Eligibility Debate.” Four witnesses provided testimony, offering a window into PERA’s prospects and the depth of feeling on both sides.
In Favor: Andrei Iancu
Andrei Iancu, Partner at Sullivan & Cromwell, Co-Chair of the Council for Innovation Promotion, and former Director of the U.S. Patent and Trademark Office, strongly endorsed PERA. His core argument was threefold: Congress has not meaningfully updated the patentability statute since 1793, long before modern technologies existed; courts have spent the past fifteen years grafting judge-made exceptions onto that centuries-old text—exceptions that Congress never wrote—driving investment, jobs, and entire industries away from the United States in fields like AI, medical diagnostics, and biotechnology; and deciding the boundaries of the patent system is a constitutional responsibility that belongs to Congress, not the courts. To illustrate the doctrine’s real-world reach, Iancu cited a diagnostic test to detect myasthenia gravis, which isa serious autoimmune condition that is only treatable if diagnosed. That invention was found ineligible as directed to a “law of nature,” even as the Federal Circuit judges who issued the ruling made clear they disagreed with their own decision but were bound by Supreme Court precedent. Iancu described PERA as doing four things: (1) preserving the broad, technology-neutral categories of eligible subject matter that have existed since 1793; (2) eliminating judicial exceptions and replacing them with a clear statutory list of ineligible matter; (3) adding guardrails for the computer age, thereby confirming that merely saying “do it on a computer” does not rescue an ineligible process, while preserving eligibility where a computer is genuinely necessary; and (4) restoring each Patent Act provision to its proper lane, with § 101 as a threshold screen and §§ 102, 103, and 112 handling the traditional requirements of novelty, non-obviousness, and disclosure.[33]
In Favor: Sue Peschin
Sue Peschin, President and CEO of the Alliance for Aging Research, testified in support of PERA from the perspective of patient advocacy. Peschin argued that PERA would restore predictability to the patent system so that medical inventors can more reliably move from the laboratory to the clinic. She emphasized the particular impact on older Americans, explaining that the Supreme Court’s decisions have made it significantly harder to obtain patent protection for methods of detecting diseases, measuring biomarkers, and translating clinical data into practical diagnostic tools for patients with multiple chronic conditions.[34]
Against: Dr. Debra Leonard
Dr. Debra Leonard, Professor Emerita at the University of Vermont and former President of the Association for Molecular Pathology, which was the named plaintiff in Myriad, testified in opposition to PERA. Dr. Leonard argued that the Supreme Court’s decisions in Myriad, Mayo, and Alice correctly established the principle that products of nature, laws of nature, and abstract ideas—including human DNA—should not be patented. She urged Congress to preserve those decisions and reject PERA. She drew on personal experience: in 1999, she received a letter demanding a license fee of $12.50 per test for genetic testing related to Canavan disease, subject to caps on the volume of tests her laboratory could perform. Dr. Leonard argued these caps prevented physicians from meeting patients’ clinical needs. On the innovation question, Dr. Leonard pushed back on the narrative that Mayo and Myriad stifled progress: since 2013, more than 175,000 genetic tests have become available in the United States, with an average of 14 new tests entering the market every day—a more than 180% increase in the number of available tests since 2016. Dr. Leonard also raised a technical concern about PERA’s carve-out for “an unmodified human gene, as that gene exists in the human body”: she argued the exception is effectively meaningless, because all genetic tests require DNA to be purified and enriched, which is a form of alteration. This means PERA’s language, she argued, runs counter to Myriad rather than codifying it, and could open the door to patents on human genetic sequences.[35]
Against: John Lee
John Lee, Senior Director and Head of Intellectual Property Policy at the Computer & Communications Industry Association (CCIA), representing companies in the computer, Internet, IT, AI, and communications industries, also testified against PERA. Lee’s testimony made three central points: patent eligibility limits are a longstanding and necessary feature of U.S. law that prevents monopolization of the basic tools of innovation; the empirical evidence shows current eligibility rules have supported, not hindered, American innovation and investment; and any legislative reform should be narrowly targeted, preserving protections against abusive patent assertion. On innovation specifically, Lee pointed to data showing that nearly 50,000 U.S. patents on AI technology were granted in 2023 alone, and that U.S. patent grants in AI have grown most significantly in the years following the Supreme Court’s most recent § 101 decisions. He also cited VC funding data: AI investment in U.S. firms grew from 30% of global VC investments in 2022 to 61% in 2025, with U.S. firms capturing 75% of total global VC funding for AI—nearly $200 billion in a single year—while the EU received 6% and China 5%. On the patent troll concern, Lee noted that many PAEs target small businesses precisely because litigation is so expensive. Before the Supreme Court’s most recent § 101 cases, PAE litigation was costing businesses nearly $30 billion per year in direct costs. Lee also reiterated concerns about PERA’s own ambiguities, including the undefined concept of a process that is “substantially economic, financial, business, social, cultural, or artistic,” and the uncertainty that would come from courts and the USPTO trying to interpret a new round of untested statutory language.[36]
Where Things Stand
As of this writing, PERA has not been scheduled for a vote, and full committee hearings have been infrequent. Mayo and Alice remain the governing law, but the future of patent eligibility remains genuinely uncertain. Eligibility has always been one of the fundamental questions in patent law, and PERA, wherever one comes down on it, appears likely to remain a fixture in that debate. Congress alone will decide what comes next. For practitioners, innovators, and businesses that depend on patent protection or fear being on the receiving end of low-quality patent litigation PERA is worth watching closely.
*Mags Martin was a summer associate in the firm's New York office.
FOOTNOTES
[1] Am. Axle & Mfg., Inc. v. Neapco Holdings LLC, 977 F.3d 1379, 1382 (Fed. Cir. 2020).
[2] Id. at 1383 (quotation omitted).
[3] 35 U.S.C. § 101.
[4] See Alice Corp. Pty. Ltd. v. CLS Bank Intern., 573 U.S. 208, 212-27 (2014); Mayo Collaborative Servs. v. Prometheus Lab’ys, Inc., 566 U.S. 66, 70-92 (2012).
[5] Alice Corp. Pty. Ltd., 573 U.S. at 217-18 (quotation omitted).
[6] E.g., Philip Hawkyard, The Collapse of Alice’s Wonderland: Mayo’s Faulty Two-Step Framework and a Possible Solution to Patent-Eligibility Jurisprudence, 74 U.C. L.J. 1221, 1224-25 (2023), https://www.uclawjournal.org/wp-content/uploads/5-Hawkyard-final.pdf.
[7] Supreme Court Issues Unanimous Decision in Alice Corp. v. CLS Bank, Software Freedom L. Ctr. (June 19, 2014) https://softwarefreedom.org/news/2014/jun/19/SCOTUS-decision-in-Alice-v-CLS/; Gene Quinn, SCOTUS Rules Alice Software Claims Patent Ineligible, IPWatchdog (June 19, 2014),
[8] Glenn Hess, Patent Ruling Dismays Biotech, 90 Chem. & Eng’g News, (Apr. 2, 2012), https://cen.acs.org/articles/90/i14/Patent-Ruling-Dismays-Biotech.html.
[9] Hawkyard, supra note 7, at 1230.
[10] S. 1546, 119th Cong. § 2 (2025).
[11] Kristen Osenga, Fact Sheet: Patent Eligibility Restoration Act of 2025 (PERA), Intell. Prop. & Innovation Inst. (Oct. 15, 2025), https://blogs.uakron.edu/ualawip/wp-content/uploads/sites/1670/2025/10/IPPI-PERA-Fact-Sheet_Osenga_2025.pdf.
[12] Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of Andrei Iancu, Partner, Sullivan & Cromwell), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Iancu_e8f353ad-215d-47e1-8eb9-a8b3ed1fbdd6.pdf.
[13] S. 1546, 119th Cong. § 2(5)(E)(i) (2025).
[14] Matthew J. Rizzolo & Kathryn C. Thornton, The Taking of Business Method Patents?, 25 Rich. J.L. & Tech. 1, 9-12 (2018).
[15] See Alice Corp. Pty. Ltd., 573 U.S. at 212.
[16] S. 1546, 119th Cong. § 2(5)(E)(i) (2025).
[17] S. 1546, 119th Cong. § 2(5)(E)(ii) (2025).
[18] Compare S. 1546, 119th Cong. (2025) (expanding scope of eligibility to include processes directed to a judicial exception if performed on generic computer) with Alice Corp. Pty. Ltd., 573 U.S. at 221 (holding processes directed to a judicial exception ineligible even if performed on generic computer).
[19] S. 1546, 119th Cong. § 2(5)(E)(ii) (2025).
[20] Mark McCarty, Analysis Finds VC Investment in Diagnostics Took $9.3B Hit in Four Years After Mayo, BioWorld (Oct. 21, 2021), https://www.bioworld.com/articles/512582-analysis-finds-vc-investment-in-diagnostics-took-93b-hit-in-four-years-after-mayo.
[21] Charles Duan, Study Claims Diagnostics Innovation Isn’t Tied to Investments, R St. Inst. (Nov. 7, 2022), https://www.rstreet.org/commentary/study-claims-diagnostics-innovation-isnt-tied-to-investments/.
[22] Mark McCarty, Analysis Finds VC Investment in Diagnostics Took $9.3B Hit in Four Years After Mayo, BioWorld (Oct. 21, 2021), https://www.bioworld.com/articles/512582-analysis-finds-vc-investment-in-diagnostics-took-93b-hit-in-four-years-after-mayo.
[23] Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 580 (2013).
[24] S. 1546, 119th Cong. § 3(b)(i)(B) (2025).
[25] Gene Quinn, Patent Eligibility Reform Returns to the Hill: PERA 2025 Explained, IPWatchdog (May 1, 2025), https://ipwatchdog.com/2025/05/01/patent-eligibility-reform-returns-hill-pera-2025-explained/. Gene Quinn submits PERA 2025 would allow the current Administration to achieve its goal of the United States becoming “the dominate [sic] AI superpower.”
[26] Key Takeaways from Senate Judiciary Hearing on Patent Eligibility, Brownstein Hyatt Farber Schreck LLP (Oct. 16, 2025), https://www.bhfs.com/insight/key-takeaways-from-senate-judiciary-hearing-on-patent-eligibility/; Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of Andrei Iancu, Partner, Sullivan & Cromwell), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Iancu_e8f353ad-215d-47e1-8eb9-a8b3ed1fbdd6.pdf; Hearing Before the Subcomm. On Intellectual Property of the S. Comm. on the Judiciary, 119th Cong. (Oct. 8, 2025) (testimony of David J. Kappos) https://www.judiciary.senate.gov/imo/media/doc/4539f98c-f893-95c0-3976-2519d3d06087/2025-10-08%20-%20Testimony%20-%20Kappos.pdf.
[27] Why C4IP Supports the Patent Eligibility Restoration Act of 2025 (PERA), Council for Innovation Promotion (Sept. 25, 2025), https://c4ip.org/why-c4ip-supports-the-patent-eligibility-restoration-act-of-2025-pera/.
[28] Katharine Trendacosta, PERA Remains a Serious Threat to Efforts Against Bad Patents, Elec. Frontier Found. (Oct. 9, 2025), https://www.eff.org/deeplinks/2025/10/pera-remains-serious-threat-efforts-against-bad-patents
[30] Alex Moss, The Perils of PERA: A Threat to Patients, Small Businesses, and Innovation, Pub. Interest Pat. L. Inst. (May 2, 2025), https://www.piplius.org/news/the-perils-of-pera2025.
[31] Id.
[32] Key Takeaways from Senate Judiciary Hearing on Patent Eligibility, Brownstein Hyatt Farber Schreck LLP (Oct. 16, 2025), https://www.bhfs.com/insight/key-takeaways-from-senate-judiciary-hearing-on-patent-eligibility/; Hearing Before the Subcomm. On Intellectual Property of the S. Comm. on the Judiciary, 119th Cong. (Oct. 8, 2025) (testimony of Mike Lemon, Vice President of Legal Affairs for the National Retail Federation) https://www.judiciary.senate.gov/imo/media/doc/4539f98c-f893-95c0-3976-2519d3d06087/2025-10-08%20-%20Testimony%20-%20Lemon.pdf.
[33] Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of Andrei Iancu, Partner, Sullivan & Cromwell), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Iancu_e8f353ad-215d-47e1-8eb9-a8b3ed1fbdd6.pdf.
[34] Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of Sue Peschin, President and CEO of Alliance for Aging Research), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Peschin_12e493f3-2112-4a63-b585-460fb059c2f6.pdf.
[35] Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of Debra Leonard, Professor Emerita in the Department of Pathology and Laboratory Medicine at the Robert Larner, M.D. College of Medicine at University of Vermont), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Leonard_1e90c911-5db8-4167-82e9-b8838c42c835.pdf.
[36] Hearing Before the S. Comm. on the Judiciary, 119th Cong. (July 14, 2026) (testimony of J. John Lee, Senior Director and Head of Intellectual Property Policy at Computer & Communications Industry Association), https://www.judiciary.senate.gov/imo/media/doc/6604221a-f383-6410-ff64-97d8ca91db57/2026-07-14_Testimony_Lee_66466573-8f0d-4def-a122-a4f0e6eb04ff.pdf.