The Patent Eligibility Restoration Act: Where Things Stand After the Senate Judiciary Committee’s First Full-Committee Hearing

This note provides an update on Section 101 patent-eligibility legislation pending in Congress. On July 14, 2026, the Senate Judiciary Committee held its first full-committee hearing on S. 1546, the Patent Eligibility Restoration Act of 2025 (“PERA”). Co-Sponsored by Senators Thom Tillis (R-NC) and Chris Coons (D-DE), PERA would eliminate all judicially created exceptions to patent eligibility under 35 U.S.C. § 101 and replace them with defined statutory exclusions, leaving Sections 102, 103, and 112 (novelty, nonobviousness, and disclosure) unchanged. The bill addresses only the threshold eligibility question.

PERA responds to Supreme Court decisions narrowing patent eligibility since 2010: Bilski (business methods/abstract ideas), Mayo (laws of nature), Myriad (isolated human genes), and Alice (abstract ideas on generic computers). Critics contend these decisions created a vague, unpredictable two-step framework, the Alice/Mayo test, that chills investment in diagnostics, biotech, and software (including artificial intelligence). Defenders argue the framework is a constitutionally grounded safeguard against monopolizing the basic tools of science.

PERA has evolved across three Congresses, including a series of hearings before the Subcommittee on Intellectual Property. The Subcommittee first examined the issue in 2019 through a three-part hearing series which drew 45 witnesses across multiple days and surfaced deep disagreement among bar associations, technology companies, patient advocates, and academics. Senator Tillis first introduced a version of the bill in the 117th Congress; the bill did not advance. A revised version, S. 2140, was introduced in the 118th Congress with Senator Coons as co-sponsor, adding statutory exclusions for mental processes and business methods and a “machine-necessity” exception. The Subcommittee held a further hearing on January 23, 2024, with testimony from former USPTO Directors Andrei Iancu and David Kappos alongside patent practitioners and industry representatives.

PERA in its current form, was introduced on May 1, 2025. It would eliminate “all judicial exceptions to patent eligibility” and amend Section 101 to provide five statutory exclusions:

(A) A mathematical formula that is not part of a claimed invention in a category described in subsection (a).
(B) A process that is substantially economic, financial, business, social, cultural, or artistic, even though at least 1 step in the process refers to a machine or manufacture.
(C) A process that—

(i) is a mental process performed solely in the human mind; or 
(ii) occurs in nature wholly independent of, and prior to, any human activity.

(D) An unmodified human gene, as that gene exists in the human body.
(E) An unmodified natural material, as that material exists in nature.

The current bill sharpens the human-gene exclusion: it now explicitly excludes unmodified human genes “as they exist in the human body,” including if “isolated”—language intended to codify Myriad’s core holding. The prior version did not expressly reach isolated genes, a gap critics argued could let gene patents return through the back door.

Four witnesses testified at the hearing.

Summary of Witness Testimony

Andrei Iancu (Partner, Sullivan & Cromwell LLP; former USPTO Director) framed eligibility as a constitutional question for Congress, not courts: Section 101’s text has remained essentially unchanged since 1793, yet courts have grafted judge-made exceptions onto it over the past fifteen years—exceptions so unworkable that, by 2021, all twelve then-sitting Federal Circuit judges had publicly lamented the incoherence of eligibility law. He cited inventions he said were wrongly invalidated under current doctrine: a multi-lens digital camera deemed an unpatentable “abstract idea”; a diagnostic test for myasthenia gravis struck down as a “law of nature” despite enabling a previously impossible diagnosis; a driveshaft manufacturing method invalidated as directed to Hooke’s law; and a Duchenne muscular dystrophy gene-therapy patent invalidated in 2024 before the Federal Circuit reversed in 2026. He noted diagnostics investment fell more than $9 billion after Mayo, that China now leads the U.S. in 66 of 74 tracked critical emerging technologies, and that unpredictable eligibility law disproportionately burdens startups and small inventors relative to large incumbents, who can rely on scale, trade secrecy, and litigation budgets instead of patents. He emphasized that PERA leaves Sections 102, 103, and 112 intact, so “bad patents” remain subject to novelty, nonobviousness, and disclosure requirements.

Sue Peschin (President and CEO, Alliance for Aging Research) testified that older Americans, who face multiple chronic or life-threatening conditions and limited time for new treatments, have the most to lose from continued Section 101 uncertainty, which she said created a vague framework that Federal Circuit judges have struggled to apply, particularly for medical diagnostics that sit at the intersection of biology, data analysis, and clinical practice. As a leading example, she cited Ariosa Diagnostics v. Sequenom, where the Federal Circuit invalidated patents on a non-invasive prenatal test despite Judge Linn’s concurrence acknowledging the invention was exactly what patents should encourage, but concluding he was compelled by Mayo’s broad language to strike it down and calling on Congress to fix the law. She also described a university-developed Alzheimer’s imaging diagnostic whose commercial partner withdrew after follow-on patent applications were rejected post-Mayo, and university-led melanoma brain-metastasis research abandoned after patent denials. She cited a 2020 study in which 74% of 475 surveyed venture capital and private equity investors called patent eligibility important to investment decisions, and 62% said they would be less likely to invest without patent protection. Ms. Peschin said PERA is meant to codify, not overturn, Myriad—excluding unmodified human genes even if isolated, while preserving eligibility for human-modified applications such as cDNA, engineered vectors, and gene-therapy uses—while leaving novelty, nonobviousness, and disclosure safeguards intact.

J. John Lee (Senior Director, Head of Intellectual Property Policy, Computer & Communications Industry Association) countered that eligibility limits are a longstanding, foundational feature of U.S. patent law dating to the Patent Act of 1793, not a recent judicial invention. He cited an Iowa Law Review study of Federal Circuit Section 101 decisions finding that, from 2012–2023, the Federal Circuit affirmed 85.3% of district court Section 101 decisions and 95.5% of USPTO Section 101 decisions—the highest affirmance rate of any patent issue studied—with dissents in only 6.5% of the appeals. He noted innovation continues to thrive: nearly 50,000 U.S. AI patents were granted in 2023, software/IT R&D spending was unaffected or increased after recent Section 101 cases, and U.S. firms received 75% of global AI venture capital in 2025 (nearly $200 billion), far ahead of the EU (6%) and China (5%). Mr. Lee emphasized that Section 101 guards against abusive litigation by patent assertion entities (“patent trolls”), which cost businesses an estimated $30 billion annually before Alice, disproportionately harming small companies. He urged that any reform be narrowly tailored and evidence-based, warning that PERA’s undefined terms—such as processes that are “substantially economic, financial, business, social, cultural, or artistic” or “necessary to practically perform the invention”—could generate new litigation and uncertainty rather than resolve it.

Dr. Debra Leonard (Professor Emerita of Pathology and Laboratory Medicine, University of Vermont; Past President, Association for Molecular Pathology, the named plaintiff in Myriad) testified from personal experience receiving pre-2013 patent enforcement letters demanding licensing fees for clinical genetic tests. Examples included a $12.50-per-test fee and volume caps for Canavan disease testing; Athena Diagnostics’ exclusive enforcement of APOE and SCA1 gene patents, which made it the sole U.S. provider and required all specimens to be shipped to Massachusetts, delaying results; a $25,000 upfront fee plus royalties from SmithKline Beecham for hemochromatosis testing; and a leukemia/lymphoma test costing her institution about $300 per test to license in 2002 when Medicare reimbursed only $55.39. Dr. Leonard argued molecular medicine has flourished since Myriad: more than 175,000 genetic tests are now available in the United States, an increase of over 180% since 2016, with roughly 14 new tests entering the market every day; and BRCA1/BRCA2 testing has expanded from a single monopoly provider charging about $4,000 to 284 available tests. She called PERA’s exclusion for an “unmodified human gene, as that gene exists in the human body” illusory because any genetic test requires purifying and enriching DNA—activity that would make the gene “modified” under the bill’s own terms and eligible again—contrary to Myriad’s actual holding.

The bipartisan bill reaches its first full-committee hearing at a critical juncture. Chairman Grassley stated the Committee is still “studying and trying to understand” the bill and has not reached a consensus, framing the session as fact-finding. The potential departure of two key proponents creates urgency for this Congress and uncertainty about who would champion the bill in a future session. Near the hearing’s end, Senators Tillis and Coons encouraged witnesses to continue their dialogue toward consensus, and Dr. Leonard was encouraged to propose language addressing her genetic-testing concerns consistent with the shared goal of codifying Myriad.