On July 14, 2026, the full Senate Judiciary Committee held a hearing titled “From Genes to Machines: The Patent Eligibility Debate,” its first full-committee session on the Patent Eligibility Restoration Act of 2025 (PERA), S. 1546. Chairman Chuck Grassley noted that until this hearing, the bill had only been examined by Senator Thom Tillis’s Intellectual Property Subcommittee, which held its own hearing on the bill on October 8, 2025. The full-committee hearing signals PERA is being taken more seriously as a legislative vehicle, even though no markup or floor vote has been scheduled.
For university technology transfer offices, the hearing is worth watching closely: much of the discussion concerned whether current patent-eligibility law under 35 U.S.C. § 101 is functioning correctly for exactly the two categories of invention TTOs handle most — medical diagnostics and software/AI-related inventions.
What PERA would change
PERA would rewrite § 101 to eliminate the judge-made “abstract idea” and “law of nature” exceptions that the Supreme Court read into the statute in Alice Corp. v. CLS Bank International (2014) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012), replacing them with a short, closed statutory list of things that cannot be patented. See CASRAI’s 35 U.S.C. § 101: Patentable Subject Matter and the Alice/Mayo Eligibility Test for how the current two-step framework operates, and the PERA dictionary entry for the bill’s legislative history and sponsors (Senators Tillis and Chris Coons; Representatives Kevin Kiley and Scott Peters, with a House companion, H.R. 3152). PERA remains proposed legislation, not current law — nothing about § 101 examination or litigation changes unless and until it is enacted.
Diagnostics: the Mayo problem, revisited
Mayo v. Prometheus is the case most directly responsible for the modern difficulty of patenting diagnostic methods: the Court held that a claim reciting a natural correlation between a drug metabolite level and drug efficacy or toxicity, plus routine, conventional steps for measuring it, was not eligible subject matter. Method-of-diagnosis claims built around a newly discovered biological correlation have been very difficult to patent since. Four witnesses testified at the hearing, evenly split. Former USPTO Director Andrei Iancu and Sue Peschin (President and CEO, Alliance for Aging Research) supported PERA as a fix for the diagnostics problem Mayo created. J. John Lee (Computer & Communications Industry Association) and Dr. Debra G.B. Leonard, a clinical pathologist and professor emerita, testified against the bill as drafted.
Dr. Leonard’s opposition centered on how PERA’s current gene-patenting language could reopen problems that predate the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics, which held isolated but otherwise unmodified human genes are not patent-eligible. She testified that pre-Myriad gene-patent enforcement had previously forced her laboratory to discontinue a clinical genetic-testing service, and cautioned that PERA’s proposed distinction between “isolated” and “purified” genetic material could functionally restore that exposure for clinical laboratories under different terminology — even though her underlying research use was not affected at the time. Peschin’s counter-position was that inventors developing a diagnostic test should retain commercial licensing rights over it, while clinicians should retain the ability to use approved tests in patient care without a separate license.
Notably, Senator Tillis signaled openness to revising PERA’s gene-related language in response, telling the committee he wants stakeholder input on wording that would preserve the Myriad holding for naturally occurring, unmodified sequences while still addressing the diagnostic-method eligibility problem Mayo created, and he asked Dr. Leonard directly to propose alternative statutory text. That is a live drafting question, not a resolved one — see CASRAI’s Patentability of Biological Subject Matter entry for how the isolated-gene and natural-correlation lines currently sit in the case law PERA would replace.
AI and software: a split on whether reform is even needed
The hearing also took up whether § 101 reform is necessary for AI-related and software inventions specifically. Lee, representing the Computer & Communications Industry Association, argued current eligibility doctrine is “cogent and consistent” as applied by the USPTO today, citing a figure of roughly 50,000 AI-related patents issued in the past year as evidence the system is already accommodating the technology. Iancu — who as USPTO Director issued the agency’s 2019 subject-matter-eligibility examination guidance credited with streamlining Alice/Mayo analysis at the examiner level — took the opposing view, arguing that entire categories of software and AI innovation remain effectively excluded from patent protection despite that administrative guidance, because USPTO guidance cannot bind courts applying the underlying judicial exceptions.
For university TTOs licensing AI-adjacent inventions — machine-learning models, algorithmic diagnostic tools, and other software-implemented inventions that often sit at the boundary of the abstract-idea exception — that disagreement is the practical question: does administrative guidance already provide enough predictability at the patent-office level, or does durable protection require a statutory fix that also binds reviewing courts? CASRAI’s Can You Patent an Idea? The Abstract-Idea Rule Explained and Patent Law Requirements guides cover how that exception is currently applied during prosecution and litigation.
What’s next
Chairman Grassley closed the hearing by acknowledging that “many members are still studying the bill,” and no committee markup or vote was scheduled as of the hearing date. The gene-patenting language Tillis flagged for revision is the most concrete near-term signal of where the bill’s text may move next; the AI/software disagreement did not produce a similar commitment to redraft. PERA’s House companion, H.R. 3152, has not advanced further in the House.
Institutions with active diagnostic or AI-related invention disclosures should treat PERA as a bill to monitor, not a rule to plan around yet: current § 101 doctrine under Alice/Mayo remains the operative law for patentability assessments in the meantime. CASRAI’s Patentability Assessment: How a TTO Evaluates an Invention Disclosure guide covers how that assessment is conducted under current law, and CASRAI will continue tracking PERA’s status as it moves (or doesn’t) through committee.
