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Patent Eligibility Restoration Act (PERA)

<p>The <strong>Patent Eligibility Restoration Act (PERA)</strong> is <strong>proposed U.S. federal legislation</strong> — not current law — that would rewrite 35 U.S.C. § 101 to replace the judge-made "abstract idea" and "law of nature" exceptions with a shorter, closed list of statutory exclusions. It has been introduced, in varying forms, across the 116th, 118th, and 119th Congresses without being enacted. The current version, <strong>S. 1546 (119th Congress, 2025–2026)</strong>, was reintroduced on May 1, 2025 by Senators Thom Tillis (R-NC) and Chris Coons (D-DE) and Representatives Kevin Kiley (R-CA) and Scott Peters (D-CA). The Senate Judiciary Subcommittee on Intellectual Property held a hearing on the bill on October 8, 2025; as of this writing it has not been marked up by the full committee, passed by either chamber, or signed into law. A page that treats PERA as settled law would be factually wrong — its defining characteristic, for research-administration purposes, is that it is a live legislative proposal responding to an unresolved doctrinal problem, not a rule anyone can rely on yet.</p><h2>The problem PERA is written to address</h2><p>Under current § 101 doctrine, the Supreme Court's <em>Mayo Collaborative Services v. Prometheus Laboratories</em> (2012) and <em>Alice Corp. v. CLS Bank International</em> (2014) decisions established a two-step framework (often called the "Alice/Mayo test" or, in USPTO examination guidance, "Step 2A/Step 2B") that lets an examiner or court invalidate a claim as directed to an unpatentable "abstract idea," "law of nature," or "natural phenomenon" even though those categories appear nowhere in the patent statute itself — they are judicial exceptions layered on top of § 101's text. See CASRAI's <a href='/guides/35-usc-101-patentable-subject-matter'>35 U.S.C. § 101: Patentable Subject Matter and the Alice/Mayo Eligibility Test</a> for the current test as it actually operates today. Critics across the patent bar, technology-transfer offices, and biotech/software industry groups argue the resulting case law is inconsistent and hard to predict at the claim-drafting stage, disproportionately affecting <strong>diagnostic methods</strong>, <strong>software and AI-related inventions</strong>, and certain <strong>life-sciences discoveries</strong> — exactly the categories a university technology transfer office most often needs to protect before licensing.</p><h2>What PERA proposes to change</h2><p>Rather than amending the Alice/Mayo case-law test directly, PERA's approach is to eliminate judicially-created exceptions from § 101 entirely and substitute a short, enumerated list of statutory exclusions from eligibility (categories such as claims to an unmodified human gene as it exists in the human body, or to a mathematical formula standing alone, are the kind of exclusion prior versions of the bill have specified) while otherwise stating that a claimed invention is eligible if it falls within one of the statute's existing categories (process, machine, manufacture, or composition of matter) and is not excluded. Sponsors describe the goal as restoring eligibility for practical, real-world applications in fields like AI, biotechnology, and diagnostics without reopening genuinely abstract claims to patenting. Because PERA has been revised between reintroductions, the exact exclusion list and definitions in the live S. 1546 text should be checked directly against <a href='https://www.congress.gov/bill/119th-congress/senate-bill/1546/text' rel='noopener'>the bill text on congress.gov</a> rather than assumed to match an earlier version.</p><h2>Why this matters for university tech transfer specifically</h2><p>A technology transfer office evaluating whether to patent a faculty invention has to make a § 101 eligibility judgment long before litigation is ever a possibility — at invention-disclosure triage, at the provisional-filing decision, and again when licensing counsel diligence the claims. Diagnostic-method inventions (a correlation between a biomarker and a disease state) and software/AI inventions (a novel algorithm or model architecture) are the two categories most exposed to Alice/Mayo rejections today, which in turn affects a TTO's practical calculus on whether patenting is worth the cost relative to protecting the same invention as a trade secret or relying on a first-mover/know-how advantage instead. PERA, if enacted, would not retroactively revive an invention a TTO already declined to patent under current doctrine — patentability is assessed as of filing — but it would change the eligibility calculus for inventions disclosed and filed after any effective date, and could affect prosecution strategy for pending applications depending on the bill's final transition provisions. None of that is triggered by introduction or a committee hearing; only enactment would change what is patentable.</p>

ByCASRAI Editorial Board
· Last updated 8 Aug 2026

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Examples

Worked examples

  • Is an instance

    A university TTO evaluating a diagnostic-biomarker invention disclosure in 2026 tracks PERA's progress through Congress because, if enacted with the exclusion list currently under discussion, it could make claims that a § 101 rejection would likely doom today more clearly eligible — changing whether the invention is worth patenting versus protecting as a trade secret. This is illustrative of how TTOs use pending legislation as one input to a filing decision; it does not describe any real, named institution's actual case.

  • Is an instance

    S. 1546, the Patent Eligibility Restoration Act of 2025, introduced in the Senate on May 1, 2025 by Sens. Tillis and Coons, referred to the Senate Judiciary Committee, and the subject of a Judiciary Subcommittee on Intellectual Property hearing on October 8, 2025 — a real, verifiable instance of PERA's current legislative posture as of this writing.

Counter-examples

Looks similar, but isn't

  • Not an instance

    The America Invents Act (AIA) of 2011 is NOT an example of PERA or of pending patent-eligibility legislation — it is enacted law (Public Law 112-29) that already reformed a different part of patent practice (first-to-file priority, post-grant review proceedings). Citing the AIA as though it resolved the § 101 eligibility question PERA targets is a common conflation to avoid: the AIA did not touch § 101 subject-matter eligibility at all.

  • Not an instance

    USPTO's 2019 Revised Patent Subject Matter Eligibility Guidance is NOT PERA. It is internal examination guidance the USPTO itself issued to standardize how examiners apply the existing Alice/Mayo case law — it works within current § 101 doctrine and has no power to override the Supreme Court's precedent the way an actual statutory amendment like PERA would.

Editorial commentary

As of 8 August 2026, the Patent Eligibility Restoration Act is not law and has not advanced beyond hearings. S. 1546 has not been marked up, has not been reported out of the Senate Judiciary Committee, has not been voted on by either chamber, and has not been signed. Everything practical on this page follows from that: nothing about United States patent eligibility has changed because PERA exists, and any advice that treats PERA’s exclusion list as a filter you can draft claims against today is wrong. What has changed since this entry was first written is the addition of a second hearing — a signal of continued sponsor interest, not of legislative progress.

Dated status, so you can tell how stale this page is

  • 1 May 2025 — S. 1546 introduced in the Senate and referred to the Committee on the Judiciary. A House companion, H.R. 3152, carries the same title in the 119th Congress.
  • 8 October 2025 — Senate Judiciary Subcommittee on Intellectual Property hearing, “The Patent Eligibility Restoration Act: Restoring Clarity, Certainty, and Predictability to the U.S. Patent System.” The subcommittee chair stated an intention to move the bill to markup during this Congress.
  • 14 July 2026 — Senate Judiciary Committee hearing, “From Genes to Machines: The Patent Eligibility Debate.” Members restated support for eligibility reform. No markup followed.
  • Still outstanding — committee markup, a committee report, Senate floor action, House action, and presidential signature. All five.

Two hearings and no markup across fifteen months is itself the informative fact. The 119th Congress ends on 3 January 2027; a bill that has not passed both chambers by then dies and must be reintroduced from scratch in the 120th. Commentary published in July 2026 noted that this is the fourth Congress in which PERA or a version of it has been introduced, and suggested that, given the legislative days remaining, the next Congress is the more realistic target.

What the exclusion list looks like in the current text

PERA’s mechanism is to strike the judicially created exceptions from 35 U.S.C. § 101 and substitute a closed statutory list of what is ineligible. As described in the current bill and in analyses of it, that list runs to categories such as: a mathematical formula that is not part of a claimed invention integrated into a useful process or tangible product; a mental process performed solely in the human mind; an unmodified human gene as it exists in the human body, including as isolated from it; an unmodified natural material as it exists in nature; and a process that is substantially economic, financial, business, social, cultural, or artistic. The bill is explicit in the other direction too — a gene that has been modified or otherwise altered by human activity is not excluded, and merely reciting a computer does not rescue an otherwise excluded business method.

Because the text has been revised between reintroductions, treat any summary of the exclusion list — this one included — as a description of the version current when it was written, and verify against the live bill text before relying on a specific clause. The exclusions matter most to the two categories university technology transfer offices file in most often: diagnostic-method claims, which sit against the natural-material and mental-process exclusions, and software and AI claims, which sit against the mathematical-formula and business-method exclusions.

What this means for a filing decision today

A patentability assessment conducted this week must be conducted under current law — the Alice/Mayo framework and the USPTO examination guidance built on it — with no discount for a possible statutory change. Concretely: an invention disclosure triaged today, a provisional filed today, and a non-provisional claiming priority to it are all examined against § 101 as it stands when examination happens, so a future amendment could in principle reach a still-pending application depending on the transition provisions any enacted version carries. That is a contingency worth a line in a file memo, not a reason to file. Where § 101 risk is the deciding factor, the live alternatives remain what they were: narrow the claims toward a concrete technical implementation, or protect the subject matter as a trade secret and accept the loss of exclusivity against independent discovery. See also patentability of biological subject matter, which is where the unmodified-gene exclusion would bite.

How to check the status yourself

No summary page stays current on a live bill, and PERA has now outlived several of them. Look up S. 1546 (119th Congress) on congress.gov and read the Actions tab, which records referral, hearings, markup, reporting, and floor votes with dates. Two distinctions are worth holding onto while reading it: a hearing is testimony and creates no legal effect, whereas a markup is the committee voting on amendments and on whether to report the bill — only the latter moves it. And a measure “introduced in the House and Senate” is two separate bills that must ultimately be reconciled, not one bill with two numbers.

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