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The Subcommittee on Intellectual Property of the Senate Judiciary Committee recently took another step towards moving forward with a redefinition of patent-eligible subject matter under Section 101 of the Patent Act when it held a hearing to consider the Patent Eligibility Restoration Act of 2025 (PERA), introduced on a bipartisan basis by Senators Coons (D-DE) and Tillis (R-NC).
PERA is hardly new; substantially similar laws were proposed in each year since 2022. But momentum may be growing. In its latest form, PERA seeks to expand the universe of patent eligibility by expanding patentable subject matter to include "[a]ny invention or discovery that can be claimed as a useful process, machine, manufacture, or composition of matter, or any useful improvement thereof," subject to specific exceptions. Relevant to the life sciences industry, the exceptions include "[a]n unmodified human gene," both as it exists in and as extracted from the body (which is new to this year's PERA), and "unmodified natural material, as the material exists in nature." Examples of the types of modification that take activity outside the exception (i.e., which are patent eligible) include isolation, purification, enrichment, or other alterations made by human activity, or other changes that employ the unmodified matter in a useful invention or discovery.
In life sciences, the medical diagnostics industry has been at the forefront of seeking the relief that PERA provides. In Mayo Collaborative Servs v Prometheus Lab'ys, 566 U.S. 66 (2012), the Supreme Court had held that a diagnostics patent was ineligible because the claims were directed to methods directed to treating a patient based on nothing more than applying a mental step to a law of nature. Since, the Federal Circuit has confronted (and found ineligible) diagnostics patents, notwithstanding their own recognition that such potentially novel inventions were valuable. See, e.g., Ariosa Diagnostics v. Sequenom., Inc. 788 F.3d 1371 (Fed. Cir. 2015); see also Ariosa Diagnostics, Inc. v. Sequenom, Inc., 809 F.3d 1282, 1284 (Fed. Cir. 2015) (Lourie, J., concurring in denial of r'hrng en banc); Athena Diagnostics v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019); CareDx v. Natera, 40 F.4th 1371 (Fed. Cir. 2022).
At the October 8 hearing, Senators Tillis, Schiff, Hirono, and Coons all decried the status quo as confusing and uncertain in light of emerging technologies, relying on nearly condemnation of the current state of Section 101 jurisprudence as lacking uniformity by the Federal Circuit, practitioners, and academics. The Subcommittee heard testimony from eight witnesses over roughly two and a half hours from two former USPTO Directors (David Kappos and Andrei Iancu), Mike Lemon (VP of Legal Affairs, National Retail Federation), Richard Blaylock (Partner, Pillsbury, Winthrop, Shaw and Pittman), Steven Caltrider (Chief IP Counsel, Dana-Farber Cancer Institute), Sue Peschin (President and CEO, Alliance for Aging Research), Corey Salsburg (VP and Global Head of IP Affairs, Novartis), and Mark Cohen (Senior Technology Fellow, Asia Society of Northern California, and Senior Fellow, University of Akron Law School).
The panel's general consensus was that Section 101 required revision to overturn the United States Supreme Court's Mayo decision and its progeny, and that innovation was being hampered by the current situation. Multiple testifying witnesses referred to China's gaining competitive advantage by undermining protection of American intellectual property. And in defense of PERA, many of the witnesses stressed that revising Section 101 would not promote "bad" patents, but instead restore the balance to rejection of patents to the other traditional reasons for invalidation (e.g., obviousness, anticipation, lack of written description, enablement, or definiteness).
Mr. Blaylock criticized PERA as it applied to the diagnostic industry, noting that returning to a pre-Mayo era would, in his view, increase costs to patients by restricting access to necessary diagnostics. Others on the panel, especially Mr. Kappos and Mr. Caltrider, rebutted this view by claiming that cost is different than availability, and that the harm of lack of IP protection may be that diagnostic methods are never developed in the first place.
Senator Tillis, who will soon be retiring, expressed a commitment to moving PERA across the finish line to a markup soon. We will continue to monitor the legislative progress of this potentially impactful bill.
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