Is the 4th Time a Charm? Congress Revisits Patent Eligibility Reform

For the last several years, and following the U.S. Supreme Court's handful of cases¹ narrowing patent eligibility jurisprudence, the U.S. Congress has been working to revert Section 101 of the Patent Act of 1952 back to the "coarse filter" that Congress originally intended it to be. On July 14, 2026, during a hearing titled "From Genes to Machines: The Patent Eligibility Debate," several members of the U.S. Senate Committee on the Judiciary reaffirmed their commitment to passing legislation that would restore such clarity.

Much of the discussion from both sides of the dais focused on whether Section 101 reform is needed for the U.S. to continue advancing in various technology sectors, including medical diagnostics, artificial intelligence (AI) and information technology. Some witnesses believe that innovation is currently thriving without a Section 101 reform. Other witnesses and senators strongly advocated for such reforms, arguing they were necessary for the U.S. to continue to advance its global leadership in technological excellence and innovation.

The bipartisan legislation under discussion is S. 1546, the Patent Eligibility Restoration Act of 2025 (PERA), which has companion legislation in the U.S. House of Representatives. Major tenets of PERA include:

• Elimination of All Judicial Exceptions. By clarifying that any useful process, machine, manufacture or composition of matter – or any useful improvement thereof – is eligible for patent protection (other than PERA's other enumerated statutory exclusions listed below), the legislation resets the baseline for patent eligibility. As several witnesses noted, whether something is eligible does not mean a patent will be granted. Eligibility is the broadest part of the patentability filter. Sections 102 (novelty), 103 (non-obviousness) and 112 (sufficient disclosure requirements) must also be satisfied.
• Creation of Specific Statutory Exclusions. After resetting the eligibility foundation, PERA proceeds to refine that foundation by defining the only categories of subject matter that are patent-ineligible. The legislation defines the following categories of subject matter as patent-ineligible:
• a mathematical formula that is not part of a useful process, machine, manufacture or composition of matter
• a mental process performed solely in the human mind
• an unmodified human gene as it exists in the human body
• an unmodified human gene isolated from the human body but otherwise the same as it exists in the body
• an unmodified natural material as it exists in nature
• a process that is substantially economic, financial, business, social, cultural or artistic
• Additional Clarifications on Statutory Exclusions. PERA further notes that in the case of "a process that is substantially economic, financial, business, social, cultural, or artistic" claims, merely adding a nonessential reference to a computer – a so-called "do it on a computer" addition – is insufficient to make the claim as a whole patent-eligible. Additionally, despite the fact that an "unmodified human gene" is not patent-eligible as such, PERA clarifies that it shall not be considered "unmodified" if that human gene is "purified, enriched, or otherwise altered by human activity; or otherwise employed in a useful invention or discovery."

This is the fourth Congress in which PERA or a version of PERA has been introduced. At one point, all 12 sitting judges of the U.S. Court of Appeals for the Federal Circuit publicly criticized the state of patent eligibility law as incoherent and unworkable, with several calling for reform from a "higher power," be it the Supreme Court or Congress. However, the Supreme Court has passed on several recent petitions for certiorari to clarify patent eligibility laws, leaving it up to Congress to act.

As the U.S. debates the patent eligibility path forward, other countries are full steam ahead. Sen. Marsha Blackburn (R-Tenn.) cited a study claiming that "China is now leading the U.S. in 57 of 64 critical and emerging technologies."² The study notes that the U.S. is falling behind global competitors in innovation, AI, global and national security, information processing and diagnostics. One witness, former U.S. Patent and Trademark Office Director Andrei Iancu, agreed with concerns raised in the study, stating that the only way for the U.S. to course-correct, maximize its investment potential and drive investment in innovation at scale is for Congress to pass PERA now. According to Iancu, the U.S.' "principal economic peers – the European Union, China, Japan and South Korea – all take a more permissive and coherent approach to patent eligibility than the United States now does, protecting categories of computing, diagnostic, and biotechnology innovation that our own courts increasingly turn away."³

So, will the fourth Congress be the charm for PERA? Several senators agreed that now is the time for this legislation to move forward, urging witnesses to caucus after the hearing to resolve any outstanding concerns. The timing is important because at least two of PERA's champions will no longer be returning to Congress next term. However, there are limited legislative days remaining in this Congress and, coupled with the outstanding substantive concerns surrounding PERA, that may mean that the fifth Congress is a more realistic aim.

Holland & Knight is carefully tracking patent policy issues and working with clients to engage with Congress and the regulatory agencies. For more information or questions, please contact the author.

Notes:

¹ Bilski v. Kappos, 561 U.S. 593 (2010); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012); Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013); Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208 (2014).

² Justin Riggi, Information Technology and Innovation Foundation: "How China Is Outperforming the United States in Critical Technologies" (2025).

³ Testimony of Andrei Iancu, hearing on "From Genes to Machines: The Patent Eligibility Debate" (July 14, 2026).

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