A new hope for biotech companies in the USA: the PERA bill and patent eligibility of diagnostics and gene or cell therapies
The Patent Eligibility Restoration Act of 2025 (PERA), currently under Senate review, offers renewed hope for innovators working on diagnostics, gene therapies, and emerging biotechnologies that have long faced barriers to patent protection in the U.S., compared to regions like the European Union and China, where broader protections is available.
For over a decade, Supreme Court rulings such as Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66 (2012) and Assoc. for Molecular Pathology v. Myriad Genetics, 569 U.S. 576 (2013) have narrowed the scope of patentable subject matter, excluding many biotech inventions. This has discouraged investment and pushed some companies toward trade secrets.
PERA seeks to reverse this trend and to favor biotech development by replacing vague judicial exceptions with clear statutory exclusions. While unmodified human genes would remain ineligible, the bill allows patents on genes that are “purified, enriched, or otherwise altered”—a crucial provision for developers of gene and cell therapies. In addition, the bill would also restore patentability for certain diagnostic methods.
Momentum is building. Following hearings in early 2024 and reintroduction in both chambers of Congress, a pivotal Senate hearing in October 2025 showcased strong bipartisan support and industry enthusiasm, although some stakeholders raised concerns regarding the bill’s broad exceptions for modified genes and its silence on non-human genetic material, which might prompt revisions that could narrow the scope of reform. The next step is a markup session in the Senate Judiciary Committee, where amendments may be proposed before a full Senate vote.
Despite uncertainties, PERA represents a rare opportunity to restore clarity and confidence in the U.S. patent system. If enacted, it could unlock a new era of biotech innovation-reviving stalled research and attracting fresh investment.
Of course Regimbeau ‘s teams are following this issue closely and will keep you informed of the next steps towards what would be excellent news for innovative companies in the biomedical field.
