Senate Advances Patent Reform Bill That Could Revitalize Biotech Innovation and Diagnostics
Key Insights
The Senate Judiciary Committee (search)'s Intellectual Property Subcommittee held a critical hearing on the Patent Eligibility Restoration Act (search) of 2025 (PERA), a bipartisan bill aimed at restoring clarity to patent law for biotech innovations.
PERA seeks to reverse Supreme Court decisions that rendered most diagnostic methods and gene-based therapies patent ineligible, potentially reopening patent protection for these critical medical technologies.
Industry leaders testified that current patent uncertainty has created a chilling effect on investment, with venture capitalists increasingly avoiding diagnostics (search) and gene therapy (search) technologies vulnerable to patent challenges.
The Senate Judiciary Committee (search)'s Intellectual Property Subcommittee held a critical hearing on the Patent Eligibility Restoration Act (search) of 2025 (PERA), marking a potential turning point for biotech patent protection in the United States. The bipartisan bill seeks to restore clarity to Section 101 of the Patent Act, addressing years of uncertainty that have plagued diagnostic methods, gene-based therapies, and emerging medical technologies.
Reversing Judicial Restrictions on Biotech Patents
PERA aims to reverse the effects of landmark Supreme Court decisions including Mayo v. Prometheus (search), Association for Molecular Pathology v. Myriad Genetics (search), and Alice v. CLS Bank (search), which have rendered most diagnostic methods and certain biotech inventions patent ineligible. The bill seeks to replace what industry stakeholders describe as vague judicial exceptions with defined statutory exclusions, potentially allowing for clearer eligibility of biotech innovations.
Industry leaders who testified at the hearing emphasized that the current court-created framework has created a chilling effect on investment in diagnostics (search) and gene therapies. Venture capitalists are increasingly avoiding technologies vulnerable to Section 101 challenges, according to testimony from industry representatives.
Addressing Gene Patent Concerns While Preserving Innovation
The legislation explicitly excludes unmodified human genes (search) from patent eligibility, directly addressing concerns raised in the Myriad case. However, PERA includes broad exceptions to that exclusion when genes have been "purified, enriched, or otherwise altered by human activity"—exceptions that stakeholders noted are critical for cell and gene therapy (search) development.
One concern raised during the hearing was that these broad exceptions essentially nullify the exclusion on patenting human genes (search). Additionally, the current language of the bill only addresses human genes, meaning genes of pathogens would remain patentable under the new law.
Trade Secrets Undermining Scientific Progress
Stakeholders testified that innovators are increasingly turning to trade secrets due to patent eligibility uncertainty, reducing public disclosure of new scientific and technological achievements and slowing downstream innovation. PERA would incentivize patenting and knowledge sharing by providing clearer patent eligibility standards.
Global Competitiveness Concerns
Witnesses warned that the United States risks losing its leadership in biotech innovation without legislative action. China and the European Union continue to allow patents on biotech inventions that are ineligible in the United States, including diagnostics (search) and artificial intelligence-driven medical tools. Industry representatives cautioned that innovators may relocate to countries that offer stronger patent protections for their work.
Legislative Path Forward
The next likely step for PERA would be for the full Judiciary Committee to "markup" the bill, where members would review the legislation, consider amendments, and vote on whether to send it to the Senate floor for consideration by the full chamber.
The broader patent reform landscape includes several other bipartisan efforts that could reshape biomedical innovation. The RESTORE Patent Rights Act seeks to reverse limitations on patent holder injunctions from the 2006 eBay v. MercExchange decision, while the PREVAIL Act aims to reduce duplicative litigation burdens on life sciences companies by streamlining patent validity challenges.
However, not all proposed reforms may benefit the biotech sector. The Eliminating Thickets to Increase Competition (ETHIC) Act would limit patent enforcement capabilities for terminally disclaimed patents, potentially creating legal uncertainty similar to issues that led to the withdrawal of a controversial USPTO rule in 2024.