The Senate Judiciary Committee’s Intellectual Property Subcommittee held a critical hearing on the Patent Eligibility Restoration Act of 2025 (PERA), a bipartisan bill that seeks to restore clarity to Section 101 of the Patent Act. For the biotech sector, PERA represents a potential turning point in how diagnostic methods, gene-based therapies and emerging technologies are protected under U.S. patent law.
FIVE KEY TAKEAWAYS FOR BIOTECH INNOVATORS
1. PERA Would Reopen the Door to Diagnostic and Gene-Based Patents
The bill aims to reverse the effects of Supreme Court decisions (Mayo v. Prometheus, Association for Molecular Pathology v. Myriad Genetics, and Alice v. CLS Bank) that have rendered most diagnostic methods and certain biotech inventions patent ineligible. PERA seeks to replace vague judicial exceptions with defined statutory exclusions, potentially allowing for clearer eligibility of biotech innovations.
2. Industry Leaders Warn of Innovation Chilling Effect under Current Law
Testimony from industry leaders emphasized that the current court-created framework discourages investment in diagnostics and gene therapies. Venture capitalists are increasingly avoiding technologies vulnerable to Section 101 challenges.
3. PERA Codifies Limits on Human Gene Patents—But Allows Modified Applications
The bill explicitly excludes unmodified human genes from patent eligibility, addressing concerns raised in Myriad. However, it lists broad exceptions to that exclusion when the gene has been “purified, enriched, or otherwise altered by human activity”—exceptions that are critical for cell and gene therapy development. One stakeholder raised a concern during the hearing that these broad exceptions essentially nullify the exclusion on patenting human genes. Further, the current language of the bill only calls out human genes—meaning genes of pathogens, for example, would be patentable under this new law.
4. Trade Secret Shift Undermines Scientific Transparency
At the hearing, stakeholders noted that innovators are increasingly turning to trade secrets due to patent eligibility uncertainty, reducing public disclosure of new scientific or technological achievements and slowing downstream innovation. PERA would incentivize patenting and knowledge sharing.
5. Global Competitiveness at Risk Without Reform
China and the European Union (EU) continue to allow patents on biotech inventions that are ineligible in the United States, including diagnostics and artificial intelligence (AI)-driven medical tools. Witnesses warned that the United States risks losing its leadership in biotech innovation without legislative action because, otherwise, innovators will flock to countries that offer patent protections for their work.
NEXT STEPS: POTENTIAL JUDICIARY COMMITTEE VOTE
The next likely step for this bill would be for the Judiciary Committee to “markup” the bill where the full committee reviews the bill, considers amendments and votes on whether or not to send the bill to the floor for the whole Senate to consider. In the meantime, stakeholders may wish to do the following:
- Meet with bill sponsors to offer feedback and establish monitoring for legislative developments
- Review your IP portfolio for inventions previously deemed ineligible
- Engage with legal counsel to prepare for potential eligibility expansion
- Evaluate investment strategies in diagnostics and gene-based platforms
Brownstein Insight: Biotech companies should closely monitor PERA’s progress and assess its impact on patent strategy, research and development (R&D) investment and regulatory planning. If enacted, PERA could significantly expand the scope of patentable subject matter in diagnostics, therapeutics and genetic technologies—reinvigorating innovation pipelines and attracting capital. Companies are encouraged to engage with policymakers and legal counsel to ensure their interests are represented as the bill advances.
Click here for an FAQ for biotech executives on the following questions:
- What is PERA and why does it matter to biotech?
- How does PERA change current patent eligibility standards?
- Will PERA allow companies to patent human genes?
- What types of biotech inventions would benefit from PERA?
- Does PERA lower the bar for patent quality?
- When could PERA become law?
- What should biotech companies do now?
- How does PERA affect investment and commercialization?
- What are the risks if PERA is not enacted?
- Will PERA increase litigation risk from patent trolls?
