The Senate Judiciary Subcommittee on Intellectual Property held an Oct. 8 hearing on the Patent Eligibility Restoration Act of 2025 (PERA, S.1546). The bill, introduced by subcommittee chair Tillis (R-N.C.) and Sen. Chris Coons (D-Del.), aims to clarify inventions that qualify for patent protection under Section 101 of the Patent Act (P.L. 82-593). In his opening remarks, Tillis emphasized that patent eligibility reform remains one of his top priorities and expressed his intent to move the legislation to a markup this Congress.
Witnesses included former U.S. Patent and Trademark Office (USPTO) directors, industry and retail representatives, and leaders from the life sciences and patient advocacy communities. Former directors Andrei Iancu and David Kappos urged Congress to restore clarity to patent eligibility rules to encourage investment and sustain U.S. innovation leadership, while others raised concerns that PERA could allow patents on natural biological relationships and biomarkers. The AAMC submitted comments to the USPTO in 2021 emphasizing the need for clear, balanced patent eligibility standards that support biomedical innovation and ensure patient access to timely care [refer to Washington Highlights, Oct. 22, 2021]. Additionally, in 2019, the AAMC submitted comments to Tillis and Coons noting that the draft legislation “would nullify settled law about the validity of issued patents in the life sciences by abrogating the current prohibitions on patenting human DNA sequences and certain methods used by clinicians to administer drugs to patients [refer to Washington Highlights, June 21, 2019].”