PERA and the Future of Patent Eligibility

The Patent Eligibility Restoration Act (PERA) is a major bipartisan legislative effort to reset the boundaries of what types of inventions can be patented in the United States. The most recent versions were introduced in the Senate on May 1, 2025, by Senator Thomas Tillis (R-NC) and Senator Christopher Coons (D-DE) (S.1546), and in the House on September 6, 2024, by Representative Kevin Kiley (R-CA) and Representative Scott Peters (D-CA) (H.R.9474). This bill has broad implications, particularly in life sciences, software, and emerging technologies.

Over the past decade, a series of U.S. Supreme Court decisions (most notably Mayo, Myriad, and Alice), along with numerous opinions by the U.S. Court of Appeals for the Federal Circuit, have dramatically narrowed the scope of patent eligibility under 35 U.S.C. § 101. These decisions have created uncertainty around whether inventions, such as diagnostic methods, personalized medicine solutions, and AI-driven software, can be protected with patents at all. The resulting uncertainty around which inventions can both successfully proceed to issuance and withstand subsequent eligibility challenges has made it more difficult for organizations and investors to confidently back developments in impacted technology areas.

PERA seeks to clarify and expand what is considered patent-eligible subject matter. It would explicitly override so-called judicial exclusions and restore eligibility to inventions that apply what the Supreme Court has referred to as “natural laws” or “abstract ideas” in practical and innovative ways. This change could reopen the door to patents for many diagnostic tests, software applications, and biotechnology inventions that are currently ineligible despite being useful, novel, and non-obvious.

While PERA is not yet law, its bipartisan introduction in both houses signals growing momentum and an openness in Congress to reform patent eligibility standards. Innovators and organizations operating in affected fields should:

• Stay Informed: Monitor the bill’s progress through Congress and be prepared to respond if it gains traction.
• Review Portfolios: Work with your patent counsel to identify innovation disclosures or pending applications that might benefit from a tailored or renewed approach in light of potential changes to eligibility standards.
• Plan Ahead: For technologies that might be considered ineligible under current law, consider strategic use of continuation applications to maintain flexibility pending potential changes in the law.

If enacted, PERA could catalyze investment in fields that have seen stagnation due to eligibility concerns. In personalized medicine, for example, more reliable patent protection could support the development of multi-biomarker diagnostics and custom therapeutic approaches. While its future is not guaranteed, the introduction of PERA represents a potential turning point in U.S. patent law.