Patent Eligibility Restoration Act Could Lead to Increased Costs for Critical Genetic Testing

Patent Eligibility Restoration Act Could Lead to Increased Costs for Critical Genetic Testing

A recent U.S. Senate hearing discussed the Patent Eligibility Restoration Act (PERA/S.1546), a bill that could have implications for the prices of and patient access to genetic tests.

The Oct. 8 hearing sought to clarify the language of patent law. Critics, including the College of American Pathologists (CAP), warn PERA could significantly increase costs and hinder innovation of genetic tests due to the potential allowance of patents on genes and natural phenomena.

The North Carolina Life Sciences Organization is among the supporters of the legislation. In a press release, the organization states: “For too long, fields like diagnostics, precision medicine, cell and gene therapy, RNA medicine, and digital health have been threatened by unclear and uncertain patent-eligibility standards that put America’s innovators at a disadvantage, and that discourage local investment. Through this legislation, our members … will be able to continue to take the bold risks and make the high levels of investment necessary to take fields like these to their next level, with the confidence that our patent laws will continue to hold up through future waves of technological progress.”

CAP was among those stakeholders that submitted public comments to express opposition to the legislation. Among their concerns, submitted in a statement on Oct. 6, was that such patents could result in exclusive licensing agreements that would drive up prices and limit patient access to certain essential genetic tests. Additionally, patents would prevent independent labs from offering confirmatory testing for second opinions. Essentially, PERA challenges the Supreme Court ruling that human genes cannot be patented, and CAP warns this could create “potential chaos in health care.”

PERA was cosponsored by Sens. Thom Tillis (R-N.C.) and Chris Coons (D-Del.) on May 1.

Sources:

https://www.judiciary.senate.gov/committee-activity/hearings/the-patent-eligibility-restoration-act_restoring-clarity-certainty-and-predictability-to-the-us-patent-system-10-08-2025

https://documents.cap.org/documents/S.1546_Impact_on_Health_Care_Letter_Final_100625.pdf?_gl=1*yyt0hm*_ga*NTAyNDM3ODcwLjE3NDg4NjYzMjg.*_ga_97ZFJSQQ0X*czE3NjA5ODc0NzkkbzI5JGcxJHQxNzYwOTg5MDU3JGo0OCRsMCRoMA..

https://www.tillis.senate.gov/2025/5/tillis-coons-kiley-and-peters-reintroduce-landmark-legislation-to-restore-american-innovation

https://www.cap.org/advocacy/latest-news-and-practice-data/october-14-2025

https://www.cap.org/advocacy/latest-news-and-practice-data/october-7-2025#story5