Legislation Threatens ASCP, Lab Community’s Supreme Court Win on Patents

• A landmark Supreme Court decision concerning gene patents is under threat of being overruled by legislation under consideration in Congress
• The legislation could threaten patient access to testing and laboratory innovation and increase patient healthcare costs

The Senate Judiciary Committee’s Intellectual Property Subcommittee recently held a hearing on the Patent Eligibility Restoration Act of 2025 (PERA), legislation to overturn several critical Supreme Court decisions.  The legislation is opposed by ASCP, one of the plaintiffs in the landmark Supreme Court decisions, Association for Molecular Pathology v. Myriad Genetics.  

In its 2013 decision, the Supreme Court ruled that naturally occurring DNA segments are “products of nature” and are not patentable, even when isolated. The Court also affirmed that cDNA is patentable, arguing that this material is synthetically created and does not occur naturally in the human body. The Supreme Court ruling provided critical benefits to patent care as it provides greater patent access to genetic testing, needed competition to allow alternatives and spur innovation, and lower patient test costs.

The hearing on PERA included two panels of experts, none of whom were physicians or healthcare providers.  The legislation is sponsored by Senator Thom Tillis (R-NC), the chair of the Intellectual Property Subcommittee.