May 28, 2025
ASCP recently joined with almost 100 other concerned medical specialty societies and patient advocacy organizations in opposing the Patent Eligibility Restoration Act. The legislation would allow companies to patent human genes and other laws of nature.
Of concern to ASCP, is that this legislation creates the possibility that patents could interfere with clinical care, scientific research, innovation and patient access to critical, life-saving health information like genetic test results. Rather than promoting innovation, patents on the fundamental building blocks of nature can stop scientific inquiry and deny patients information about their health.
The legislation seeks to override current judicial precedent, set by the landmark 2013 Supreme Court’s unanimous decision vacating a U.S. Patent and Trademark Office (USPTO) award of an exclusive patent to the BRCA1 and BRCA2 genes, which are associated with breast and ovarian cancer. ASCP was one of the plaintiffs in the successful 2009 lawsuit challenging the USPTO’s decision.
ASCP and the other plaintiffs argued that the USPTO’s BRCA 1/2 patent violated §101 of the Patent Act because they were laws of nature and that they limit scientific progress. Under the Patent Act, three categories of “inventions” are not patentable: laws of nature, natural phenomena, and abstract ideas. The Court held that the BRCA 1/2 genes are naturally occurring, and their gene sequences and natural derivatives are NOT patent eligible.
ADVERTISEMENT