In a Congressional Research Service (CRS) paper titled “Mayo v. Prometheus: Implications for Patents, Biotechnology, and Personalized Medicine,” visiting scholar John Thomas considers how the U.S. Supreme Court ruling limiting the patentability of diagnostic methods that simply describe natural phenomena and relations may affect innovation and public health. He provides overviews of the biotechnology industry, the U.S. patent system, the Court’s ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc., responses to the decision by experts in affected disciplines, and the potential impact on Myriad Genetics and the patent eligibility of isolated DNA molecules “that encode sequences identical to human genes.”

Observing that Mayo v. Prometheus “arguably limited the ability of medical innovators to patent diagnostic methods” and could affect the products of biotech research, Thomas concludes, “As judicial rulings continue to influence the availability of patent protection in the healthcare and biotechnology fields, interested parties may encourage Congress to clarify the doctrine of patentable subject matter through legislative amendments.”