By David J. Dykeman and Roman Fayerberg In Greek mythology, Prometheus was a titan who played a p

By David J. Dykeman and Roman Fayerberg

In Greek mythology, Prometheus was a titan who played a pivotal role in the early history of mankind by stealing fire from Zeus and giving it to mortals. On March 20, the U.S. Supreme Court launched its own fireworks through the medtech industry by issuing its titanic decision regarding medical diagnostic patents in Mayo Collaborative Services v. Prometheus Laboratories Inc. The “Prometheus” decision will directly impact diagnostics, personalized medicine, and genomic patents, and has sent shockwaves through the medtech and life-sciences industries.

In a unanimous decision, the U.S. Supreme Court invalidated two patents covering the optimization of the therapeutic efficacy of a drug regimen as claiming patent-ineligible subject matter. In doing so, the Supreme Court reversed the Court of Appeals for the Federal Circuit that twice upheld the patentability of the diagnostic method patent claims. The Supreme Court’s Prometheus decision held that all claims of the two patents are invalid as directed to unpatentable “laws of nature.”

The ruling is causing uncertainty and concern in the diagnostics and personalized medicine fields, where some of the world’s largest pharmaceutical companies are trying to target treatments to the unique genetic makeup of a patient through use of diagnostic tests. Although this ruling indicates a willingness of the Supreme Court to address perceived problems in the patent system, it also introduces new standards and uncertainties. To build and maintain a strong patent portfolio, medtech companies will need to pursue patent strategies that account for this major decision.