Invalidating Human Gene Patenting: The U.S. Supreme Court Rules in Association for Molecular Pathology v. Myriad Genetics

Abstract

In its June 2013 ruling in the Association for Molecular Pathology v. Myriad Genetics (1), the U.S. Supreme Court held that DNA fragments are naturally occurring phenomena that are ineligible for patenting under Title 35, Section 101 of U.S. patent law, regardless of their isolation from the rest of the human genome. This landmark decision clarifies an important area of intellectual property law and deviates from prior positions of the U.S. Patent and Trademark Office on new plant breeds. The ruling immediately invalidates many breast and ovarian gene patents (BRAC1 and BRAC2) held by Myriad Genetics as well as roughly 4000 other genetic patents now held in the United States. The decision could have a profound impact on health care economics, innovation, and patient care across medical subspecialties worldwide, including neurosurgery. The decision highlights the conflicting interests patent law aims to advance: promoting medical innovation by maximizing personal incentives, while maximizing public access to its benefits. The classic argument supporting genetic patenting has been that companies will not invest in genetic technologies if they do not have protections in place to recoup their substantial investments. In some respects, Myriad Genetics can be viewed as a successful example of this model. BRAC1 and BRAC2 mutation testing by Myriad Genetics has benefited thousands of women in the United States who are at high risk for developing breast or ovarian cancer, and the investors in these technologies have been rewarded. However, this model also has prevented competition from other companies, researchers, and health care providers, likely thwarting further testing innovation and quality improvements. Opponents of genetic patents, including James Watson, the codiscoverer of the double helix structure of DNA and a founding member of the Human Genome Project, believe permitting patents on genes blocks innovation. They believe that this practice has resulted in “hundreds, if not thousands, of individual obstacles to developing and commercializing” new assays. Testifying in the Myriad Genetics case, Watson stated that the practice is unnecessary because “the international effort was proceeding on schedule without the need to file patent applications.” More fundamentally, he argued that patenting genes is morally at odds