By Diane Allingham-Hawkins, PhD, FCCMG, FACMG, Senior Director, Genetic Test Evaluation Program and Technical Editing
Today, the 9 Justices of the Supreme Court ruled unanimously that human genes are not patentable in the case of Association of Molecular Pathology V. Myriad Genetics. In ruling that a gene constitutes a “product of nature,” which is not eligible for patenting, the Justices have issued a decision that will change the face of genetic testing in the United States. As Justice Clarence Thomas wrote in the opinion, “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The location and order of the nucleotides existed in nature before Myriad found them. Nor did Myriad create or alter the genetic structure of DNA.” The decision effectively invalidates not only far-reaching patents on the BRCA1 and BRCA2 genes held by Myriad Genetics but also calls into question other similarly broad patents on other human genes. This is a major victory for the plaintiffs in the case, which include the Association for Molecular Pathology (AMP), American College of Medical Genetics and Genomics (ACMG), American Society for Clinical Pathology, College of American Pathologists, and other healthcare organizations and individuals. More importantly, the ruling is also a major victory for patients, who will now have choices related to who performs their genetic testing and options to seek second opinions from independent laboratories.
As predicted in my earlier blog post on this topic, the Justices did compromise somewhat in their decision in that while human genes as they exist in nature were ruled not patentable, the opinion allowed that synthetic copies—so-called complementary DNA or cDNA—may be patentable. As noted by Justice Thomas, “...the lab technician unquestionably creates something new when cDNA is made.” A footnote to the opinion indicated, however, that the Court was not ruling that cDNA meets all of the requirements of patent eligibility; just that cDNA would not be considered a “product of nature.” Notably, the opinion also clearly stated that the Court was not ruling on any methods patents related to the two genes or on any applications regarding what Myriad had learned about the genes, leaving the door open for narrower genetic testing patents.
This ruling is a significant milestone in the 30-year gene patenting story and one that most patent opponents would claim as a victory for ensuring access to genetic testing and improving patient outcomes. Hayes congratulates the Justices for their insight and courage to meet the issue head on.