U.S. Supreme Court disallows patenting of naturally occurring human genes

June 21, 2013

“Myriad did not create anything. To be sure, it found an important and useful gene, but separating the gene from its surrounding genetic material is not an act of invention.” So wrote Justice Clarence Thomas for a unanimous Supreme Court when, on June 13, it announced its decision on the controversial gene patenting case, “Association for Molecular Pathology v. Myriad Genetics.” The justices ruled that the company does not have the right to patent naturally occurring human genes. Such genes, Justice Thomas noted, are “products of nature.” The ruling means that no company can seek to patent isolated DNA.

The genes in question (BRCA-1 and BRCA-2) correlate with an increased risk of ovarian and breast cancer. The Court did make a distinction between isolated, naturally occurring DNA and synthetic, or complementary, DNA (cDNA) created in the lab. It ruled the latter can be protected under patent law.

The decision was hailed not only by the Association for Molecular Pathology but by other organizations and stakeholders in the clinical laboratory community which had been concerned that, if the Court had sided with Myriad, fewer patients would have had access to genetic testing, the price of testing would have been prohibitive, and a chilling effect on research would have occurred.

The ruling had immediate consequences. Ambry Genetics and the University of Washington quickly announced they would begin offering testing for BRCA-1 and -2. Quest Diagnostics indicated it would do so before the end of the year. And, DNATraits said it would provide the test for $995—a quarter of the price before the ruling. For a good summary of the argument laboratory organizations made against Myriad, read a letter written by Steven H. Kroft, MD, FACP, president-elect of the American Society for Clinical Pathology printed in the June 2013 issue of MLO.