On June 13, the United States Supreme Court announced its decision on the controversial gene patenting case, “Association for Molecular Pathology v. Myriad Genetics. The decision was unanimous: by a vote of 9-0, the justices ruled that the Utah-based company does not have the right to patent human genes. Writing for the Court, Justice Clarence Thomas spoke in plain language: “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.” Such genes, Justice Thomas wrote, are “products of nature” isolated DNA cannot be patented.
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) that is created in the lab. It ruled that the latter can be protected under patent law.
The decision was hailed not only by AMP but by other organizations and stakeholders in the clinical laboratory community who had been concerned that, if the Court had sided with Myriad, fewer patients would have had access to genetic testing, the price of such testing would have remained high or increased, and a chilling effect on research would have occurred. For a good summary of the case that laboratory organizations made against Myriad, see the letter by Steven H. Kroft, MD, FACP, the president-elect of the American Society for Clinical Pathology (ASCP), which I was pleased to include in the “Observatory” department of the current (June 2013) issue of MLO.The ruling had immediate consequences.
By the next day, California-based Ambry Genetics and the University of Washington announced that they would begin offering testing for BRCA-1 and -2, and Quest Diagnostics indicated it would do so before the end of the year. And, Texas-based DNATraits said it would provide the test for $995—barely a quarter of the price before the ruling. What is your, or your institution’s, perspective on this important case? We’d like to know your opinion.
