Association for Molecular Pathology v. Myriad Genetics, Inc.

The Supreme Court ruled unanimously on June 13, 2013, that isolated human genes may not be patented.   The opinion, written by Justice Clarence Thomas for the unanimous Court, stated: “Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.  But the processes used by Myriad to isolate DNA were well understood by geneticists at the time.” Cancer patient advocates, oncologists, and cancer researchers had closely monitored the case because of the implications of the ruling for the cost of the BRCA1 and BRCA2 gene tests as well as the potential impact on research and development of additional gene tests.

The plaintiffs in the case — Association for Molecular Pathology v. Myriad Genetics, Inc. – claimed that the ruling would have an immediate impact on people’s health by reducing the cost of the BRCA tests.   Robert Cook-Deegan, a research professor at Duke University’s Institute for Genome Sciences and Policy, was quoted in the New York Times, “I think that there might be some blustering or saber rattling, but I would be really surprised if they sue anybody for patent infringement for a diagnostic test.”

Others described the ruling as a partial victory for Myriad because the court held that complementary DNA, or cDNA, could be patented.  Peter Meldrum, Myriad President and CEO, was quoted in the Washington Post: “We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRCAnalysis test moving forward.”