The United States Supreme Court has today (June 13) unanimously ruled that isolated human genes cannot be patented, but the Justices also ruled that synthetic DNA sequences—known as complimentary DNA (cDNA)—are eligible for protection. “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” wrote Justice Clarence Thomas, “but cDNA is patent eligible because it is not naturally occurring.”
The decision throws out patents held by Utah-based Myriad Genetics on two genes—BRCA1 and BRCA2—that when mutated cause breast and other types of cancer. Researchers, physicians, and patients who sued Myriad are claiming victory because the ruling means that the company no longer has a monopoly on diagnostic tests based on these two genes. This could result in increased competition, falling costs, and greater access for low-income patients.
“The Court struck down a major barrier to patient care and medical innovation,” Sandra Park, an attorney with the American Civil Liberties Union Women’s Rights Project, told USA Today. “Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing, and scientists can engage in research on these genes without fear of being sued.”
Francis Collins, Director of the National Institutes of Health, added: "The decision represents a victory for all those eagerly awaiting more individualized, gene-based approaches to medical care. The right to control exclusively the use of a patient's genes could have made it more difficult to access new tests and treatments."
The decision is also something of a compromise, however, because it allows biotech companies to patent artificial DNA sequences. Myriad and other companies had argued that a ruling against gene patenting would undermine billions of dollars of investment from the biotech industry and impede medical progress. With this ruling, they still have ways to profit from their research.
Update (June 13): This article has been update to include a quote from NIH Director Francis Collins.