The Supreme Court will decide whether human genes can be patented, a long-disputed legal question that has implications for the future of personalized health care.
The justices will consider a challenge to Myriad Genetics’ patents on genetic material—BRCA1 and BRCA2—used in tests to identify an increased risk of hereditary breast and ovarian cancer.
The question for the Court is whether genes removed from the cell in a laboratory are human-made inventions eligible for patent protection or products of nature that cannot be patented.
In a 2-1 ruling on Aug. 16, a panel of the U.S. Court of Appeals for the Federal Circuit upheld the biotechnology company’s right to patent isolated genes. “The isolated DNA molecules before us are not found in nature,” wrote Judge Alan D. Lourie. “They are obtained in the laboratory and are man-made, the product of human ingenuity.”
But the patents have been challenged by a variety of medical associations and doctors, led by the Association for Molecular Pathology. They contend that Myriad’s monopoly on BRCA genetic testing restricts scientific research and patients’ access to medical care.
“Myriad and other gene patent holders have gained the right to exclude the rest of the scientific community from examining the naturally occurring genes of every person in the U.S.,” the plaintiffs, represented by the American Civil Liberties Union, say in their petition seeking review of the appeals court decision.
“These patents endanger women who deserve access to the best possible care as they make life-changing medical decisions,” says ACLU staff attorney Sandra S. Park.
Myriad’s diagnostic test has helped almost 1 million people learn about their risk of hereditary cancer, says Peter D. Meldrum, the company’s CEO. “The discovery and development of pioneering diagnostics and therapeutics require a huge investment, and our U.S. patent system is the engine that drives this innovation,” he says.
The court likely will hear the case in early spring 2013 and rule before the end of June.