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The US Supreme Court ruled that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.
In a unanimous decision, the US Supreme Court ruled on June 13 that naturally occurring isolated biological material is not patentable, but a synthetic version of gene material may be patented.
In the case, Association for Molecular Pathology v. Myriad Genetics, patient groups sued Myriad Genetics over the company’s claim of patents relating to the genes BRCA1 and BRCA2, whose mutations are linked to increased hereditary risk for breast and ovarian cancer. Since Myriad held the patents to the genes, it was the only company that could test for potential abnormalities.
The case illustrated the debate over costly genetic research and patient access to affordable care. Companies that spend tens or hundreds of millions of dollars in genetic research argue that patents encourage medical innovation that can save lives. Patient rights groups argue the high cost of tests provided by patent holders restricted the availability of diagnostic care to high-risk patients.
In the court decision, Justice Clarence Thomas wrote, "Genes and the information they encode are not patent-eligible under [federal law] simply because they have been isolated from the surrounding genetic material.
"Myriad did not create anything," wrote Thomas. "To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention."
However, the court also noted, "cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments."
"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 BRACAnalysis test moving forward," said Peter D. Meldrum, Myriad Genetics president and CEO in a press statement. "More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples' lives and lowering overall healthcare costs."