June 17, 2013 | by Hiu Chung So
Months after hearing the arguments and weeks before concluding its current session, the Supreme Court unanimously ruled that human genes are a product of nature and are not patentable.
In the court's majority opinion, Justice Clarence Thomas wrote: "A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated."
The immediate effect of the June 13 ruling: Myriad Genetics no longer holds the patent on the BRCA1 and BRCA2 genes, as well as the monopoly on testing for the genes' cancer-causing mutations. This means other companies can test for these genes, likely for a fraction of the approximately $3,000 Myriad is currently charging. Additionally, panel tests that scan for multiple mutations at the same time can now include BRCA genes in their mix.
Myriad's BRCA patents were set to expire in two years even if they had been upheld, but "the principle is important," Jeffrey Weitzel, M.D., director of City of Hope's Division of Clinical Cancer Genetics, told the Los Angeles Times. The ruling sets a precedent affecting future genetic research and the development of gene-based tests and therapies, he said.
Cy Stein, M.D., Ph.D., the Arthur & Rosalie Kaplan Chair in Medical Oncology at City of Hope, talked to TIME.com about a few of the ruling's long-term impacts. He predicted:
However, the ruling isn't a complete defeat for Myriad; the Supreme Court did uphold Myriad's patents for synthetically created complementary DNA. In its post-ruling statement, Myriad said it still "has more than 500 valid and enforceable claims in 24 different patents conferring strong patent protection for its BRACAnalysis® test."
In the meantime, clinicians and patients should get ready for new test options. And scientists will have plenty of catching up to do to match the 17 years' worth of BRCA gene research that Myriad has already gathered.
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