In a unanimous decision, the U.S. Supreme Court ruled Thursday morning that human genes are not patentable.
The case centered around Myriad Genetics, the holder of patents on two genes, BRCA1 and BRCA2. Some mutations of these genes are associated with an increased risk of breast and ovarian cancer. For women with a strong family history of these cancers, the only place they could be tested was Myriad Genetics, which sometimes charged more than $3,000 for the test.
Breast Cancer Action, an advocacy group based in San Francisco, was a plaintiff in the case, and executive director Karuna Jaggar sounded jubilant in a phone call Thursday morning.
“From our perspective, these patents never should have been granted in the first place,” Jaggar said. “There’s no question that DNA is a product of nature, and so it’s very affirming to see the court rule in our favor.”
BRCA1 and 2 mutations became international news when actress Angelina Jolie revealed that she’d had a preventive double mastectomy after testing showed that she had a specific mutation that put her at very high risk of developing breast cancer.
Breast Cancer Action has long argued against the high cost of the test, and said that the patent gave an unfair monopoly to Myriad Genetics, which is located in Salt Lake City. With the court’s ruling, Jaggar believes that more companies will be able to offer a test to women.
“They’ll have access to new tests at lower costs and will have access to second opinions,” Jaggar said. “Currently Myriad offers the one and only test. It has not been peer reviewed; it has not been scientifically validated. New labs will now be able to offer new tests using new methodologies.”
In a statement Myriad Genetics played down the magnitude of the decision, pointing to its 500 other valid patent claims as well as the BRCA test. The court upheld patent claims on what’s known as synthetic DNA or “cDNA.” Synthetic DNA is man-made, not a “product of nature,” and is still patentable.
“We believe the Court appropriately upheld our claims on cDNA,” Myriad’s CEO Peter Meldrum said in a release, “ensuring strong intellectual property protection for our BRACAnalysis test moving forward.”
But Breast Cancer Action insists the Supreme Court’s decision opens the door to new options for women who worry about inherited risk of breast cancer. “Laboratories can conduct genetic testing without using cDNA and this means that Myriad no longer holds a monopoly on the BRCA genes,” Jaggar said in a release this morning.
Roughly 5 to 10 percent of women carry a BRCA1 or 2 mutation, according to the National Cancer Institute. Not all mutations are harmful, but some can be devastating. Angelina Jolie said that she had a mutation that put her at an 87 percent risk of breast cancer.