Supreme Court says no patent on natural DNA, upholds other Myriad patents
The impact of the ruling goes well beyond Myriad Genetics. As much as 60 percent of the human genome has been patented and there are close to 3,000 genetic tests of various kinds, some patented and some in the public domain.
In an opinion written by Justice Clarence Thomas, the court said that separating the gene from its surrounding genetic material "is not an act of invention. Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the inquiry." But Myriad removed elements of DNA that don't code for proteins. The court said those altered genes Myriad created by removing elements of natural DNA can be patented. That synthetic DNA is called cDNA.
The court "appropriately upheld our claims on cDNA and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection" for the test in the future, said Myriad president and CEO Peter D. Meldrum.
The court said Myriad can continue to make money from its work on the BRCA genes. "Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent," he said. Other patents, including on application of knowledge about the two genes, were not part of the lawsuit.
Time will tell exactly what the ruling means. Expectations are varied.
Removing the patent they hold on the gene itself leaves it open for other companies to develop new ways to test for the genes, which will spur competition, said Brett Parkinson, imaging director of Breast Care Services at Intermountain Medical Center. That's a good thing for patients.
Whenever testing is more available and less costly, which he thinks will be likely following the court decision, more women will avail themselves of the opportunity to be tested. Parkinson also believes it will bring down insurance premiums.
“Myriad did a wonderful job in isolating this gene and it has served women well. But it is time that genetic testing is widely available at an affordable cost and this will let that happen.”
It’s particularly important, he said, for women who have Medicaid, which does not cover genetic testing to look for BRCA mutations, or for women who can’t afford it.
That reduced cost and better access is Sterin's hope. If the ruling "makes the test less expensive, if it makes it easier for people to find out what their risk factors are, that's great," she said. Her mom died of breast cancer, but because she was diagnosed when she was in her 70s, it was not considered likely that it raised the risk for her daughters. Sterin's cancer was detected during a routine mammogram. Because of her mom's breast cancer and the fact that her heritage includes Ashkenazi Jews, who are higher risk of having BRCA mutations, she opted to be tested.
Had she had the genetic mutation, Sterin said it "would very much have changed what I did for treatment."
She did not have the gene — and neither do most women; it's about 1 in 400. That’s still a lot of women. For those with a mother or sister who had breast cancer before menopause, genetic testing is an important part of choosing options. Some with the mutation may, like Jolie, opt to have both breasts removed as a preventive measure. Finding the gene can spur earlier, more consistent screening.
Because there is no screening test like mammography for ovarian cancer, Parkinson said genetic testing is an opportunity to identify women who carry the gene and thus the heightened risk. Some who know they have a BRCA mutation may opt to have their ovaries removed.
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