Joanna Rudnick, a breast cancer survivor and BRCA-1 gene carrier, turned 39 today — and got one heck of a birthday present.
The Supreme Court unanimously ruled that human genes cannot be patented, although it reiterated that synthetic or altered genes may be subject to patent law. In other words, human DNA cannot be patented without being altered in some way.
Advocates called the decision a major victory.
“My life has exploded over the Myriad ruling,” she gushed on the phone. “This is an incredible birthday present. It is a victory. The barrier for women to get tested for BRCA 1 and 2 will now be gone. “
Rudnick is one thousands of Jewish women to be affected by this ruling: Ashkenazi Jews are much more likely to carry the BRCA mutation than the general population.
The court case pitted the American Civil Liberties Union (ACLU) against Myriad Genetics Inc., the biopharmaceutical company that owned the patents on the BRCA-1 and BRCA-2 genes, whose mutations are linked to increased hereditary risk for breast and ovarian cancer.
Writing for the court, Justice Clarence Thomas explained: “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” he said. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA-1 and BRCA-2 genes.” “Groundbreaking, innovative or even brilliant discovery does not by itself satisfy the criteria” for patent eligibility, he added.
For Arthur Caplan, head of the Division of Bioethics at New York University’s Langone Medical Center, the Supreme Court made the right decision.
“Immediately [the decision] means that testing should become more available for breast cancer and ovarian cancer using the Myriad test at a lower price,” explained. “Longer term this decision throws into a tizzy a huge number of existing patents,” Caplan said. “The other fallout [is still] uncertain. It’s clear that you can take [out] patents, you just have to take them on products, not on genes.
Sue Friedman, founder and executive director of FORCE: Facing Our Risk Of Cancer Empowered, agreed. As a 17-year cancer survivor and a BRCA-2 carrier, Friedman was elated.
“Personally for me, for my family, for my relatives, this is significant, but also for people who may have a mutation and have not been able to get access to that information. They are part of that extended family that we’ve built through FORCE,” she said.
“We’re very excited, over the moon,” she added. “This will really open up the ability of other tests to be developed. This is a strong message and a victory for the community that we serve.”
For Lisa Schlager, an official with FORCE, this news was a long time coming.
“I’m thrilled, I feel like this has been an ongoing battle for the past two years, and there have been so many question marks and so many opinions on how this might hinder research,” she said. “I think that nothing that happens naturally in our bodies should be patentable, and the Supreme Court obviously agrees. “
Schlager, 46, pointed out that in addition to lowering costs, this decision would potentially enable genetic clinics and counseling services that already provide testing to also test for the BRCA mutations. This especially relevant in the Jewish community, where testing for common genetic diseases like Tay Sachs is a well-developed and organized practice.
“We are big advocates of genetic counseling and an ideal place would be a Jewish genetics service that already does testing for the community,” she said. “We would love to see some of the genetic services offer this as part of their genetic testing routine for families. It could be very useful information for family planning.”
As for the partial ruling, Schlager said it was expected. “If a company develops a test that will isolate DNA certainly they should be able to patent that. What doesn’t make sense to me is to be able to patent something that occurs naturally.”
But though the ruling has been seen as a partial victory for Myriad by some, Ellen Matloff, research scientist in genetics and director of cancer genetic counseling at the Yale School of Medicine, that is not really the case.
“It is really misunderstanding the ruling to think this is a partial victory for Myriad. Believe me, its not,” Matloff wrote in an email. “This means that they have lost their patents and their exclusive monopoly. This means that other labs will immediately be offering BRCA testing. I expect that within the next 3 months. And the race is on for cheaper, faster, better testing in the long run — I expect this within the year, if not sooner.
“In the longer run, today is a huge victory for patients because research in the BRCA world will now open up,” she added. “[You can] expect the pace of research to accelerate 20 fold within the next 2 years.”
But as Joanna Rudnick pointed out, the fight for hereditary cancer awareness is far from over.
“We need to get the data back,” she explained. “That’s the next movement I’m going to get involved with. Myriad has not been publishing data [about BRCA mutations] since 2006. It’s in our hands to get that data out there and work with clinicians and reseachers.”
“I feel that justice has been done today,” she said. “But I feel there’s a lot more work to be done. We can’t stop here. “