from the just-because-it's-your-genome,-don't-think-you-own-it dept
One of the biggest victories on the patent front was when the US Supreme Court finally ruled that naturally-occurring DNA cannot be patented. The company involved in this case, Myriad Genetics, didn’t give up at this point, but tried to claim that despite this ruling, its patents on genetic testing were still valid. Fortunately, the courts disagreed, and struck down those patents too.
However, as we noted at the time, there’s another issue that remains unresolved, which concerns the huge database of DNA that Myriad Genetics has built up over years of sequencing the BRCA1 and BRCA2 genes that have variants linked to cancer. Because of Myriad’s unwillingness to provide that important data to the people whose DNA was sequenced, the American Civil Liberties Union (ACLU) has decided to take action:
On May 19, 2016, the ACLU filed a complaint pursuant to the Health Insurance Portability and Accountability Act (“HIPAA”) with the U.S. Department of Health & Human Services (“HHS”) on behalf of four patients against Myriad Genetics, a genetic testing laboratory based in Utah. The complaint was filed by patients who have experienced cancer, including breast and bladder cancers, or who are members of families with substantial histories of cancer.
All of the patients received genetic testing from Myriad Genetics in order to determine their hereditary risk for various forms of cancer and to guide treatment decisions. They later asked for all of their genetic information, not just the results, but Myriad refused to provide it. As the ACLU explains:
The patients want full access to their genetic information because they know that the understanding of genes and their variants is constantly evolving, and they want to be able to proactively monitor their own cancer risk and that of their family members as scientific knowledge and clinical interpretation of genomic information advances. Most importantly, the patients, many of whom have uncommon genetic variants, are concerned that Myriad controls much of the data about BRCA1 and BRCA2 genetic variants in a proprietary database. This impedes the ability of researchers to better understand whether these variants are connected with various types of cancer. The patients want to have the option of sharing their data with the broader research community.
The last point is key. Myriad is sitting on a wealth of information that might well lead to new treatments and even cures for the many cancers involved. Instead, it is asserting its proprietorial right over DNA that comes from other people. That’s particularly egregious since the scientists who first sequenced DNA on a large scale were pioneers in data sharing. As early as 1996, laboratories taking part in the Human Genome Project not only agreed to share their data, but to do so immediately, and with no restrictions. Myriad Genetics’ action is totally at odds with the ethos of sharing that lies at the heart of genomics.
As a blog post on the ACLU site notes, on the eve of the HIPAA complaint being filed, Myriad suddenly agreed to provide the information requested, but only on a “voluntary” basis. That is, it refused to recognize the broader rights of patients to their own genetic information. However, the ACLU believes that the law is straightforward here:
Patients are guaranteed access to their health information — including their genetic data — under HIPAA. In 2014, the U.S. Department of Health and Human Services amended the HIPAA regulations to make clear that all laboratories, which were previously exempted, are subject to this obligation. And earlier this year, HHS released guidance stating that with respect to genetic testing, patients have a right to access “not only the laboratory test reports but also the underlying information generated as part of the test,” including “the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test.”
Let’s hope this case leads to yet another defeat for Myriad, and establishes once and for all that DNA sequences belong to the people from whom they were obtained. That way they will be free to make data available to researchers for the benefit of everyone, not just for a few companies like Myriad Genetics.