In a landmark decision this morning, the US Supreme Court ruled that companies that isolate human genes cannot secure patents on them. The unanimous ruling came in a case involving Myriad Genetics, a Utah company, that held patents on genes associated with increased risk of hereditary breast and ovarian cancer.
A number of UChicago physicians and researchers have weighed in on the decision. Check back as we add more throughout the day.
“It will have a major impact not only on cancer genes but on numerous aspects of human genetic testing and diagnosis, including diabetes. People have argued whether or not this will advance the cause of science in testing in that companies with gene licenses will now not have an exclusive right to do testing. It suggests that costs of at least some genetic testing will drop dramatically, ending or at least diminishing the cost argument for NOT doing genetic testing. We recently published a paper (Greeley et al) that showed that even at current costs testing for neonatal monogenic diabetes is cost-effective. Another study we have submitted (Naylor et al) clearly shows that testing for monogenic diabetes beyond infancy into adulthood is also cost effective at the price point per gene we are about to see. These studies were funded in part with support from the American Diabetes Association. This ruling really is a game changer and one hopes that it will only help the field of using genetics to diagnose and understand various forms of diabetes and other human diseases.”
The Kovler Diabetes Center is sponsoring a conference on monogenic diabetes Thursday-Saturday, July 18-20, where this topic and its implications will be a highlight of the meeting.
Olufunmilayo Olopade, MD, FACP, Director of the University of Chicago Center for Clinical Cancer Genetics, focused on increased accessibility to genetic screening:
“The principle of Genetic Justice has finally been upheld by the highest court of the land. The public contributed tax dollars to find BRCA genes and the most vulnerable in society have been systematically excluded from benefiting because the test cost too much. Genetic testing has remained prohibitively expensive in this country and without insurance and or third party payer approval, those who could benefit the most from knowing their mutation status have been denied access to life saving information. Myriad provided excellent service by developing the first clinical grade assay in 1997 but then competition should have allowed cost to come done for everyone and that never happened because of the patent.”
Dr. Olopade also spoke to the Chicago Sun-Times about increased access to testing.
Ralph Weichselbaum, MD, Chairman of the Department of Radiation and Cellular Oncology, urged caution, however, given Myriad’s large portfolio of patents:
“I think comment without a careful reading of the decision is difficult. As I understand the decision the Court ruled 5 of Myriad’s claims are not patent eligible. Myriad has more than 500 enforceable claims in 24 different patents which confer strong protection to the BRCA test. The fact that Myriad’s stock is sharply higher makes me think this is likely. So much for social justice.”
Suzanne Conzen, MD, professor of medicine and breast cancer specialist, was cautiously optimistic:
“This appears to be good news for clinicians hoping to make testing for inherited disease susceptibility more accessible. There will likely still be patents for individual assays of inherited genetic variation in a particular gene, but a single company will not have exclusivity over developing those assays.”
Daniel Sulmasy, MD, PhD, Associate Director of the University of Chicago MacLean Center for Clinical Medical Ethics, spoke about the scientific merits of the idea of patenting genes:
“It has always been nonsensical for anyone to claim ownership over genes. Genes are part of our common human microanatomy, our common patrimony. Because Vesalius discovered the liver in early anatomic dissection he laid no claims to owning the liver and all diagnostic tests associated with it. The Supreme Court has decided correctly that genes are not intellectual property but elements of nature.”