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Last week, the US Supreme Court ruled on a significant gene patenting case. The issue before the Court was whether or not a company’s patents on the BRCA1 and BRCA2 genes could be upheld. The landmark ruling states that a gene is a naturally occurring product of nature, and therefore cannot be patented. The Supreme Court’s ruling has important implications for clinicians, cancer patients, and individuals who are at higher risk of a BRCA mutation than the average population either by personal or family history. Many say that the Court’s ruling will increase access to genetic testing by eliminating the monopoly on the test, which will thereby reduce the cost of testing significantly and allow for consumer choice. For many years, the American College of Medical Genetics has asserted that gene patents “stand firmly in the way of good patient care, interfere with informed decision-making by patients, impede training of the next generation of lab professionals and restrict the flow of information that is critical to advancing medical knowledge and better medical care accessible to all.” Therefore, some anticipate that this decision will better enable appropriate and more affordable testing, particularly for those who are uninsured or underinsured.
Carrie Horton, MS, CGC
Director of Genetic Counseling
Brad Somer, MD
This morning, the Supreme Court rendered its decision in the gene patenting case, holding that “genes and the information they encode are not patent eligible under §101 [of The Patent Act] simply because they have been isolated from the surrounding genetic material.” The Court noted that Myriad Genetics, the laboratory that currently offers testing for the BRCA1 and BRCA2 mutations found in 1 in 40 Ashkenazi Jews, did not create or alter either the genetic information encoded in the BRCA1 and BCRA2 genes or the genetic structure of the DNA. Though the Court noted that Myriad found an important and useful gene, it acknowledged that groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry and is therefore not subject to patent protection.
What does the Court’s decision mean for thousands of women and families at risk of breast or ovarian cancer or considering genetic counseling or testing?
Call us at Sharsheret or chat live with our staff genetic counselor. Thousands of women, men, and families reach out to us for support and information about cancer genetics. We’ll walk you through your options, and connect you to others who have done the same.
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