Today the Supreme Court of the United States ruled that human genes cannot be patented. This ruling has broad implications for our work in gynecologic and breast cancers, and for genetic research in many other fields. It is a big step forward towards our goals of individualized medicine and cancer risk assessments.
The case originated with concerns over exclusivity granted by a patent to a single company to control rights to testing for BRCA1 and BRCA2 mutations. When present in women, these two inherited genetic abnormalities dramatically increase a woman’s chances of ovarian and breast cancer. The tests are expensive—potentially costing over $4,000.
In a rare unanimous decision, the Supreme Court ruled that “products of nature”– in this case, human genes–are not patentable like “human-made inventions.” Therefore, the discovery of the genetic sequence of the BRCA1 and BRCA2 genes is not eligible for patent protection. Justice Clarence Thomas said, writing for the court, “A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”
This ruling has immediate implications for our work in women’s cancers, as it is expected to make testing for BRCA mutations more affordable and widely accessible. It also should help women in other countries as the test becomes more widely acceptedand cancer risk more easily identified. Women and their doctors will begin to have much more information to help guide them in making decisions about preventative treatments.
There may be other long term ramifications on research. While some believe this will temper the willingness of companies to invest in research, I believe it may actually encourage continued growth and discovery in biotechnology, particularly those companies who have been hesitant to makemajor investment while awaiting the decision in this case.
Today let’s celebrate a great achievement in our fight to end cancer as a threat to women. For years, our run for her family has helped us make genetic counseling and testing available to our patients.
The Supreme Court’s ruling ensures even greater access to BRCA testing for all women.
Beth Y. Karlan, MD