The U.S. Supreme Court on Thursday ruled unanimously that isolated human genes cannot be patented. The gene patents case involved Myriad Genetics, the company that holds patents on the BRCA1 and BRCA2 genes, which are linked to high risk of breast and ovarian cancer.
We talked to Sofia D. Merajver, M.D., Ph.D., director of the Breast and Ovarian Risk Evaluation Program at the University of Michigan Comprehensive Cancer Center, who has been doing research on hereditary breast and ovarian cancer for 20 years.
mCancer Partner: What does this ruling mean?
Dr. Merajver: The Supreme Court stated that naturally occurring DNA is not eligible for a patent simply because it’s isolated. This basically opens up the market for gene tests to be developed for naturally occurring DNA.
The ruling does allow for the possibility of altered DNA, such as cDNA, to be patented still. These are different substances, not naturally occurring in the body, but put together from naturally occurring DNA. Because of this distinction, some people are calling it a partial victory. I would call this a true victory, because this is what makes sense: naturally occurring DNA cannot be patented. cDNA contains many sequences that are not needed for most disease-associated gene tests. Even if someone holds a patent for cDNA, other entities can compete in the free market with tests using parts of the DNA that cannot be patented.
mCancer Partner: How will this affect patients?
Dr. Merajver: The natural expectation from this ruling would be that the cost of genetic testing would go down, which means increased opportunities for more eligible patients to be tested. I’m hopeful industry, laboratories, and universities will begin to develop genetic tests that can be done inexpensively, and create better tests for research purposes to allow us to learn more about these genes and help save lives.
mCancer Partner: As new genes are discovered, if they cannot be patented, is that a disincentive to researchers or companies?
Dr. Merajver: Companies will need to be creative now. I hope this will encourage new clever methodologies that can be patented. New technologies have already been developed but haven’t really been applied to developing gene tests for human disease. So there is opportunity.
mCancer Partner: Overall, do you think this ruling is good news?
Dr. Merajver: This creates a free market, not a monopoly, which is definitely for the public good. As a researcher, I’m also excited about the possibilities. Because BRCA1 and BRCA2 were patented, there were huge barriers to developing in-house testing, and that decreased the scientific community’s enthusiasm. I’m hoping this ruling will lead to new inquiry, new directions and new discoveries that ultimately help our patients.
The Breast and Ovarian Cancer Risk Evaluation Clinic at the U-M Comprehensive Cancer Center provides an accurate assessment of personal risk for developing breast and other related cancers, education regarding availability of genetic testing and current research programs, and a plan for follow-up and preventive care.
The University of Michigan Comprehensive Cancer Center’s 1,000 doctors, nurses, care givers and researchers are united by one thought: to deliver the highest quality, compassionate care while working to conquer cancer through innovation and collaboration. The center is among the top-ranked national cancer programs, and #1 in Michigan for cancer patient care. Seventeen multidisciplinary clinics offer one-stop access to teams of specialists for personalized treatment plans, part of the ideal patient care experience. Patients also benefit through access to promising new cancer therapies.