On June 13, 2013 the U.S. Supreme Court ruled (in a unanimous decision) that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…” Across the country, breast cancer patients, women’s groups, physicians, researchers, and other medical professionals celebrated the outcome of this landmark case.
What made this case (Association for Molecular Pathology v. Myriad Genetics) such a critical women’s health issue? Briefly, Myriad Genetics has owned patents on two human genes known as BRCA1 and BRCA2 since the early 1990s. A woman who carries a defective copy of either of these genes has a greatly increased lifetime risk of developing breast and/or ovarian cancer. By owning the patent for these genes, Myriad Genetics has had a monopoly on genetic testing for breast and ovarian cancer risk and was able to control the cost of the test without fear of competition. With its patent on the genes, Myriad was able to prevent other biomedical research companies from developing their own tests for the defective genes. Typically, such a test would cost in the range of $3000 to $4000.
Not all women need the BRCA gene test. Research indicates that genetic mutations (defects) cause only about 5% of breast cancers and 10 to 15% of ovarian cancers. Since most of these cancers are NOT related to the genes, genetic testing is NOT RECOMMENDED for women whose family history of these cancers makes it unlikely that they carry a defective gene. But according the National Cancer Institute, “currently, there are no standard criteria for recommending or referring someone for BRCA1 or BRCA2 mutation testing.” As a result, insurance companies and government payers have varied in their willingness to pay for the expensive BRCA tests.
Women, their healthcare providers, and advocacy groups hope that the Supreme Court’s ruling will have an immediate effect on the cost of genetic testing for breast/ovarian cancer risk. In fact, reports in the media suggest that the test is already becoming available at a reduced price. “Acutely, what we are seeing is a drop in prices, down from $4000 to $995 for the same test, in less than 1 week,” [the director of the Women’s Cancer Program, Samuel Oschin Comprehensive Cancer Institute at Cedars Sinai Medical Center, Los Angeles, California.Dr. Karlan] told Medscape Medical News.”
Although the statement that human genes cannot be owned seems like common sense, Myriad and others in the biomedical industry have argued that, without the patent and the profits it protects, there would be no incentive for research and development of new technologies. The Supreme Court did not entirely disregard this argument, allowing Myriad to retain its patent on certain elements of its test, but not on the genes themselves.
As the cost of BRCA gene testing decreases, insurance providers may relax their criterion for paying for the blood test. Equally important, the cost of all healthcare technology—whether insured privately or by the government—is ultimately shared across society in the form of higher insurance premiums or taxes. The termination of Myriad’s control over the BRCA genes may also open the door to the possibility of a second-opinion test for a woman considering very serious decisions based on her genetic test. Finally, the Myriad case is likely to have an affect the development and availability of new genetic testing for other conditions.
Most important: we want our patients to remember that most breast and ovarian cancers are not related to the defective BRCA genes. Please keep us informed of changes in your family history.