WASHINGTON, D.C. (WUSA9) -- The Supreme Court heard arguments today in a patent case with far-reaching implications for medical research, as well as patients at high risk for inherited diseases. This includes those who carry gene mutations that increase their chances of developing breast or ovarian cancer.
"The Supreme Court has held for 150 years that you can't patent a product of nature, like gold or iron. The human gene is nothing more than the same thing," says Christopher Hansen, an attorney with the American Civil Liberties Union. He is representing a large group of petitioners who believe companies should not be able to hold patents on genes.
"The human gene is in fact part of the human body, its structure and function dictated by nature. It is not an invention, " Hansen told reporters gathered outside the high court.
At issue in this specific case are several patents held by Myriad Genetics on the BRCA 1 and BRCA 2 genes; the company isolated these genetic sequences and developed a test for mutations. When those mutations are inherited, they greatly increase a person's risk of developing breast or ovarian cancer. More and more women have sought out the testing, and some have chosen to prophylactically have their breasts and ovaries removed to lessen the chances of cancer.
Lisa Schlager is Vice President of Community Affairs & Public Policy for the non-profit patient advocacy group "FORCE: Facing Our Risk of Cancer Empowered." She is also a carrier of the BRCA 1 mutation. "The reality is that the BRCA gene is a naturally occurring thing in the body. Myriad doesn't own my DNA, they have no right to own my DNA."
Myriad has a monopoly on BRCA testing, and according to published reports, made more than 400 million dollars in its last fiscal year on the diagnostic test. Women can't get a second opinion from another company, and some say their insurance doesn't cover the cost of the test, which runs about $4,000.
But inside the Supreme Court today, lawyers for Myriad argued that without the company's research investment and its scientists' ingenuity, the specific gene sequences would never have been isolated, nor synthetically recreated in the lab to allow for diagnostic testing.
Local patent attorney Michelle Wales, who wrote one of the amicus briefs in support of Myriad's position, says gene patenting has been allowed in the United States for almost thirty years. She says a reversal of that would impact the future of the entire biotech industry.
Wales says, "If its decided that DNA sequences are not patentable, it changes the rules. What that could potentially mean is less medicines and vaccines, less food for hungry people, less alternative fuel sources, less tools to clean up the environment."
In a company statement about the case, Myriad also says most patients pay an average of just $100 in out-of-pocket expenses for testing, and that more than one million have benefitted from finding out their BRCA gene status.
Lisa Schlager says she's rallying against the patents because she wants future generations, like her daughter, to have even greater access to this information.
Shlager says, "They (Myriad) are hindering progress for people at high-risk of breast and ovarian cancer by keeping this information to themselves."
The Supreme Court is expected to rule on the case this summer.