The Supreme Court has announced it will hear the controversial Myriad Genetics case, which will ultimately decide whether or not human genes can be patented. On August 16th, a panel of the U.S. Federal Circuit Court of Appeals in Washington, D.C., ruled 2-1 that the biotech company could indeed patent the “isolated” genes it had discovered that account for most inherited forms of breast and ovarian cancer.
The same ruling denied Myriad’s effort to patent ways of “comparing” or “analyzing” DNA sequences. Nevertheless, the company’s shares dropped as much as 9 percent after the ruling.
“Some critics say it is unjust to give a company over a monopoly over something as intrinsic to people’s health as their genes,” explains research scholar Josephine Johnston. “From an ethics perspective, one could argue that genes are owned by everybody, and that patenting them amounts to a commoditization of an element of the human body.”
Sandra Park, a lawyer for the ACLU Women’s Rights Project,” says the Supreme Court’s announcement is a “huge step” toward ensuring patient protection and letting people access their own genetic information. “For many people,” she says, “understanding their genetic risk of disease is crucial to planning medical care. People need to understand that risk so they can plan for screening and other major medical decisions with their doctors.”
On the other hand, Myriad and its supporters — including the AARP, the American Medical Association, the March of Dimes Foundation, and the National Breast Cancer Foundation — argue that denying patent protection could slow the development of personalized medicine, which uses genetic tests to determine specialized therapies for individual patients.
According to Myriad CEO Peter Meldrum, the company’s diagnostic test has helped nearly 1 million people learn about their risk of inheriting cancer. “The discovery and development of pioneering diagnostics and therapeutics require a huge investment,” he says, “and our U.S. patent system is the engine that drives this innovation.”
Still, critics argue that the patents will prohibit standard clinical testing of the two genes and restrict research and patient access. “DNA’s importance flows from its ability to encode and transmit the instructions for creating humans,” says Dr. James Watson, who helped discovered the double helix structure of DNA. “Life’s instructions ought not to be controlled by legal monopolies created at the whim of Congress or the courts.” The Supreme Court’s decision is expected by the end of June.