Defendants in a high-profile lawsuit that could have significant implications for thousands of patents on human genes have now asked a federal judge to dismiss the case, calling it a "thinly veiled attempt to challenge the validity of patents."
Two months ago, more than 150,000 researchers, doctors, activists and cancer patients filed a federal lawsuit in New York City against Myriad Genetics, Inc., the University of Utah Research Foundation and the U.S. Patent and Trademark Office (USPTO). Under the organization of the American Civil Liberties Union (ACLU), they are challenging the legality and constitutionality of gene patents, with a focus on two of the most controversial: BRCA1 and BRCA2. Both genes are associated with breast and ovarian cancers, and both are held by Myriad. The information encoded in our DNA should belong to everyone, the plaintiffs argue, and the current standards for obtaining a patent are too low.
"There's a sense that the privatization of certain things has gone too far," says Debra Greenfield, an attorney and postdoctoral fellow at the Center for Society and Genetics at the University of California, Los Angeles, who is not associated with the lawsuit. "Abstract things are being patented now, whether it's something in your body or a business method."
But in their motion to dismiss filed last week, Myriad and the University of Utah argue otherwise. "The patent system has worked exactly as it was designed to do," the defendants wrote, explaining that they "spent considerable time, effort and money, in competition with other researchers" to win the patents.
The history of gene patents
Almost 30 years ago, the U.S. Supreme Court held in Diamond v. Chakrabarty that a genetically modified bacterium was a patentable subject matter. The Court called the scientist's discovery of the bacteria with improved capacity for degrading crude oil, "not nature's handiwork, but his own." This opened the door for companies to pluck out a segment of DNA and put their name on it.
The USPTO has since granted thousands of patents for biological entities, always with the caveat that they must be first isolated, purified or modified in some way. Today, one out of every five human genes is privately owned. Those opposed to gene patents complain that no one without the permission of the patent holder is allowed to freely work with, or even think about using, this 20 percent.
Myriad is just one of many companies in possession of these genes, but is one of only a few that has not licensed the information to others to conduct research or create their own test. Since the mid-90s, the company has owned the exclusive rights to the BRCA1 and BRCA2 genes. Whereas only 5 to 10 percent of breast cancer patients have a mutation at one of these genes, those having it face a 40 to 85 percent chance they will develop breast cancer at some point in their lives.
Given these odds, a screening test for the mutations can provide useful information for women who are considering proactive interventions to prevent future cancer. "If you want the test done, you have to go through Myriad," says Josephine Johnston, director of research operations at The Hastings Center, a nonpartisan bioethics and public policy research institute. "And they hold those patents pretty close to their chests." The test currently costs around $3,000, although most insurance companies do cover it. "People think it's a pretty steep price," Johnston adds. "But when you have this kind of control, you can set the price. They could've made it $30,000 if they wanted to."
In another five years, the exclusive rights that the USPTO granted Myriad based on the isolation and purification of the two genes will expire. But according to many who oppose gene patents, that's five years too many—too many more women will be without a second opinion or an opportunity to purchase a cheaper test to help decide whether or not to undergo a radical surgical procedure.