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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.
Details of the patent argument
Geoffrey Karny, a patent lawyer in Virginia, doesn't buy the argument that gene patents hurt patients. "What they're trying to do is advance patient care," he says, suggesting the price tag is key to improving diagnostic tools. After his recent trip to Hong Kong and China, the connection between "cheaper" gene tests and pirated products, like DVDs, became obvious to Karny. "Myriad has done the heavy lifting. Of course, someone could piggyback on that and sell it for $100," he says. "But stuff doesn't just jump from lab to marketplace." Companies, he suggests, require patent protection to invest the "years of effort and millions of dollars needed to develop a product to be used in a clinic."
In China Karny also witnessed a growing biotechnology industry that could threaten the U.S. economy. "We need that tech here," he says, noting a special concern for small start-ups. "Why should investors put money into companies if they'll never get a return on that investment?"
The lawsuit has brought to the forefront broader ethical questions that had already been stirring: Where do you draw the line between what is considered a product of nature and what is a product of man? Where does discovery end and invention begin? In its complaint, the ACLU states, "An 'isolated and purified' human gene performs the exact same function as a nonisolated and purified human gene in a person's body."
The Hasting Center's Johnston suggests that Myriad and other owners of gene patents haven't really changed the gene-that it is still essentially a product of nature: "I'm sympathetic to people who say that it's like taking gold out of the ground," Johnston says. "You haven't created anything new."
Others take this argument one step further. "It was an error on the part of the patent office to grant the patents," says Marcy Darnovsky of the Center for Genetics and Society in Oakland, Calif., which has voiced their support for the plaintiffs in the case. "Things that are 'products of nature' should be a commons, like the air we breathe."
What about research on patented genes?
The ACLU's complaint also rests on the belief that Myriad's monopoly is stifling research. "If everybody had that gene, who knows what different kinds of diagnostics, what different kinds of treatments might emerge," says U.C.L.A.'s Greenfield. "Those could be patentable, but when you patent and monopolize the underlying basic research tool, maybe one company has a lot of incentive, but everybody else doesn't." She adds that there is actually little incentive for the patent holder to improve the quality of the tests or lower its price.
Myriad Genetics refused to speak about the case, as did the USPTO, both noting their policies against commenting on pending litigation measures. But in the 2008 PBS documentary, In the Family, Myriad founder Mark Skolnick responded to producer Joanna Rudnick's patent questioning very simply: "There's no controversy."
Karny would agree, actually calling the lawsuit "garbage." He adds, "If courts were to buy the argument, it would be devastating for the biotech industry and for our health in general." Karny compares the issue with a classic Mark Twain analogy. "Myriad has produced a flash of lightning and ACLU has given us a lightning bug," he says. "The court should squash the lightning bug."
Myriad's motion for dismissal will be heard on August 26 in New York's Southern District Court.
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