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.