Author: Elizabeth Weise
For Lisbeth Ceriani, news that a judge had invalidated the patent on the gene that almost killed her was a victory.
Gene patents, she says, are "turning our bodies into commerce."
Ceriani, of Newton, Mass., developed an aggressive form of cancer in both breasts at age 42. She wanted to be tested for mutations in the BRCA gene, which would tell her whether she was also at high risk for ovarian cancer.
But it took an agonizing year and a half, because the company that makes the tests and owns the patent on the gene had chosen not to contract with her insurance provider, MassHealth, a form of Medicaid, because the rate of reimbursement wasn't high enough. Only when the company, Myriad Genetics of Salt Lake City, donated 200 tests to the state was she able to be tested, she says.
"I didn't want to just go ahead and have my ovaries removed if I didn't necessarily have to," Ceriani says.
The results showed she had the mutation. Ceriani had her ovaries removed prophylactically in December.
Ruling against Myriad surprised many
In the interim, her cancer went into remission, and she joined a lawsuit to overturn Myriad's patent. "It's like patenting blood or gold that comes out of the ground. It's ridiculous," she says. "Myriad treats the gene like a franchise. If you want to pay them a certain amount of money, they'll let you look at it."
The case was filed by the ACLU and the New York-based Public Patent Foundation on behalf of doctors, patients and several medical groups, including the Association for Molecular Pathology and the American College of Medical Genetics.
The ruling against Myriad March 29 surprised many in the legal and business community, who had been basing tens of millions of dollars' worth of business on the ability to patent genes since the 1980s.
The genes for both BRCA1 and BRCA2 were first patented by geneticist and Myriad founder Mark Skolnick, who in the 1990s began looking at detailed family histories to zero in on the genetic basis for breast cancer. Family histories helped him figure out which genes probably carried the mutations. Using gene sequencing, he found exactly where on the genes the mutations occur.
In the ruling, U.S. District Court Judge Robert Sweet in New York state invalidated part of seven patents granted to Myriad on the BRCA1 and BRCA2 genes. In doing so, he might have changed the face of genomic medicine.
"This really goes to the fundamental question of 'Does the U.S. patent system work?' " says Richard Marsh, Myriad's general counsel. "We spent hundreds of millions of dollars until we broke even before we got (the test) out, to fund the research."
Without the patent on the gene, investors wouldn't have put in money to support Myriad during those lean years, he says. It's only now, when the company is actually making money, that people feel it's unfair. "Where were these people 10 years ago?"
Sweet's ruling was "surprising," says Hank Greely, a law professor at Stanford University and expert on biotech law. The legal underpinnings of whether genes are patentable "had been left open over the last 30 years" because the original decisions to allow such patents weren't as clear as they might have been, he says. But "because the patent office had been granting and courts had been upholding them for 30 years, plus the tens of millions of dollars invested," everyone thought they would stand.
Instead, Sweet in effect said, " 'You didn't invent this, you didn't make it, you shouldn't get a patent on it,' " Greely says.
Myriad, which has appealed the decision, believes the Court of Appeals for the Federal Circuit will reverse it. Bio, the biotechnology industry group that filed an amicus brief, says companies aren't patenting the actual genes in people's bodies, but the purified version — and the understanding of what a gene does and "whether it has the utility necessary to be a therapeutic or a diagnostic," says general counsel Tom DiLenge.
A matter of time
The ACLU believes the proper time for a patent does not come when a company has isolated a gene, but when it has developed a drug or test based on that gene. "That's what actually happens in much of biotech, they're actually patenting things they're creating," says Sandra Park, one of the lawyers who argued the case.
Myriad argues that gene patents offer companies the time to develop those drugs and tests.
However the appeals court rules, the case probably will end up at the U.S. Supreme Court, experts say. How it will affect companies that rely on such patents isn't clear.
"The key, as in many issues around intellectual property, will be clarity and stability," says Fiona Murray, a professor at the MIT Sloan School of Management in Cambridge, Mass., who researches intellectual property and business. "Once we know what is in fact patentable, then firms can focus their attention on those investments that will lead to protectable innovations that can be the basis for their competitiveness."
A ruling from the appeals court isn't expected for at least a year.
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