A federal court ruling striking down patents on two cancer-causing genes has the potential to shake up the world of genetic patenting.
Last year, the American Civil Liberties Union, together with 18 individual plaintiffs, brought a suit against Myriad Genetics, which holds the licenses to the patents on the BRCA1 and BRCA2 genes, which can cause breast and ovarian cancer. The genes in question carry mutations that dramatically increase the risk of breast, ovarian and prostate cancer, and are disproportionately common among Ashkenazi Jews.
In March of this year, U.S. District Court Judge Robert Sweet ruled that “isolating” a genetic sequence found in nature does not fundamentally change it, nor the information it holds, and therefore does not constitute a patentable product.
Myriad has appealed the decision, and many believe that it could prove to be a pivotal case that will shape the future of genetic patenting.
“I think this would be a landmark case for two reasons,” said Dr. Harry Ostrer, a plaintiff in the case. “One is that it’s specific and the other is that it’s generic. It’s specific to these genes, but it’s generic in that a ruling may apply to other genes as well. Then I think the whole notion of patenting natural products would be questioned.”
Opponents of genetic patents say that they stifle research and lead to artificially inflated test costs, limiting access to testing. Supporters of genetic patenting say that it gives incentives for research by allowing holders of patents to earn royalties from tests and research done by others on the gene.
“We sit in our research committees and say, ‘Do we have patent protection for this?’ ‘No?’ ‘Well, then we’re not going to do research and spend $40 million on it just to have another company create a knockoff product,’” Richard Marsh, executive vice president and general counsel at Myriad, told the Forward.
“We are the poster child that the patent system works,” Marsh said. “We spent over $2 million over the past 10 years to mature this product so that today a woman in middle America can walk into her doctor’s office and say, ‘You know, I have a family history of breast cancer,’ and he’ll say, ‘What insurance do you have?’ ‘Blue Cross.’ ‘That’s covered. We can get you the test.’ No other company would have spent the money and the time. You just don’t do that without the promise of patent exclusivity.”
A staff attorney with the ACLU, Chris Hansen, disputed the notion that the promise of a patent spurred the research in this area.
“We know for a fact that it’s not true in this instance,” Hansen said. “There were other labs looking for the gene who announced that they would not patent the genes or would patent it and make it available to everybody. The gene would have been found, and it would have been available.”
Lisbeth Ceriani, a plaintiff in the suit, is a 43-year-old woman who was diagnosed with cancer in both breasts. She claims that Myriad will not accept her insurance and that she is unable to get the tests to determine if she needs ovarian surgery.
“Myriad holds my fate and future in its administrative hands, unless of course I am able to pay $3,225 out-of-pocket. Unfortunately, as a result of my illness and treatment, I do not have an extra three grand right now,” she wrote in her plaintiff’s statement.
“There will always be a small percentage of people whose unique circumstance puts them outside the square box,” Marsh said. “There were five plaintiffs in the case [who claimed they were unable to receive testing due to costs], and I distinguish them against the 400,000 tests we’ve done. We appreciate that there are some people who can’t afford the test, and if you can’t afford the test, we’ll do it for free.”
But Ellen Matloff, director of genetic counseling at the Yale Cancer Center, pointed to the high cost of comprehensive BRCA1 and BRCA2 testing through Myriad.
“I’ve seen the cost of testing rise from $1,600 in the late 1990s to almost $4,000 today, even though the price of technology has gone so far down that the cost should have gone down as well,” said Matloff, who is also a plaintiff in the suit. “This test could easily be offered for less than $1,000.”