In a decision that could undo thousands of questionable patents, freeing scientists and citizens from corporate overreach, the Supreme Court has ruled unanimously that human genes—as products of nature—cannot be claimed as private property.
The Thursday morning decision—in Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al.—focused on Myriad Genetics, a Utah-based biotech company that claimed the rights to two naturally occurring genes that foster breast and ovarian cancer when they carry certain mutations. Scientists at Myriad identified the two genes, known as BRCA1 and BRCA2, during the early 1990s and went on to develop and market tests that women can use to determine their own risk.
Myriad and other biotech companies saw gene patenting as a legitimate exercise of intellectual property rights. But the court’s ruling codifies a common-sense answer that Dr. Jonas Salk offered in a 1955 television interview, when Edward R. Murrow asked him who owned the patent on the polio vaccine.
The people own it
Salk had recently developed the breakthrough inoculation with his colleagues at the University of Pittsburgh. Millions of school kids were lining up to receive it, and the greatest scourge of the postwar era was receding. Salk understood that the virus itself was a product of nature. He and his colleagues had simply discovered that the right injection of killed virus could immunize people against the live one.
“Well, the people [own the vaccine],” Salk told Murrow. “There is no patent. Could you patent the sun?”
No one has disputed Myriad’s exclusive right to the cancer tests it developed. But by staking a claim to the BRCA genes themselves, the company impounded a piece of biology, the court ruled. For nearly two decades, its patents have blocked the use of better, cheaper technologies, forcing patients and insurers to pay $3,000 to $4,000 for tests that would cost less than $100 in an open market.
The high court has now declared it an unlawful effort to patent the sun. “Nobody ‘invents’ genes, so no one should be able to claim ownership of them,” the Public Patent Foundation said in a statement on the decision. “We are not talking about a new drug or a new tool to fight cancer. We are talking about a genetic marker that occurs naturally in the human body. That cannot, and should not, be patented.”
Under the Patent Act of 1952, “human-made inventions” can become private property but “products of nature” cannot. The distinction was still clear in the 1980s when bioengineers started synthesizing artificial DNA molecules for diagnostic and therapeutic use. These “probes” and “primers” were laboratory inventions, and the Patent Office treated them accordingly. But as genetic science expanded during the '90s, the Patent Office went further, allowing thousands of companies to patent useful segments of naturally occurring DNA (i.e., genes) that scientists had extracted from human chromosomes. The Patent Office reasoned that these naturally occurring genes qualified as “human-made inventions” because scientists had isolated them from their natural surroundings.
Under that controversial policy, Myriad secured patents on the BRCA genes that reside in every human cell. The company also claimed ownership of all possible mutations in those genes, and all possible methods for finding those mutations. For good measure, it also patented the correlations between BRCA mutations and the risk of breast or ovarian cancer. As the ACLU noted in a backgrounder on the case, “anyone who makes or uses a patented gene without permission of the patent holder—whether it be for commercial or noncommercial purposes—is committing patent infringement.”
After securing those rights, Myriad enforced them aggressively, alienating scientists and health advocates at every turn. A coalition representing both groups pushed back in 2009, challenging the patents’ legality, and a federal district court ruled in their favor. The district court found that as “products of nature,” the BRCA genes couldn’t legitimately become private property. But a three-judge appeals panel overturned the ruling, voting two-to-one that Myriad has made the genes more useful by isolating them from the surrounding DNA in human chromosomes.
Now that the Supreme Court has rejected that finding, the case will return to the appeals court, which will determine the next steps in the case.
Other existing patents could come under question
Biotech industry analysts had predicted that the court would side with Myriad. They pointed to a recent decision in which the justices sided unanimously with Monsanto in its dispute with a farmer who failed to pay royalties on soybeans derived from its own genetically modified variety. But the analogy was imperfect. Unlike the BRCA genes, Monsanto’s patented soybeans differ from anything found in nature. The company reconfigured the natural bean genes to create a plant that would stand up to pesticides. In short, the patent covered an invention, not a “product of nature.”
A 2012 case involving the Mayo Clinic and Prometheus Laboratories offered a better window into the court’s thinking. In that case, Prometheus sued Mayo for developing a test that doctors could use to predict different patients’ reactions to the same class of drugs. Prometheus, which had already patented such a test, claimed (like Myriad) that it owned not only the tool it invented but also the physiological relationships the tool measured. The court rejected that claim, ruling that “the relationships . . . are not themselves patentable” and that a patent on an invention can’t legitimately “monopolize” the natural correlations the invention illuminates.
That insight may have been lost on the Patent Office and the biotech industry, but the rest of the world seems to get it. The plaintiffs in the original complaint against Myriad include organizations representing 150,000 scientists, medical groups, women’s groups and anti-cancer activists. After it reached the Supreme Court, the case drew amicus briefs from the U.S. Solicitor General, a host of medical societies and even Nobel laureate James Watson, who co-discovered the structure of DNA in 1953.
“A human genome cluttered with no trespassing signs…inhibits scientific progress,” Watson wrote in his brief. “The resources devoted to cancer research, neurological diseases, and other areas will be diverted to concerns about whether one can use a particular human gene. For a new assay using hundreds of human genes, the sea of patents and patent applications would create hundreds, if not thousands, of individual obstacles to developing and commercializing the assay. The best way . . . to resolve this problem is to eliminate the unnecessary patenting of human genes.”
Thursday’s decision effectively does just that. It may invalidate some 4,000 existing gene patents. And it will broaden the quest for medical knowledge.