The US Supreme Court unanimously decided Thursday that human genes cannot be patented, in a landmark decision that is seen as a major win for researchers and patients, who argued that allowing such patents impedes research and harms patients’ ability to know the disease risks that lurk in their DNA.
Companies, on the other hand, said prohibiting such patents could undermine the biotechnology industry, slowing innovation and the development of genetic tests and treatments.
In the case, the Association for Molecular Pathology, a group representing professionals involved in laboratory testing, as well as scientists and patients, challenged the patents that Utah-based biotechnology company Myriad Genetics holds on breast cancer risk genes. Those genes have recently been catapulted into the national spotlight by actress Angelina Jolie’s revelation that she had her breasts removed after discovering she had a high genetic risk of developing breast cancer.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” justice Clarence Thomas wrote on behalf of the court, which struck down five of Myriad’s claims for patent protection. The court decided that synthetically-generated strands of DNA, called cDNA, however, are eligible for patent protection.
“Myriad did not create or alter either the genetic information encoded in the BRCA1 and BRCA2 genes or the genetic structure of the DNA,” Thomas wrote. “It found an important and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself” make the work patent eligible.
Myriad Genetics holds patents on gene sequences related to risk of breast and ovarian cancer. Patents are awarded for inventions and new ways of making things, and Myriad argued that pinpointing the location of mutated genes that caused increased cancer risk, and isolating and sequencing those genes amounted to information that could be eligible for patent protection. The Court disagreed, and the ruling invalidated five claims the company had made in patents. But it also upheld the patent eligibility of cDNA, which is synthesized by scientists.
In a statement, Myriad Genetics said that it believed it still had strong patent protection for its breast cancer test, called the BRACAnalysis, including more than 500 claims in two dozen patents that remain valid.
“We believe the court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” Peter D. Meldrum, president of Myriad Genetics said in a statement.
Patrick Waller, a partner in the biotechnology practice group at Wolf, Greenfield and Sacks, a Boston-based law firm focused on intellectual property, said that the decision was significant, but not as bad as it could have been for biotechnology companies. He said that there are many gene-related patents that fall in a middle ground that weren’t explicitly addressed by the decision, and that the court left intact many of Myriad’s claims. He also said that the ruling would benefit a new generation of companies that offer genome sequencing, which would now no longer have to worry about whether disclosing a certain genetic risk would put them at risk of patent infringement.
“It’s not a funeral for the entire diagnostics industry,” Waller said. “It basically probably means some companies will be emboldened by it and try and go out and develop competing tests; there will be more litigation. Some companies may have some of their patents reissued with narrower claims.”
The industry’s largest lobbying group, the Biotechnology Industry Organization, said the Supreme Court decision could create business uncertainty for drug makers and related businesses.
The high court decision “represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences,” BIO president Jim Greenwood said in a statement.
But he applauded the ruling that so-called cDNA remains eligible for patenting, saying that would create certainty for biotechnology companies that rely on cDNA patents to invest in potential therapies.
Eric Lander, director of the Broad Institute, a genetics research center in Cambridge, and a leader of the human genome project, said the decision was a huge victory for patients and for basic researchers.
“I think they got it exactly right,” Lander said. “You can’t have a patent on something that nature invented, not you. ... It’s common sense, almost anybody would say that the breast cancer gene was invented by nature, not by a biotech company.”
He also predicted that the impact on industry would be fairly minimal. He said it was not likely to affect companies working on the development of new drugs and therapies, and that even among companies developing genetic tests, the impact would be small.
“I don’t think there are many diagnostics companies that will be affected,” Lander said. “But I think any diagnostics company that’s trying to create a monopoly by owning a human gene now no longer has that outcome available to it and that’s wonderful for patients.”