The US Supreme Court unanimously ruled Thursday that human genes are “a product of nature” and cannot be patented, a landmark decision that scientists said could remove impediments to research and enhance patients’ ability to learn the disease risks that lurk in their DNA.
The ruling came in a challenge to patents that Utah-based biotechnology company Myriad Genetics Inc. holds on gene mutations that convey higher risks for breast and ovarian cancer. 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 cancer.
Doctors and patients said they hoped the ruling would alter the genetic testing landscape, enticing new companies to offer tests for the cancer gene mutations and provide competition that might bring down the test’s cost, now about $3,300. The decision may also help clarify the situation for hospitals and genome sequencing companies that examine the full genome and provide information to patients about genes that have been patented.
“A naturally occurring DNA segment is a product of nature” and can’t be patented, Justice Clarence Thomas wrote on behalf of the court, which struck down five of Myriad’s claims for patent protection.
“Myriad did not create or alter either the genetic information encoded in the . . . genes or the genetic structure of the DNA,” Thomas wrote. “It found an important and useful gene, but ground-breaking, innovative, or even brilliant discovery does not by itself” make the work patent eligible.
Biotech companies argue that being able to patent genes is crucial to encourage innovation, but they downplayed any negative impact of the decision, because the court said patents could still be issued for a kind of synthetic DNA called cDNA, which is similar to genes.
Over the past two decades, the type of gene patents sought by companies has shifted, especially after the human genome project put gene sequences into the public domain. Patents now often focus on synthetic DNA forms.
Myriad Genetics holds patents on the BRCA1 and BRCA2 gene mutations that have been shown to increase the 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, and isolating and sequencing those genes, amounted to information that was eligible for patent protection. The court disagreed.
Myriad’s leadership said the company still has strong patent protection for its breast cancer test, called the BRACAnalysis.
“The intellectual property landscape, candidly, in terms of the protection we have around our testing, hasn’t changed,” the company’s general counsel, Richard Marsh, said. The company’s stock closed Thursday at $32.06, down 6 percent.
The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation on behalf of researchers, genetic counselors, patients, and medical professionals.
One plaintiff, Lisbeth Ceriani, 47, of Newton, said she was delighted by the decision. After she was diagnosed with an aggressive form of breast cancer five years ago, Ceriani was advised to get a genetic test because the findings could show her risk of ovarian cancer. The single mother who worked two part-time jobs said she called her insurer and was told they would cover the test. But she said Myriad Genetics would not accept her insurance, and no other firm offered the test.
“I am just so relieved that basically a wrong has been righted and our genes are not being held captive by private corporations anymore,” Ceriani said.
Eventually, she found a grant program that would provide the test. Ceriani found out she carried a BRCA mutation and had her ovaries removed. She said she hopes the decision would lead to more companies offering the genetic test.
It’s unclear, however, whether other companies will step up and whether Myriad will try to enforce its patents if one did. Patrick Waller — a partner at Wolf, Greenfield and Sacks, a Boston-based law firm focused on intellectual property — said the court left intact many of Myriad’s claims. “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’ll be more litigation.”
More broadly, the biotechnology industry was still assessing the decision’s impact.
Leda Trivinos, chief patent counsel for Momenta Pharmaceuticals Inc. in Cambridge, said companies have been preparing for such a decision by writing patent claims in a way that would protect research using cDNA, rather than naturally-occurring genes.
“I was actually pleased by it,” Trivinos said of the decision, “given that a lot of people in our area thought the Supreme Court would blow it up, and they didn’t.’’
But Harry Glorikian, managing partner at Cambridge consulting firm Scientia Advisors, said he feared that the ruling may cause investors to pull back on funding life sciences.
“It’s going to introduce more questions than clarity in what’s covered by patents,’’ Glorikian said. “If someone doesn’t believe that their intellectual property is protected, they may not make the investment.”
Leaders of the Massachusetts Biotechnology Council, the state’s trade group, have not been told of any Massachusetts biotech companies that will be hurt immediately by the prohibition on patenting human genes, council vice president Sarah MacDonald said.
“The biggest question . . . is not the direct results of this decision but whether the concepts in the decision are extrapolated to other drug discovery techniques such as stem cells and immunotherapies, which are naturally developed proteins and antibodies,’’ she said. “That could put a damper on the cutting-edge research.”
But many scientists saw the finding as a boon to the type of research that fuels new therapies and diagnostics. 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 doctors.
“I think they got it exactly right,” Lander said. “As someone who worked on the human genome project with many people to create a public resource for all of mankind, this ruling gives me a special pleasure, since it confirms that the human DNA in its basic form is completely free and clear to know and read and to use to improve human health.”