ASSOCIATED PRESS Enlarge
WASHINGTON — Isolated human genes may not be patented, the Supreme Court ruled unanimously Thursday.
The case concerned patents held by Myriad Genetics on genes that correlate with increased risk of hereditary breast cancer and ovarian cancer.
The patents were challenged by scientists and doctors who said their research and ability to help patients had been frustrated.
The genes at issue received public attention after the actress Angelina Jolie disclosed in May that she had a preventive double mastectomy after learning that she had inherited a faulty copy of a gene that put her at high risk for breast cancer.
The price of the test, often more than $3,000, was partly a product of Myriad’s patent, putting it out of reach for some women.
The price of the test “should come down significantly,” said Dr. Harry Ostrer, one of the plaintiffs in the case decided Thursday. The ruling, he said, “will have an immediate impact on people’s health.”
The decision “sets a fair and level playing field for open and responsible use of genetic information,” said Dr. Robert Darnell, president and scientific director of the New York Genome Center.
“At the same time, it does not preclude the opportunity for innovation in the genetic world, and should be seen as an important clarifying moment for research and the health-care industry.”
The high court’s judgment, written by Justice Clarence Thomas, reverses three decades of patent awards by government officials and immediately prompted one of Myriad’s competitors to announce it would offer the same test at a far lower price.
DNATraits, part of Houston-based Gene By Gene Ltd., said it would offer BRCA gene testing in the United States for $995 — less than a third of the current price.
“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park, a lawyer for the American Civil Liberties Union Women’s Rights Project.
“Myriad did not invent the BRCA genes and should not control them. Because of this ruling, patients will have greater access to genetic testing and scientists can engage in research on these genes without fear of being sued,” she said.
American Medical Association President Dr. Jeremy Lazarus agreed.
“Removing the patents on the building blocks of life ensures that scientific discovery and medical care based on insights into human DNA will remain freely accessible and widely disseminated, not hidden behind a vast thicket of exclusive rights,” he said.
The court’s ruling also will shape the course of scientific research and medical testing in other fields, and it may alter the willingness of businesses to invest in the expensive work of isolating and understanding genetic material.
The decision hewed closely to the position of the Obama Administration, which had argued that isolated DNA could not be patented, but that complementary DNA, or cDNA, which is an artificial construct, could.
The split decision mitigates potential damage to the multibillion-dollar biomedical and biotechnological industries in the United States, experts said.
It will affect companies like Myriad and others doing similar work, said Courtenay Brinckerhoff, a lawyer at Foley & Lardner.
For the most part, biotech companies already have moved on from trying to patent isolated DNA, instead looking at synthetic options and other ways of protecting their multimillion-dollar investments, said Matthew McFarlane of Robins, Kaplan, Miller & Ciresi LLP.
Myriad’s stock price was up about 10 percent in early trading, a sign that investors believed that Myriad had retained the ability to protect its business from competition.
The central question for the justices in the case was whether isolated genes are “products of nature” that may not be patented or “human-made inventions” eligible for patent protection.
Myriad’s discovery of the precise location and sequence of the genes at issue, BRCA1 and BRCA2, did not qualify, Justice Thomas wrote for the court.
“A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated,” he said. “It is undisputed that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes.”
“Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the criteria” for patent eligibility, he said.
But manipulating a gene to create something not found in nature, Justice Thomas added, is an invention eligible for patent protection.