Supreme Court rejects gene patents
WASHINGTON — The Supreme Court ruled that human genes are a product of nature and cannot be patented and held for profit, a decision that medical experts said will lead to more genetic testing for cancers and other diseases and to lower costs for patients.
In a unanimous ruling Thursday, the nine justices declared that human genes are not an invention, so they cannot be claimed as a type of private property.
The decision invalidates a Utah company’s patents on two genes that are linked to breast and ovarian cancer, and is likely to lead to several thousand other gene patents being tossed as well.
“This is a landmark decision,” said Dr. Stanley Robboy, president of the College of American Pathologists. “Genomic medicine has the potential to be a cornerstone of medical testing, treatment and clinical integration, but the question of who owns your genes needed a definitive answer. Now we have it.”
The broad reach of the court’s decision goes well beyond genetic testing for cancer.
Dr. Wayne Grody, a UCLA medical geneticist, said he planned to add a host of genetic tests — including genes for congenital hearing loss, spinocerebellar ataxia and various muscular dystrophies — “right back on our test menu” for patients at UCLA.
Indeed, competitors to Myriad Genetics Inc. in Salt Lake City, which held patents on the BRCA1 and BRCA2 genes and a monopoly on testing for the genes, cropped up quickly Thursday.
Stanford Cardiologist Euan Ashley, whose laboratory researches the genetic basis to heart disease, said he received two slickly produced marketing emails from laboratories announcing they were jumping into the niche of sequencing the genes.
“They obviously had it ready to go,” he said.
Supreme Court Justice Clarence Thomas, writing for the court, left little room for doubt about the justices’ view.
“Myriad did not create anything,” he wrote. “To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.”
For Dr. Harry Ostrer, who brought the action against Myriad, the decision “will have an immediate impact on people’s health.”
“This will drive down the costs of genetic testing. It should open up the competition and improve the quality of testing,” said Ostrer, a professor of pathology and genetics at Albert Einstein College of Medicine in New York.
Ostrer sued to challenge Myriad’s gene patents when the company tried to block him from testing patients who had the genetic mutation that put them at high risk for breast or ovarian cancer. Myriad said patients could use only its test — at a cost of more than $3,000.
The court’s decision also came as a relief to much of the biotech industry. While the justices agreed a “naturally occurring DNA segment” cannot be patented, they also said DNA “synthetically created” in a lab is an invention that can be patented.
Industry lawyers had worried the court could issue a sweeping decision that would wipe out patents for genetically engineered drugs or farm products, on the theory they were derived from or copied from natural genes.
The stock prices of Myriad and some other biotech companies initially went up Thursday when it was clear the court had not undercut all gene-related patents. Myriad shares, which soared 12% early, ended up losing $1.91, or 5.6%, to $32.01.
“The worst fears of the biotechnology industry have not been realized, and inventions in the field of molecular genetics remain patent eligible,” said Gregory Dolin, co-director for the Center for Medicine and Law at the University of Baltimore School of Law.
Striking down gene patents had become a rallying cry for cancer patients and their doctors. The nation’s major medical groups had urged the court to rein in the patent office and free doctors and researchers from the hold placed on so-called patented genes.
Last month, actress Angelina Jolie put a national spotlight on the problem by disclosing that she had a “faulty” gene, as she described it. She said she had a double mastectomy after learning she had inherited a dangerous mutation in the BCRA1 gene for which Myriad had the patent.
Jolie said her doctors told her she had a 87% risk of developing breast cancer and a 50% risk of ovarian cancer. Myriad also held a patent for the BRCA2 gene, another indicator of breast and ovarian cancer.
“I’m very happy,” Raluca Kurz, a genetic counselor with Cedars-Sinai Medical Center in Los Angeles, said about the court’s decision. “I think we’ve all been waiting for this to happen for a long time.”
Roughly 80% of Cedars’ genetic testing for cancer involves the BRCA genes, Kurz said. But Myriad’s $3,300 sticker price for the tests blocked many eligible women without insurance from getting screened. And the price has risen incrementally over the past several years, Kurz said.
“It was very disheartening and heartbreaking because we had families that couldn’t afford the test,” she said.
The court’s opinion said the “average American woman has a 12% to 13% risk of developing breast cancer, but for women with certain genetic mutations, the risk can range from 50% to 80% for breast cancer and 20% to 50% for ovarian cancer.”
But it will take scientists years to catch up with the data and analysis that Myriad Genetics has been able to accumulate during the 17 years it held a U.S. monopoly on the BRCA1 and BRCA2 genes, said Eric Topol, director of the Scripps Translational Science Institute in La Jolla.
“This is like a non-issue for them because they own the treasure chest” of information, he said. “They’ve been mission control for all these years and I don’t think people realize that.”
The patent would have expired in 2015, he said.
Myriad has been conducting tests on some 250,000 women annually, including relatives of clients seeking the testing, and those tests have given the company valuable insight into the populations carrying variations of the genes, Topol said.
He pointed out that the court’s decision did not address that data and the analysis that resulted from it, which he and others said should be made public.
The ruling is the latest to reflect the high court’s growing skepticism about the nation’s patent system. Patents are supposed to spur innovation by giving inventors an exclusive license to profit for up to 20 years from what they have created.
Critics have said that granting too many patents in a fast-changing area of technology can discourage innovation if one company has legal control over an area and can charge monopoly profits and keep out competitors.
The justices in the past decade have taken up the issue and issued a series of unanimous rulings rejecting the views of the U.S. Patent and Trademark Office and the federal courts that handle patent claims.
The justices have said that supposed “inventors” cannot obtain patents for claimed innovations that are obvious or rely on natural laws such as gravity or natural processes such as chemical reactions in the body.
In Thursday’s opinion, the justices said that parts of the human body — whether a kidney or a tiny gene — cannot be patented even if it takes great skill to isolate this body part.
In a one-paragraph concurring opinion, Justice Antonin Scalia said he could not vouch for the “fine details of molecular biology” set out in Thomas’s opinion, but agreed with the conclusion that DNA “in its natural state” cannot be patented.
Times staff writers Geoffrey Mohan and Amina Khan in Los Angeles contributed to this report.
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