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Supreme Court rejects gene patents

In unanimous ruling, justices declare that human genes are a product of nature and cannot be patented and held for profit.

June 14, 2013|By David G. Savage, Los Angeles Times
  • In a unanimous ruling, the U.S. Supreme Court declared that human genes are not an invention, so they cannot be claimed as a type of private property. Above, a technician in 2002 loads patient samples into a machine for testing at Myriad Genetics Inc. in Salt Lake City.
In a unanimous ruling, the U.S. Supreme Court declared that human genes… (Douglas C. Pizac, AP )

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.

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