By Jean Marbella, The Baltimore Sun
9:31 PM EDT, June 13, 2013
Researchers hailed the Supreme Court ruling Wednesday that bans the patenting of human DNA, saying it would expand access to genetic testing for disease at lower cost to patients.
In a unanimous decision, the justices said Myriad Genetics did not have exclusive rights to the BRCA 1 and BRCA 2 genes that are linked to significantly greater risk for breast cancer and thus should not be the only company allowed to test for it.
"Myriad did not create anything," Justice Clarence Thomas wrote for his fellow justices. "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."
The ruling could have broad implications as scientists continue to work on identifying gene sequences as a way of providing "personalized" medicine — developing tests that predict who is at greater risk of contracting illnesses and enabling patients to take preventive measures to head off the disease.
Myriad was sued by the American Civil Liberties Union on behalf of patients and researchers, including Dr. Haig Kazazian, a professor at the McKusick-Nathans Institute of Genetic Medicine at the Johns Hopkins University.
Kazazian had been testing hundreds of patients a year for BRCA when a letter from Myriad arrived in 1999 at the University of Pennsylvania lab where he was working: "Cease and desist."
"We actually had to stop," said Kazazian, a bit of outrage still evident in his voice 14 years later. "This was not good for women who were at risk for this serious disease.
"We had to refer all our patients to Myriad," said Kazazian. "There was no competition, so they could charge whatever they wanted to charge. You couldn't get a second opinion if you had a positive result."
Actress Angelina Jolie recently underwent a double mastectomy after learning she carries the BRCA 1 mutation. Her mother had died of ovarian cancer in 2007 at the age of 56.
"My chances of developing breast cancer have dropped from 87 percent to under 5 percent," the actress wrote in a New York Times opinion piece.
Hereditary versions of breast and ovarian cancers make up a fraction of total cases. But BRCA mutations are responsible for most of the inherited forms of those cancers.
Dr. Alan Shuldiner, who directs the University of Maryland's program in personalized and genomic medicine, expects the Supreme Court ruling to increase access to testing. He noted that one company is the sole tester for an uncommon form of diabetes because it has a patent.
"I think more people will be screened pre-emptively," he said, "and costs will come down."
The ruling did not go entirely against Myriad. The justices' ban on the patenting of genes applies only to natural human genes; synthetically produced genetic material known as cDNA can still be patented.
"There is still some room here," Shuldiner said. "Where more money is to be made is with the identification of the genetic cause of a disease — that essentially identifies new targets for pharmaceutical companies to develop new drugs. And that's perfectly patentable."
"It's a huge step forward in clarifying whether the discovering of genetic information can be patented, and the answer is no," said Dr. Jeffrey Kahn, professor of bioethics and public policy at Hopkins' Berman Institute of Bioethics.
Kahn said it was telling that Myriad's stock initially rose after the ruling, before ending the day down 5 percent. Rather than squelch research and development, he said, the ruling could spark more of it.
"That is how the system ought to work," he said, with basic science conducted at universities or agencies such as the National Institutes of Health, then made available for everyone to use, including private companies that develop tests and treatments.
The ruling should "provide greater incentive to innovate," he said, "but we'll see."
Industry lawyers had worried that the court might issue a sweeping decision that wiped away patents for genetically engineered drugs or farm products on the theory that they were derived from or copied from natural genes.
"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.
In Maryland, where Gov. Martin O'Malley has made the biotech industry a key component of the state's economic development, the decision could have wide ramifications.
The ruling could prompt potential investors to more carefully scrutinize smaller companies to make sure their projects lead to patentable products, said Judy Britz, executive director of BioMaryland, an office within the state's Department of Business and Economic Development that supports the life sciences industry. But "it's a little bit early to tell how this will impact companies," she added.
Britz said there are roughly 500 life sciences companies in Maryland, employing 34,000 people, and she estimated that up to 30 percent of them have "some element of genomics" and might be affected by the justices' decision.
"The industry might have preferred a ruling that said there should be some value in protecting" the discovery of something like a BRCA gene, Britz said, but companies are also glad that the "long-brewing" issue has been resolved.
"In general, the Supreme Court ruling is clarifying," she said, "and businesses like predictability."
Britz said companies should still be able to protect other aspects of tests or treatments, even if naturally occurring DNA is no longer patentable.
"There are many ways to protect the invention surrounding the gene sequence," said Britz, an immunologist and microbiologist who has taken products through FDA approval to market. "If a company has been smart, they will have anticipated the need to protect not just the gene sequence but the way it is used and the format for delivering it."
The decision was hailed by the ACLU, which had sued Myriad on behalf of patients, researchers and other medical professionals.
"Today, the court struck down a major barrier to patient care and medical innovation," said Sandra Park, senior staff attorney with the group's 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."
Myriad charges several thousand dollars for the test. The ACLU points to how Myriad refused to contract with the insurance company of one of its plaintiffs because the reimbursement was too low. The woman waited more than a year before getting a grant to pay for the test, and learned that she did have a BRCA mutation.
Tribune Newspapers contributed to this article.
Supreme Court on DNA
The ruling: Human genes are a product of nature and cannot be patented and held for profit
Potential impact: More options for genetic testing, lower costs
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