WASHINGTON — The Supreme Court ruled unanimously Thursday that human genes cannot be patented, a decision that is likely to shape the future of medical and biotech research.
Those who challenged the notion that something that occurs naturally in the body can be “owned” by a company said the decision could open a new era of expanded research and lower costs for genetic testing.
At the same time, the ruling held out hope for industry that certain research methods and the creation of synthetic DNA can be protected and thus worth the investment.
“Today, the court struck down a major barrier to patient care and medical innovation,” said Sandra Park of the American Civil Liberties Union, which represented doctors, researchers and patients who brought the challenge.
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“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.”
The issue received national attention last month when actress Angelina Jolie revealed that she had a double mastectomy because genetic testing showed she carried the defective gene that greatly increased her chance for cancer.
The ruling was a split decision for Myriad Genetics, which holds patents on genes that have been linked to breast and ovarian cancer and thus is the only company that offers the genetic tests, which can cost more than $3,000.
Not long after the ruling, another firm said it would offer BRCA testing in the United States for $995.
Justice Clarence Thomas, writing for the court, said that merely isolating those specific genes — called BRCA1 and BRCA2 — was not worthy of a patent. The decision was a departure from decades of decisions to the contrary from the Patent and Trademark Office.
“Myriad did not create anything,” Thomas 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.”
He added that “groundbreaking, innovative, or even brilliant discovery does not by itself” overcome the fact that “laws of nature, natural phenomena, and abstract ideas” are beyond the domain of patent protection.
On the other hand, Thomas wrote, when Myriad and others create a synthetic form of DNA — called cDNA and particularly useful in conducting experiments and tests, such as cancer screening — their work does deserve patent protection. “The lab technician unquestionably creates something new when cDNA is made,” Thomas wrote.
Myriad focused on that part of the decision.
“We believe the Court appropriately upheld our claims on cDNA, and underscored the patent eligibility of our method claims, ensuring strong intellectual property protection for our BRACAnalysis test moving forward,” said CEO and President Peter Meldrum.
The average American woman has a 12 percent to 13 percent chance of developing breast cancer, according to the court’s opinion, but mutations in the two genes isolated by Myriad increase the risk to as much as 80 percent for breast cancer and 50 percent for ovarian cancer. Myriad developed tests useful in detecting those mutations.
Jim Greenwood, president and chief executive of the Biotechnology Industry Organization, said the decision will put U.S. companies at a disadvantage.
“The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences,” Greenwood said in a statement.
Those who challenged the patents said the ruling will spur research and competition. “The cost of genetic testing should come down considerably,” said Harry Ostrer of the Albert Einstein College of Medicine at Yeshiva University in New York.
Ostrer noted that there were about 4,000 gene-related patents that now can be challenged, and he predicted that additional tests for heart conditions and neuromuscular diseases will become available.
While the briefs and opinion in the case often offered theoretical arguments, reaction to the decision was more emotional.
Lisbeth Ceriani, one of the plaintiffs represented by the ACLU, said the decision means that a part of the human body is “not being held hostage by a private company anymore.”
The case is Association for Molecular Pathology v. Myriad Genetics.
Material from The Associated Press is included in this report.