Supreme Court decision is a win for women with genetic risk of breast and ovarian cancers, as well as geneticists and researchers who had criticized a Utah company’s exclusive patent.
WASHINGTON — The Supreme Court ruled Thursday that human genes cannot be patented, a decision with both immediate benefits for some breast and ovarian cancer patients and long-lasting repercussions for biotechnology research.
The decision represents a victory for cancer patients, researchers and geneticists who claimed that a single company’s patent raised costs, restricted research and sometimes forced women to have breasts or ovaries removed without sufficient facts or second opinions.
But the court held out a lifeline to Myriad Genetics, the company with an exclusive patent on the isolated form of genes that can foretell an increased genetic risk of cancer. The justices said it can patent a type of synthesized DNA that goes beyond extracting the genes from the body.
Justice Clarence Thomas wrote the decision for a unanimous court. “Myriad did not create anything,” Thomas said. “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 decision will allow other scientists and laboratories to provide genetic diagnostic testing, now that the patent on the BRCA1 and BRCA2 genes themselves has been lifted. That should lead to lower costs and greater access.
“It is splendid news for patients, for physicians, for scientists and for common sense,” Mary-Claire King, the geneticist who in 1990 discovered the abnormality on chromosome 17 that proved to be the breast cancer gene, told USA TODAY. “The marketplace will now be open.”
Myriad emphasized the bright side of the decision for the company — that cDNA, which is not naturally occurring, remains patentable. As a result, it said, 24 patents containing more than 500 valid claims remain in effect.
“More than 250,000 patients rely upon our BRACAnalysis test annually, and we remain focused on saving and improving peoples’ lives and lowering overall health care costs,” said Peter Meldrum, the company’s president and CEO.
THOUSANDS OF PATENTS INVALIDATED
The complex scientific case was perhaps the most important on the high court’s calendar other than its more celebrated cases involving same-sex marriage, voting rights and affirmative action.
And unlike those cases, which are expected to divide the court sharply along ideological lines, the controversial concept of gene patenting gave all nine justices something to agree on.
The decision was based on past patent cases before the high court in which the justices ruled that forces of nature, as opposed to products of invention, are not patent-eligible.
“Jonas Salk once said that the polio vaccine could not be patented — it belonged to the public,” said Rep. Louise Slaughter, D-N.Y., a microbiologist and leader on genetic issues. “I am pleased the Supreme Court has applied this same standard to all genetic material.”
Since 1984, the U.S. Patent and Trademark Office has granted more than 40,000 patents tied to genetic material. About one-fourth of the 22,000 human genes have been patented — patents that are now invalidated. That could open up competition in genetic testing for diseases ranging from Duchenne muscular dystrophy to inheritable heart arrhythmia.
Still, the bulk of the biotechnology industry’s products are not affected by the ruling, said Lawrence Brody of the National Human Genome Research Institute.
Armed with its patents, Myriad has tested more than 1 million women since the late 1990s for mutations that often lead to breast and ovarian cancer. Most women who want testing must pay its price — $3,340 for the breast cancer analysis and $700 for an additional test that picks up a genetic link in about 10% of women who test negative the first time. Myriad officials say about 95% of its patients receive insurance coverage, often without co-payments, so that most patients pay only about $100.
Myriad and a broad array of industry trade groups argued that without patent protection, research and development would dry up. Doctors, geneticists, women’s health groups and cancer patients contended that competition would lower prices, improve outcomes and lead to more discoveries.
“The court struck down a major barrier to patient care and medical innovation,” said Sandra Park, senior staff attorney with the ACLU Women’s Rights Project, which filed the original lawsuit. “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,” Park said.
COST OF TESTING SLASHED BY 75 PERCENT
Harry Ostrer, a medical geneticist who became the last remaining plaintiff in the case, heralded the decision as “thrilling” and predicted it would slash the cost of breast and ovarian cancer testing for women with a genetic risk from $4,000 to less than $1,000. That will make it more available to lower-income women and those without quality health insurance, he said.
As if to make Ostrer a prophet, by late afternoon a Houston-based genetics testing company called DNATraits, a division of Gene by Gene, said it would offer the test for $995.
Karuna Jaggar, executive director of Breast Cancer Action, hailed the decision as one that put “patients’ health before corporate profits.”
“This ruling makes a huge and immediate difference for women with a known or suspected inherited risk of breast cancer,” Jaggar said. “And it is a tremendous victory for all people everywhere. The Supreme Court has taken a significant stand to limit the rights of companies to own human genes by striking down Myriad’s monopoly.”
The two sides had battled to a draw in lower courts: A federal district court in New York sided with the patent’s challengers, while a divided court of appeals that handles patent cases ruled for the company.
During oral argument in April, the court was presented with opposite interpretations of Myriad’s contribution to genetic research. Christopher Hansen, the lawyer for the American Civil Liberties Union representing the patent’s challengers, said Myriad had invented “nothing.” Myriad’s attorney, Gregory Castanias, said the company created “a new molecule that had never been known to the world.”
The justices generally agreed that Myriad deserved credit for its process of isolating the gene and its use — but not for the gene itself. “In isolation, it has no value,” Justice Sonia Sotomayor said. “It’s just nature sitting there.”
Thomas’ decision was slightly more diplomatic. “We merely hold that genes and the information they encode are not patent-eligible … simply because they have been isolated from the surrounding genetic material,” he said.
The compromise that emerged Thursday was evident during that 65-minute debate. Several of the more conservative justices said a complete denial of patent rights could jeopardize investments by other biotechnology companies — and that could limit progress on a range of research, from agriculture to the environment.
University of Michigan professor Shobita Parthasarathy said that compromise is significant, since scientists still must contend with gene patents. “This will likely continue to have a deleterious effect on genetics research and access to health care in the United States,” she said.
Contributing: Dan Vergano and Liz Szabo in McLean, Va.
Follow @richardjwolf on Twitter.
