The four-year court battle over the genetic marker of an elevated risk of breast cancer was, for many, a mind-numbing slog through complicated science. Now begins the even longer and murkier process of assessing the sum of gains or possible losses for university researchers and the wider public.
The Supreme Court, in its 9-to-0 decision, issued on Thursday, ruled that Myriad Genetics Inc. did not have a right to claim ownership of the BRCA1 and BRCA2 genes, which it discovered along with partners that include the University of Utah. The court found that the genes—segments of human DNA—are naturally occurring and thus ineligible for patent protection, contradicting years of decisions by the U.S. Patent and Trademark Office.
The clearest immediate beneficiaries of the outcome of the case, Association for Molecular Pathology v. Myriad Genetics Inc., No. 12-398, are women because Myriad had been charging them $3,000 apiece to learn of a hidden cancer risk. With its patent right now removed, competitors are expected to quickly drive that price down, expanding the ability of women to afford the test.
The most immediate benefit for university research could be a rapid expansion of clinical-lab experiments involving DNA sequencing that would not have been possible before the court ruling.
The Supreme Court’s ruling “encourages a much more confident movement into whole-genome sequencing for medical purposes, without the fear it will be tied up in legal challenges for the next 10 years,” said Francis S. Collins, director of the National Institutes of Health.
The optimism of Dr. Collins that the court ruling promises wider benefits for university research is widely shared, though not universally. Some experts now fear that future discoverers of important genetic breakthroughs, realizing they too won’t have patent protection, may prove less willing to share what they find.
“That’s what we’re worried about,” said Dan L. Burk, a professor of law at the University of California at Irvine.
Myriad, in recent years, began to withhold from public release the new data it kept acquiring about how genetic variations affected cancer risks, hoping to keep for itself some competitive edge if it lost the underlying patent rights.
“The perverse outcome here,” Mr. Burk said of the Supreme Court’s ruling, which he supports over all, “could be that companies will begin to act the way that Myriad has already begun acting.”
And it’s not just corporate labs that may grow more secretive, said Jason A. Rantanen, an associate professor of law at the University of Iowa. Some universities, increasingly reliant on research revenue to supplement their budgets, may behave similarly, Mr. Rantanen said.
“It may encourage, at least at the margins,” he said, “some pressure toward secrecy.”
Dr. Collins said he put little stock in such fears. In an academic setting, researchers will still be motivated primarily by publishing their findings, he said. And in a corporate setting, he said, companies will need to advertise any new genetic test they create, and show data to prove its validity.
Debates Over ‘Complementary’ DNA
Myriad did not directly block laboratory research involving the BRCA1 and BRCA2 genes, which have been the subject of more than 10,000 published studies. But Myriad’s exercise of its patent rights meant clinics could not better inform that research by routinely conducting screening tests for the genes, Dr. Collins said.
“They could, and did, drive out any competitors, quite aggressively, maintaining a complete monopoly on the ability to offer that test,” Dr. Collins said of Myriad.
The company rejects such characterizations, which were widespread during the court battle.
The image of Myriad as aggressively protecting its BRCA patents is a result of “falsehoods” promoted by emotional critics of the company, said a Myriad spokesman, Ronald S. Rogers. The company hasn’t sent out a cease-and-desist letter in more than 15 years and never sued any party for violating its monopoly right to the BRCA tests, he said.
Mr. Rogers acknowledged on Monday, however, that Myriad and another company, OncorMed, had traded infringement lawsuits in 1997 over rights to the BRCA1 gene. He also acknowledged that Myriad had filed a legal action against the University of Pennsylvania but “never served it.”
While rejecting Myriad’s claim to ownership of the segment of DNA associated with a higher risk of breast cancer, the Supreme Court affirmed the patents that Myriad held on “complementary” DNA, allowing it exclusive rights to its particular method of testing for the two genes. The complementary DNA, or cDNA, is a molecular structure devised by Myriad that contains the human genetic code of the BRCA genes.
There was some disagreement among plaintiffs in the case over whether the court should have also denied patent rights for the cDNA. But Dr. Collins helped lead the Obama administration in arguing that Myriad should keep its cDNA patent rights.
It was the subject of “long debates” within the administration, he said, given that some experts could see a scientific rationale for arguing that the essential component of cDNA is a naturally occurring code of genetic data. But forbidding a patent on cDNA could have had wider implications, raising doubts about the validity of patents in such areas as synthetic biology and the creation of therapeutic products using man-made proteins, he said.
Such a ruling would have been “threatening to biotechnology interests because we do want our biotechnology industry to continue to flourish,” Dr. Collins said.
And the benefits of the court’s rejection of the central DNA claim should prove highly valuable for cancer research beyond breast cancer, Dr. Collins said, because many genes associated with tumor sequences are also genes with patent claims.
“Concerns were mounting that if this decision went the other way, that the whole revolution in cancer genomics might also be tied up in battles about royalty payments,” he said.
Other Questions Likely to Arise
Other uncertainties remain. Beyond the question of rights to human genes, the courts can be expected to face other important patent-related questions on how to regard man-made compounds, such as those involving microbial life, said Ryan B. Abbott, an associate professor of law at Southwestern Law School, in Los Angeles.
The court’s decision to draw the line at cDNA may not have a strong scientific basis, Dr. Abbott said. But over all, the environment for open discovery is enhanced when courts show greater caution in awarding patent protections in areas of basic science, he said.
Despite the unanimous vote of the court, in a decision written by Justice Clarence Thomas, there were indications the justices weren’t as sure of the science as they were of the important economic and societal implications. During oral arguments in the case back in April, some justices admitted being uncertain about the scientific terminology. And in the ruling last week, one justice, Antonin G. Scalia, filed his own statement saying he agreed with the decision but could not fully attest to all the scientific rationales.
Despite Justice Scalia’s reservations about the court’s discussion in its opinion of the “fine details of molecular biology,” Dr. Collins—who led the government’s Human Genome Project in the 1990s—said he found no inaccuracies in the ruling beyond perhaps a typo.
“It gets most of the science right,” he said. “So they clearly have absorbed some pretty technical stuff here.”
Correction (6/17/2013, 9:15 a.m.): The original version of this article referred mistakenly to “composite DNA,” rather than to “complementary DNA.” The article has been corrected. The article has also been updated with additional information from a Myriad Genetics spokesman about legal maneuvers over the patents.
