SALT LAKE CITY — The U.S. Supreme Court is expected to announce sometime this month whether it is possible to patent human genes.
The American Civil Liberties Union represented research scientists and health advocates who teamed up in 2009 to challenge patents issued in the 1990s to Myriad Genetics, a Utah-based biotech company, and the University of Utah Research Foundation. Myriad has patented the BRCA1 and BRCA2 genes; mutations indicate a hereditary predisposition to certain breast and ovarian cancers. The Supreme Court heard arguments in April in the case of Association for Molecular Pathology, et al. v. Myriad Genetics Inc.
Before the court
The ACLU briefing notes said that “Myriad’s monopoly on the BRCA genes makes it impossible for women to access other tests or get a second opinion about their results and allows Myriad to charge a high rate for its test — over $3,000.” Critics said the company, which has vigorously enforced its patents, has blocked development and use of better technologies and driven up costs.
Advocates of the patents and Myriad Genetics said companies must be able to reap financial rewards for investment in genetic research and that isolating genes and other processes amount to “invention” that can be patented. Myriad spokesman Ron Rogers said the test is covered by all insurance companies and pricing is in line with other molecular diagnostic tests. If someone doesn't have insurance, Myriad provides inexpensive and sometimes free testing, he said.
There’s no question that the tests Myriad developed to find BRCA mutations can be patented. But lower courts have been divided on whether Myriad can claim that isolating and pulling out that gene from the human body is “creative” enough to patent, since “nature” cannot be patented. The federal district court tossed the patents. An appeals court disagreed with the lower court, 2-1, and ruled Myriad Genetics made the genes more useful when it isolated segments. That court was unanimous in saying that cDNA, which resulted from removing noncoding material, was patentable.
The Supreme Court has three options, said Shobita Parthasarathy, associate professor in the Ford School of Public Policy at the University of Michigan.
First, it can uphold the status quo and say that isolated DNA can be patented. That would mean Myriad Genetics would continue to control genetic testing and research to develop new tests and treatments.
“Whoever controls the gene patent can control everything — including the test costs and whether and how scientists can conduct further research,” Parthasarathy said. On one hand, the right to such a patent can encourage a company to invest in research. It has potential, though, to stifle other research or prevent development of other tests that might be as or more effective, she said.
Far from stifling research, Rogers countered, the "BRCA genes are the most-studied genes in history" and the company has allowed research and collaborated "quite extensively" with other scientists. Myriad argued cDNA is not DNA in natural form, but required "the handiwork of man," as Rogers put it, to create a form valuable for diagnostics. The company said that made it an “invention." Scientists said the function is unchanged.
In an analysis for the Genomics Law Report, John Conley outlined the likelihood the justices will choose a second option. “Almost everyone who has heard or read the Myriad argument has the same prediction: The court may well strike down isolated genomic DNA patents while upholding those on cDNA. I agree,” wrote Conley, the Kenan Professor of Law at the University of North Carolina and an intellectual property and biotechnology attorney.
Parthasarathy said despite some concern and uncertainty about how the patent office would interpret such a decision, it would likely maintain much of the status quo.
The third option would invalidate patents on both isolated and cDNA. That would create some uncertainty among American businesses that would have to rethink their patent strategy, Parthasarathy said. She predicts it would not have a chilling effect on innovation, since patents could still be held for therapies, testing methods and other diagnostics.
Advocates of that ruling say it would open the door to more researchers and more innovation. It could lower the price of the test. Myriad contends it would discourage companies from investing in expensive research, overturn 30 years of patent precedent and make the United States the only developed country in the world not to allow such patents. "We don't think that would be good for innovation in the United States," Rogers said.
Parthasarathy watched the Supreme Court arguments and said she was impressed at the level of engagement she saw from the justices.
The question: Can companies patent human DNA?
What's at stake: The U.S. Supreme Court's decision will have potential implications for genetic research, cost of diagnostic tests and perhaps treatment for certain ovarian and breast cancers and testing, and who controls research, tests and treatments.
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