The legal case against patents on human genes was given new life this spring after the Supreme Court vacated a federal appeals court's ruling that upheld Myriad Genetics' patents on human genes linked to inherited forms of breast and ovarian cancer.
With the backing of medical, research and patient advocacy groups, the American Civil Liberties Union and the Public Patent Foundation originally filed suit against Myriad's BRCA1 and BRCA2 gene patents in 2009. A US District Court invalidated the patents in 2010, but last fall the US Court of Appeals for the Federal Circuit upheld Myriad's patents in a 2-1 decision. Now the Supreme Court has ordered those same three judges to reconsider their ruling.
It was significant that the Supreme Court even agreed to take up the matter, says ACLU attorney Sandra Park.
"Most petitions that are filed at the court are denied—the vast, vast majority of them," Park says. "It was for us a very good development that the court granted the petition and vacated the lower court's decision."
Gene patent opponents have another case to thank for the development. Shortly before vacating the Myriad decision, the Supreme Court ruled on Mayo v. Prometheus, unanimously finding invalid Prometheus Labs' patents on methods of evaluating patients' drug responses. Prometheus, having patented a method of adjusting dosages based on patients' biological response, originally brought the case against Mayo Collaborative Services, which had developed a similar test. The Supreme Court's ruling in favor of Mayo hinged on its finding that Prometheus' claimed patent matter was a law of nature—reaffirming, Park points out, its well established precedent of finding laws of nature and natural phenomena not patentable.
A key element of the Mayo decision is the Supreme Court's assertion that patents of natural phenomena hamper future innovation. The Myriad plaintiffs—who also filed an amicus brief siding with Mayo—have made the same argument against gene patents, and Park sees it as a good sign that the Supreme Court cited it before vacating the Myriad decision.
"We have argued all along that patents on DNA impede innovation because they prevent others from working or examining the DNA itself."
However, the future of the case against gene patents is far from certain.
"No court has yet applied Prometheus to the issue of DNA patents, so we don't know yet how that will play out," Park says. And either way, it's doubtful the case will stop there: "Regardless of the outcome at the Federal Circuit, it's likely that whatever side does not win will appeal the case further."