Our Shared Code: The Myriad Decision And The Future Of Genetic Research
Jacob Sherkow, a fellow at the Center for Law and the Biosciences, spoke to Sharon Levy of Environmental Health Perspectives on the Court's decision on AMP v. Myriad and shared what he believes is the greatest significance of this decision.
Christopher Mason felt euphoric. On the morning of 13 June 2013 Mason, a geneticist at Weill Cornell Medical College in New York, had just heard news of the Supreme Court’s opinion in the case Association for Molecular Pathology et al. v. Myriad Genetics, Inc., et al. The Court had decided that “a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated.”1
“I was ecstatic,” Mason says. “This was a huge victory for patients, scientists, and clinicians; the genome is finally free, your genes are finally yours.” For 15 years Myriad’s patents had given it a monopoly on BRCA gene testing in the United States, limiting the availability of the test and making it impossible for some patients to obtain a second opinion on their results. Concerned that gene patents put him and other researchers at risk of expensive lawsuits, Mason had worked as an expert witness in the case and coauthored a paper in Genome Medicine exploring the ways in which patents like Myriad’s clashed with basic concepts in genetics and could stifle genetic research.2
Burk believes this philosophical shifting of gears mid-decision shows the justices were seeking a way to limit gene patenting without undermining the numerous patents involved in the biotechnology and pharmaceutical industries. Jacob Sherkow, a fellow at Stanford University’s Center for Law and the BioSciences, agrees that the Court’s decision frees up clinical genetic testing, which nearly always uses isolated genes.
Other processes, such as splicing human DNA into bacteria in order to mass-produce a human protein, require the use of cDNA. But Sherkow believes such patents won’t present much of a practical problem. “Any clever researcher or patent agent will be able to work their way around patents on cDNAs,” he says. “Add a couple nucleotides, take out one exon, manipulate the sequence a bit, and you’re almost certain to fall outside of patent protection.”
For Sherkow, the greatest significance of the Supreme Court decision is that it ends the 30-year-old practice of granting patents on isolated DNA. However, the decision could have implications that reach far beyond gene patenting if it is used to overturn the century-old legal doctrine that allows the patenting of all sorts of biological substances isolated from nature.
Harkness now believes the Supreme Court decision in Myriad has corrected Learned Hand’s century-old mistake. Sherkow would welcome the demise of the Parke-Davis doctrine, but he isn’t sure that it’s done for; the wording of the ruling suggests, but never clearly states, that Hand’s Parke-Davis decision is defunct as a precedent. Just what this means in terms of future efforts to patent isolated molecules other than DNA is unclear.