DNA Sequence a Law of Nature? How Mayo v. Promethus Might Effect Myriad
On March 26, the Supreme Court ordered the Federal Circuit to rehear the gene-patenting case Molecular Pathology v. Myriad Genetics in light of their recent decision in Mayo v. Prometheus. Myriad has had a particularly prominent history; in 2010 the Justice Department had opposed the isolated-gene patents in an amicus brief. The Federal Circuit held, however, that the isolated DNA sequence was patentable.
Mayo v. Prometheus also considered a biological test, but involved completely different circumstances. In Mayo the patent covered a process for determining whether a dose of a drug used to treat an auto-immune disorder would be effective or harmful in a patient by measuring metabolites in a patient’s blood. While doctors were already aware of the correlation, the patented process articulated particular concentrations of the metabolites. Mayo’s alleged infringing test measured the same metabolites but used slightly different concentration levels. The Court, in a unanimous decision, held that this test articulated merely the “law of nature” (the different reaction) and did not add enough to the description of the natural process to be patentable. This decision was seen as a blow to the recent increase in grants of such biological patents.
The question that the Federal Circuit will have to resolve in rehearing Myriad is whether the isolated gene merely describes a “law of nature” or whether it is “more than a drafting effort designed to monopolize the law of nature itself.” Examining the Federal Circuit’s original decision does not definitively reveal whether the decision will change in light of Mayo; the Supreme Court’s decision does not dictate a correct solution. This is because the Federal Circuit found that the value was in the isolated gene.
There are some similarities between Mayo and Myriad: both were the product of observation of patients and resulted in a test to examine a risk; identifying the metabolite concentration in Mayo and the correlating DNA sequence in Myriad. However, the researchers who isolated the DNA sequence in Myriad had to take several additional steps that the Federal Circuit originally cited as critical to the determination — the act of isolation. In this holding, the court found that the isolated DNA was not a product of nature. Additionally, the Federal Circuit invalidated Myriad’s method claims, which patented the process of comparing the DNA sequence — a process more similar to the test invalidated in Mayo. Had the Federal Circuit ruled differently, this would have been nearly explicitly precluded by Mayo.
However, lawyers who have examined the cases cited by the Supreme Court in the Mayo opinion note that the opinion is not limited to the medical tests and that the court may be arguing for the adoption of a stricter idea of what is patentable, which may even extend to software patents. This discussion suggests that Mayo should not be construed narrowly and could have a more far-reaching impact on Myriad. The most likely outcome for Myriad is that, however the Federal Circuit rules, the case or a similar one will be brought up to the Supreme Court again.