While the Supreme Court’s decision does settle the legal standing of isolated gene product patents, experts predict that lower courts will soon grapple with other diagnostics- related cases including cases involving methods patents, application of knowledge about the genes, and potentially whether cDNAs are unpatentable because they are “obvious.” In a recent interview with DTTR, John Conley, the Kenan Professor of Law at the University of North Carolina, Chapel Hill, and editor of the Genomics Law Report, said that while much of the diagnostics industry’s focus has been on the product patents in the Myriad case, patent lawyers are paying close attention to a series of method patent cases that could have a larger impact on the industry. “Putting together Mayo and the Federal Circuits ruling in Myriad [regarding methods patents] it is increasingly difficult to get a patent on diagnostics methods,” says Conley. “The Supreme Court seemed to say that most correlations doctors rely upon are laws of nature and acting in an obvious way in response to a correlation is not actionable. . . . The Supreme Court found the method so simple, primitive, and obvious.” But most patent cases end at the Federal Circuit, and its recent rulings have been fractured. “The Federal Circuit is a complete mess right now with respect to methods. They twice allowed Mayo to go through and the Supreme Court saw it as blindingly obvious. . . . There will be a market impact if the Federal Circuit cannot agree on standards for methods patents.” Given the increasing reliance on bioinformatics for interpretation of genomic data, Conley notes that the Federal Circuit’s decision in CLS Bank Int’l v. Alice Corporation Pty Ltd. regarding software patents could impact the diagnostics industry. The court ruled that the method and computer-readable medium claims of four patents were not patent-eligible as they covered an “abstract idea.” The panel stated that “adding generic computer functions to facilitate performance provides no substantial limitation and therefore is not ‘enough’ to satisfy section 101.” Court observers note that while seven of 10 participating judges rejected the patents, there was no majority opinion. With five different opinions rendered in the case there was little clear guidance on what functions should be considered “generic” and what functions would add enough technical substance to substantiate a claim.

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