Detroit patent attorney David Suter spoke to Law360 about the ongoing lack of clarity regarding whether medical diagnostic tools are patentable subject matter.

The uncertainty and concerns regarding the law in this area were underscored as the Federal Circuit, sitting en banc, declined to rehear a decision that found a myasthenia gravis diagnostic unpatentable, in Athena Diagnostics, Inc., v. Mayo Collaborative Services, LLC, 915 F.3d 743, 753 n.4 (Fed. Cir. 2019). Suter’s observations regarding the Federal Circuit’s decision were cited in the article, Fractured Full Fed. Circ. Won’t Eye Eligibility Rules, Law 360 (July 3, 2019).

Due to Supreme Court precedent, a 7-5 majority of Court felt legally bound to rule that the diagnostic is patent ineligible. The 86-page decision included 4 concurring and 4 dissenting opinions. As discussed in the article, however, all 12 Federal Circuit judges appeared to feel that such diagnostics should be patent eligible, and called on Congress or the Supreme Court to clarify the law.

Many view Congress as the best option to clean up the laws around patent eligibility. Recent legislative action could, in fact, lead to revisions in the patent statutes that could overrule Supreme Court decisions, including its 2012 decision in Mayo v. Prometheus, which is the precedent underlying the Athena decision. Pointing to the Federal Circuit’s decision, Senators Tillis and Coons of the Senate Judiciary Subcommittee on Intellectual Property issued a statement that addressed the current state of the law and characterized their legislative reform efforts as both “urgent and critical.”

For fans of legislative overhaul, such as Suter, the case is evidence that the Senators are on the right path. “I think the fix does have to come from Congress,” he says. “We’ll see what happens, but at least it looks like there’s some momentum.”

The Supreme Court could also help clarify the laws by taking on the Athena case or other new cases that would allow them to issue new patent eligibility standards and expand coverage for medical diagnostics. There appears to be some skepticism that SCOTUS will take up such a case, however, considering that they have denied dozens of petitions for eligibility cases. Even if they agree to take on a case, changes will likely be incremental at best.

“Congress may be able to get something out of its legislative sausage-making process, but I have no faith that the Supreme Court is going to do anything with this,” Suter says. “They created the problem, after all.”

For now, Suter believes the best approach is for Congress to overhaul the law. Attorneys, judges and patent owners may want to turn up the AC until the Senators’ new bill is introduced, likely later this summer.

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