Note: Mayo, Myriad, and a Muddled Analysis: Do Recent Changes to the Patentable Subject Matter Doctrine Threaten Patent Protections for Epigenetics-Based Inventions?

By Mike Sikora. Full text here

In articulating the Mayo test for patentable subject matter under 35 U.S.C. § 101, the Supreme Court effectively replaced decades of judicial tests with a single streamlined analysis. Large-scale invalidations of software, business method, and communications patents swiftly followed, yet biotechnology patents have largely been spared. Even so, it may simply be a matter of time before the other shoe drops.

This Note takes the Supreme Court at its word that the Mayo test is the test for patentable subject matter and explores the doctrinal holes left by the Myriad decision’s failure to apply the test to biotechnology. With the Supreme Court’s silence, and the Federal Circuit holding that patent claims can be “directed to” natural phenomena even when the claim scope excludes all natural phenomena, biotechnology innovations may categorically fail the first step of the Mayo test. If so, this would leave biotechnology patents inherently susceptible to § 101 invalidations, with validity hinging on a judicial determination of whether the claim nevertheless contains an “inventive concept sufficient to transform” it into a patentable invention. As this Note demonstrates with epigenetics-based technology, the Mayo test will likely lead to inconsistent patentability determinations—and therefore uncertain patent rights—hindering innovation in nascent biotechnology fields. Accordingly, exempting certain biotechnology fields from the patentable subject matter requirements of § 101 may be necessary to ensure access to future advancements, treatments, and cures.