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Abstract

35 U.S.C. § 101 allows a patent for “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof.” Recently, the Supreme Court issued several key decisions affecting the doctrine of patentable subject matter under § 101. Starting with Bilski v. Kappos (2011), and continuing with Mayo Collaborative Services, Inc. v. Prometheus Laboratories (2012), Association for Molecular Pathology v. Myriad Genetics (2013) and, most recently, Alice Corporation Pty. Ltd. v. CLS Bank International (2014), every year has brought another major change to the way in which the Court assesses patentability. In Myriad, the Court directly addressed the patentability of isolated genetic material. Due to the underlying biological phenomena involved, this decision split genetic material into two groups. Large, complex animal, plant, and fungal genes remain patentable under some limited circumstances, while viral, bacterial, and simple eukaryotic genes are categorically unpatentable. The biotechnology industry evolved in an era in which gene patents were freely granted. As a result, legal and regulatory pathways have emerged that allow existing biotechnology products to be protected in many of the same ways as traditional pharmaceutical products. However, entirely new areas of biotechnology, those emerging in the shadow of Myriad, may be threatened by a deprivation of the incentives and protection that the patent system offers. This Note discusses one such new area of biotechnology, non-coding RNA therapeutics and diagnostics, and the ways in which the categorical exclusion of some genes threatens this promising area of innovation. In addressing this, I propose a re-ordering of the patentable subject matter analysis that would ameliorate many of these issues.

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