' Averyn Lee | MTTLR

SCOTUS Dodges Patent Eligibility Question, Ball is Now in Congress’s Court

What is the line dividing nature and patentable invention in life sciences and biotechnology? On January 13, 2020, the U.S. Supreme Court refused to answer this question by denying all pending petitions concerning patent eligibility.[i] Under 35 U.S.C. § 101, patent eligibility is defined as “any new and useful process, machine, manufacture, or composition of matter,” but excludes discovery concerning the laws of nature, physical phenomena, as well as newly discovered naturally occurring plants and minerals from patent protection.[ii] Section 101’s impact on the future of biotechnology and life sciences sparked interest after a string of recent cases by the Supreme Court invoked this exclusion, and when Federal Circuits invalidated the vast majority of patents challenged for their subject matter eligibility.[iii] In 2012, the Supreme Court found in Mayo Collaborative Services v. Prometheus Laboratories, Inc. that a method of determining the proper and optimized dosage of a drug was patent-ineligible since it pertained to “the underlying laws of nature themselves.”[iv] Subsequently, the Court articulated a two-part test for determining patent eligibility in Alice v. CLS Bank.[v] According to the test, the Court must first examine whether the claim was directed to a patent-ineligible concept. If so, the Court then determines “whether the additional elements ‘transformed the nature of the claim’ into a patent-eligible application.”[vi] Mayo and Alice established the precedent that patents involving a naturally-occurring phenomenon must produce something the court classifies as non-natural.[vii] Following these cases, the Supreme Court and Federal Circuits have progressively narrowed the types of claims which are patentable under Section 101[viii], despite groundbreaking and life-saving discoveries in the industry.[ix],[x] Such decisions risk invalidating thousands...