The Mayo Framework Is Bad for Your Health

Abstract

This Article begins by providing a brief historical retrospective of the development of the patent eligibility doctrine, and then delves into the related questions of: (1) what are the Supreme Court’s policy objectives for the recent reinvigoration of the patent eligibility doctrine; and (2) has it achieved those objectives? The article then discusses three important out-standing questions regarding the application of the new test for patent eligibility: (1) what constitutes a natural phenomenon; (2) what constitutes an inventive step; and (3) what, if any, role does preemption play in the analysis? The article then provides four examples of recent lower court decisions that have applied the new test, often referred to as the Mayo Framework, in a literal manner. This application has resulted in the invalidation of claims directed towards processes that would have easily passed patent eligibility muster prior to the most recent wave of Supreme Court decisions. The Article concludes by suggesting that the Supreme Court should revisit the question of patent eligibility and re-articulate the standard in a manner better-suited to ensure the availability of meaningful patent protection for the next generation of innovation, particularly in the life sciences. If the Court fails to do so, Congress should seriously consider addressing the problem through an amendment of the statute.

Keywords: patent eligibility, patent, Mayo, biotechnology, diagnostics