Alice’s Patent Puzzle: Unlocking Patent Eligibility for Diagnostic Methods Within Wonderland’s Faulty Two-Step Framework
Anjali Dhamsania | 27 Vand. J. Ent. & Tech. L. 129 (2025)
As it stands today, diagnostic tests and their methods are largely unpatentable. In 2012, the Supreme Court, in Mayo Collaborative Services v. Prometheus Laboratories, Inc., redefined the scope of patent subject matter, leaving a profound impact in the context of medical diagnostics. The subsequent decision by the Court in Alice Corporation v. CLS Bank International two years later significantly expanded the range of judicially created exceptions to statutory patent eligibility criteria to encompass “abstract ideas,” solidifying this “Alice-Mayo” framework as the definitive test to determine patent-eligible subject matter.
But this shift has made it exceedingly difficult to secure diagnostic method patents and has led to a surge in patent invalidation under 35 U.S.C. § 101. The Alice-Mayo framework has resulted in inconsistent outcomes as courts and the United States Patent and Trademark Office struggle to apply the framework to diagnostic methods. The persistent legal ambiguity underscores the need for clarity, with the patent law community clamoring for large-scale guidance from either the Supreme Court or Congress. This Note examines several proffered approaches to handling the legal ambiguity that persists in light of the Alice-Mayo framework, weighing the advantages of carving out exceptions against complete upheaval through congressional reform statutes. This Note’s hybrid solution combines (i) a current practice under the two-step framework with the implementation of (ii) a new statutory exception and (iii) a compulsory licensing provision. It aims to create a narrow pocket that would allow diagnostic methods to be patent eligible so long as they are tied to a specific treatment and, at the same time, dispel accessibility concerns regarding the excessive costs of patented diagnostics.