Eliminating Judicial Exceptions: The Promise of the Patent Eligibility Restoration Act

Section 101 of the United States Patent Act defines patent-eligible subject matter as any “new and useful process, machine, manufacture, or composition of matter.” The interpretation of this section has been significantly influenced by key Supreme Court cases, particularly Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012) and Alice Corp. v. CLS Bank International, 573 U.S. 208 (2014). These decisions have established a two-step framework for determining patent eligibility that has been criticized for its lack of clarity and consistency, leading to unpredictable outcomes. Lower courts and the United States Patent and Trademark Office (USPTO) have struggled to apply the framework consistently, resulting in significant legal uncertainty. 

The Supreme Court first introduced the two-step framework for subject matter eligibility in Mayo. The first step is to determine whether the claims at issue are directed to a patent-ineligible concept, such as a law of nature, natural phenomenon, or abstract idea. In Mayo, the Court found that the claims were directed to a law of nature — the relationship between drug dosages and metabolite levels in the blood. If the claim is directed to a patent-ineligible concept, the second step is to determine whether the claim contains an “inventive concept” sufficient to transform the nature of the claim into being patent-eligible. This involves examining whether the claim elements, individually and as an ordered combination, add enough to the natural law to ensure that the claim amounts to significantly more than the natural law itself. The Court established in Mayo that well-understood, routine, and conventional activities are not enough to transform a natural phenomenon into patent-eligible subject matter because they do not add any inventive concept or technological improvement.