Patent eligibility under 35 U.S.C. Section 101 has been in flux since the U.S. Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, 566 U.S. 66 (2012), and Alice v. CLS Bank International, 573 U.S. 208 (2014). Given the court’s recent denial of certiorari in three closely watched eligibility appeals (Berkheimer, Athena and Hikma), it is likely to remain that way.

The U.S. Court of Appeals for the Federal Circuit has gradually fleshed out Alice over the past few years while working within the confines of its two-part test. For example, the court has held that the presumption of validity applies to eligibility under Section 101 (Cellspin Soft v. Fitbit, 927 F.3d 1306 (Fed. Cir. 2019)) and that it is improper to render a Section 101 decision without resolving underlying claim construction disputes (MyMail Ltd. v. ooVoo LLC, 934 F.3d 1373 (Fed. Cir. 2019)). Most importantly, it has held that whether a claim is directed to an inventive concept (i.e., a concept that is not well-understood, routine or conventional) under step two is a question of fact that must be proven by clear and convincing evidence (see Berkheimer v. HP, 881 F.3d 1360 (Fed. Cir. 2018)).