It has nearly been ten years since the Supreme Court’s landmark Mayo v. Prometheus (132 S.Ct. 1289 (2012)) decision, in which the Court established a two-prong test for determining patentable subject matter under 35 U.S.C. § 101. And, yet, the law regarding patent eligibility for biotech/pharma inventions remains unsettled. In part, this is due to the paucity of appellate court decisions confirming the eligibility of claims under 35 U.S.C. §101. As highlighted in the court’s opinion in denying en banc rehearing of Athena v. Mayo1, intervention from either the Supreme Court or Congress will likely be required to provide clarity on the matter. However, based on the Court’s reluctance in taking up such cases2 and Senator Tillis’ recent comments3, significant modification to the existing legal framework for determining patentable subject matter under 35 U.S.C. § 101 is unlikely to take place any time soon.
Under Mayo’s two-prong test, the first step asks whether a claim is directed to a judicially recognized exception, i.e., natural product, natural phenomenon, or abstract idea. If the answer is no, the claimed subject matter is patent eligible. If the answer is yes, however, the claim is further examined in step two to determine whether the additional elements recited in the claim, considered both individually and as an ordered combination, “transform the nature of the claim” into a patent eligible application by reciting an “inventive concept” that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself” (i.e., not well-understood, routine, conventional activity). Mayo at 1294. For step two of the analysis, the judicially recognized exception is treated as if it was part of the prior art base.
To facilitate examination and to help fill the void left by the Supreme Court and Congress, the USPTO has released Interim Guidance documents with example claims (see, e.g., Eligibility Examples) that it considers eligible under current case law4. A revised Guidance was published on January 7, 2019 (“January Guidance”)5, with further updates (e.g., Examples 43-36) and clarification provided more recently on October 17, 20196. The January Guidance differs from the earlier Guidance in several ways. First, the January Guidance provides that all “abstract ideas” should fall into one of three categories7: (1) mathematical concepts (e.g., mathematical relationships, mathematical formulas or equations, mathematical calculations), (2) certain methods of organizing human activities (e.g., fundamental economic principles or practices, commercial or legal interactions, managing personal behavior or relationship or interactions between people), and (3) mental processes (e.g., concepts performed in the human mind)8. Next, the January Guidance breaks step one of the above-described two-prong test into two sub-steps9: (i) whether the claim recites a judicial exception; and (ii) if the claim recites a judicial exception, whether the judicial exception is integrated into a practical application. In assessing this latter sub-step, the January Guidance expressly provides that “whether the additional elements represent well-understood, routine, conventional activity” should be excluded10. Such analysis should be reserved for step two of the two-prong test, which is only conducted if step one of the test is satisfied. Accordingly, claims reciting a judicial exception may be directed to patentable subject matter even where the additional elements that integrate the judicial exception into a practical application are well-understood, routine, and/or conventional.
To help understand when additional elements recited in a claim integrates a judicial exception into a practical application, the January Guidance provides several non-limiting examples: (i) “additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field” (e.g., Rapid Litigation Management Ltd. v. CellzDirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016)); (ii) “additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition” (e.g., Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Limited, 887 F.3d 1117 (Fed. Cir. 2018)); (iii) “additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a...
