The Federal Circuit’s seminal decision in In re Wands, 858 F.2d 731 (Fed. Cir. 1988), was a frequent topic of conversation in the Amgen v. Sanofi argument at the US Supreme Court on Monday, March 27, 2023. Wands sets forth an eight-factor test that courts use to determine whether a skilled artisan could practice a claimed invention without “undue experimentation” (and thus whether the claimed invention is enabled). The eight factors include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. Notably, Amgen and Sanofi and the United States (appearing as amicus curiae) all agreed that Wands sets forth an appropriate framework for analyzing enablement. Given that agreement, it appears likely that, whatever the Supreme Court does with the Amgen case, Wands will remain a critical part of the legal standard for enablement.
The person responsible for establishing this now 35-year-old framework is none other than Sterne, Kessler, Goldstein & Fox’s own Jorge Goldstein.
Jorge successfully briefed and argued the Wands case in 1988 on behalf of the Massachusetts General Hospital, where Dr. Jack Wands was then a researcher. In response to the argument and references to Wands, Goldstein remarked, “I’m delighted that after more than three decades, spanning most of my legal career, Wands still is - and apparently will remain - good law on the enablement of patent claims.”