USPTO Says Wands Is Still The Test Post-Amgen

The United States Patent and Trademark Office issued a notice in the Federal Register on January 10, 2024, providing guidelines to assist USPTO personnel in assessing enablement under 35 U.S.C. 112(a), in view of and consistent with the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) and post-Amgen Federal Circuit precedent.

In Amgen, the Supreme Court held that claims drawn to a genus of functionally claimed monoclonal antibodies were invalid due to a lack of enablement. While the Supreme Court emphasized the trial-and-error nature of experimentation that would be required to practice the invention in the absence of additional guidance, such as common structural characteristics, it maintained a patent specification may still require a reasonable amount of experimentation to make and use the invention. What is reasonable, it stated, will depend on the nature of the invention and the underlying art.