On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines for assessing enablement in view of the Supreme Court’s 2023 decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023) (hereafter Amgen). The Guidelines are intended to guide both Examiners and the public on how to interpret and implement the Amgen opinion. The conclusion is that the USPTO will continue to use the In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988) (hereafter Wands) factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable. In other words – status quo.
In Amgen, the Supreme Court unanimously held that several of Amgen’s patent claims to a class of antibodies were invalid for lack of enablement. While Amgen’s patents specifically identified 26 amino acid sequences for antibodies that would block or inhibit PCSK9, the Court held that Amgen had not enabled “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9” and “block PCSK9 from binding to [LDL receptors].” According to the Court, Amgen attempted to claim an entire class of compounds by their function, namely antibodies that bind to the “sweet spot” of PCSK9 thereby inhibiting it from binding to LDL, while only describing 26 amino acid sequences in its specification.
The Federal Circuit had previously identified factors in Wands that can be used to assess whether the specification provides sufficient enablement to make and use the full scope of the claimed invention. While the Supreme Court did not expressly use these Wands factors in Amgen, the Guidelines concluded that they are still “probative of the essential inquiry in determining whether one must engage in more than a reasonable amount of experimentation.”
The Guidelines highlighted several Federal Circuit decisions preceding and following the Amgen decision, showing how the Wands factors were used. Notably, in all of these cases the claims were found to not be enabled. This is where the Guidelines fall short since it instructs the Examiner to apply the Wands factors without giving any examples where antibody claims would in fact be enabled. Therefore, questions still remain as to what amount of disclosure is adequate for enablement under Amgen.