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January 12, 2024 - Litigation, United States, Intellectual Property

USPTO Enablement Guidelines After Amgen v. Sanofi

MoFo Life Sciences

On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.

The guidelines clarify that the USPTO’s framework for assessing enablement is unchanged after the Supreme Court’s decision in Amgen v. Sanofi. Specifically, the USPTO “will continue to use the In re Wands factors to ascertain whether the amount of experimentation required to enable the full scope of the claimed invention is reasonable.”

The Wands factors include:

(A) The breadth of the claims;

(B) The nature of the invention;

(C) The state of the prior art;

(D) The level of one of ordinary skill;

(E) The level of predictability in the art;

(F) The amount of direction provided by the inventor;

(G) The existence of working examples; and

(H) The quantity of experimentation needed to make and use the invention based on the content of the disclosure. (MPEP 2164.01(a).)

Although the Supreme Court in Amgen v. Sanofi did not mention the Wands factors, the USPTO guidelines point to the Federal Circuit’s application of the Wands factors in the underlying Federal Circuit case.[1] The USPTO guidelines also point to three post-Amgen Federal Circuit decisions that did apply or at least discuss the Wands factors in finding lack of enablement for genus claims, including for a functionally defined genus of antibodies.[2] The USPTO guidance and the decisions emphasize and cite Amgen v. Sanofi for the proposition that “[t]he more one claims, the more one must enable.”[3]

Key Takeaways

  • The Wands factors are the accepted framework for assessing enablement of genus claims.
  • Nested back-up positions covering narrower subgenera should be crafted and include as many exemplified species as possible.
  • If possible, enablement of a genus should be strengthened by disclosing “some general quality . . . running through the class that gives it a peculiar fitness for the particular purpose.”[4]

[1] Amgen Inc. v. Sanofi, Aventisub LLC, 987 F.3d 1080 (Fed. Cir. 2021).

[2] See Baxalta Inc. et al. v. Genentech Inc., 2023 U.S. App. LEXIS 24863 (Fed. Cir. 2023); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023); and In re Starrett, 2023 WL 3881360 (Fed. Cir. 2023) (non-precedential).

[3] Amgen, 143 S. Ct. at 1254.

[4] See USPTO Guidelines (citing Amgen at 1254–1255).