On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the U.S. Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al." (Guidelines).[1] The Guidelines are applicable, "regardless of the technology, for ascertaining compliance with the enablement requirement of the patent laws during the examination of utility patent applications and the review of utility patents" and state that "USPTO personnel 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," referring to the 1988 decision of the Court of Appeals for the Federal Circuit.[2] The Guidelines state that they "are intended to inform USPTO personnel and the public on the USPTO's implementation of the Supreme Court decision in Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023)" but "are not intended to announce any major changes to USPTO practice or procedure."[3]
Amgen v. Sanofi
On May 18, 2023, the Supreme Court unanimously affirmed a Federal Circuit decision holding invalid for lack of enablement Amgen's patents that claimed a genus of low-density lipoprotein (LDL) cholesterol-lowering antibodies solely by their function of binding to a specific portion of the PCSK9 protein and blocking the binding of PCKS9 to LDL receptors that control the level of LDL cholesterol.[4] In particular, the Supreme Court concluded that Amgen's patent specification did not provide an enabling disclosure for the full scope of the claimed genus.[5] The Supreme Court held that Amgen's genus claims are invalid because they covered a "vast" number of antibodies ("at least millions of candidates"), but the specification only described 26 examples and provided nothing more than "research assignments" and a "trial and error method" to arrive at the other antibodies within the scope of the claims.[6] The Supreme Court held that although a patentee is not required to disclose every embodiment in a functionally-defined genus, the patentee must provide guidance on how to arrive at the full scope of embodiments, for example, by the disclosure of a "general quality…running through the class that gives it a peculiar fitness of the particular purpose."[7] The Supreme Court in Amgen relied on a number of its prior decisions dating from the 19th and early 20th centuries supporting the proposition that "the more a party claims, the broader the monopoly, the more it must enable."[8] Moreover, the Supreme Court concluded that while under its precedent, a patent specification "may call for a reasonable amount of experimentation to make and use a patented invention,…Amgen [had] failed to enable all that it has claimed, even allowing for a reasonable degree of experimentation."[9] The Supreme Court noted that "[w]hat is reasonable in any case will depend on the nature of the invention and the underlying art."[10]
Further discussion of the Amgen decision can be found here.
USPTO Examiners Are Directed to Continue to Apply the Wands Factors
While the Guidelines acknowledge that the "Supreme Court did not explicitly address the Wands factors in Amgen," the Guidelines state that "[t]he Wands factors are probative of the essential inquiry in determining whether one must engage in more than a reasonable amount of experimentation."[11] Specifically, Wands provides the following non-exhaustive list of factors to be considered when determining what is within the bounds of a reasonable amount of experimentation: "(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."[12] The Guidelines also note that the Wands factors were applied by the Federal Circuit in the underlying decision that the Supreme Court affirmed in Amgen and that the Federal Circuit has continued to apply the Wands factors in decisions subsequent to Amgen.[13] Finally, the Guidelines emphasize that patent examiners should apply Amgen and the Wands factors in determining enablement across all technologies.[14]
The Take Home from the Guidelines
Practitioners should expect that the USPTO and the federal district courts and the Federal Circuit will continue to analyze whether a patent specification enables the full scope of the claims without requiring more than "reasonable" experimentation by applying the Wands factors. Patent claims that attempt to encompass a subject matter genus by its function are unlikely to be enabled under Amgen unless guidance is provided on how to obtain the full scope of the genus with no more than a reasonable amount of experimentation by, for example, the disclosure of a "general quality…running through the class that gives it a peculiar fitness of the particular purpose."[15] How this can be accomplished consistently with Amgen and Wands is likely to be the subject of further enablement challenges both in the USPTO and in the courts.
View the full Guidelines here.
[1] 89 Fed. Reg. 1563 (Jan. 10, 2024).
[2] Id.; see In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
[3] Id. at 1563-1564.
[4] Amgen Inc. v. Sanofi, 143 S. Ct. 1243 (2023).
[5] Id. at 1256.
[6] Id.
[7] Id. at 1254.
[8] Id. at 1256; see also O'Reilly v. Morse, 56 U.S. 62 (1853); The Incandescent Lamp Patent, 159 U.S. 465 (1895); Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928).
[9] Id. at 1255-1256.
[10] Id at 1255. It should be noted that the Wands decision held that a patent claim was not enabled if it required "undue experimentation" to practice it. While the Supreme Court did not use the term "undue experimentation," the Guidelines quote the Federal Circuit's recent decision in Baxalta Inc. et al. v. Genentech Inc., 81 F. 4th 1362, 1367 (Fed. Cir. 2023) for the proposition that "[w]e see no meaningful difference between Wands' 'undue experimentation' and Amgen's '[un]reasonable experimentation' standards." Guidelines, 89 Fed. Reg. at 1566.
[11] Guidelines, 89 Fed. Reg. at 1565.
[12] 858 F.2d at 737.
[13] See Baxalta Inc. et al. v. Genentech Inc., 81 F. 4th 1362, 1367 (Fed. Cir. 2023) ("We do not interpret Amgen to have disturbed our prior enablement case law, including Wands and its factors."); Medytox, Inc. v. Galderma S.A., 71 F.4th 990 (Fed. Cir. 2023).
[14] In re Starrett, 2023 WL 3881360, *1 (Fed. Cir. Jun. 8, 2023) (affirming the PTAB decision, which Amgen and Wands claim covering "a nontransitory computer readable medium for maintaining augmented telepathic data for telepathic communication").
[15] Amgen, 143 S. Ct. at 1254.