The Court Issues a Decision Concerning the Patent Enablement Requirement: They like it Just the Way It Is

Today the Supreme Court issued a unanimous opinion in Amgen, Inc. v. Sanofi, the only patent

case that the Court is hearing this term. At issue was whether Amgen’s claims to a broad class

of antibodies for reducing cholesterol were invalid for not having been enabled by its patent

applications. The Court found that the claims were invalid, because Amgen’s disclosure would

require one skilled in the art to engage in an undue amount of experimentation to produce the

antibodies covered by the full scope of the claims.

Patent Application Enablement Requirement

In order to meet the enablement requirement a patent application must contain a “description of

the invention, and of the manner and process of making and using it, in such full, clear, concise,

and exact terms as to enable any person skilled in the art to which it pertains, or with which it is

most nearly connected, to make and use the same,” 35 USC 112(a). Here Amgen contended

that the 26 examples of antibodies that were disclosed in its applications, coupled with the

description in the applications of a process for how other antibodies could be produced, was

sufficient to meet the enablement requirement to support claims to a broad class of such

antibodies.

However, as the Court stated, “the more a party claims, the broader the monopoly it demands,

the more it must enable.” While the 26 example antibodies were sufficiently described, the

amount of experimentation that would be required to produce the full range of antibodies was

undue – essentially Amgen was describing a level of experimentation that would require one

skilled in the art to engage in a random trial-and-error method of experimentation on a wide

range of candidate antibodies in order to produce the full range of antibodies covered by the

claims. Thus, the claims at issue were found invalid as not enabled by Amgen’s filed patent

applications.

The USPTO Approach

The USPTO takes a similar approach in evaluating enablement during examination of

applications, applying the Wands factors (named for a 1988 Federal Circuit case) listed in

MPEP 2164.01(a), looking at: “(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 or use the invention based

on the content of the disclosure.” Although the Court did not mention this list of factors explicitly

in its decision, its opinion touched on several of them in the analysis, such as the breadth of the

claims, the existence of working examples in the application, and (most importantly) the quantity

of experimentation needed to make or use the invention based on the content of the disclosure.

At Renner Otto, the oldest intellectual property firm in Cleveland, we specialize in assisting our

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