Bloomberg Law
May 22, 2023, 8:00 AM

It’s Time to Change How Antibodies Are Claimed in Patent Strategy

Daniel Pereira
Daniel Pereira

The US Supreme Court announced its ruling May 18 in favor of Sanofi in its dispute with Amgen over the enablement requirement as it pertained to antibody claims.

Practically, this affirms the Federal Circuit’s position for several years that a genus of antibodies, largely defined by function, is not enabled—or in some instance doesn’t meet the description requirement—with a more limited exemplification of species shown to have that function.

The decision isn’t remarkable and maintains the status quo of the case law. Justice Neil Gorsuch, writing for the unanimous court, went back into history, including the provision of the 1790 patent act requiring a specification “to distinguish the invention or discovery from other things before known and used.” This is also applied to someone who would “make, construct, or use the same.”

As would be further expected, the decision cites several of the court’s prior decisions to set the stage for affirming the Federal Circuit’s decisions in this specific area over the last several years—United States v. Dubilier Condenser Corp., 289 U. S. 178, 187 (1933), Grant v. Raymond, 6 Pet. 218, 247 (1832); Whittemore v. Cutter, 29 F. Cas. 1120, 1122 (No. 17,600) (CC Mass. 1813); and others.

Prior to the enactment of 35 USC § 112 and particularly the sixth paragraph of this section—“An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof”—the court routinely found purely functional claim elements, including those with single means or means-plus-function, to be improper, as is evident from the decision.

Congress enacted 35 USC § 112 ¶ 6 to overrule the holding in Halliburton Oil Well Cementing Co. v. Walker. In place of the Halliburton rule, Congress adopted a compromise solution that permitted the use of means-plus-function language in claims, but limited the breadth of such claim language by restricting its scope to the structure disclosed in the specification and equivalents thereof.

This is not to say that the sixth paragraph of § 112 is a simple substitute for the enablement requirement. Nonetheless, it is interesting to think if functional recitations of the antibody were presented as in compliance with the functional definition(s) without structure, if suitable scope is achieved instead of defining specific antibody sequences in the claim.

Along these lines, perhaps now is the time to consider changing how antibodies, or even similar types of compositions, are claimed as at least part of one’s patent strategy. Some additional careful drafting of the specification will be needed.

We can look to Aristocrat Technologies Australia Pty Ltd v. International Game Technology citing Medical Instrumentation & Diagnostics Corp. v. Elekta AB: “If the specification is not clear as to the structure that the patentee intends to correspond to the claimed function, then the patentee has not paid the price but is attempting to claim in functional terms unbounded by any reference to structure in the specification.”

This article does not necessarily reflect the opinion of Bloomberg Industry Group, Inc., the publisher of Bloomberg Law and Bloomberg Tax, or its owners.

Author Information

Daniel Pereira is Oblon’s managing partner, co-head of the chemical practice group and member of the management committee.

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