It's Time To Change How Antibodies Are Claimed In Patent Strategy

• Published date: 30 May 2023
• Subject Matter: Intellectual Property, Patent
• Law Firm: Oblon, McClelland, Maier & Neustadt, L.L.P
• Author: Mr Daniel J. Pereira

Oblon's Daniel Pereira analyzes the impact of the US Supreme Court's ruling in Amgen v. Sanofi, saying that the opinion maintains status quo. He suggests a revision of how antibodies are claimed as part of patent strategy.

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...