Supreme Court Gives “Teeth” To Enablement Requirement In Striking Down Broad Functional Claims

The U.S. Supreme Court in Amgen Inc. v. Sanofi, No. 21-757 (May 18, 2023) applied enablement principles from its prior precedents involving Morse’s telegraph and Edison’s lightbulb filament to strike down Amgen’s broad functional claims directed to antibodies for lowering LDL cholesterol.  Although Amgen described in its specification the amino acid sequences for 26 particular antibodies, Amgen broadly claimed any antibody capable of binding to a specific location on a protein and blocking that protein from raising LDL cholesterol levels.  As the Court explained, such functional claiming covered a “vast” number of additional antibodies that Amgen never described, and Amgen provided no method for discovering operable antibodies without extensive trial and error experimentation.  Amgen’s two approaches for further antibody discovery were, according to the Court, “little more than two research assignments.”  Emphasizing that “the more a party claims . . . the more it must enable,” the Court held that Amgen’s limited disclosure was woefully inadequate to enable the full scope of the claims, particularly given the unpredictable link between an antibody’s amino acid sequence and its function in the body.  The Court so found without applying the Federal Circuit’s Wands test regarding undue experimentation, stating simply that the level of experimentation must be “reasonable.”  The Court also noted that a specification need not necessarily describe how to make “every single embodiment” within a claimed class.  But because Amgen had not described how to make and use the full scope of its broad claims without undue experimentation, the Court affirmed the Federal Circuit’s decision invalidating Amgen’s claims for lack of enablement.