The Supreme Court unanimously held last week in Amgen v. Sanofi that a patent’s specification must enable a person skilled in the art to make and use the full scope of the invention as defined by its claims.
Amgen sued Sanofi in 2014, alleging that Sanofi had infringed its cholesterol-lowering drug patents, which disclosed 26 exemplary antibodies by amino acid sequences. The antibodies are known to bind to and inhibit proteins that interfere with receptors responsible for extracting “bad” cholesterol from the blood. Although Amgen’s patents disclosed 26 antibodies, the subject claims covered much more (any antibody that functioned similarly). Sanofi argued that Amgen’s patents were invalid because they did not enable the full scope of the claimed invention without undue experimentation. The District Court and Federal Circuit agreed with Sanofi, and Amgen’s appeal to the Supreme Court followed.
In a unanimous opinion by Justice Gorsuch, the Supreme Court held that Amgen’s patents enabled the 26 exemplary antibodies but failed to enable the full scope of the invention as defined by the relevant claims, even allowing for a reasonable degree of experimentation. The Court discussed its prior decisions and explained that they reinforce a “simple statutory command: If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Yet, the Court noted that a specification does not always need to “describe with particularity how to make and use every single embodiment within a claimed class.”
The enablement requirement allows “for reasonable amount of experimentation to make and use a claimed invention,” but what is “reasonable in any case will depend on the nature of the invention and the underlying art.” Amgen argued that the full scope of its claims (an entire universe of antibodies) is enabled because scientists would know how to make and use functional antibodies by simply following the disclosed “roadmap” or a “conservative substitution.” The Court disagreed, finding that the disclosed approaches amount to little more than research assignments and Amgen’s own trial-and-error method for finding functional antibodies. The Court further found that there was not any quality that Amgen had disclosed common to every functional embodiment, disclosure of which may have enabled the full scope of the claims.
The Court disagreed with Amgen’s alternative arguments that the Federal Circuit improperly applied the enablement test by requiring a heightened standard or conflating enablement with how long it may take a person of ordinary skill in the art to make every embodiment of a claim. Finally, the Court was not convinced by Amgen’s argument that its decision would disincentivize innovation. The Court reasoned that Congress has offered a patent bargain since 1790—disclosure in exchange for a limited monopoly. That bargain requires the disclosure to enable the invention. Thus, the Court explained its duty is simply to apply the enablement requirement according to its statutory terms.