Amgen v. Sanofi: Supreme Court Finds Amgen’s Patent Not Enabled for Requiring 'Trial and Error Discovery' to Generate and Identify Claimed Species

Addressing the issue of enablement for functionally defined genus patent claims, the Supreme Court recently affirmed the Federal Circuit’s judgment that claims to a genus of antibodies defined by their function were invalid for lack of enablement. Amgen’s claims were directed to genus of antibodies defined in terms of their function (binding to the PCSK9 receptor and inhibiting its tendency to exacerbate LDL or “bad” cholesterol). Generating these antibodies required an extensive (albeit routine) process of experimentation to generate and identify candidate antibody species and to confirm their characteristics and membership in the genus—while the processes disclosed in the patent specification would eventually create every claimed antibody, any individual species was not intrinsically predictable as being inside or outside the genus.

The Supreme Court held that because the experimentation required to generate and identify candidate species amounted to little more than a "research program" characterized by “trial and error,” and because Amgen did not identify a “quality common” to the members of the genus that would aid in their identification, the claims failed to conform to the “patent bargain” implicit in the enablement requirement – enabling a person of ordinary skill in the art (POSITA) to make an use an invention in exchange the so-called patent monopoly. Thus the claims were invalid.

The Court’s unanimous decision, authored by Justice Gorsuch, analyzed a body of Supreme Court enablement precedent (much of it from the 19th-century) and concluded that “[o]ur decisions in Morse, Incandescent Lamp, and Holland Furniture reinforce the 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. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable.” Because, the Court concluded, Amgen had not enabled the full scope of its claimed genus, the challenged claims were invalid.

As reflected in the Court’s extensive discussion and invocation of precedent, the Court’s opinion does not appear intended to either radically alter existing law nor necessarily to set a new bright-line precedent on enablement. Indeed, the Court suggested that even a genus reliant on the same or similar process taught by Amgen might still be enabled as long as there was a “quality common” to the species of the genus so as to guide a POSITA as to how to make and identify them. The Court likewise took care to note that the specification need not always "describe with particularity how to make and use every single embodiment within a claimed class" and that “a reasonable degree of experimentation” would not, in and of itself, preclude enablement. Some level of "adaptation or testing" may be permissible. To the contrary, because Amgen’s claim was to "vast" genus (potentially in the millions of antibodies), it required a commensurately enabling disclosure and because the process for generating candidate antibodies and confirming their membership in the claimed genus was little more than “random trial-and-error dis­covery,” Amgen’s claims were not enabled.

As a result of the Court’s reliance on pre-existing precedent and the relatively fact-specific basis of its holding, some practitioners believe the Amgen opinion may have relatively little import beyond biologics and the issue in the case—functionally defined genus claims encompassing species that are the result of routine, but non-deterministic, experimental processes. However, the high-tech world also should take note. The Court's cited precedent and its rationale explicitly extends beyond biologics to processes and devices—"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."

The Court’s suggestions that (1) the enablement requirement is commensurate with the scope of a claimed genus, (2) that a “quality common” to elements of a claimed genus that serves to aid a POSITA in generation and identification of claimed species, and (3) that “random trial-and-error dis­covery” without more may not be within the scope of reasonable experimentation, may all bear to some degree on the prosecution and litigation of patent of enablement issues of patents in all industries.