The Supreme Court Weighs in on Full-Scope Enablement in Amgen v. Sanofi

In an opinion issued on May 18, 2023, in Amgen Inc. v. Sanofi, the Supreme Court affirmed the Federal Circuit’s opinion that claims 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of U.S. Patent No. 8,859,741 were invalid for failing to meet the enablement requirement of 35 U.S.C. Section 112(a). Although concerns had been expressed regarding the potential breadth of the Supreme Court’s decision; for example, whether the decision would call into question the viability of functional claiming, the decision appears to be closely aligned with precedent and does not appear to introduce any unexpected or unintended changes to the law governing "full scope” enablement.

After a helpful primer on antigens and antibodies (Section IB), the Court summarized the patents and technology at issue in three old enablement chestnuts – O’Reilly v. Moore, 15 How. 62 (1854); The Incandescent Lamp Patent, 159 U.S. 465 (1895); and Holland Furniture Co. v. Perkins Glue Co., 277 U.S. 245 (1928). In particular, the Court reemphasized that: “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. See §112(a); see also Continental Paper Bag Co. v. Eastern Paper Bag Co., 210 U. S. 405, 419 (1908) (“[T]he claims measure the invention.”).” Slip Op. at 13.

The Court was quick to clarify that “[t]hat is not to say a specification always must describe with particularity how to make and use every single embodiment within a claim class. For instance, it may suffice to give an example (or a few examples) if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose.’” Slip Op. at 13 (quoting Incandescent Lamp, 159 U. S., at 475). “Nor is a specification necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing” Slip Op. at 14.

“Decisions such as Wood and Minerals Separation establish that a specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art. See Minerals Separation, 242 U. S., at 270–271; see also Mowry v. Whitney, 14 Wall. 620, 644 (1872) (‘[T]he definiteness of a specification must vary with the nature of its subject. Addressed as it is to those skilled in the art, it may leave something to their skill in applying the invention.’). But in allowing that much tolerance, courts cannot detract from the basic statutory requirement that a patent’s specification describe the invention ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art’ to ‘make and use’ the invention. §112(a).” Slip Op. at 15.

The Court rejected Amgen’s argument that the two methods it disclosed in the specification for identifying antibodies – “roadmap” or “conservative substitution” – complied with the enablement requirement of 35 USC 112(a). “These two approaches amount to little more than two research assignments. The first merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies—calling on scientists to create a wide range of candidate antibodies and then screen each to see which happen to bind to PCSK9 in the right place and block it from binding to LDL receptors. See Part I–B, supra; 987 F. 3d, at 1088; 2019 WL 4058927, *10–*13. The second isn’t much different. It requires scientists to make substitutions to the amino acid sequences of antibodies known to work and then test the resulting antibodies to see if they do too—an uncertain prospect given the state of the art.” Slip Op. at 16-17.

Finally, the Court rejected three policy arguments Amgen posited:

• First, that the Federal Circuit “conflated the question whether an invention is enabled with the question how long may it take a person skilled in the art to make every embodiment within a broad claim.” “While we agree with Amgen that enablement is not measured against the cumulative time and effort it takes to make every embodiment within a claim, we are not so sure the Federal Circuit thought otherwise. That court went out of its way to say that it “do[es] not hold that the effort required to exhaust a genus is dispositive.” 987 F. 3d, at 1088 (emphasis deleted). Instead, the court stressed, the problem it saw is the same problem we see: Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” Slip Op. at 18.
• “Amgen next argues that the Federal Circuit erroneously ‘raise[d] the bar’ for enablement of claims that, like Amgen’s, encompass an entire ‘genus’ of embodiments defined by their function.” Again, the Court agreed in principle with Amgen but said that the Federal Circuit had not said anything different. “But, once more, we do not understand the Federal Circuit to have thought differently. Instead, we understand that court to have recognized only that the more a party claims for itself the more it must enable. As we have seen, that much is entirely consistent with Congress’s directive and this Court’s precedents.” Slip Op. at 18.
• “Finally, Amgen warns that an affirmance risks ‘destroy[ing] incentives for breakthrough inventions.’ Id., at 38. But striking the proper balance between incentivizing inventors and ensuring the public receives the full benefit of their innovations is a policy judgment that belongs to Congress.” Slip Op. at 19.

Although this opinion had the potential for significantly roiling the patent landscape as to enablement, it appears—at first blush—to be consistent with well-understood precedent and less far-reaching that some recent Supreme Court decisions affecting patent law. It remains, of course, to see if and how this plays out in the lower courts.