SCOTUS Patent Scorecard Update

On May 18, 2023, the Supreme Court issued its most recent patent decision, Amgen, Inc. v. Sanofi. ?

Amgen addresses what it takes to enable a patented, i.e., claimed, invention.????

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That is, under 35 U.S.C. § 112(a), a patent specification must include “a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art . . . to make and use the same.” ??

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Amgen broadly holds that “[i]f 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.”??

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Amgen then limits that holding in two ways:

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(1) ?A specification does not “always [have to] describe with particularity how to make and use every single embodiment within a claimed 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.’” and

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(2) ?A “specification [is not] necessarily inadequate just because it leaves the skilled artist to engage in some measure of adaptation or testing. … ‘the certainty which the law requires in patents is not greater than is reasonable.’”?Stated differently, “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.”

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As to the claims at issue in Amgen, which were directed to antibodies that help reduce levels of low-density lipoprotein (LDL), i.e., bad, cholesterol, the Supreme Court affirmed the Federal Circuit’s (CAFC) invalidation of those claims for lack of enablement.?The Supreme Court explained that “the problem [the CAFC] saw is the same problem we see: Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’”

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As a practical matter, Amgen may result in patent applications with fewer claims directed to an entire class or overly broad swath of processes, machines, manufactures or compositions of matter.

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More interestingly, Amgen raises two bigger picture issues.?

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First, what is the impact of artificial intelligence (AI) on enablement now and what will it be in the future?? In the inventorship context, the CAFC has concluded that only a natural person/human being can be an inventor, i.e., the CAFC has concluded that AI cannot be an inventor, and has left open “the question of whether inventions made by human beings with the assistance of AI are eligible for patent protection.”?See Thaler v. Vidal (CAFC Aug. 5, 2022).?Let’s put aside, for now, whether Congress should or will amend the Patent Act so that the term “person” includes “assistive” or “stand-alone” AI for purposes of inventorship or enablement or for all purposes.?The AI-enablement issue on the table is this: when an accused infringer asserts that a patent claim is not enabled because of the need to engage in an unreasonable amount of experimentation, i.e., trial and error, what does or will that mean where AI is an available tool for experimentation???

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Second, where is patent eligibility headed??That is, Amgen recognizes that “[j]udges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them.”?To some, that may be an odd statement because the Supreme Court recently and repeatedly has shown that it has no appetite for clarifying 35 U.S.C. § 101, i.e., patent eligible subject matter, which, to some, impermissibly has been pruned, if not uprooted, by judges.?Perhaps that recognition is a message to lower courts, including the CAFC, to refine current approaches for assessing whether subject matter is patent eligible.?Perhaps it is a message to Congress to amend § 101.?Perhaps it is both.?In any case, it underscores the Supreme Court’s role as the team’s punter. ??

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With that, the patent bottom line: Amgen is patent neutral because it applies the law as written and is limited as noted above. ??

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In the past 19 years, the Supreme Court has issued 42 patent decisions.?The tally: 22 decisions are not pro-patent, 9 decisions are pro-patent and 11 decisions are patent neutral.??