The Tyranny Of Large Numbers: Their Grip on s. 102 Inquiries

So that I don’t have to explain the claims and the arguments presented by the parties, please read my posts on the Supreme Court’s opinion on Amgen v. Sanofi on May 22, 2023 and the Fed. Cir.’s opinion on February 13, 2021. In Amgen the Supreme Court affirmed the Fed. Cir.’s opinion, ruling that the disclosure of 26 antibodies did not enable the functional claims that encompassed millions of antibodies, because the effort to identify the other members of the genus would amount to undue experimentation. Earlier I wrote that “While Lourie tries to cabin the undue effort holding by writing ‘We do not hold that the effort required to exhaust a genus is dispositive’, he contradicts himself in the same paragraph by concluding that ‘no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of the claimer embodiments.” The Supreme Court quoted the first sentence I quoted but ignored the second and wrote, “Instead the court stressed, the problem it saw was the same problem we see: Amgen offers persons skilled in the art little more than advice to engage in ‘trial and error.’” So Sanofi succeeded in being found not-guilty of infringement of their antibody-based therapeutic simply by waiving the “at least millions of candidates” that would have to be screened for the recited bioactivity, and this effort involves “undue experimentation.”

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Does the “Patent Eligibility Restoration Act of 2023” Revive Diagnostic Claims?

On June 22, Senator Chris Coons, along with Thom Tillis introduced the “Patent Eligibility Restoration Act of 2023” (hereinafter “the Act”) to amend 35 USC s. 101 to clarify the scope of patent-eligible subject matter. Section 100 would be amended to delete “includes a new use of a known process” and insert to s. 101(b) “includes a use, application, or method of manufacture of a known or naturally occurring process.” A section (k) would be added to define the term “useful” as meaning that the invention or discovery has a “specific and practical utility” from the perspective of a POSA. So far, so good. The use of a naturally occurring process can be read to cover the use of a naturally occurring correlation, an “If A then B” claim. The mental recognition of the discovery of the utility of a naturally occurring correlation, which leads to a diagnostic conclusion would seem to be included in this broad language.

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Supreme Court Voids Amgen’s Patents using “Undue Experimentation” Standard

In Appeal no. 21-257 (May 18, 2023), the Supreme Court affirmed the judgement of the Fed. Cir. by ruling that all of the claims of Amgen’s U.S. Patent nos. 8,829,165 and 8,859, 741 were invalid due to their failure to meet the enablement requirement of s. 112(a). For an introduction of the landmark decision, please re-read my post of Feb. 13, 2021 which summarizes the issues addressed by the Fed. Cir. Judge Lourie summarized the claims as “claiming a monopoly over all antibodies that (1) bind to specific proteins on a naturally occurring protein known as PCSK9, and (2) block PCSK9 from impairing the body’s mechanism for impairing the body’s mechanism to remove LDL cholesterol from the blood stream.”

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From SLW International: Info on the Unitary Patent and the Unified Patent Court

Guest contribution from SLW International:

A short paper with information on the Unitary Patent and the Unified Patent Court can be found here.

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