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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Chromadex v. Elysium Health – It’s Only Natural!

On February 13, 2023, a Fed. Cir. panel of Judges Prost, Chen and Stoll (Prost writing) held, in Appeal no. 2022-1116, that the asserted claims 1-3 of U.S. Patent No. 8,197, 807 are directed to unpatentable subject matter, namely to a natural product, nicotinamide riboside (“NR”). Since the panel relied heavily on its opinion in Natural Alternatives International, Inc. v. Creative Compounds, LLC., 918 F.3d 1338 (Fed. Cir, March 15, 2019), it would be helpful to read my post of March 18, 2019. With respect to the composition claims in suit in Natural Alternatives, claim 6 of U.S. Patent No. 7,504,376 depended from claim 1, a claim that almost certainly would have been found patent ineligible. It recited a “naked” composition comprising a simple mixture of two natural products, glycine and beta-alanine, its esters and amides, and beta-alanine di-peptide and another dipeptide.

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