Federal Circuit Finds Patent for Dietary Supplements Invalid Under § 101 for Reciting Naturally Occurring Milk Components

| Ashley C. MoralesMichael L. Fuller

In ChromaDex, Inc. v Elysium Health, Inc., Appeal No. 2022-1116, the Federal Circuit upheld the invalidity of a claim reciting a supplement comprising nicotinamide riboside (“NR”), a component found in cow’s milk, under 35 U.S.C. § 101, finding that the claim read on a product of nature.

ChromaDex asserted U.S. Patent No. 8,197,807 (“the ’807 patent”) against Elysium Health, Inc. (“Elysium”). The ’807 patent relates to a dietary supplement containing isolated NR. When NR is ingested, NR is converted into the coenzyme nicotinamide adenine dinucleotide (“NAD+”), the absence of which can cause diseases in humans. NR is present in cow’s milk in a non-isolated form.

The asserted claims of the ’807 patent recited a composition comprising isolated NR in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein the combination is in an admixture with a carrier such as sugar, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration. After claim construction, Elysium moved for summary judgement of invalidity under 35 U.S.C. § 101, which the district court granted, concluding that the claims were directed to a natural phenomenon, compositions containing NR, which occurs naturally in cow’s milk. The district court rejected arguments by ChromaDex that the characteristics of isolated NR differ from naturally occurring NR, as the allegedly different characteristics argued by ChromaDex were not part of the claims as written.

On appeal, the Federal Circuit compared the claims of the ’807 patent to milk, concluding that the claims of the patent read on milk, with only one difference, namely that the NR in milk is not isolated. Cow’s milk is known to contain the other elements recited in the supplement claims, such as tryptophan and nicotinic acid. The Federal Circuit looked to Supreme Court decisions Ass’n for Molecular Pathology v. Myriad Genetics, Inc.[1], and Diamond v. Chakrabarty[2].The Federal Circuit distinguished the claims of the ’807 patent from those in Chakrabarty, noting that the patentee in Chakrabarty produced a bacterium with markedly different characteristics from any in nature, with the potential for significant utility, leading the Supreme Court to uphold the claims.[3] In contrast, the Federal Circuit found that the act of isolating NR was not sufficient to, on its own, confer patent eligibility, because the isolated NR was not different structurally or functionally from NR naturally occurring in milk. To be patent eligible, the NR would need to have markedly different characteristics and the potential for significant utility.

The Federal Circuit also considered the claims of the ’807 patent under the Alice/Mayo two-step framework. Using the Alice/Mayo framework, the Federal Circuit concluded that the asserted claims were directed to a product of nature, and that the claims lacked an inventive step, as they were directed to nothing more than compositions that increase NAD+ biosynthesis. The act of isolating the NR, no matter how difficult, did not turn the patent-ineligible product of nature into a patentable invention.

Editor: Brenden S. Gingrich, Ph.D.

[1] 569 U.S. 576 (2013)

[2] 447 U.S. 303 (1980)

[3] Diamond v. Chakrabarty, 447 U.S. at 309-310.