In Chromadex, Inc. v. Elysium Health, Inc., [2022-1116] (February 13, 2023), the Federal Circuit affirmed the grant of summary judgment that the asserted claims of U.S. Patent No. 8,197,807 on dietary supplements containing isolated nicotinamide riboside are directed to unpatentable subject matter.
The district court construed several claim terms including “isolated nicotinamide riboside” to mean “nicotinamide riboside that is separated or substantially free from at least some other components associated with the source of nicotinamide riboside.” The district court concluded that the claims were directed to a natural phenomenon, namely, “compositions
comprising isolated nicotinamide riboside, a naturally occurring vitamin present in cow milk.”
The only difference between at least one embodiment within the scope of the claim and natural milk is that the NR in the former is isolated. The asserted claims do not have characteristics markedly different from milk. Both the claimed compositions and milk “increase NAD+ biosynthesis upon oral administration.
The Federal Circuit noted that the claims cover several different composition embodiments, some of which are structurally different from milk. However, the claims also encompass—as both parties agree—at least one embodiment that covers milk, except that the NR element is “isolated.” Because the claims are broad enough to encompass a product of nature, it is invalid under § 101.
Chromadex argud that the claims, in fact, possess markedly different characteristics that render them patent-eligible. Chromadex bases this argument on two main points: (1) “NR is found in milk in only trace amounts,” i.e., one part per million; and (2) “what little NR is found in milk is not bioavailable” because it is bound to the lactalbumin whey protein. However, the Federal Circuit found this argument unpersuasive first because the claims do not require that the NR, specifically, increase NAD+, and milk increases NAD+ biosynthesis (albeit because it contains tryptophan rather than because of the trace amounts of NR), but that is the only therapeutic effect that the claims require. Second, the claims simply do not reflect the distinctions Chromadex relied upon: they do not require any specific quantity of isolated NR, and the district court’s construction for “isolated [NR],” which Appellants do not challenge on appeal, does not require that the NR be separated from the lactalbumin whey protein but only from “some of the other components associated with the source of [NR].”
The Federal Circuit said that the act of isolating the NR by itself, no matter how difficult or brilliant it may have been (although the specification makes clear that it was conventional), similarly does not turn an otherwise patent-ineligible product of nature into a patentable invention.