The Federal Circuit has affirmed a district court’s decision granting a motion for summary judgment that the asserted claims of a dietary supplement patent are invalid under 35 U.S.C. § 101.
Under 35 U.S.C. § 101,
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Courts have interpreted these statutory categories to exclude laws of nature, natural phenomena, and abstract ideas, such as scientific principles, naturally occurring phenomena, mental processes, and mathematical algorithms.
In Chromadex, Inc. v. Elysium Health, Inc., the patent at issue is directed to dietary supplements containing isolated nicotinamide riboside (“NR”), a form of vitamin B3 naturally present—in non-isolated form—in cow’s milk and other products.
ChromaDex sells dietary supplements in the form of compositions of NR embodying the patent. It sued Elysium, a former customer, for asserted patent infringement in 2018.
The district court construed several patent claim terms, including construing “isolated [NR]” to mean “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].”
Elysium moved for summary judgment, arguing that the asserted claims were invalid under 35 U.S.C. § 101, and the district court granted the motion.
The district court concluded that the claims were directed to a natural phenomenon, namely, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk.”
The court rejected ChromaDex’s claims that the characteristics of isolated NR that were purportedly different from naturally occurring NR— stability, bioavailability, sufficient purity, and therapeutic efficacy —render the claims patent-eligible, because none of those characteristics were part of the claims.
The district court concluded that the purported invention was “simply applying a patent-ineligible law of nature.”
The Federal Circuit agreed, noting that the only difference between the supplement and natural milk is that the NR in the former is isolated.
Said the court,
the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility. … The claimed compositions remain indistinguishable from natural milk because, other than separation from some other components, the isolated NR is no different structurally or functionally from its natural counterpart in milk.
The court rejected the arguments that
(1) “NR is found in milk in only trace amounts,” i.e., one part per million; and
(2) “what little NR is found in
The court found that there were two problems with these arguments.
First,… milk increases NAD+ biosynthesis (albeit because it contains tryptophan rather than because of the trace amounts of NR), and that is the only therapeutic effect that the claims require. Second, the claims simply do not reflect the distinctions Appellants rely on: 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 claims, therefore, do not necessarily require that the isolated NR be bioavailable, meaning that the claimed compositions do not necessarily possess markedly different characteristics from milk, as they must to be patent-eligible.
Also, the court found that there was no “inventive step,” because the claims are directed to “nothing more than compositions that increase NAD+ biosynthesis, which is the very natural principle that renders the claims patent-ineligible.”
The court concluded 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.
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