DC invalidation of “isolated” vitamin B3 compositions under 101 affirmed

ChromaDex, Inc., Trustees of Dartmouth College v. Elysium Health, Inc.

Docket No. 2022-1116 (https://cafc.uscourts.gov/opinions-orders/22-1116.OPINION.2-13-2023_2079642.pdf)


February 13, 2023

Brief Summary:   Invalidation of claims to isolated vitamin B3 (NR) compositions as unpatentable under section 101 affirmed. Summary:  ChromaDex appealed DC decision granting Elysium’s motion for summary judgment (SJ) that the asserted claims of US 8,197,807 are directed to unpatentable subject matter under 35 U.S.C. section 101.  The ‘807 claims are directed to dietary supplements containing nicotinamide riboside (“NR”), “a form of vitamin B3 naturally present—in non-isolated form—in cow’s milk and other products”.  Asserted representative ‘807 claim 1 is directed to “[a] composition comprising isolated [NR] in combination with one or more of tryptophan, nicotinic acid, or nicotinamide, wherein said combination is in admixture with a carrier comprising a sugar, starch, cellulose, powdered tragacanth, malt, gelatin, talc, cocoa butter, suppository wax, oil, glycol, polyol, ester, agar, buffering agent, alginic acid, isotonic saline, Ringer’s solution, ethyl alcohol, polyester, polycarbonate, or polyanhydride, wherein said composition is formulated for oral administration and increased NAD+ biosynthesis upon oral administration.”  The DC construed ‘isolated [NR]” to mean “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].”   The DC concluded that the claims were directed to a natural phenomenon, namely, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk”, rejected “ChromaDex’s argument that the characteristics of isolated NR purportedly different from naturally occurring NR— stability, bioavailability, sufficient purity, and therapeutic efficacy—render the claims patent-eligible” (the DC “observing that none of those characteristics were part of the claims”), and concluding that creating “an oral formulation of NR after discovering that NR is orally bioavailable is simply applying a patent-ineligible law of nature.”   The FC panel opinion wrote that “[t]he claims are very broad and read on milk with only one difference” in that milk contains NR, but the NR is not isolated as in the claimed composition.  The FC panel explained that its 2019 Natural Alternatives decision as being particularly instructive.  Nat. Alts. Int’l, Inc. v. Creative Compounds (918 F.3d 1338, 1342 (Fed. Cir. 2019)) that “upheld…claims directed to dietary supplements containing beta-alanine” as those “claimed ‘specific treatment formulations that incorporate[d] natural products’” and “ha[d] different characteristics and c[ould] be used in a manner that beta-alanine as it appears in nature cannot.”  Specifically, the “natural products ha[d] been isolated and then incorporated into a dosage form” (i.e., “between about” 0.4-16 g “with particular characteristics” (“effectively increase[] athletic performance”, “specific treatment formulations that incorporate[d] natural products”).  Further, it stated, “[t]he claims… do not necessarily require that the isolated NR be bioavailable”, “recognizing the utility of Nr is nothing more than recognizing a natural phenomenon, which in not inventive”, and “the act of isolating the NR by itself, no matter how difficult or brilliant it may have been…does not turn an otherwise patent-ineligible product of nature into a patentable invention.”

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