CAFC Says ChromaDex Patent Claiming Isolated Form of Vitamin B3 Fails Under 101

As in Myriad, under the circumstances presented here, the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility.” – CAFC

CAFCThe U.S. Court of Appeals for the Federal Circuit (CAFC) today issued a precedential decision affirming a Delaware court’s grant of summary judgment for Elysium Health that the asserted claims of ChromaDex, Inc.’s patent on an isolated form of vitamin B3 are directed to unpatentable subject matter under Section 101. Judge Prost authored the opinion.

U.S. Patent No. 8,197,807 is titled “Nicotinamide riboside kinase compositions and methods for using the same.” Nicotinamide riboside (NR) is a form of vitamin B3 that is naturally present in cow’s milk. The invention covers a composition containing isolated NR that results in increased biosynthesis of the coenzyme nicotinamide adenine dinucleotide (NAD+) upon oral administration.

ChromaDex sells dietary supplements embodying the patent, which it licenses from Dartmouth College, and sued Elysium for patent infringement in 2018. Elysium moved for summary judgment that the claims were invalid under Section 101 and the district court agreed, finding that the claims were directed to a natural phenomenon, specifically, “compositions comprising isolated [NR], a naturally occurring vitamin present in cow milk.”

Nothing ‘Markedly Different’ to See Here

In its discussion, the CAFC agreed with the U.S. District Court for the District of Delaware that the claims are directed to a product of nature under Ass’n for Molecular Pathology v. Myriad Genetics, Inc. and Diamond v. Chakrabarty. “As in Myriad, under the circumstances presented here, the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility,” wrote the court. The proper inquiry was defined in Chakrabarty, the opinion continued, where the Supreme Court said that, “to be patentable, the claimed composition must ‘ha[ve] markedly different characteristics and have the potential for significant utility.’” But naturally occurring NR in milk increases NAD+ biosynthesis when taken orally, just like the claimed invention.

Distinguishing the case from Natural Alternatives Int’l, Inc. v. Creative Compounds, LLC, the CAFC explained that the patent here is not markedly different from milk. While the appellants claimed the compositions are preferable to milk because isolating the NR allows for greater NAD+ biosynthesis than found in milk alone and that the isolated NR alone can increase NAD+ biosynthesis, the CAFC said that 1) the claims lack a minimum required quantity of isolated NR and 2) the claims attribute the increase in NAD+ only to the composition, rather than the isolated NR alone. The court further explained:

“To be sure, the claims cover several different composition embodiments, some of which are structurally different from milk. However, as noted above, 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 argued the claims do possess markedly different characteristics from milk, including 1) that “NR is found in milk in only trace amounts”; and (2) “what little NR is found in milk is not bioavailable” as it is bound to lactalbumin whey protein. The Federal Circuit explained that, despite the trace amounts of NR, milk does increase NAD+ biosynthesis, due to the presence of tryptophan. Since the only therapeutic effect required by the patent claims is increased NAD+ biosynthesis, there is no marked difference. Secondly, the court said the district court’s unchallenged construction of “isolated NR” 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].”

No Help from Alice-Mayo

While the court noted that the discussion could end there, it next addressed the relevance of the two-part Alice-Mayo analysis. “[I]f resort to Alice/Mayo is necessary, then at step one we conclude the asserted claims are directed to a product of nature for the reasons stated above, and at step two the claims lack an inventive step because they are directed to nothing more than compositions that increase NAD+ bio-synthesis, which is the very natural principle that renders the claims patent-ineligible,” said the court.

The court dismissed ChromaDex’s assertions that recognizing the benefits of NR on health and the wisdom of isolating the NR to increase concentrations compared to those that occur naturally in milk represented inventive steps. The opinion concluded:

“[R]ecognizing the utility of NR is nothing more than recognizing a natural phenomenon, which is not inventive…. And 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. So the claims would likewise fail at step two.” [citations omitted]

Elysium and ChromaDex have been engaged in litigation on several fronts since 2016.


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Join the Discussion

9 comments so far.

  • [Avatar for Xtian]
    February 15, 2023 08:37 am

    I didn’t review any of the other claims, but a preamble of “A solid dosage form” or “A pharmaceutical dosage form” or ” A solid, pharmaceutical tablet comprising” would have had a better chance, no?

    How about a dependent claim where the dosage for is recited. Or, a dependent claim where cellulose is included (which is in any tablet or capsule).

  • [Avatar for Pro Say]
    Pro Say
    February 14, 2023 05:12 pm

    Ahhh . . . when in doubt . . . when 102 or 103 is simply too much work . . . there’s always the 101 toxic witches’ brew at the ready to douse innovation . . .

    No need to wait for Halloween.

    Never a need.

  • [Avatar for David Lewis]
    David Lewis
    February 14, 2023 03:18 pm

    milk has nicotinamide riboside in combination with … tryptophan, …. wherein said combination is in admixture with … a sugar, …, wherein said composition is formulated for oral administration and increases NAD+ biosynthesis upon oral administration.

    I am not sure if in milk lactose (the sugar) can be considered a “carrier,” but if it can then milk meets the claim other than the B3 is not isolated. If it cannot, it would seem to be a small difference possibly inherent in the difference between isolated and naturally occurring B3. Perhaps that is why the decision was considered precedential. Under 102, it would seem to fail, since the B3 of milk is not isolated (I would hate to see the scope of what is considered anticipated under 102 expanded in that way).

    The decision would seem to be consistent with Alice-Mayo decision and it would seem like the Supreme Court would likely affirm the decision, were it appealed.

    Nonetheless, I certainly would prefer to see the Alice-Mayo decision overturned (but that is just wishful thinking).

  • [Avatar for Anon]
    February 14, 2023 02:52 pm


    Cue Sherry Knowles.

  • [Avatar for B]
    February 14, 2023 01:31 pm

    ““[R]ecognizing the utility of NR is nothing more than recognizing a natural phenomenon, which is not inventive”

    Maybe not, but it does fall under “discovers” – a word the courts have written out of 35 USC 101.

  • [Avatar for B]
    February 14, 2023 01:25 pm

    @ xtian “Did the court just ignore all the other elements in this formulation? Such a horrible decision!!!”

    That is EXACTLY what the CAFC does in every single Alice/Mayo decision: ignore 99% of a claim’s content.

  • [Avatar for xtian]
    February 14, 2023 10:05 am

    Should have been disposed of under 102. From the opinion: “So the only difference between at least one embodiment within the scope of the claims and natural milk is that the NR in the former is isolated.” The court could have used a straight up 102 or that some of the NR is inherently isolated in milk and not relied upon 101. Sloppy intellect.

  • [Avatar for xtian]
    February 14, 2023 09:56 am

    A composition comprising isolated nicotinamide riboside 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 increases NAD+ biosynthesis upon oral administration.

    Did the court just ignore all the other elements in this formulation? Such a horrible decision!!!

  • [Avatar for Model 101]
    Model 101
    February 13, 2023 03:29 pm

    Crook stuff!

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