ChromaDex Fails to Milk Its Patent for Subject Matter Eligibility

Holding

In ChromaDex, Inc. v. Elysium Health, Inc., No. 22-1116 (Fed. Cir. Feb. 13, 2023), the Court of Appeals for the Federal Circuit (“the Federal Circuit”) affirmed the district court’s grant of summary judgment that the claims at issue, directed to dietary supplements, were unpatentable as ineligible subject matter under 35 U.S.C. § 101.

Background

ChromaDex licenses U.S. Pat. No. 8,197,807 (“the ’807 patent”) from Dartmouth College. ChromaDex sells dietary supplements containing isolated nicotinamide riboside (“NR”), which is a form of vitamin B₃naturally present in cow’s milk and other products. Id. at *2-3. Representative claim 1 reads:

1. 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 increased NAD+ biosynthesis upon oral administration.

ChromaDex sued Elysium for patent infringement. The district court construed “isolated nicotinamide riboside” to mean “[NR] that is separated or substantially free from at least some other components associated with the source of [NR].” Id. at *3.

On motion for summary judgment, the district court determined that the claims were directed to a natural phenomenon and, as such, were directed to ineligible subject matter under 35 U.S.C. §101. Id. ChromaDex’s argument that isolated NR is different from naturally occurring NR was rejected because none of the asserted different characteristics, such as stability, bioavailability, purity, and efficacy, were part of the claims. Id.

Federal Circuit

The Federal Circuit began by noting that the broad claims read on milk with only one difference from natural milk: the NR is isolated as claimed but is not isolated in natural milk. Drawing from the Supreme Court’s decision in Ass'n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013), the Federal Circuit then determined that “the act of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibility.” Id. at *6. Isolated NR is neither structurally nor functionally different from non-isolated NR. Therefore, the court found that “[t]he claimed compositions do not exhibit markedly different characteristics from natural milk and are, therefore, invalid for claiming a patent-ineligible product of nature.” Id. at *7.  

The Federal Circuit also found support for its conclusion in Nat. Alts. Int’l, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1342 (Fed. Cir. 2019). In Nat. Alts., the claimed dietary supplement formulations were defined to have different characteristics from their naturally occurring components, which “preserved the claims’ validity.” Id. at *7. “Here, in contrast, the asserted claims do not have characteristics markedly different from milk.” Id. Because the claims were broad enough to cover a product of nature, the Federal Circuit held that the claims were invalid as patent-ineligible. Id. at *8.

The Federal Circuit then conducted an Alice/Mayo two-step analysis, finding, at step one, that the claims are directed to a product of nature and, at step two, that the claims lack an inventive step because the inventors did no more than recognize the utility of a natural law and isolate a natural product. Id. at *9-10.

Takeaways

This case serves as a cautionary tale to patent drafters. Reminiscent of In re Roslin Institute (Edinburgh), 750 F.3d 1333 (Fed. Cir. 2014), ChromaDex’s claimed invention is potentially patentable, but the claims at issue were not drafted such that they could clear the hurdle of patentable subject matter eligibility. The Federal Circuit noted several times in the ChromaDex opinion that, although ChromaDex highlighted several advantages of the claimed compositions over milk, the asserted claims did not have any limitations directed to those advantages.

For instance, ChromaDex asserted that a sufficient quantity of isolated NR in their compositions increases NAD+ production, whereas natural milk contains just trace amounts of NR (not sufficient to increase NAD+ production). The claims, however, only required the composition to increase NAD+ biosynthesis, but the tryptophan in natural milk also achieved this benefit. Id. at *9.

Practitioners are encouraged, therefore, to draft claims explicitly reciting any “markedly different characteristics” from the naturally occurring product, or to at least explicitly define claim terms in the specification such that those terms require the “markedly different characteristics.” The goal in drafting claims and disclosures in this way is to tie the unexpected advantages of the isolated natural product to the claimed features of that product so as to distinguish it from its native context. And if your issued patents don’t do that, think about possible continuations, continuations-in-part, or even reissues to achieve such objectives.