Fed. Circuit Says Isolated Milk Nutrient Not Patent-Eligible Subject Matter

ChromaDex, Inc. v. Elysium Health, Inc., No. 2022-1116 (Fed. Cir. Feb. 13, 2023)

Procedural History

This is an appeal from a District of Delaware summary judgement order that held that the asserted claims of U.S. Patent No. 8,197,807 (the ‘807 Patent), entitled “Nicotinamide riboside kinase compositions and methods for using the same,” are directed to unpatentable subject matter under 35 U.S.C. § 101.

Facts

The ‘807 Patent underlies dietary supplements containing isolated nicotinamide riboside (NR), a vitamin that is naturally present in, among other things, cow’s milk. The body converts ingested NR into the coenzyme nicotinamide adenine dinucleotide (NAD+). The asserted claims, claims 1-3 of the ‘807 Patent, relate to a composition containing NR that increases NAD+ biosynthesis. ChromaDex, Inc. (ChromaDex) licenses the ’807 Patent from Dartmouth College (Dartmouth) and sells dietary supplements embodying the patent.

ChromaDex sued Elysium Health, Inc. (Elysium) for patent infringement in September 2018, and Elysium moved for summary judgment that the asserted claims were invalid under 35 U.S.C. § 101, arguing that NR is a naturally occurring vitamin present in cow’s milk. ChromaDex opposed, arguing that the NR recited in the claims is “isolated,” making it have markedly different properties than the naturally occurring NR in cow’s milk. The district court concluded that the claims were directed to a natural phenomenon and entered a judgment of invalidity.

Holding

The Federal Circuit Court of Appeals affirmed the district court’s decision. The Appeals Court held that the claimed compositions are invalid because the isolated NR did not have “markedly different characteristics” from the naturally occurring NR found in cow’s milk. (Slip Op. at 7.) Further, the Court found that the claims lack an inventive step because they were directed towards the same natural principle (increased NAD+ biosynthesis) as the naturally occurring NR in cow’s milk. (Slip Op. at 9-10.)

Key Takeaways

1. In evaluating patent eligible subject matter under 35 U.S.C. § 101, the specific elements of the claim distinguishing the subject matter from a naturally occurring substance, and whether those claim elements are “markedly different” from their naturally occurring counterparts and have potential for significant utility, is critically important.
2. The Federal Circuit appears to question whether step two of the Alice/Mayo framework applies in these circumstances. Cf. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 217 (2014); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 77–80 (2012).