Got Markedly Different Milk?: The Federal Circuit Weighs in on 101 and Products of Nature

In ChromaDex, Inc., v. Elysium Health, Inc., a Federal Circuit panel (“Panel”) contributed to the ongoing discussion on patent-eligible subject matter.1 The Panel affirmed the district court’s judgment that the asserted claims of U.S. Patent No. 8,197,807 (“’807 patent”) are invalid under Section 101 of the Patent Act2 for claiming subject matter that is not patent eligible.3 Specifically, the asserted claims were found invalid for claiming a product of nature.4

This case arose when ChromaDex, a dietary supplement provider, sued its former customer, Elysium, for patent infringement in 2018.5 Elysium moved for summary judgment, arguing that the asserted claims were invalid under 35 U.S.C. § 101.6 The district court granted Elysium’s motion and entered a judgment of invalidity.7 ChromaDex appealed.8

The ’807 patent claims are directed to dietary supplements containing isolated nicotinamide riboside (“NR”).9 NR is a form of vitamin B3 naturally present in cow’s milk.10 The parties agreed that NR is naturally present in milk product and it is undisputed that cow’s milk is a naturally occurring product and is not patent eligible. The Federal Circuit addressed two issues on appeal from the Federal District Court of Delaware. First, whether the claims were directed to a patent-ineligible product of nature, and second, if the subject matter is directed to a product of nature, whether the claims included an inventive concept that transformed the product of nature into a patent-eligible invention.

ChromaDex first argued that because the NR claimed in the ’807 patent is isolated NR, unlike that of cow’s milk, that under the requisite 101 analyses, it is distinct from cow’s milk and is patent-eligible subject matter. The Court disagreed.

Under Section 101 of the Patent Act, “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.”11 However, “laws of nature, natural phenomena, and abstract ideas,” in contrast, “are not patentable.”12

The Panel relied on two Supreme Court cases in finding that the ’807 patent claimed compositions that are not distinct from milk and are therefore patent ineligible. In Chakrabarty the Supreme Court held that to be patentable, a claimed composition must “have markedly different characteristics and have the potential for significant utility.”13 Further, under Myriad, products of nature, such as DNA, are not patent eligible merely because they have been isolated.14 The Panel explained that other than separation from some other components, isolated NR is neither functionally nor structurally different from that of NR in milk.15 Thus, under Chakrabarty and Myriad, isolating NR is not enough to make a claim that otherwise reads on cows’ milk patent eligible.

ChromaDex argues that the ’807 patent claims possess additional markedly different characteristics than cow’s milk, beyond isolation, that render the claims patent eligible.16 ChromaDex offers first, “NR is found in cow’s milk in only trace amounts,” i.e., one part per million; and second, “what little NR is found in milk is not bioavailable.”17 ChromaDex’s argument fails for two reasons. First, the claims do not require the therapeutic effect that NR in greater quantities than trace amounts possesses.18 And second, the ’807 claims do not require that the isolated NR be bioavailable.19 So the Panel rejected these arguments and concluded the ’807 claims lack markedly different characteristics from the NR in milk, making them unpatentable subject matter.20

The Panel compared the ’807 claims to those of their Natural Alternatives decision.21 The claims in Natural Alternatives were directed to dietary supplements containing beta-alanine.22 The patents claimed formulations that incorporated products of nature, however the formulations “had different characteristics and could be used in a manner that beta-alanine as it appears in nature cannot.”23 The patents in Natural Alternatives claimed isolation of beta-alanine and incorporating the isolated product into a dosage form that is not naturally available.24 That difference was sufficient for the Federal Circuit to conclude the claimed beta-alanine supplements had markedly different characteristics from natural beta-alanine.25 The ChromaDex Panel compared the isolated NR claimed to that of cow’s milk and found that there were not any markedly different characteristics between the claimed compositions and NR in cow’s milk to render the claims patent-eligible.26

The Panel did not opine on whether the Alice/Mayo test applies in the product-of-nature eligibility arena. The Panel did explain that in one prior case, they analyzed composition of-matter claims under the “‘markedly different characteristics framework’” of Myriad and Chakrabarty but analyzed method claims under Mayo.27 Regardless, the Panel noted that if analyzing the patents under Alice/Mayo is necessary, then at step one “the asserted claims are directed to a product of nature” for the conclusions drawn from their Myriad and Chakrabarty analysis, and at step two “the claims lack an inventive step because they are directed to nothing more than compositions that increase NAD+ biosynthesis, which is the very natural principle that renders the claims patent-ineligible.”28 Thus, under either Myriad and Chakrabarty or Alice/Mayo tests the ’807 Patent claims patent ineligible subject matter.29

This decision is a lesson to patent drafters. It is critical to claim the unique characteristics that make your inventions markedly different from the product of nature to which they will be compared. It is not enough to merely mention that they may possess unique properties in the specification. The claim should include the unique characteristics to get over the 101 hurdle when the technology is closely related to a product of nature. Here, if ChromaDex had included the therapeutic effect and bioavailability that they argue their invention possesses, the analysis may have turned out differently. It is important to draft claims to expressly include at least one characteristic that indicates a difference between the claimed invention and the product of nature.

1 ChromaDex, Inc., v. Elysium Health, Inc., No. 2022-1116, WL 1944134, slip op. (Fed. Cir. Feb. 13, 2023). (“Slip op.”).
2 35 U.S.C. § 101.
3 Slip op. at 10-11.
4 Id.
5 Id. at 3. See ChromaDex, Inc. v. Elysium Health, Inc., 561 F. Supp. 3d 460 (D. Del. 2021), aff'd, No. 2022-1116, 2023 WL
1944134 (Fed. Cir. Feb. 13, 2023).
6 Slip op. at 3
7 Id. at 3-4. .
8 Id. a 4.
9 Id. at 2.
10 Id.
11 Id. at 4-5 (citing 35 U.S.C. § 101).
12 Id. at 5 (citing Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 589 (2013)) .
13 Id. at 7 (citing Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)),
14 Id. (citing Myriad, 569 U.S. at 590–93).
15 Slip op. at 7.
16 Id. at 8.
17 Id.
18 Id. at 9.
19 Id.
20 Id.
21 Id. at 7 (citing 918 F.3d at 1341).
22 Id.
23 Id.
24 Id.
25 Id.
26 Id. at 7-8.
27 Id. at 10 (citing In re BRCA1- and BRCA2, 774 F.3d 755, 759–61 (Fed. Cir. 2014)).
28 Id. at 9-10.
29 Id. at 10.