Chromadex, Inc. v. Elysium Health, Inc.

Case: 25-1227 Document: 56 Page: 1 Filed: 10/30/2026 NOTE: This disposition is nonprecedential. United States Court of Appeals for the Federal Circuit ______________________ CHROMADEX, INC., TRUSTEES OF DARTMOUTH COLLEGE, Plaintiffs-Appellants v. ELYSIUM HEALTH, INC., Defendant-Appellee ______________________ 2025-1227 ______________________ Appeal from the United States District Court for the District of Delaware in No. 1:18-cv-01434-CFC-JLH, Chief Judge Colm F. Connolly. ______________________ Decided: October 30, 2026 ______________________ MARK MOSIER, Covington & Burling LLP, Washington, DC, argued for plaintiffs-appellants. Also represented by ROBERT ALLEN LONG, JR.. JEREMY YOUNKIN, Foley Hoag LLP, Boston, MA, ar- gued for defendant-appellee. Also represented by DONALD ROSS WARE. ______________________ Case: 25-1227 Document: 56 Page: 2 Filed: 10/30/2026 2 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. Before PROST, CHEN, and STOLL, Circuit Judges. CHEN, Circuit Judge. In 2023, this court affirmed the U.S. District Court for the District of Delaware’s grant of summary judgment that the asserted claims of a patent owned by ChromaDex, Inc. and the Trustees of Dartmouth College (collectively, Chro- maDex) are directed to a product of nature and thus not patent eligible under 35 U.S.C. § 101. See ChromaDex, Inc. v. Elysium Health, Inc., 59 F.4th 1280, 1285–86 (Fed. Cir. 2023) (ChromaDex I). After our decision, defendant Ely- sium Health, Inc. (Elysium) moved for an award of attor- neys’ fees pursuant to 35 U.S.C. § 285, arguing that the case was exceptional, because in its view, ChromaDex never attempted to show how its claims could survive the Supreme Court’s decision in Association for Molecular Pa- thology v. Myriad Genetics, Inc., 569 U.S. 576 (2013). See ChromaDex, Inc. v. Elysium Health, Inc., No. CV 18-1434- CFC, 2024 WL 1255520, at *1 (D. Del. Mar. 25, 2024) (De- cision). The district court agreed with Elysium that Myr- iad specifically decided the particular patent-eligibility issue in this case, id. at *3, and awarded Elysium $9.1 mil- lion in attorneys’ fees, see ChromaDex, Inc. v. Elysium Health, Inc., No. CV 18-1434-CFC, 2024 WL 5105618 (D. Del. Aug. 20, 2024) (Fee Order). We disagree because the patent-eligibility question here required evaluating several considerations beyond Myriad. The district court thus erred in its understanding of the substantive strength of ChromaDex’s § 101 position, and we therefore conclude that the district court abused its discretion in granting the § 285 fee award. We reverse. BACKGROUND I ChromaDex owns U.S. Patent Nos. 8,197,807 (’807 pa- tent) and 8,383,086 (’086 patent). The claimed inventions in both patents concerns dietary supplements containing Case: 25-1227 Document: 56 Page: 3 Filed: 10/30/2026 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 3 several elements, including isolated nicotinamide riboside (NR), to increase NAD+ biosynthesis upon oral administra- tion. 1 Increased NAD+ biosynthesis can treat a disease as- sociated with the NR kinase pathway. See ’807 patent col. 4 ll. 24–31. Claim 1 of the ’807 patent is representative for both patents and recites: 1. A composition comprising isolated nicotinamide riboside [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, pow- dered 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, polycar- bonate, or polyanhydride, wherein said composition is formulated for oral ad- ministration and increases NAD+ biosynthesis upon oral administration. Id. col. 53 l. 59 – col. 54 l. 59 (emphasis added). Relevant here, NR is a form of vitamin B3 naturally present in cow’s milk. 2 No one disputes that NR is found in milk only in trace amounts, and that those trace amounts of NR are not bioavailable (because it is bound to the lactalbumin whey protein) and thus do not themselves increase NAD+ biosynthesis. But the tryptophan in milk, however, increases NAD+ biosynthesis. The inventor of 1 A more detailed description of the claimed inven- tion can be found in ChromaDex I. See 59 F.4th at 1281– 85. 2 “Milk,” throughout this opinion, refers to natural cow’s milk. Case: 25-1227 Document: 56 Page: 4 Filed: 10/30/2026 4 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. the ’807 patent purports to have discovered that a compo- sition comprising isolated NR—that is, unbound from other components such as the lactalbumin whey protein—has the benefit of increasing NAD+ biosynthesis upon oral ad- ministration. See ’807 patent col. 4 ll. 24–31; see also J.A. 62, 3326. II In July 2017, Elysium filed a petition requesting inter partes review (IPR) of claims 1–3 of the ’807 patent before the Patent Trial and Appeal Board (Board). Elysium’s pe- tition contended that milk falls within the scope of the claims and therefore anticipates the claims. J.A. 1321. The parties disputed the meaning of the claim term “iso- lated,” and the Board construed the term to require the NR to be “separated or substantially free from at least some of the other components . . . such that it constitutes at least about 25% (w/w) of the composition,” i.e., 25% purity. J.A. 1319–20. In January 2018, the Board denied instituting the IPR, finding that milk does not anticipate the chal- lenged claims because the NR in milk is not “isolated,” as construed by the Board. In September 2018, after the Board’s denial of institu- tion, ChromaDex sued Elysium for infringement of claims 1–3 of the ’807 patent and claim 2 of the ’086 patent. The parties again disputed the meaning of the claim term “iso- lated [NR]”; ChromaDex proposed a construction similar to the Board’s 25% purity requirement, 3 whereas Elysium ar- gued that such a requirement is unsupported. The district 3 ChromaDex’s proposed construction in district court varied from the Board’s 25% purity requirement in that it calculates the 25% purity requirement by dividing “the weight of [NR]” by “the total weight of the [NR] and any other components associated with the source of the mol- ecule in said composition.” J.A. 1127 (emphasis added). In Case: 25-1227 Document: 56 Page: 5 Filed: 10/30/2026 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 5 court agreed with Elysium, thus disagreeing with the Board’s construction, and construed the term as “[NR] that is separated or substantially free from at least some of the other components associated with the source of the [NR].” J.A. 1838. Although ChromaDex indicated that it would not resist the district court’s articulated construction, it in- dicated that it would continue to argue that “separated or substantially free” included a 25% purity requirement. See J.A. 4190 (29:8–22); J.A. 4191 (30:3–20). Elysium then moved for summary judgment, arguing that the asserted claims are invalid under 35 U.S.C. § 101 because they claim patent-ineligible products of nature. Elysium asserted that all the elements of the claimed com- positions exist in naturally-occurring milk, except the claim requirement that NR is “isolated,” and that the claims are thus not materially different from milk. Chro- maDex responded that the claimed compositions possess characteristics markedly different from milk and have the potential for significant utility beyond milk, because, un- like the claimed compositions, the NR in milk is neither bioavailable nor stable, and cannot, on its own, increase NAD+ biosynthesis. The district court determined that the asserted claims are directed to a natural phenomenon and granted Ely- sium’s summary judgment motion. Elysium appealed to this court, and we affirmed the district court’s judgment that claims 1–3 of the ’807 patent are ineligible under § 101. 4 ChromaDex I, 59 F.4th at 1285. other words, the denominator used to calculate the purity differs from that under the Board’s construction. 4 Because the invalidity challenge to claim 2 of the ’086 patent was voluntarily dismissed, we did not address it. See ChromaDex I, 59 F.4th at 1281 n.1. Case: 25-1227 Document: 56 Page: 6 Filed: 10/30/2026 6 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. In ChromaDex I, we explained that, when comparing a claim to a product of nature, such as milk, “Chakrabarty defines the inquiry: to be patentable, the claimed composi- tion must ‘ha[ve] markedly different characteristics and have the potential for significant utility.’” Id. at 1284 (quoting Diamond v. Chakrabarty, 447 U.S. 303, 310 (1980)). As to the structural distinction in the claimed com- positions that the NR is isolated, we relied on Myriad to determine 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. (citing Myriad, 569 U.S. at 590–93). That is, NR’s structural “separation from some other components” did not amount to a markedly dif- ferent characteristic. ChromaDex’s main argument, however, rested on a dif- ferent theory: the claimed compositions, due to the NR be- ing “isolated,” allowed for significantly increased NAD+ biosynthesis upon administration, resulting in a character- istic markedly different from those found in nature because milk has only trace amounts of NR that are not bioavaila- ble (due to being bound to the lactalbumin whey protein). Id. at 1284–85. In ChromaDex’s view, the claimed compo- sitions’ significantly increased utility was analogous to the significant utility recited in the claims at issue in Natural Alternatives International, Inc. v. Creative Compounds, LLC, 918 F.3d 1338, 1348 (Fed. Cir. 2019) (concluding that claimed dietary supplements containing the natural prod- uct beta-alanine had markedly different characteristics over the natural product because the claims recited a par- ticular amount of beta-alanine sufficient to “effectively in- crease[] athletic performance when administered.”). Id. We concluded that the claimed increased NAD+ biosyn- thesis could not be considered a markedly different charac- teristic, after considering several factors. First, we observed that milk also increases NAD+ biosynthesis “al- beit because it contains tryptophan rather than because of the trace amounts of NR.” Id. at 1285. Second, we noted Case: 25-1227 Document: 56 Page: 7 Filed: 10/30/2026 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 7 that the claims “do not require any specific quantity of iso- lated NR,” which could then result in a certain amount of increased NAD+ biosynthesis. Id. Third, we concluded that the claims do not specifically attribute the claimed in- creased NAD+ biosynthesis to the isolated NR. Id. at 1284–85. Finally, after considering the district court’s claim construction, we determined that the “isolated NR” as construed need not necessarily be bioavailable for all embodiments because the NR was required to be separated only from “some of the other components,” which could leave the NR still bound to the lactalbumin whey protein. Id. at 1285. For those reasons, we found ChromaDex’s re- liance on our decision in Natural Alternatives unpersua- sive. III After ChromaDex I, Elysium moved for an award of at- torneys’ fees pursuant to § 285, arguing that “ChromaDex has pursued this litigation against Elysium as if the Myr- iad case did not exist.” J.A. 2885. ChromaDex responded that it had addressed Myriad during expert discovery and in response to Elysium’s sum- mary judgment motion. J.A. 3262. Furthermore, Chro- maDex pointed to its arguments relying on Chakrabarty and Natural Alternatives—how in its view, the claimed compositions possess characteristics markedly different from milk, above and beyond the mere structural distinc- tion of NR that is “isolated.” Id.; see J.A. 2378–83. The district court found the case exceptional and granted Elysium’s attorneys’ fee motion. See Decision, 2024 WL 1255520, at *3. In the district court’s view, “Chro- maDex’s litigation position generally and with respect to Myriad specifically was so lacking in substance that it ‘st[oo]d out’ from the dozens of [other] § 101 challenges” the court had encountered. Id. As a basis for the § 285 fee award, the court explained that Myriad “addressed the spe- cific issue presented” and “ChromaDex made no attempt to Case: 25-1227 Document: 56 Page: 8 Filed: 10/30/2026 8 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. distinguish Myriad in its summary judgment briefing.” Id. The court rejected ChromaDex’s argument that “it believed that the asserted claims were analogous to the claims at issue in Natural Alternatives and distinguishable from those in Myriad” by pointing to our § 101 analysis of the claims under Chakrabarty’s markedly different character- istics framework in ChromaDex I. Id. (cleaned up). The district court awarded $9,151,133 to Elysium, over ChromaDex’s objection to the inclusion of approximately $3.9 million incurred before the Markman hearing. See Fee Order, 2024 WL 5105618, at *1. The court noted that Chro- maDex stipulated to the court’s construction and “the out- come of this case would not have changed had [the court] adopted the purity requirement in the construction of ‘iso- lated NR’ originally proposed by ChromaDex.” Id. ChromaDex timely appealed. We have jurisdiction un- der 28 U.S.C. § 1295(a)(1). STANDARD OF REVIEW “The court in exceptional cases may award reasonable attorney fees to the prevailing party.” 35 U.S.C. § 285. “District courts may determine whether a case is ‘excep- tional’ in the case-by-case exercise of their discretion, con- sidering the totality of the circumstances.” Octane Fitness, LLC v. ICON Health & Fitness, Inc., 572 U.S. 545, 554 (2014). An exceptional case is “one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated.” Id. While we review “all aspects of a district court’s § 285 determination for abuse of discretion,” Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., 572 U.S. 559, 561 (2014), the “abuse-of-discretion standard does not preclude an ap- pellate court’s correction of a district court’s legal or factual error,” id. at 563 n.2. “A district court would necessarily Case: 25-1227 Document: 56 Page: 9 Filed: 10/30/2026 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 9 abuse its discretion if it based its ruling on an erroneous view of the law or on a clearly erroneous assessment of the evidence.” Id. (citation omitted). DISCUSSION “A party’s position on issues of law ultimately need not be correct for them to not ‘stand[ ] out,’ or be found reason- able.” SFA Sys., LLC v. Newegg Inc., 793 F.3d 1344, 1348 (Fed. Cir. 2015) (quoting Octane Fitness, 572 U.S. at 554). In other words, an exceptionality finding hinges not on “the correctness or eventual success of [a party’s] position,” but on its “substantive strength.” Id. The substantive strength of the party’s position must be “exceptionally meritless” to warrant an award of attorneys’ fees pursuant to 35 U.S.C. § 285. See Realtime Adaptive Streaming L.L.C. v. Sling TV, L.L.C., 113 F.4th 1348, 1356 (Fed. Cir. 2024). Here, the district court grounded its exceptionality finding on its view that Myriad completely foreclosed Chro- maDex’s § 101 position. See Decision, 2024 WL 1255520, at *3 (“And even though the law of patent eligibility has perhaps become unpredictable and unclear on the fringes, the law is very clear when, as here, the Supreme Court has addressed the specific issue presented.”) (cleaned up). The court reasoned that “[t]he holding of Myriad is crystal clear—the mere isolating of a naturally occurring molecule without changing the chemistry of that molecule is not pa- tent eligible under § 101,” and “that holding—which Chro- maDex essentially ignored—was dispositive.” Id. at *2. The court also found it significant that “ChromaDex’s brief- ing in opposition to Elysium’s summary judgment motion . . . mentioned Myriad just once.” Id. That is, in the court’s view, “ChromaDex made no attempt to distinguish Myriad” to defend the validity of the patents-in-suit. Id. at *3. In our view, it was legal error to treat Myriad as the beginning and the end of the patent-eligibility analysis for ChromaDex’s claims. To be sure, Myriad played a key role in our analysis in ChromaDex I. As we explained, “the act Case: 25-1227 Document: 56 Page: 10 Filed: 10/30/2026 10 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. of isolating the NR compared to how NR naturally exists in milk is not sufficient, on its own, to confer patent eligibil- ity.” 59 F.4th at 1284 (emphasis added) (citing Myriad, 569 U.S. at 590–93). Had ChromaDex’s § 101 arguments rested solely on the distinction that its NR is structurally “isolated” from other components in its claimed composi- tions, such an argument “on its own” would have closely resembled the rejected § 101 argument for the isolated DNA at issue in Myriad. But ChromaDex’s arguments went further, thus re- quiring additional, meaningful analysis. Namely, Chro- maDex’s patent-eligibility position centered on the alleged similarity between its claimed composition and the compo- sition in Natural Alternatives, and how the patent eligibil- ity analysis there could apply equally here. See J.A. 2383. In particular, ChromaDex argued that its claimed compo- sitions possessed markedly different characteristics and had the potential for significant utility because its isolated NR can increase NAD+ biosynthesis in a way that natu- rally-occurring NR cannot. See ChromaDex I, 59 F.4th at 1284–85; see also J.A. 3314–27 (expert report from Dr. Sobol, who opined that the claimed compositions “have sig- nificant utility to be used in ways that NR appearing in nature cannot.”). Evaluating the merits of ChomaDex’s po- sition required working through several distinct consider- ations, beyond just Myriad, including whether the claimed compositions have markedly different characteristics and the potential for significant utility, the amount of NR re- quired by the claims, and NR’s role in increasing NAD+ bi- osynthesis. Our decision in ChromaDex I illustrates this point. 59 F.4th at 1284–85. There, we explained that the claimed dietary supplements in Natural Alternatives were patent eligible because they possess significant utility and mark- edly different characteristics over naturally occurring beta- alanine. ChromaDex I, 59 F.4th at 1284. Specifically, the Case: 25-1227 Document: 56 Page: 11 Filed: 10/30/2026 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. 11 “natural products ha[d] been isolated and then incorpo- rated into a dosage form” in an amount to “effectively in- crease[] athletic performance. Id. (quoting Natural Alternatives, 918 F.3d at 1348–49). Likewise, ChromaDex contended that its claimed compositions provided the same sort of “significant utility” because “the isolation of NR al- lows for significantly more NAD+ biosynthesis than is found in milk and that the large quantity of NR itself can alone increase NAD+ biosynthesis.” Id. We ultimately rejected that argument and its reliance on Natural Alternatives after considering a number of fac- tors. Our analysis reached the following conclusions: (1) the claims “do not require any specific quantity of isolated NR” and do not “attribute the claimed increase in NAD+ biosynthesis to the isolated NR”; (2) under the district court’s claim construction for “isolated [NR],” the isolated NR need not be separated from the lactalbumin whey pro- tein and thus need not be bioavailable; and (3) milk, through tryptophan rather than the trace amounts of NR, increases NAD+ biosynthesis. ChromaDex I, 59 F.4th at 1284–85. These were factors we had to consider beyond the facts and analysis provided in Myriad in addressing Chro- maDex’s “markedly different characteristics” argument. Thus, we do not view this case as open and shut in light of Myriad. For the foregoing reasons, we conclude that while ChromaDex’s arguments ultimately did not prevail, it can- not be said that the substantive strength of its § 101 posi- tion was so exceptionality meritless or unreasonable as to make this case stand out from others. Because the district court legally erred in finding Myriad dispositive, it abused Case: 25-1227 Document: 56 Page: 12 Filed: 10/30/2026 12 CHROMADEX, INC. v. ELYSIUM HEALTH, INC. its discretion in granting the § 285 fee award. 5 See High- mark, 572 U.S. at 561. CONCLUSION We have considered Elysium’s remaining arguments and find them unpersuasive. For the foregoing reasons, we reverse the district court’s § 285 fee award. REVERSED COSTS Costs to Appellant. 5 We also reject Elysium’s invitation to remand the case to the district court. We conclude that neither the dis- trict court’s analysis nor the record developed and argu- ment presented by Elysium, see, e.g., J.A. 2883–89, can support the exceptionality finding. Under these circum- stances, “[a] remand is not warranted in this case for addi- tional costly proceedings to give [Elysium] a chance to develop and present new evidence or arguments.” mCom IP, LLC v. City Nat’l Bank of Fla., 175 F.4th 1370, 1381 (Fed. Cir. 2026) (citing Fox v. Vice, 563 U.S. 826, 838 (2011) (“The determination of fees ‘should not result in a second major litigation.’”)).