Court Opinion

ID: 9370404
Source: CourtListenerOpinion
Date Created: 2023-02-13 15:00:35.464062+00
Date Added: 2024-06-11T17:16:21.592814
License: Public Domain

Case: 22-1116    Document: 44    Page: 1   Filed: 02/13/2023

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

  CHROMADEX, INC., TRUSTEES OF DARTMOUTH
                  COLLEGE,
              Plaintiffs-Appellants

                            v.

                ELYSIUM HEALTH, INC.,
                    Defendant-Appellee
                  ______________________

                        2022-1116
                  ______________________

     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: February 13, 2023
                 ______________________

      WILLIAM L. MENTLIK, Lerner, David, Littenberg,
 Krumholz & Mentlik, LLP, Cranford, NJ, argued for plain-
 tiffs-appellants.  Also represented by RUSSELL W.
 FAEGENBURG, STEPHEN F. ROTH; ROBERT JASON FOWLER,
 CHRISTOPHER NEIL SIPES, ASHLEY MARIE WINKLER, Coving-
 ton & Burling LLP, Washington, DC.

    JEREMY YOUNKIN, Foley Hoag LLP, Boston, MA, ar-
 gued for defendant-appellee. Also represented by DONALD
 ROSS WARE.
                 ______________________
Case: 22-1116      Document: 44    Page: 2     Filed: 02/13/2023

 2                    CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.

         Before PROST, CHEN, and STOLL, Circuit Judges.
 PROST, Circuit Judge.
     ChromaDex, Inc. (“ChromaDex”) and the Trustees of
 Dartmouth College (“Dartmouth”) (collectively, “Appel-
 lants”) appeal the decision of the U.S. District Court for the
 District of Delaware granting Elysium Health, Inc.’s (“Ely-
 sium”) motion for summary judgment that the asserted
 claims of U.S. Patent No. 8,197,807 (“the ’807 patent”) are
 directed to unpatentable subject matter under 35 U.S.C.
 § 101. 1 We affirm.
                         BACKGROUND
                               I
     The ’807 patent is directed to dietary supplements con-
 taining isolated nicotinamide riboside (“NR”), a form of vit-
 amin B3 naturally present—in non-isolated form—in cow’s
 milk and other products. 2 See ’807 patent col. 27 ll. 42–45.
 Animal cells convert ingested NR into the coenzyme nico-
 tinamide adenine dinucleotide, or NAD+. NAD+ deficien-
 cies can cause diseases in both animals and humans.
    The asserted claims are claims 1–3 of the ’807 patent.
 Representative claim 1 recites:
     1. A composition comprising isolated nicotinamide
     riboside in combination with one or more of trypto-
     phan, nicotinic acid, or nicotinamide, wherein said
     combination is in admixture with a carrier

     1   Appellants also sought review of the district court’s
 invalidation of claim 2 of U.S. Patent No. 8,383,086. The
 voluntary dismissal of a related appeal mooted that part of
 the case.
     2   For the sake of brevity, we use the word “milk” in
 the rest of this opinion to describe natural cow’s milk.
Case: 22-1116      Document: 44     Page: 3    Filed: 02/13/2023

 CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.                     3

     comprising a sugar, starch, cellulose, powdered
     tragacanth, malt, gelatin, talc, cocoa butter, sup-
     pository wax, oil, glycol, polyol, ester, agar, buffer-
     ing agent, alginic acid, isotonic saline, Ringer’s
     solution, ethyl alcohol, polyester, polycarbonate, or
     polyanhydride, wherein said composition is formu-
     lated for oral administration and increased NAD+
     biosynthesis upon oral administration.
                               II
     ChromaDex sells, among other products, dietary sup-
 plements in the form of pharmaceutical compositions of NR
 embodying the ’807 patent. It licenses the patent from
 Dartmouth. Appellants sued Elysium, a former Chro-
 maDex customer, for patent infringement in September
 2018. The district court construed several claim terms; rel-
 evant here, the court construed “isolated [NR]” to mean
 “[NR] that is separated or substantially free from at least
 some other components associated with the source of [NR].”
 J.A. 22.
      Elysium moved for summary judgment, arguing that
 the asserted claims were invalid under 35 U.S.C. § 101,
 and the district court granted the motion. See ChromaDex,
 Inc. v. Elysium Health, Inc., 561 F. Supp. 3d 460 (D. Del.
 2021). The district court concluded that the claims were
 directed to a natural phenomenon, namely, “compositions
 comprising isolated [NR], a naturally occurring vitamin
 present in cow milk.” Id. at 464 (cleaned up). It rejected
 ChromaDex’s argument that the characteristics of isolated
 NR purportedly different from naturally occurring NR—
 stability, bioavailability, sufficient purity, and therapeutic
 efficacy—render the claims patent-eligible, observing that
 none of those characteristics were part of the claims. Id.
 at 465. It concluded that “the decision to create an oral for-
 mulation of NR after discovering that NR is orally bioavail-
 able is simply applying a patent-ineligible law of nature.”
 Id. at 467.
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 4                   CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.

     The district court entered judgment of invalidity, and
 this appeal followed. 3     We have jurisdiction under
 28 U.S.C. § 1295(a)(1).
                         DISCUSSION
                               I
     We review the district court’s grant of summary judg-
 ment under the law of the regional circuit, here the Third
 Circuit, which reviews such issues de novo. Junker v. Med.
 Components, Inc., 25 F.4th 1027, 1032 (Fed. Cir. 2022) (cit-
 ing Gonzalez v. Sec’y of Dep’t of Homeland Sec., 678 F.3d
 254, 257 (3d Cir. 2012)). Summary judgment is appropri-
 ate when, drawing all reasonable inferences in the non-
 moving party’s favor, “there is no genuine dispute as to any
 material fact and the movant is entitled to judgment as a
 matter of law.” Fed. R. Civ. P. 56(a); Anderson v. Liberty
 Lobby, Inc., 477 U.S. 242, 255 (1986). Eligibility under
 § 101 may involve questions of fact but is, ultimately, a
 question of law that we review de novo. Nat. Alts. Int’l, Inc.
 v. Creative Compounds, LLC, 918 F.3d 1338, 1342
 (Fed. Cir. 2019); Interval Licensing LLC v. AOL, Inc., 896
 F.3d 1335, 1342 (Fed. Cir. 2018).
     “Whoever invents or discovers any new and useful pro-
 cess, machine, manufacture, or composition of matter, or
 any new and useful improvement thereof, may obtain a

     3    Appellants also challenge the district court’s orders
 granting-in-part Elysium’s motion to dismiss for lack of
 standing and denying its motion for leave to amend, as well
 as one of its claim constructions. The district court’s stand-
 ing order only dismissed claims of infringement based on
 activities alleged to have occurred on or after March 13,
 2017, see J.A. 16–17, so the eligibility issue remained
 live. Because we affirm the district court’s invalidity judg-
 ment, we do not reach either the standing or the claim con-
 struction issues.
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 CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.                   5

 patent therefor, subject to the conditions and requirements
 of this title.” 35 U.S.C. § 101. “Laws of nature, natural
 phenomena, and abstract ideas,” in contrast, “are not pa-
 tentable.” Ass’n for Molecular Pathology v. Myriad Genet-
 ics, Inc., 569 U.S. 576, 589 (2013).
                               II
      The parties agree that NR is naturally present in milk.
 It is undisputed that milk is a naturally occurring product
 that is not patent eligible. The parties also acknowledge
 that milk contains tryptophan and lactose, a sugar. And
 no one disputes that the tryptophan in milk treats NAD+
 deficiencies. The claims are very broad and read on milk
 with only one difference as shown:

      Element                          Milk

     [1p] “A       composition Milk is a composition.
  comprising”

      [1a] “isolated [NR]”          Milk contains NR, but the
                                    NR is not isolated. J.A.
                                    10095.

      [1b] “in combination Milk contains tryptophan
  with one or more of trypto- and nicotinamide. J.A.
  phan, nicotinic acid, or nico- 10095.
  tinamide”

      [1c] “wherein said com- Milk is an admixture con-
  bination is an admixture taining a sugar (lactose).
  with a carrier comprising a J.A. 10096
  sugar, starch, cellulose,
  powdered tragacanth, malt,
  gelatin, talc, cocoa butter,
  suppository wax, oil, glycol,
  polyol, ester, agar, buffering
  agent, alginic acid, isotonic
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 6                   CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.

  saline, Ringer’s solution,
  ethyl alcohol, polyester, pol-
  ycarbonate, or polyanhy-
  dride”

      [1d] “wherein said com- Milk is formulated for oral
  position is formulated for administration. See J.A.
  oral administration”        10096.

      [1e] “and increases Milk (through tryptophan)
  NAD+ biosynthesis upon increases NAD+ biosyn-
  oral administration.”   thesis upon consump-
                          tion. See J.A. 10096.

     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 Supreme Court’s decisions in Myriad and Dia-
 mond v. Chakrabarty, 447 U.S. 303, 309 (1980), apply here.
 In Chakrabarty, the Court found eligible claims to a genet-
 ically engineered bacterium “capable of breaking down
 multiple components of crude oil.” 447 U.S. at 305, 318.
 No naturally occurring bacteria possessed the same prop-
 erty. Id. Accordingly, in the Court’s view, the “claim [was]
 not to a hitherto unknown natural phenomenon, but to a
 nonnaturally occurring manufacture or composition of
 matter—a product of human ingenuity having a distinctive
 name, character and use.” Id. at 309–10 (cleaned up). Be-
 cause “the patentee ha[d] produced a new bacterium with
 markedly different characteristics from any found in na-
 ture and one having the potential for significant utility,”
 the Court upheld the claims. Id. at 310.
     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. See Myriad, 569 U.S. at 590–93. The claimed
 compositions remain indistinguishable from natural milk
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 CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.                  7

 because, other than separation from some other compo-
 nents, the isolated NR is no different structurally or func-
 tionally from its natural counterpart in 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.” 447 U.S. at 310.
 Milk, like the claimed compositions, undisputedly “in-
 crease[s] NAD+ biosynthesis” upon oral administration.
 The claimed compositions do not exhibit markedly different
 characteristics from natural milk and are, therefore, inva-
 lid for claiming a patent-ineligible product of nature. Cf.
 Myriad, 569 U.S. at 579 (concluding “that a naturally oc-
 curring DNA segment is a product of nature and not patent
 eligible merely because it has been isolated” (emphasis
 added)).
     Our Natural Alternatives decision is particularly in-
 structive. There, we upheld, at the motion-to-dismiss
 stage, claims directed to dietary supplements containing
 beta-alanine. See 918 F.3d at 1341. We concluded that the
 patents there claimed “specific treatment formulations
 that incorporate[d] natural products” and that those for-
 mulations “ha[d] different characteristics and c[ould] be
 used in a manner that beta-alanine as it appears in nature
 cannot.” Id. at 1348. Specifically, the “natural products
 ha[d] been isolated and then incorporated into a dosage
 form”—“between about 0.4 grams to 16 grams”—“with par-
 ticular characteristics”—namely, to “effectively increase[]
 athletic performance.” Id. at 1348–49. Those markedly dif-
 ferent characteristics distinguished the claimed supple-
 ments from natural beta-alanine and preserved the claims’
 validity. Id. at 1349.
     Here, in contrast, the asserted claims do not have char-
 acteristics markedly different from milk. Both the claimed
 compositions and milk “increase[] NAD+ biosynthesis upon
 oral administration.” Appellants argue that the claimed
 compositions are advantageous over milk because the iso-
 lation of NR allows for significantly more NAD+
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 8                   CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.

 biosynthesis than is found in milk and that the large quan-
 tity of NR itself can alone increase NAD+ biosynthesis. But
 the asserted claims do not require any minimum quantity
 of isolated NR. Nor do these claims attribute the claimed
 increase in NAD+ biosynthesis to the isolated NR, requir-
 ing only that the composition increase NAD+ production.
 Because milk increases NAD+ biosynthesis, the claimed
 compositions do not possess characteristics markedly dif-
 ferent from those found in nature. 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 inva-
 lid under § 101.
      Appellants nonetheless argue that the claims, in fact,
 possess markedly different characteristics that render
 them patent-eligible. See Appellants’ Br. 28–31. They base
 this argument on two main points: (1) “NR is found in milk
 in only trace amounts,” i.e., one part per million; and
 (2) “what little NR is found in milk is not bioavailable” be-
 cause it is bound to the lactalbumin whey protein. Id. at
 29. 4 The problem for Appellants is two-fold. First, as

     4    Appellants also identify a factual error in the dis-
 trict court’s opinion. The court stated that it was “undis-
 puted that NR in milk . . . enhances NAD+ biosynthesis.”
 ChromaDex, 561 F. Supp. 3d at 465. Appellants correctly
 point out that the NR in milk does not enhance NAD+ bio-
 synthesis, that it argued as much to the district court, and
 that Elysium conceded the point. See, e.g., J.A. 10245 (Ely-
 sium admitting that “one can’t eat enough of anything [con-
 taining trace amounts of NR] to boost NAD+ levels”). That
 error was harmless, however, because the claims do not re-
 quire that the NR, specifically, increase NAD+
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 CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.                  9

 discussed above, milk increases NAD+ biosynthesis (albeit
 because it contains tryptophan rather than because of the
 trace amounts of NR), and that is the only therapeutic ef-
 fect that the claims require. Second, the claims simply do
 not reflect the distinctions Appellants rely on: they do not
 require any specific quantity of isolated NR, and the dis-
 trict court’s construction for “isolated [NR],” which Appel-
 lants do not challenge on appeal, 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].” J.A. 22 (emphasis added). The claims,
 therefore, do not necessarily require that the isolated NR
 be bioavailable, meaning that the claimed compositions do
 not necessarily possess markedly different characteristics
 from milk, as they must to be patent-eligible.
     We conclude that the asserted claims lack markedly
 different characteristics from milk. They claim a product
 of nature and are not patent eligible.
                              III
      The inquiry could end here—the Supreme Court in
 Myriad relied on Chakrabarty’s “markedly different char-
 acteristics” framework for analyzing whether the claimed
 compositions there were directed to a natural phenomenon;
 the Court never applied the Alice/Mayo two-step frame-
 work despite deciding the case after Mayo. See Myriad, 569
 U.S. at 593–95; see also 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). But
 if 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

 biosynthesis; it is enough if the claimed composition accom-
 plishes that objective, and milk does so.
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 10                  CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.

 nothing more than compositions that increase NAD+ bio-
 synthesis, which is the very natural principle that renders
 the claims patent-ineligible. 5
      Appellants identify only two possible inventive steps:
 “[1] recognizing the utility of NR for enhancing health and
 well-being and [2] the wisdom of isolating the NR to pro-
 vide concentrations higher than what occur naturally.” Ap-
 pellants’ Br. 31 (emphasis original). But recognizing the
 utility of NR is nothing more than recognizing a natural
 phenomenon, which is not inventive. See Myriad, 569 U.S.
 at 591. 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), simi-
 larly does not turn an otherwise patent-ineligible product
 of nature into a patentable invention. See id. So the claims
 would likewise fail at step two.
                        CONCLUSION
     We have considered Appellants’ remaining arguments
 and find them unpersuasive. As Appellants conceded at
 oral argument, our resolution of the patent-eligibility issue
 moots the standing question. For the reasons set forth

      5   In Natural Alternatives, we purported to analyze
 the patent-eligibility of the claimed compositions under Al-
 ice/Mayo’s two-step framework. See Nat. Alts., 918 F.3d at
 1342, 1348–49. But because we concluded that factual al-
 legations relating to the claimed compositions’ markedly
 different characteristics from natural beta-alanine pre-
 cluded judgment on the pleadings, the analysis function-
 ally examined only the Chakrabarty question. See id. at
 1348. Indeed, in one prior case, we analyzed composition-
 of-matter claims under Myriad and Chakrabarty but ana-
 lyzed method claims under Mayo. Compare In re BRCA1-
 and BRCA2, 774 F.3d 755, 759–61 (Fed. Cir. 2014), with
 id. at 761–765.
Case: 22-1116    Document: 44     Page: 11   Filed: 02/13/2023

 CHROMADEX, INC.   v. ELYSIUM HEALTH, INC.                11

 above, we affirm the district court’s judgment that the as-
 serted claims of the ’807 patent are invalid under 35 U.S.C.
 § 101.
                         AFFIRMED