Janssen Ortho, LLC v. United States ( 2021 )


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  • Case: 20-1663    Document: 49-2     Page: 1   Filed: 04/13/2021
    United States Court of Appeals
    for the Federal Circuit
    ______________________
    JANSSEN ORTHO, LLC,
    Plaintiff-Appellee
    v.
    UNITED STATES,
    Defendant-Appellant
    ______________________
    2020-1663
    ______________________
    Appeal from the United States Court of International
    Trade in No. 1:13-cv-00296-JCG, Judge Jennifer Choe-
    Groves.
    ______________________
    SEALED OPINION ISSUED: April 13, 2021
    PUBLIC OPINION ISSUED: April 26, 2021 ∗
    ______________________
    GREGORY DISKANT, Patterson Belknap Webb & Tyler
    LLP, New York, NY, argued for plaintiff-appellee. Also
    represented by ANDREW D. COHEN, DANIEL M. EISENBERG,
    EMMA ELLMAN-GOLAN, JOSHUA A. KIPNEES, AMY VEGARI;
    LARS-ERIK ARTHUR HJELM, Akin Gump Strauss Hauer &
    Feld LLP, Washington, DC.
    ∗   This opinion was originally filed under seal and has
    been unsealed in full.
    Case: 20-1663    Document: 49-2     Page: 2   Filed: 04/13/2021
    2                                 JANSSEN ORTHO, LLC   v. US
    GUY EDDON, International Trade Field Office, United
    States Department of Justice, New York, NY, argued for
    defendant-appellant. Also represented by JEFFREY B.
    CLARK, JEANNE DAVIDSON, JASON M. KENNER, PATRICIA M.
    MCCARTHY, MONICA PERRETTE TRIANA; ALEXANDRA
    KHREBTUKOVA, Office of Assistant Chief Counsel, United
    States Bureau of Customs and Border Protection, New
    York, NY.
    ______________________
    Before PROST, Chief Judge, MAYER and WALLACH, Circuit
    Judges.
    WALLACH, Circuit Judge.
    Appellee, Janssen Ortho, LLC (“Janssen”), filed suit
    against Appellant, the United States (“the Government”),
    in the U.S. Court of International Trade (“CIT”), challeng-
    ing U.S. Customs and Border Protection’s (“Customs” or
    “CBP”) classification of Janssen’s darunavir ethanolate,
    the active ingredient in Prezista®, a medication for the
    treatment of the human immunodeficiency virus (“HIV”),
    under the Harmonized Tariff Schedule of the United States
    (“HTSUS”) and the Pharmaceutical Appendix to the Tariff
    Schedule (“Pharmaceutical Appendix”). 1 Janssen alleges
    that it has paid approximately $100 million in duties for
    entries of darunavir ethanolate that should have received
    duty-free treatment. Following a bench trial, the CIT con-
    cluded that the subject merchandise was properly classi-
    fied under HTSUS subheading 2935.00.60 and subject to
    duty-free treatment under the Pharmaceutical Appendix.
    Janssen Ortho LLC v. United States, 
    425 F. Supp. 3d 1352
    ,
    1   All citations to the HTSUS are to the 2010 version,
    in keeping with Janssen’s initial entries at issue. See
    LeMans Corp. v. United States, 
    660 F.3d 1311
    , 1314 n.2
    (Fed. Cir. 2011).
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    JANSSEN ORTHO, LLC   v. US                                 3
    1355 (Ct. Int’l Trade), as amended (Feb. 19, 2020), judg-
    ment entered, 
    429 F. Supp. 3d 1383
     (Ct. Int’l Trade 2020);
    see J.A. 36 (Judgment).
    The Government appeals the CIT’s decision as to da-
    runavir ethanolate’s duty-free treatment. We have juris-
    diction pursuant to 
    28 U.S.C. § 1295
    (a)(5). We affirm.
    BACKGROUND
    I. Statutory Framework
    The HTSUS governs the classification of merchandise
    imported into the United States. See Wilton Indus., Inc. v.
    United States, 
    741 F.3d 1263
    , 1266 (Fed. Cir. 2013). “The
    HTSUS scheme is organized by headings, each of which
    has one or more subheadings; the headings set forth gen-
    eral categories of merchandise, and the subheadings pro-
    vide a more particularized segregation of the goods within
    each category.” 
    Id.
     “The first four digits of an HTSUS pro-
    vision constitute the heading, whereas the remaining dig-
    its reflect subheadings.” Schlumberger Tech. Corp. v.
    United States, 
    845 F.3d 1158
    , 1163 n.4 (Fed. Cir. 2017).
    “[T]he headings and subheadings . . . are enumerated in
    chapters 1 through 99 of the HTSUS (each of which has its
    own section and chapter notes)[.]” R.T. Foods, Inc. v.
    United States, 
    757 F.3d 1349
    , 1353 (Fed. Cir. 2014). There
    are two types of HTSUS headings, “eo nomine [and] use
    provisions.” Schlumberger, 845 F.3d at 1164. “[A]n eo
    nomine provision . . . describes an article by a specific
    name.” CamelBak Prods., LLC v. United States, 
    649 F.3d 1361
    , 1364 (Fed. Cir. 2011) (citation omitted). A use provi-
    sion describes an article by its principal or actual use. See
    Aromont USA, Inc. v. United States, 
    671 F.3d 1310
    , 1313
    (Fed. Cir. 2012).
    The HTSUS is “considered . . . [a] statutory provision[]
    of law for all purposes.” 
    19 U.S.C. § 3004
    (c)(1). “The legal
    text of the HTS[US] includes all provisions enacted by Con-
    gress or proclaimed by the President,” HTSUS, Preface 1
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    4                                    JANSSEN ORTHO, LLC    v. US
    (22d ed. 2010), including the headings, subheadings, “Gen-
    eral Rules of Interpretation” (“GRI”), “Additional [U.S.]
    Rules of Interpretation” (“ARI”), “General Notes,” and “var-
    ious appendices for particular categories of goods.” R.T.
    Foods, 757 F.3d at 1353 (footnote omitted); see Chemtall,
    Inc. v. United States, 
    878 F.3d 1012
    , 1026 (Fed. Cir. 2017)
    (explaining that “the tenth-digit statistical suffixes . . . are
    not statutory,” as those suffixes are not incorporated in the
    HTSUS’s legal text). 2
    “In 1995, the United States and [twenty-one] other
    countries” entered into the “Pharmaceutical Zero-for-Zero
    Initiative,” agreeing “to [reciprocally] eliminate tariffs on
    pharmaceutical products, their derivatives, and certain
    chemical intermediates used to manufacture pharmaceuti-
    cals.” Advice Concerning the Addition of Certain Pharm.
    Prod. & Chem. Intermediates to the Pharm. Appendix to the
    [HTSUS] (“USITC Pharma. Advice”), Inv. No. 332-476,
    USITC Pub. 3883, 
    2006 WL 2950495
    , at *1 (2006). The
    United States codified this agreement through HTSUS
    General Note 13 and the Pharmaceutical Appendix. Id.
    at *6. “General Note 13 permits duty free treatment of cer-
    tain pharmaceutical products[.]” Forest Labs., Inc. v.
    United States, 
    476 F.3d 877
    , 882 (Fed. Cir. 2007). It pro-
    vides that “[w]henever” an HTSUS heading or subheading
    has the “symbol ‘K’ in parentheses” in the “‘Special’ [duty
    rate] subcolumn,” “any product (by whatever name known)
    classifiable in such provision which is the product of a
    2   The GRI and ARI govern the classification of goods
    within the HTSUS. See Otter Prods., LLC v. United States,
    
    834 F.3d 1369
    , 1375 (Fed. Cir. 2016). The GRI “govern the
    proper classification of all merchandise.” Carl Zeiss, Inc. v.
    United States, 
    195 F.3d 1375
    , 1379 (Fed. Cir. 1999). The
    ARI are specific to use provisions. See Schlumberger, 845
    F.3d at 1163 n.5 (explaining that the ARI do not apply to
    eo nomine provisions).
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    JANSSEN ORTHO, LLC   v. US                                    5
    country eligible for tariff treatment . . . shall be entered
    free of duty, provided that such product is included in the
    [P]harmaceutical [A]ppendix.” HTSUS, General Note 13
    (emphasis omitted); see USITC Pharma. Advice, 
    2006 WL 2950495
    , at *6 (similar).
    Table 1 of the Pharmaceutical Appendix “enumerates
    products described by International Non-proprietary
    Names [(‘INN’)],” 3 with “[t]he Chemical Abstracts Service
    [(‘CAS’)] registry numbers also set forth . . . to assist in the
    identification of the products concerned,” 4 to “be entered
    free of duty under [G]eneral [N]ote 13 to the [HTSUS].”
    Pharmaceutical Appendix at 2 (Table 1 Chapeau). The
    chapeau to Table 1 further provides that, “[f]or purposes of
    the [HTSUS], any references to a product enumerated in
    [Table 1] includes such product by whatever name known.”
    
    Id.
     Table 1 lists “darunavir,” along with the CAS registry
    number “206361-99-1.” Pharmaceutical Appendix at 15.
    Table 2 of the Pharmaceutical Appendix provides that the
    “[s]alts, esters[,] and hydrates of the products enumerated
    in [T]able 1 . . . that contain in their names any of the pre-
    fixes or suffixes listed [in Table 2] shall also be entered free
    of duty under [G]eneral [N]ote 13” so long as they are “clas-
    sifiable in the same” HTSUS heading “enumerated in
    [T]able 1.” Pharmaceutical Appendix at 57 (Table 2
    3  INNs are invented, non-proprietary names as-
    signed to “[p]harmaceutical [s]ubstances” by the World
    Health Organization (“WHO”). J.A. 1348; see J.A. 369–70,
    443–44.
    4  CAS is a division of the American Chemical Society
    that collects and indexes publications and research in
    chemistry and related sciences, including creating and
    maintaining a “registry of substances.” J.A. 1119–21,
    1248. CAS assigns “[e]ach unique chemical substance” its
    own CAS registry number. J.A. 1153–54.
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    6                                    JANSSEN ORTHO, LLC    v. US
    Chapeau); see 
    id.
     (providing that Table 2 similarly covers
    “such product by whatever name known”).
    II. The Subject Merchandise
    This appeal involves multiple entries of darunavir eth-
    anolate, made by Janssen at the port of San Juan, Puerto
    Rico, between September 2010 and March 2012. J.A. 1246,
    4452–55; see J.A. 1246–50 (Stipulated Facts), 4452–55
    (Summons); see also Janssen, 425 F. Supp. 3d at 1355,
    1361. 5 Janssen is a subsidiary of Johnson & Johnson and
    the owner of 
    U.S. Patent No. 7,700,645
     (“the ’645 patent”),
    which discloses darunavir ethanolate. J.A. 1247; see
    ’645 patent, col. 29 l. 62–col. 30 l. 65 (claims 1–8) (expressly
    claiming darunavir ethanolate solvate).
    “[D]arunavir in the form of darunavir ethanolate” is
    “[t]he active pharmaceutical ingredient in Prezista,” a
    medication for the treatment of HIV. Janssen, 425 F. Supp.
    3d at 1357; see id. (“Prezista is a human [HIV-1] protease
    inhibitor indicated for the treatment of HIV-1 Infection.”);
    J.A. 1247 (“Darunavir is the non-proprietary or generic
    name for Prezista[.]”). “Darunavir” is the INN assigned to
    TMC-114, a compound developed by Janssen’s predecessor
    in interest to the ’645 patent, for the treatment of HIV.
    J.A. 1280–81 (INN Application), 1348–49 (INN Assign-
    ment). “Darunavir” is also the INN for Prezista and da-
    runavir ethanolate. Janssen, 425 F. Supp. 3d at 1357.
    Darunavir ethanolate has the chemical names “Car-
    bamic acid, N-[(1S,2R)-3-[[(4-aminophenyl)sulfonyl](2-
    methylpropyl)amino]-2-hydroxy-1-(phenylmethyl)propyl]-,
    (3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl ester, compd.
    with ethanol (1:1)” and “Carbamic acid, [(1S,2R)-3-[[4-ami-
    nophenyl)sulfonyl](2-methylpropyl)amino]-2-hydroxy-1-
    5  Unless otherwise noted, we cite to the CIT’s undis-
    puted recitation of the facts for ease of reference. See
    Janssen, 425 F. Supp. 3d at 1355–57.
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    JANSSEN ORTHO, LLC   v. US                                  7
    (phenylmethyl)propyl]-, (3R,3aS,6aR)-hexahydrofuro[2,3-
    b]furan-3-yl ester, compd. with ethanol (1:1) (9CI).”
    Janssen, 425 F. Supp. 3d at 1356; see J.A. 1347; see also
    J.A. 1249 (stipulating to the same). It is a sulfonamide.
    Janssen, 425 F. Supp. 3d at 1356; see id. (“Darunavir con-
    tains a sulfonamide moiety.”). Further, as indicated by its
    chemical names, darunavir ethanolate is darunavir com-
    pounded with ethanol. Id. at 1356; see J.A. 1249. Da-
    runavir ethanolate is produced “by crystallizing darunavir
    and ethanol molecules into a crystal lattice structure.”
    Janssen, 425 F. Supp. 3d at 1356; see id. (“Darunavir is
    crystalized in an ethanol bath to form darunavir ethano-
    late.”). “Darunavir ethanolate is a channel solvate,” id.,
    that presents as a “white powder,” J.A. 355; see J.A. 280–
    81 (explaining that, prior to crystallization, darunavir is a
    yellow liquid at normal temperature and pressure).
    In June 1998, CAS assigned darunavir CAS registry
    number 206361-99-1. J.A. 1248 (“CAS assigned the CAS
    registry no. 206361-99-1 to darunavir on June 4, 1998.”);
    see J.A. 1185. In January 2004, following publication of the
    application that led to the ’645 patent, CAS assigned da-
    runavir ethanolate CAS registry number 635728-49-3.
    J.A. 1248 (“CAS assigned the CAS registry no. 635728-49-
    3 to darunavir ethanolate on January 9, 2004.”); see ’645
    patent, Title Page; J.A. 1286 (parent PCT application); see
    also J.A 1661 (CAS Registry). Generally, CAS does not sep-
    arately index solvates, J.A. 1150, unless, for example the
    solvate is specifically patented, J.A. 1151–52, 1179–80.
    In 2006, the U.S. Food and Drug Administration
    (“FDA”) approved Prezista. J.A. 1415–16, 1420. The FDA
    adopted Prezista’s existing INN, “darunavir,” as the ge-
    neric name for darunavir ethanolate. J.A. 363, 457–58,
    1005–06; see Janssen, 425 F. Supp. 3d at 1357 (“The pre-
    scribing information for Prezista describes the product as
    ‘PREZISTA (darunavir), in the form of darunavir ethano-
    late[.]’” (citation omitted)); id. (“The United States Adopted
    Name (‘USAN’) for Prezista is darunavir.”). Following
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    8                                   JANSSEN ORTHO, LLC   v. US
    importation, Janssen tablets darunavir ethanolate with
    various inactive ingredients to make Prezista. J.A. 354–
    56, 1418; see Janssen, 425 F. Supp. 3d at 1357 (“Darunavir
    ethanolate is the drug substance in Prezista.”). “Darunavir
    ethanolate is the only commercially available form of da-
    runavir.” Janssen, 425 F. Supp. 3d at 1357; see id.
    (“Janssen has not developed darunavir in a form other than
    darunavir ethanolate for commercial use.”).
    III. Procedural History
    Customs liquidated Janssen’s entries under HTSUS
    subheading 2935.00.95, at a duty rate of 6.5 percent ad val-
    orem. J.A. 4453; see HTSUS subheading 2935.00.95 (cov-
    ering “Sulfonamides: Other: Drugs: Other”). Janssen filed
    protests of these actions, asserting that its darunavir eth-
    anolate should have been classified under HTSUS sub-
    heading      3003.90.00,     duty     free,    or    HTSUS
    subheading 2935.00.60, duty free. Janssen, 425 F. Supp.
    3d at 1355; J.A. 4453; see 
    19 U.S.C. § 1514
    (a)(2) (providing
    that an importer may protest to Customs “the classification
    and rate and amount of duties chargeable” on an entry);
    HTSUS subheading 3003.90.00 (covering certain
    “[m]edicaments . . . consisting of two or more constituents
    which have been mixed together for therapeutic or prophy-
    lactic uses”); HTSUS, General Note 13 (providing for duty-
    free treatment for certain HTSUS headings or subheadings
    that have the “symbol ‘K’ in parentheses” in the “‘Special’
    [duty rate] subcolumn” as “included in the [P]harmaceuti-
    cal [A]ppendix”). Customs denied Janssen’s protests.
    Janssen, 425 F. Supp. 3d at 1355; see 
    19 U.S.C. § 1515
    (providing Customs with the authority to review protests
    made under 
    19 U.S.C. § 1514
    ).
    In December 2013, Janssen filed a summons and com-
    plaint before the CIT, contesting Customs’ denial of its pro-
    tests. Janssen, 425 F. Supp. 3d at 1355; see J.A. 76–97
    (Complaint), 4452–55 (Summons); see also 
    28 U.S.C. § 1581
    (a) (giving the CIT “exclusive jurisdiction of any civil
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    JANSSEN ORTHO, LLC   v. US                                   9
    action commenced to contest the denial of a protest, in
    whole or in part, under [
    19 U.S.C. § 1515
    ]”). Janssen sub-
    sequently amended its complaint to raise claims under the
    Due Process Clause of the Fifth Amendment. Janssen, 425
    F. Supp. 3d at 1355; see J.A. 111–41 (First Amended Com-
    plaint). 6 The Government filed a partial motion to dismiss
    Janssen’s Due Process claim. Janssen, 425 F. Supp. 3d
    at 1355. The CIT “bifurcated the action into two trials,”
    the first to address the merits of Janssen’s tariff classifica-
    tion arguments, the second to address Janssen’s Due Pro-
    cess claim. Id.; see id. (staying the Government’s partial
    motion to dismiss and “reserv[ing] scheduling of the second
    trial pending the outcome of the first trial”). The parties
    filed pre-trial briefs, and in July 2019, the CIT conducted a
    three-day bench trial, hearing testimony from fact and
    6    Specifically, Janssen claimed that “the CBP offic-
    ers who adjudicated Janssen’s [claims] had institutional,
    structural, and financial interests in ruling against
    Janssen,” thereby “deny[ing] Janssen both the reality and
    the appearance of a neutral and unbiased decision” and vi-
    olating the Due Process clause of the Fifth Amendment.
    J.A. 138. Janssen alleged that its tariff classification was
    the result of “the unique funding structure of CBP’s Puerto
    Rico operations, the financial condition of those operations,
    and the huge sums potentially available to CBP as a result
    of the classification decision.” J.A. 124 (citing 
    48 U.S.C. § 740
    ); see 
    48 U.S.C. § 740
     (“The duties and taxes collected
    in Puerto Rico . . . shall be paid into the treasury of Puerto
    Rico to be expended as required by law for the government
    and benefit thereof[.]”); J.A. 124–25 (stating that “CBP’s
    Puerto Rico operations . . . are financed” by duties and
    taxes collected), 125 (alleging that CBP began investigat-
    ing the classification of Janssen’s entries of darunavir eth-
    anolate as a way of making up for “recurring budget
    shortfalls”).
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    10                                  JANSSEN ORTHO, LLC   v. US
    expert witnesses. 
    Id.
     Following post-trial briefs, in No-
    vember 2019, the CIT heard closing arguments. 
    Id.
    The CIT held that darunavir ethanolate “is properly
    classified under HTSUS subheading 2935.00.60 and is eli-
    gible for duty-free treatment under the Pharmaceutical
    Appendix.” 
    Id.
     The CIT explained that “[b]ecause da-
    runavir ethanolate is a sulfonamide,” it “belongs to the
    ‘[s]ulfonamides’ class or kind of organic compounds that are
    classifiable under HTSUS subheading 2935.00.60.” 
    Id. at 1363
     (second alteration in original); see HTSUS sub-
    heading 2935.00.60 (covering “Sulfonamides: Other:
    Drugs: Other”). 7 The CIT then noted that HTSUS sub-
    heading 2935.00.60 lists the symbol “K” in the special duty
    rate subcolumn and, therefore, “cross-references the Phar-
    maceutical Appendix.” Janssen, 425 F. Supp. 3d at 1364;
    see HTSUS, General Note 13. The CIT concluded that “‘da-
    runavir’ is a product listed on the Pharmaceutical Appen-
    dix” for duty-free treatment. Janssen, 425 F. Supp. 3d at
    1364; see Pharmaceutical Appendix at 2, 15. The CIT fur-
    ther found that, because the “evidence at trial” established
    “that darunavir ethanolate is a name by which the INN da-
    runavir is known,” darunavir ethanolate falls “within the
    terms of Table 1 of the Pharmaceutical Appendix” and
    should receive duty-free treatment. Janssen, 425 F. Supp.
    3d at 1365; see id. (discussing exemplary evidence in sup-
    port, including expert testimony); see also id. at 1357 (find-
    ing, inter alia, that “[t]he INN for darunavir ethanolate is
    darunavir,” “[d]arunavir ethanolate is also known as da-
    runavir,” and “[d]arunavir ethanolate is the only commer-
    cially available form of darunavir”). The CIT reasoned
    that, while “darunavir ethanolate [has been] assigned a
    separate CAS registry number” from “darunavir,” this did
    7   Neither the Government nor Janssen challenge
    this classification on appeal. See generally Appellant’s Br.;
    Appellee’s Br.
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    JANSSEN ORTHO, LLC   v. US                                   11
    not alter its conclusion, because “[b]y the terms of the cha-
    peau, CAS registry numbers are not exclusive or exhaus-
    tive identifiers as to whether a named product is within the
    scope of the Pharmaceutical Appendix.” Id. at 1364–65. 8
    DISCUSSION
    I. Standard of Review and Legal Standard
    In reviewing a decision of the CIT, “we give great
    weight” to its “informed opinion”; “it is nearly always the
    starting point of our analysis.” Schlumberger, 845 F.3d
    at 1162 (internal quotation marks, alterations, and citation
    omitted); see Chemtall, 878 F.3d at 1018 (noting the CIT’s
    “expertise in international trade matters, including classi-
    fication rulings”). “The classification of merchandise in-
    volves a two-step inquiry.” ADC Telecomms., Inc. v. United
    States, 
    916 F.3d 1013
    , 1017 (Fed. Cir. 2019). First, we “de-
    termin[e] the proper meaning” of the terms within the rel-
    evant tariff provision and, second, we determine whether
    the subject merchandise “falls within” those terms. Sigma-
    Tau HealthSci., Inc. v. United States, 
    838 F.3d 1272
    , 1276
    (Fed. Cir. 2016). “The first step presents a question of law
    that we review de novo, whereas the second involves an is-
    sue of fact that we review for clear error.” Schlumberger,
    845 F.3d at 1162. “Where . . . no genuine dispute exists as
    to the nature of the subject merchandise, the two-step in-
    quiry collapses into a question of law we review de novo.”
    ADC, 916 F.3d at 1017 (internal quotation marks and cita-
    tion omitted). 9
    8   The CIT subsequently dismissed Janssen’s Due
    Process claim as moot. J.A. 39.
    9   “[A] tariff classification has no claim to judicial def-
    erence under Chevron, there being no indication that Con-
    gress intended such a ruling to carry the force of law”;
    rather, generally, Customs’ “ruling is eligible to claim
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    12                                  JANSSEN ORTHO, LLC   v. US
    II. The CIT Properly Classified Janssen’s Darunavir
    Ethanolate as INN “Darunavir”
    The CIT concluded that darunavir ethanolate “is
    properly classified under HTSUS subheading 2935.00.60
    and is eligible for duty-free treatment under the Pharma-
    ceutical Appendix.” Janssen, 425 F. Supp. 3d at 1355. The
    CIT explained that because “‘darunavir’ is a product listed
    on the Pharmaceutical Appendix,” and “‘darunavir ethano-
    late’ is a name by which darunavir is known,” it “is within
    the terms of Table 1 of the Pharmaceutical Appendix.” Id.
    at 1364–65. The Government argues that the CIT erred “in
    its interpretation of General Note 13 and the Pharmaceu-
    tical Appendix,” Appellant’s Br. 9 (capitalization normal-
    ized), because neither the “INN ‘darunavir’” nor “CAS
    Registry No. 206361-99-1 . . . identif[ies] darunavir
    respect according to its persuasiveness” under Skidmore.
    United States v. Mead Corp., 
    533 U.S. 218
    , 221 (2001) (cit-
    ing Chevron U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 
    467 U.S. 837
     (1984); Skidmore v. Swift & Co., 
    323 U.S. 134
    (1944)). Here, however, the Government “has represented
    that it will not seek deference in accordance with Skid-
    more . . . with respect to [Customs] ruling HQ H231485[.]”
    J.A. 4457; see J.A. 4456–57 (Order Regarding [Govern-
    ment’s] Motion for a Protective Order). The Government
    states that Customs’ classification ruling is “presumed to
    be correct.”      Appellant’s Br. 8 (quoting 
    28 U.S.C. § 2639
    (a)(1)). However, § 2639(a)(1) does not impact or
    “change the rules of construction of the HTSUS”; rather, it
    means that the “burden of proof [is] on the importer[.]” An-
    hydrides & Chems., Inc. v. United States, 
    130 F.3d 1481
    ,
    1486 (Fed. Cir. 1997).
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    JANSSEN ORTHO, LLC   v. US                                    13
    ethanolate,” id. at 10, 12 (capitalization normalized). 10 We
    disagree with the Government.
    First, the Pharmaceutical Appendix expressly includes
    products described by the INN “darunavir.” Table 1 of the
    Pharmaceutical Appendix “enumerates products described
    by [their] International Non-proprietary Names” or “INN”
    for duty-free treatment, with “any references to a product
    enumerated” encompassing “such product by whatever
    name known.” Pharmaceutical Appendix at 2. It further
    provides associated “[CAS] registry numbers . . . to assist
    in the identification of the products concerned[.]” Id. That
    is, by its plain language, the Pharmaceutical Appendix co-
    vers “such products,” by “whatever name known,” that are
    “described by” an INN listed in Table 1. Id.; see United
    States v. Clarke, 
    445 U.S. 253
    , 254 (1980) (“[T]his is a case
    in which the meaning of a statute may be determined by
    the admittedly old-fashioned but nonetheless still entirely
    appropriate ‘plain meaning’ canon[.]”). CAS registry num-
    bers are provided to “assist in the identification of the prod-
    ucts,” and, therefore, while helpful, are not dispositive.
    Pharmaceutical Appendix at 2; see Barnhart v. Peabody
    Coal Co., 
    537 U.S. 149
    , 168 (2003) (“We do not read the
    enumeration of one case to exclude another unless it is fair
    to suppose that Congress considered the unnamed possibil-
    ity and meant to say no to it.”). Table 1 lists the INN “da-
    runavir,” along with the CAS registry number “206361-99-
    1.” Pharmaceutical Appendix at 15. Therefore, the Phar-
    maceutical Appendix covers “such products,” by “whatever
    name [otherwise] known,” that are “described by” the INN
    “darunavir,” with the CAS registry number 206361-99-1
    provided to “assist in [its] identification[.]” Id. at 2, 15; see
    10   “There is no dispute that the products [at issue]
    were imported from eligible countries.” Janssen, 425 F.
    Supp. 3d at 1364 n.6; see generally Appellant’s Br.; Appel-
    lee’s Br.
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    14                                  JANSSEN ORTHO, LLC   v. US
    Carl Zeiss, 
    195 F.3d at 1379
     (“Absent contrary legislative
    intent, HTSUS terms are to be construed according to their
    common and commercial meanings, which are presumed to
    be the same.”).
    Second, darunavir ethanolate is a product described by
    the INN “darunavir.” The CIT found that “[t]he INN for
    darunavir ethanolate is darunavir,” “[d]arunavir ethano-
    late is also known as darunavir,” and the INN for Prezista,
    of which “[t]he active pharmaceutical ingredient” is “da-
    runavir in the form of darunavir ethanolate,” is also “da-
    runavir[.]” Janssen, 425 F. Supp. 3d at 1364; see J.A. 1246–
    50 (Stipulated Facts). The CIT further found, based on “ev-
    idence at trial,” that the “INN darunavir” is commonly and
    commercially used to refer to “darunavir ethanolate.”
    Janssen, 425 F. Supp. 3d at 1364; see id. at 1357 (finding
    that “[t]he prescribing information for Prezista describes
    the product as ‘PREZISTA (darunavir), in the form of da-
    runavir ethanolate,’” and “[d]arunavir ethanolate is the
    only commercially available form of darunavir”); id.
    at 1364 (finding that the WHO “identifies that the INN
    ‘[d]arunavir’ is manufactured as ‘[d]arunavir (ethano-
    late),’” as well as the National Institute of Health, National
    Center for Biotechnology Information PubChem Com-
    pound database, and the FDA (citing, inter alia, J.A. 1778–
    83, 1784–91, 1860–62)). The CIT acknowledged the Gov-
    ernment’s evidence that “darunavir ethanolate is assigned
    a separate CAS registry number” from darunavir, Janssen,
    425 F. Supp. 3d at 1364–65; see J.A. 1248, but found this
    difference “unavailing” because, by Table 1’s plain lan-
    guage, “CAS registry numbers are not exclusive or exhaus-
    tive identifiers as to whether a named product is within the
    scope of the Pharmaceutical Appendix,” Janssen, 425 F.
    Supp. 3d at 1365. Based on the evidence presented, the
    CIT concluded that darunavir ethanolate falls within the
    products described by the INN “darunavir.” Id. We per-
    ceive no clear error in this finding. See Renda Marine, Inc.
    v. United States, 
    509 F.3d 1372
    , 1378 (Fed. Cir. 2007) (“A
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    JANSSEN ORTHO, LLC   v. US                                15
    finding is ‘clearly erroneous’ when although there is evi-
    dence to support it, the reviewing court on the entire evi-
    dence is left with the definite and firm conviction that a
    mistake has been committed.” (quoting United States v.
    U.S. Gypsum Co., 
    333 U.S. 364
    , 395 (1948))).
    The Government’s counterarguments are unpersua-
    sive. First, the Government argues that the CIT “errone-
    ously construed” Table 1 to the Pharmaceutical Appendix
    because both “the INN ‘darunavir’ and the CAS registry
    number ‘206361-99-1[]’ uniquely identify the darunavir
    molecule, not darunavir ethanolate.” Appellant’s Br. 10
    (capitalization normalized). Framing an issue of fact as a
    legal challenge, the Government asserts that “[b]ecause
    the INN ‘darunavir’ does not describe darunavir ethano-
    late, and because the unique CAS registry number as-
    signed to darunavir ethanolate, number 635728-49-3, is
    not included in [T]able 1, darunavir ethanolate is not a
    ‘product enumerated in [Table 1].’” 
    Id.
     (capitalization nor-
    malized). The Government is incorrect.
    Table 1’s listing of INN “darunavir” does not uniquely
    identify the darunavir molecule. Table 1 expressly “enu-
    merates products,” not molecules, “described by” their INN.
    Pharmaceutical Appendix at 2; see Forest Labs., 
    476 F.3d at 882
     (“General Note 13 permits duty free treatment of
    certain pharmaceutical products[.]” (emphasis added));
    cf. J.A. 1348 (WHO, noting that INNs are assigned broadly
    to “[p]harmaceutical [s]ubstances”). It is well-established
    that “HTSUS terms are to be construed according to their
    common and commercial meanings” and that “eo nomine
    designation[s] . . . will ordinarily include all forms of the
    named article.” Carl Zeiss, 
    195 F.3d at 1379
     (internal quo-
    tation marks and citations omitted). Further, contrary to
    the Government’s understanding, darunavir ethanolate is
    the darunavir molecule. Specifically, darunavir ethanolate
    is the darunavir molecule compounded with ethanol to
    form a solvate. Janssen, 425 F. Supp. 3d at 1356 (finding
    that “[d]arunavir ethanolate is created by crystallizing
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    16                                  JANSSEN ORTHO, LLC   v. US
    darunavir and ethanol molecules into a crystal lattice
    structure,” “[d]arunavir ethanolate is a channel solvate,”
    and “[e]thanol molecules in the channels of darunavir eth-
    anolate support the crystal lattice”); see id. (finding that
    the chemical names for darunavir ethanolate are da-
    runavir “comp[oun]d[ed] with ethanol” in equal parts); see
    J.A. 1249 (same).
    Nor does Table 1’s listing of the CAS registry num-
    ber “206361-99-1” exclude all but the darunavir molecule.
    As explained above, Table 1 provides that CAS numbers
    are included “to assist in the identification of the products”
    listed by INN. Pharmaceutical Appendix at 2. That is, as
    the Government acknowledges, CAS numbers are not dis-
    positive and cannot be read to exclude other CAS numbers.
    See Appellant’s Br. 14 (“The Government [has] never con-
    tended that CAS registry numbers are ‘dispositive[.]’”). It
    is unclear, then, what result the Government expects from
    its assertion that the CIT should have, nonetheless, more
    closely “evaluated” “the listed CAS registry numbers.” Id.;
    see 
    28 U.S.C. § 2111
     (explaining that, under the “[h]arm-
    less error” rule, we “give judgment after an examination of
    the record without regard to errors or defects which do not
    affect the substantial rights of the parties”). Further, the
    Government’s own expert witness testified that CAS num-
    bers default to including both the indexed compound and
    their solvate forms, J.A. 1150 (Government’s expert, testi-
    fying that “solvates are not indexed in the system gener-
    ally”), 1179 (Government’s expert, agreeing that “CAS[,] as
    a baseline rule, won’t separately index solvates” but rather
    indexes them “under the unsolvated form”); see Janssen,
    425 F. Supp. 3d at 1356 (finding that “darunavir ethanolate
    is a channel solvate” formed by “crystallizing darunavir
    and ethanol”), such that, while darunavir ethanolate, hav-
    ing been patented, has its own CAS registry number,
    J.A. 1661 (CAS registry entry for darunavir ethanolate);
    see J.A. 1151–52 (Government’s expert, explaining that “in
    the case of solvates, those would be separately registered
    Case: 20-1663     Document: 49-2      Page: 17     Filed: 04/13/2021
    JANSSEN ORTHO, LLC   v. US                                   17
    when they’re in a patent example or claim” because “it’s a
    disclosure”), 1179–80 (similar), the CAS number for da-
    runavir may nonetheless “assist in the identification” of da-
    runavir ethanolate as the product INN “darunavir,”
    Pharmaceutical Appendix at 2, 15; see J.A. 1178–79 (Gov-
    ernment’s expert, agreeing that “if you search [the CAS
    registry] for [darunavir’s CAS registry number]” or the
    name “darunavir,” “it will return the entry for darunavir
    ethanolate”); see also J.A. 1012–13 (the Government’s sec-
    ond expert, testifying that “[o]bviously” “if you use the
    structure of the darunavir molecule to search in the CAS
    system, among the associated index entries is the entry for
    darunavir ethanolate”); J.A. 633 (Janssen’s expert, ex-
    plaining that the CAS registry number for darunavir “as-
    sists in identifying darunavir ethanolate” because their
    CAS registry numbers “are linked numbers”).
    The Government further asserts that “[w]ithout expla-
    nation,” the CIT erroneously “disregarded the CAS registry
    number identified in [T]able 1.” Appellant’s Br. 14. How-
    ever, as noted above, the CIT did address darunavir’s CAS
    registry number. See Janssen, 425 F. Supp. 3d at 1365 (ex-
    plaining that, while darunavir has a different CAS registry
    number than darunavir ethanolate, that difference was not
    “dispositive”). In effect, the Government argues that the
    CIT failed to give sufficient weight to the fact that da-
    runavir and darunavir ethanolate have different CAS reg-
    istry numbers. See Appellant’s Br. 14. This argument is
    misplaced. “The weighing of conflicting evidence is a task
    within the special province of the trial judge who, having
    heard the evidence, is in a better position than we to eval-
    uate it.” Pac. Gas & Elec. Co. v. United States, 
    668 F.3d 1346
    , 1353 (Fed. Cir. 2012) (citation omitted).
    Second, the Government asserts that the CIT’s “expan-
    sive reading of” the Table 1 chapeau “renders [T]able 2 [of
    the Pharmaceutical Appendix] inoperative.” Appellant’s
    Br. 18. The Government argues that the “purpose of
    [T]able 2” is to “identif[y] . . . the specific derivative forms
    Case: 20-1663     Document: 49-2      Page: 18     Filed: 04/13/2021
    18                                   JANSSEN ORTHO, LLC    v. US
    of the products listed [i]n [T]able 1 that are afforded duty-
    free treatment,” such that, in order for Janssen’s product
    to receive duty-free treatment, it must be listed in both Ta-
    ble 1 and Table 2. 
    Id.
     at 18–19 (citing Sigma-Tau
    HealthSci., Inc. v. United States, 
    98 F. Supp. 3d 1365
    , 1377
    (Ct. Int’l Trade 2015), rev’d and remanded on other
    grounds, 
    838 F.3d 1272
     (Fed. Cir. 2016)); see Sigma-Tau,
    98 F. Supp. 3d at 1377 (quoting General Note 13 and con-
    cluding that “[t]hus to qualify for K designation, the [deriv-
    ative] products at issue must be listed in both Table 1 and
    Table 2”); see also Sigma-Tau, 838 F.3d at 1277 n.2 (noting
    that the CIT’s conclusions as to General Note 13 were not
    at issue on appeal). This argument is without merit.
    General Note 13 provides that “product[s] in the
    [P]harmaceutical [A]ppendix” may be entered “free of
    duty,” and, further, that “[p]roducts in the pharmaceutical
    appendix include the salts, esters and hydrates [of INN]
    products enumerated in [T]able 1 . . . that contain in their
    names any of the prefixes of suffixes listed in [T]able 2[.]”
    HTSUS, General Note 13 (emphasis added). “[T]he term
    ‘include’ . . . signifies a non-exhaustive list.” Apple Inc. v.
    Voip-Pal.com, Inc., 
    976 F.3d 1316
    , 1323 (Fed. Cir. 2020).
    Table 1 “enumerates products” to “be entered free of duty
    under [G]eneral [N]ote 13,” Pharmaceutical Appendix at 2,
    and Table 2 further provides that the “[s]alts, esters[,] and
    hydrates of the products enumerated in [T]able 1 . . . that
    contain in their names any of the prefixes or suffixes listed”
    in Table 2, may “also be entered free of duty under [G]en-
    eral [N]ote 13 . . . provided that [each] is classifiable in the
    same 6-digit tariff provision as the relevant product enu-
    merated in [T]able 1,” id. at 57 (emphasis added). That is,
    by its plain language, Table 2 provides an additional list of
    products that may “also be entered duty free.” Id.; see
    King v. St. Vincent’s Hosp., 
    502 U.S. 215
    , 221 (1991)
    (“Words are not pebbles in alien juxtaposition; they have
    only a communal existence[.]” (quoting NLRB v. Federbush
    Co., 
    121 F.2d 954
    , 957 (2d Cir. 1941) (L. Hand, J.))); cf.
    Case: 20-1663    Document: 49-2    Page: 19    Filed: 04/13/2021
    JANSSEN ORTHO, LLC   v. US                               19
    USITC Pharma. Advice, 
    2006 WL 2950495
    , at *1 (explain-
    ing that the “Pharmaceutical Zero-for-Zero Initiative,” as
    codified at General Note 13, “eliminate[s] tariffs on phar-
    maceutical products, their derivatives, and certain chemi-
    cal intermediates”).
    Here, because Table 1 covers “such products,” by
    “whatever name [otherwise] known,” that are “described
    by” the INN “darunavir,” Pharmaceutical Appendix at 2,
    15, and darunavir ethanolate is a product described by the
    INN “darunavir,” Janssen, 425 F. Supp. 3d at 1357 (“The
    INN for darunavir ethanolate is darunavir.”), it is unnec-
    essary to reach Table 2. Janssen’s entries of darunavir eth-
    anolate are subject to duty-free treatment under Table 1.
    See HTSUS, General Note 13. The CIT did not erroneously
    “render” Table 2 inoperative, Appellant’s Br. 2; Table 2 is
    simply irrelevant to the classification of darunavir ethano-
    late, see Pharmaceutical Appendix at 2, 57. Accordingly,
    the CIT did not err in concluding that Janssen’s entries of
    subject merchandise, “properly classified under HTSUS
    subheading 2935.00.60,” are “eligible for duty-free treat-
    ment under the Pharmaceutical Appendix.” Janssen, 425
    F. Supp. 3d at 1366.
    CONCLUSION
    We have considered the Government’s remaining argu-
    ments and find them unpersuasive. 11 Accordingly, the
    11   Because we resolve darunavir ethanolate’s classifi-
    cation as INN “darunavir,” duty free, at Table 1 of the
    Pharmaceutical Appendix, we do not reach the parties’ ar-
    guments as to how darunavir ethanolate may or may not
    be classified under Table 2, or Janssen’s Due Process claim,
    as they are moot. See E.T. Horn Co. v. United States, 
    367 F.3d 1326
    , 1336 (Fed. Cir. 2004); NEC Corp. v. United
    States, 
    151 F.3d 1361
    , 1369 (Fed. Cir. 1998); see also Ap-
    pellee’s Br. 20 (noting that Janssen’s Due Process claim has
    Case: 20-1663   Document: 49-2    Page: 20    Filed: 04/13/2021
    20                               JANSSEN ORTHO, LLC    v. US
    Judgment of the U.S. Court of International Trade is
    AFFIRMED
    been mooted by the duty-free classification), 57 (arguing
    that “[i]n the event of reversal, Janssen’s Due Process
    claim remains to be tried” (capitalization normalized)).