Customs
HTSUS
Tariff Classification
Pharmaceutical Appendix
Import - Export
Learned Hand
Appeal from the United States Court of International Trade
in No. 1:13-cv-00296-JCG.
This opinion was originally filed under seal and has been
unsealed in full.
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).
Appellee,
Janssen Ortho, LLC (“Janssen”), filed suit against Appellant, the United States
(“the Government”), in the U.S. Court of International Trade (“CIT”),
challenging 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”). 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 concluded that
the subject merchandise was properly classified 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, 1355
(Ct. Int’l Trade), as amended (Feb. 19, 2020), judgment
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 darunavir
ethanolate’s duty-free treatment. We have jurisdiction pursuant to 28 U.S.C. §
1295(a)(5). We affirm.
“The first four digits of an HTSUS provision constitute the
heading, whereas the remaining digits reflect subheadings.” Schlumberger
Tech. Corp. v. United States, 845 F.3d 1158, 1163 n.4 (Fed. Cir. 2017).
“The 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. “An 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 provision 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 HTSUS
includes all provisions enacted by Congress or proclaimed by the President,”
HTSUS, Preface 1 (22d ed. 2010), including the headings, subheadings,
“General Rules of Interpretation” (“GRI”), “Additional U.S. Rules of
Interpretation” (“ARI”), “General Notes,” and “various 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).
“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 pharmaceuticals.” 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
certain pharmaceutical products.” Forest Labs., Inc. v. United States,
476 F.3d 877, 882 (Fed. Cir. 2007). It provides that “whenever” 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 country eligible for tariff treatment
. . . shall be entered free of duty, provided that such product is included in
the Pharmaceutical Appendix.” 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’),” with “the
Chemical Abstracts Service (‘CAS’) registry numbers also set forth . . . to
assist in the identification of the products concerned,” to “be entered free of duty
under General Note 13 to the HTSUS.” Pharmaceutical Appendix at 2 (Table 1
Chapeau). The chapeau to Table 1 further
provides that, “for 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 “salts, esters, and hydrates of the products enumerated in
Table 1 . . . that contain in their names any of the prefixes or suffixes
listed in Table 2 shall also be entered free of duty under General Note 13” so
long as they are “classifiable in the same” HTSUS heading “enumerated in Table 1.” Pharmaceutical Appendix at 57 (Table 2 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
ethanolate, 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. 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).
III. Procedural History
Customs liquidated Janssen’s entries under HTSUS subheading
2935.00.95, at a duty rate of 6.5 percent ad valorem. J.A. 4453; see HTSUS
subheading 2935.00.95 (covering “Sulfonamides: Other: Drugs: Other”). Janssen
filed protests of these actions, asserting that its darunavir ethanolate 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 “medicaments . . .
consisting of two or more constituents which have been mixed together for
therapeutic or prophylactic 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
Pharmaceutical Appendix”). 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 complaint before the CIT, contesting Customs’
denial of its protests. 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 action commenced to
contest the denial of a protest, in whole or in part, under 19 U.S.C. § 1515”).
Janssen subsequently 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 Complaint). 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 classification arguments, the second to address
Janssen’s Due Process claim. Id.; see id. (staying the
Government’s partial motion to dismiss and “reserving 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 expert witnesses. Id.
The CIT
held that darunavir ethanolate “is properly classified under HTSUS subheading
2935.00.60 and is eligible for duty-free treatment under the Pharmaceutical
Appendix.”
Id. The CIT explained that “because darunavir ethanolate is a
sulfonamide,” it “belongs to the ‘sulfonamides’ class or kind of organic
compounds that are classifiable under HTSUS subheading 2935.00.60.” Id. at
1363 (second alteration in original); see HTSUS subheading 2935.00.60
(covering “Sulfonamides: Other: Drugs: Other”). The CIT then noted that HTSUS
subheading 2935.00.60 lists the symbol “K” in the special duty rate subcolumn
and, therefore, “cross-references the Pharmaceutical Appendix.” Janssen,
425 F. Supp. 3d at 1364; see HTSUS, General Note 13. The CIT
concluded that “‘darunavir’ is a product listed on the Pharmaceutical Appendix”
for duty-free treatment. Janssen, 425 F. Supp. 3d at 1364; see Pharmaceutical
Appendix at 2, 15. The CIT further found that, because the “evidence at
trial” established “that darunavir ethanolate is a name by which the INN
darunavir 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
support, including expert testimony); see also id. at 1357 (finding,
inter alia, that “the INN for darunavir ethanolate is darunavir,” “darunavir
ethanolate is also known as darunavir,” and “darunavir ethanolate is the only
commercially available form of darunavir”). The CIT reasoned that, while
“darunavir ethanolate has been assigned a separate CAS registry number” from
“darunavir,” this did not alter its conclusion, because “by the terms of the
chapeau, CAS registry numbers are not exclusive or exhaustive identifiers as to
whether a named product is within the scope of the Pharmaceutical Appendix.”
Id. at 1364–65.
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
Pharmaceutical Appendix.” Janssen, 425 F. Supp. 3d at 1355. The CIT
explained that because “‘darunavir’ is a product listed on the Pharmaceutical
Appendix,” and “‘darunavir ethanolate’ 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 Pharmaceutical Appendix,” Appellant’s Br. 9
(capitalization normalized), because neither the “INN ‘darunavir’” nor “CAS
Registry No. 206361-99-1 . . . identifies darunavir ethanolate,” id. at
10, 12 (capitalization normalized). 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 covers “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) (“This 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 numbers are provided to “assist in the identification of the products,”
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 possibility and meant to say no to
it.”). Table 1 lists the INN “darunavir,” along with the CAS registry number
“206361-99- 1.” Pharmaceutical Appendix at 15. Therefore, the Pharmaceutical
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
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 “the INN for darunavir ethanolate is darunavir,” “darunavir ethanolate
is also known as darunavir,” and the INN for Prezista, of which “the active
pharmaceutical ingredient” is “darunavir in the form of darunavir ethanolate,”
is also “darunavir.”
Janssen, 425 F. Supp. 3d at 1364; see J.A. 1246– 50 (Stipulated
Facts). The CIT further found, based on “evidence 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 “the prescribing information for Prezista describes the
product as ‘PREZISTA (darunavir), in the form of darunavir ethanolate,’” and “darunavir
ethanolate is the only commercially available form of darunavir”); id. at
1364 (finding that the WHO “identifies that the INN ‘darunavir’ is manufactured
as ‘darunavir (ethanolate),’” as well as the National Institute of Health,
National Center for Biotechnology Information PubChem Compound database, and
the FDA (citing, inter alia, J.A. 1778– 83, 1784–91, 1860–62)). The CIT
acknowledged the Government’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 language, “CAS registry numbers are not exclusive
or exhaustive 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
perceive no clear error in this finding. See Renda Marine, Inc. v. United
States, 509 F.3d 1372, 1378 (Fed. Cir. 2007) (“A finding is ‘clearly
erroneous’ when although there is evidence to support it, the reviewing court
on the entire evidence 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 unpersuasive. First,
the Government argues that the CIT “erroneously 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 “because the INN
‘darunavir’ does not describe darunavir ethanolate, and because the unique CAS
registry number assigned to darunavir ethanolate, number 635728-49-3, is not
included in Table 1, darunavir ethanolate is not a ‘product enumerated in Table
1.’” Id. (capitalization normalized). The Government is incorrect.
Table 1’s
listing of INN “darunavir” does not uniquely identify the darunavir molecule.
Table 1 expressly “enumerates 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 “pharmaceutical substances”). It is well-established that “HTSUS
terms are to be construed according to their common and commercial meanings”
and that “eo nomine designations . . . will ordinarily include all forms of
the named article.” Carl Zeiss, 195 F.3d at 1379 (internal quotation
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 “darunavir
ethanolate is created by crystallizing darunavir and ethanol molecules into a
crystal lattice structure,” “darunavir ethanolate is a channel solvate,” and “ethanol
molecules in the channels of darunavir ethanolate support the crystal
lattice”); see id. (finding that the chemical names for darunavir
ethanolate are darunavir “compounded with ethanol” in equal parts); see J.A.
1249 (same).
Nor does Table
1’s listing of the CAS registry number “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 dispositive and cannot be read to exclude other CAS numbers. See
Appellant’s Br. 14 (“The Government has never contended 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 “harmless 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 numbers default to including both the
indexed compound and their solvate forms, J.A. 1150 (Government’s expert, testifying
that “solvates are not indexed in the system generally”), 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, having 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 when they’re in a patent example or claim”
because “it’s a disclosure”), 1179–80 (similar), the CAS number for darunavir
may nonetheless “assist in the identification” of darunavir ethanolate as the
product INN “darunavir,” Pharmaceutical Appendix at 2, 15; see J.A.
1178–79 (Government’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 second expert, testifying that “obviously” “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, explaining that the CAS registry number for darunavir “assists
in identifying darunavir ethanolate” because their CAS registry numbers “are
linked numbers”).
The Government further asserts that “without explanation,”
the CIT erroneously “disregarded the CAS registry number identified in Table
1.” Appellant’s Br. 14. However, as noted above, the CIT did address
darunavir’s CAS registry number. See Janssen, 425 F. Supp. 3d at 1365
(explaining 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 darunavir and darunavir ethanolate have different CAS registry 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 evaluate
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 “expansive
reading of” the Table 1 chapeau “renders Table 2 of the Pharmaceutical Appendix
inoperative.” Appellant’s Br. 18. The Government argues that the “purpose of Table
2” is to “identify . . . the specific derivative forms of the products listed in
Table 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 Table
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 concluding
that “thus to qualify for K designation, the derivative 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.
(…) “A
tariff classification has no claim to judicial deference under Chevron,
there being no indication that Congress intended such a ruling to carry the
force of law”.
(…) “There
is no dispute that the products at issue were imported from eligible
countries.” Janssen, 425 F. Supp. 3d at 1364 n.6.
(…) General Note 13 provides that “products in the Pharmaceutical
Appendix” may be entered “free of duty,” and, further, that “products in the
pharmaceutical appendix include the salts, esters and hydrates of INN
products enumerated in Table 1 . . . that contain in their names any of
the prefixes of suffixes listed in Table 2.” HTSUS, General Note 13
(emphasis added). “The 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 General Note 13,”
Pharmaceutical Appendix at 2, and Table 2 further provides that the “salts,
esters, and hydrates of the products enumerated in Table 1 . . . that contain
in their names any of the prefixes or suffixes listed” in Table 2, may “also
be entered free of duty under General Note 13 . . . provided that each is
classifiable in the same 6-digit tariff provision as the relevant product enumerated
in Table 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. USITC Pharma. Advice,
2006 WL 2950495, at *1 (explaining that the “Pharmaceutical Zero-for-Zero
Initiative,” as codified at General Note 13, “eliminates tariffs on pharmaceutical
products, their derivatives, and certain chemical 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 unnecessary to reach Table 2.
Janssen’s entries of darunavir ethanolate 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 ethanolate, 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 treatment under the
Pharmaceutical Appendix.” Janssen, 425 F. Supp. 3d at 1366.
Because we
resolve darunavir ethanolate’s classification as INN “darunavir,” duty free, at
Table 1 of the Pharmaceutical Appendix, we do not reach the parties’ arguments
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 Appellee’s Br. 20 (noting
that Janssen’s Due Process claim has been mooted by the duty-free classification),
57 (arguing that “in the event of reversal, Janssen’s Due Process claim remains
to be tried” (capitalization normalized)).
(U.S. Court of
Appeals for the Federal Circuit, April 26, 2021, Janssen Ortho, LLC v. United
States, Docket No. 20-1663, WALLACH,
Circuit Judge)
