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)
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