Court Opinion

ID: 4392618
Source: CourtListenerOpinion
Date Created: 2019-05-01 15:00:44.276916+00
Date Added: 2024-06-11T13:32:03.048807
License: Public Domain

United States Court of Appeals
       for the Federal Circuit
                        ______________________

           AMARIN PHARMA, INC., AMARIN
          PHARMACEUTICALS IRELAND LTD.,
                    Appellants

                                       v.

       INTERNATIONAL TRADE COMMISSION,
                   Appellee

  ROYAL DSM NV, DSM MARINE LIPIDS PERU
S.A.C., DSM NUTRITIONAL PRODUCTS LLC, DSM
    NUTRITIONAL PRODUCTS CANADA, INC.,
 PHARMAVITE LLC, NORDIC NATURALS, INC.,
            NORDIC PHARMA, INC.,
                    Intervenors
              ______________________

                              2018-1247
                        ______________________

   Appeal from the United States International Trade
Commission in Investigation No. 337-TA-3247.

---------------------------------------------------------------------------------

        IN RE: AMARIN PHARMA, INC., AMARIN
         PHARMACEUTICALS IRELAND LTD.,
                       Petitioners
                 ______________________

                               2018-114
                        ______________________
2                               AMARIN PHARMA, INC.   v. ITC

    On Petition for Writ of Mandamus to the United States
International Trade Commission in No. 337-TA-3247.
                  ______________________

                 Decided: May 1, 2019
                ______________________

    ASHLEY CHARLES PARRISH, King & Spalding LLP,
Washington, DC, argued for appellants and petitioners.
Also represented by LISA MOLOT DWYER, JESSE SNYDER,
JEFFREY MARK TELEP.

    HOUDA MORAD, Office of the General Counsel, United
States International Trade Commission, Washington, DC,
argued for appellee and respondent. Also represented by
DOMINIC L. BIANCHI, WAYNE W. HERRINGTON.

    MARK S. DAVIES, Orrick, Herrington & Sutcliffe LLP,
Washington, DC, argued for intervenors Royal DSM NV,
DSM Marine Lipids Peru S.A.C., DSM Nutritional Prod-
ucts LLC, DSM Nutritional Products Canada, Inc., Phar-
mavite LLC. Also represented by JORDAN COYLE, THOMAS
KING-SUN FU; ANDREW D. SILVERMAN, New York, NY;
ANNETTE LOUISE HURST, ROBERT SHWARTS, San Francisco,
CA.

   JOSEPH FORREST BUSA, Appellate Staff, Civil Division,
United States Department of Justice, Washington, DC, ar-
gued for amicus curiae United States. Also represented by
JOSEPH H. HUNT, SCOTT R. MCINTOSH.

    ANDREW F. PRATT, Venable LLP, Washington, DC, for
intervenors Nordic Naturals, Inc., Nordic Pharma, Inc.

    DEANNA TANNER OKUN, Adduci, Mastriani & Schaum-
berg, LLP, Washington, DC, for amici curiae Council for
Responsible Nutrition, Global Organization for EPA and
AMARIN PHARMA, INC.   v. ITC                              3

DHA Omega-3S. Also represented by ASHA ALLAM, PAUL
M. BARTKOWSKI, PAULINA MARIA STAROSTKA.
               ______________________

   Before PROST, Chief Judge, WALLACH and HUGHES,
                    Circuit Judges.
    Opinion for the court filed by Chief Judge PROST.
   Dissenting opinion filed by Circuit Judge WALLACH.
PROST, Chief Judge.
    Amarin Pharma, Inc. (“Amarin”) appeals the decision
of the International Trade Commission (“Commission”),
which determined not to institute an investigation and, ac-
cordingly, dismissed Amarin’s complaint. The Commission
held that Amarin’s complaint failed to allege a cognizable
claim based on an unfair method of competition or unfair
act under 19 U.S.C. § 1337(a)(1)(A). We affirm.
                               I
    Amarin markets Vascepa® capsules, a prescription
drug that consists of 1 gram of eicosapentaenoic acid (the
omega-3 acid commonly known as “EPA”) in a 1-gram cap-
sule. The EPA in Vascepa® is in ethyl ester form and is
synthetically produced from fish oil. Amarin obtained ap-
proval from the Food and Drug Administration (“FDA”) to
market and sell Vascepa®, which is designed to reduce tri-
glyceride levels in adult patients with severe hypertriglyc-
eridemia. Vascepa® is the only purified ethyl ester E-EPA
product sold in the United States as an FDA-approved
drug.
    On August 30, 2017, Amarin filed under oath a com-
plaint alleging violations under § 337 of the Tariff Act of
1930, as amended. J.A. 4–114 (Compl.). The complaint al-
leges that certain companies were falsely labeling and de-
ceptively advertising their imported synthetically
produced omega-3 products as (or for use in) “dietary
4                                AMARIN PHARMA, INC.   v. ITC

supplements,” where the products are actually “new drugs”
as defined in the Food, Drug, and Cosmetic Act (“FDCA”)
that have not been approved for sale or use in the United
States. J.A. 9 ¶ 1.
    Specifically, Amarin articulated two claims in its com-
plaint: (1) that the importation and sale of the articles is
an unfair act or unfair method of competition under § 337
because it violates § 43(a) of the Lanham Act, 15 U.S.C.
§ 1125(a), see J.A. 31–56 ¶¶ 53–105; and (2) that importa-
tion of the articles violates the Tariff Act “based upon the
standards set forth in the FDCA,” see J.A. 56 ¶ 106. By
way of relief, Amarin’s complaint seeks an order under
§ 337(d) that would exclude synthetically produced omega-
3 products from entry into the United States, as well as a
cease-and-desist order under § 337(f) to prohibit the pro-
posed respondents from importing, using, or selling syn-
thetically produced omega-3 products. J.A. 112–13 ¶¶ D–
F.
    After Amarin filed its complaint, the FDA submitted a
letter urging the Commission not to institute an investiga-
tion and instead to dismiss Amarin’s complaint. J.A. 627–
37. In the FDA’s view, the FDCA prohibits private enforce-
ment actions, including unfair trade practice claims that
seek to enforce the FDCA. J.A. 630. The FDA contended
that the FDCA precludes any claim that would “require[]
the Commission to directly apply, enforce, or interpret the
FDCA.” J.A. 631. The FDA further contended that the
Commission should decline to institute an investigation
based on principles of comity to the FDA. J.A. 629.
    On October 27, 2017, the Commission issued its deci-
sion declining to institute an investigation and dismissing
the complaint. J.A. 1–3. The Commission reasoned that
Amarin’s allegations are precluded by the FDCA. Id.; see
also POM Wonderful LLC v. Coca-Cola Co., 573 U.S. 102,
109 (2014) (“Private parties may not bring [FDCA] enforce-
ment suits.” (citing 21 U.S.C. § 337)).
AMARIN PHARMA, INC.   v. ITC                                 5

    In December 2017, Amarin filed in this court a petition
for review and, separately, a petition for a writ of manda-
mus. We consolidated the two cases. Royal DSM NV, DSM
Marine Lipids Peru S.A.C., DSM Nutritional Products
LLC, and Pharmavite LLC (collectively, “DSM”); and Nor-
dic Natural, Inc. and Nordic Pharma, Inc. (collectively,
“Nordic”) (both, “the Intervenors”) intervened in the ap-
peal. ECF Nos. 14, 23, 25, 49.
                               II
    At the outset, we begin by confirming that we have ju-
risdiction to review the Commission’s decision in this case.
We then address Amarin’s argument that the Commission
has a mandatory, non-discretionary duty to institute an in-
vestigation when presented with a complaint under oath.
Finally, we address whether the Commission correctly de-
termined that Amarin’s allegations are precluded by the
FDCA.
                               A
   Amarin contends that we have appellate jurisdiction
under 28 U.S.C. § 1295(a)(6), but the Intervenors and the
Commission disagree.
     Our jurisdictional statute gives this court exclusive ju-
risdiction “to review the final determinations of the United
States International Trade Commission relating to unfair
practices in import trade, made under section 337 of the
Tariff Act of 1930 (19 U.S.C. [§] 1337).” § 1295(a)(6). “Final
determinations appealable under § 1295(a)(6) are specified
in § 1337(c) . . . .” Crucible Materials Corp. v. ITC, 127 F.3d
1057, 1060 (Fed. Cir. 1997).
    The Intervenors and the Commission argue that the
only “final determinations” subject to appellate review are
those listed in § 1337(c). Intervenors’ Br. 18–19; Commis-
sion’s Br. 52–56. And these decisions, according to the In-
tervenors, can only be made “as a result of an
investigation.” Intervenors’ Br. 19.
6                                  AMARIN PHARMA, INC.   v. ITC

    The question as to our jurisdiction in this case is re-
solved by our decision in Amgen Inc. v. ITC, 902 F.2d 1532
(Fed. Cir. 1990). In Amgen, the complainant alleged that a
company violated § 337 by importing articles made by a pa-
tented process. See 19 U.S.C. § 1337(a)(1)(B)(ii). The Com-
mission instituted an investigation. Amgen, 902 F.2d at
1534. Ultimately, however, the Commission dismissed the
complaint because the patent at issue did not contain a pro-
cess claim, which the Commission considered to be a juris-
dictional prerequisite for an investigation under
§ 1337(a)(1)(B)(ii). Id. at 1535.
     On appeal in Amgen, we first addressed our jurisdic-
tion under 28 U.S.C. § 1295(a)(6). Interpreting 19 U.S.C.
§ 1337(c), we recognized that § 1337(c) “has been inter-
preted as requiring a ‘final determination decision on the
merits, excluding or refusing to exclude articles from entry’
under section 1337(d), (e), (f) or (g).” Id. (quoting Block v.
ITC, 777 F.2d 1568, 1571 (Fed. Cir. 1985)). But instead of
adopting the rigid approach Intervenors argue for in this
case, we concluded that the Commission’s decision was “in-
trinsically a final determination, i.e., a determination on
the merits,” thus making it appealable under § 1295(a)(6).
Id. (emphasis in original).
    In reaching that conclusion, we carefully explained the
difference between our holding there and our earlier hold-
ing in Block, a case in which we held that a Commission
order was not a final determination. In Block, the Commis-
sion initiated an investigation on its own motion. The
Commission later terminated that investigation after the
patent at issue was amended during reexamination. See
id. As we explained in Amgen, “nothing in the termination
Order [in Block] prejudiced the Commission or any private
party in a future proceeding.” Id. Unlike in Block, how-
ever, the Commission order in Amgen “clearly reach[ed] the
merits of [the] complaint and determinatively decide[d]
[the complainant’s] right to proceed in a section 1337 ac-
tion.” Id. We further explained that “any future action
AMARIN PHARMA, INC.   v. ITC                                   7

brought by [the complainant] would necessarily raise the
same issue, and would presumably be dismissed for the
same reason.” Id. at 1536.
    As in Amgen, the Commission’s decision not to institute
in this case is “intrinsically a final determination, i.e., a de-
termination on the merits.” See id. at 1535 (emphasis in
original). Here, the Commission declined to institute an
investigation because the claims were precluded by the
FDCA and, therefore, the complaint failed to state a cog-
nizable claim under § 337. See J.A 1–3. As in Amgen, this
decision “clearly reach[ed] the merits of [the] complaint
and determinatively decide[d] [Amarin’s] right to proceed
in a section 1337 action.” See id.; see also Import Motors,
Ltd., Inc. v. ITC, 530 F.2d 940, 946–47 (CCPA 1976) (ana-
lyzing the right to appeal a Commission order by asking
whether the order “has the operative effect of a ‘final deter-
mination under subsection (d) or (e)’” and noting that
“[s]ubstance, not form, must control”). Any future com-
plaint brought by Amarin alleging these same facts “would
necessarily raise the same issue” and “would presumably
be dismissed for the same reason”—i.e., for lack of a private
right of action to enforce the FDCA. See Amgen, 902 F.2d
at 1536. 1 In other words, as discussed below, as long as

    1    The Commission’s decision to dismiss the com-
plaint presented a pure question of law regarding FDCA
preclusion. Based on that holding, Amarin was in no way
free to file another complaint on the same grounds, as the
dissent suggests. See Dissent at 12. Our recognition of the
possibility that Amarin’s complaint may not be precluded
in the future, under a different set of facts (i.e., where FDA
has provided guidance as to whether these particular arti-
cles violate the FDCA) does not make the Commission’s de-
termination “without prejudice.” Indeed, that future
possibility would not have existed but for our ability to
8                                 AMARIN PHARMA, INC.   v. ITC

Amarin’s complaint is based on proving violations of the
FDCA (at least where the FDA has not provided guidance
as to whether the articles violate the FDCA), Amarin’s
claims will be precluded. The Commission’s decision is
therefore intrinsically a final determination that effec-
tively denies Amarin’s request for relief under § 337(d) and
(f). 2
    We are unpersuaded by the Intervenors’ and the Com-
mission’s argument that a final determination can be made
only after institution. See Intervenors’ Br. 3; Commission’s
Br. 52. Although the decision in Amgen occurred after in-
stitution, the court’s reasoning in that case was not based
on that procedural detail. See Amgen, 902 F.2d at 1535.
Instead, the court’s analysis focused on the operative effect
of the Commission decision. See id.; Import Motors, 530
F.2d at 946–47 (“Substance, not form, must control.”).
    The dissent makes essentially the same argument, con-
tending that a “final determination” can exist only after

review and narrow the Commission’s even broader preclu-
sion holding through this appeal.
     2    The dissent’s attempt to characterize the Commis-
sion’s decision in this case as an order under § 1337(b), ra-
ther than as effectively being an order under § 1337(d) or
(e), cannot be reconciled with Amgen. Amgen also did not
involve a formal order under § 1337(d), (e), (f), or (g). Re-
gardless, and as the dissent recognizes, see Dissent at 11–
12, we held in Amgen that the substance of the Commis-
sion’s analysis meant that it “should have dismissed on the
merits.” 902 F.2d at 1536. But a dismissal on the merits
would still not produce a formal order under § 1337(d), (e),
(f), or (g). Instead, as our predecessor court emphasized in
Import Motors, what matters is that the order “ha[s] the
same operative effect, . . . as a final determination under
subsections (d) and (e). Substance, not form, must control.”
530 F.2d at 945–46.
AMARIN PHARMA, INC.   v. ITC                               9

institution. Dissent at 4–5, 7, 11. But this approach ele-
vates form over substance. The dissent’s approach would
require the Commission to formally institute an investiga-
tion—which requires publication of notice in the Federal
Register—just long enough for the Commission to issue the
same dismissal order it already issued in this case. There
is no indication from the statutory text or context that Con-
gress intended such rigid formality.
     Because the Commission’s decision is intrinsically a fi-
nal determination on the merits that has the operative ef-
fect of denying Amarin’s request for relief under § 337(d)
and (f), the decision is a “final determination” under
§ 337(c). We therefore have jurisdiction to review that de-
cision under 28 U.S.C. § 1295(a)(6).
    Having found our jurisdiction proper, we need not ad-
dress Amarin’s alternative argument for jurisdiction—that
we have authority to compel agency action under 5 U.S.C.
§ 706(1). 3
                               B
    We next address Amarin’s argument that the Commis-
sion had a mandatory duty to institute an investigation in

    3   It is unclear whether Amarin is also arguing that
we may review the decision via mandamus aside from
§ 706(1). Indeed, Amarin states that “[t]he judicial review
provisions of the Administrative Procedure Act have effec-
tively displaced the need for courts to issue writs of man-
damus when asked to review agency decisions.”
Appellant’s Br. 26 (emphasis added). Regardless, to the ex-
tent Amarin contends that some other basis for mandamus
review is warranted, Amarin has failed to explain how it
would satisfy the traditional mandamus requirements. See
Cheney v. U.S. Dist. Court for D.C., 542 U.S. 367, 380–81
(2004) (listing the three requirements that must be satis-
fied before a writ may issue).
10                                 AMARIN PHARMA, INC.   v. ITC

this case. Amarin contends that 19 U.S.C. § 1337(b)(1) im-
poses a non-discretionary duty on the Commission to insti-
tute an investigation when presented with a complaint
under oath. See § 1337(b)(1) (“The Commission shall inves-
tigate any alleged violation of this section on complaint un-
der oath or upon its initiative.”).
    The relevant statutory scheme contemplates certain
scenarios in which the Commission need not institute an
investigation. See § 1337(b)(3) (stating, for example, that
the Commission “may institute” under specified circum-
stances); see also § 1330(d)(5) (stating that an investigation
shall occur if “one-half of the number of commissioners vot-
ing agree that the investigation should be made”). The
Commission Rules also contemplate non-institution. Rule
210.10 provides that “[t]he Commission shall determine
whether the complaint is properly filed and whether an in-
vestigation should be instituted on the basis of the com-
plaint.” 19 C.F.R. § 210.10(a)(1) (emphases added). That
Rule further explains that “[i]f the Commission determines
not to institute an investigation on the basis of the com-
plaint, the complaint shall be dismissed.” 19 C.F.R.
§ 210.10(c); see also 19 C.F.R. § 210.9(a) (“Upon receipt of a
complaint alleging violation of section 337 . . . [t]he Com-
mission shall examine the complaint for sufficiency and
compliance with the applicable sections of this chapter.”).
    The question remains, then, in what circumstances
may the Commission decline to institute an investigation?
Our precedent recognizes at least one such circumstance.
See Syntex Agribusiness, Inc. v. ITC, 659 F.2d 1038 (CCPA
1981). In Syntex, our predecessor court held that the Com-
mission was correct to dismiss a complaint without insti-
tuting an investigation where the complaint contained
insufficient factual allegations to support a monopolization
or conspiracy claim. Id. at 1044. The court framed the is-
sue in that case as whether the complaint was a “‘com-
plaint’ within the meaning of section 337.” Id. at 1041.
Noting the absence of a definition of “complaint,” the court
AMARIN PHARMA, INC.   v. ITC                              11

recognized that a complaint must comply with then-Com-
mission Rule 210.20, which set forth requirements for a
complaint under § 337, including a requirement that the
complaint include a statement of the facts constituting the
alleged acts of monopolization and conspiracy. Id. at 1042. 4
The court explained that its disposition was based on the
complaint’s failure to comply with the requirements set
forth in that Commission Rule.
    Although Amarin appears to raise a broader argument
regarding whether the Commission has discretion gener-
ally not to institute an investigation, we need not address
that question here. Instead, we simply hold, consistent
with Syntex, that the Commission may decline to institute
an investigation where a complaint fails to state a cogniza-
ble claim under § 337.
    The facts alleged as the basis for Amarin’s complaint
demonstrate that Amarin’s allegations are based entirely
on violations of the FDCA. As we explain below, claims
based on such allegations are precluded by the FDCA, at
least where the FDA has not yet provided guidance as to
whether violations of the FDCA have occurred. Thus, un-
der the facts of this case, where Amarin’s complaint fails to
state a cognizable claim for relief, the Commission did not
err in its decision not to institute.
                               C
     We next address the Commission’s holding that Ama-
rin’s complaint “does not allege an unfair method of compe-
tition or unfair act cognizable under 19 U.S.C.
§ 1337(a)(1)(A), as required by the statute and the Commis-
sion’s rules.” J.A. 1. The Commission explained that “the
Lanham Act allegations in this case are precluded by the
Food, Drug and Cosmetic Act,” and that “the Food and

    4   The Commission Rule at issue in Syntex has since
been re-codified as Commission Rule 210.12.
12                                 AMARIN PHARMA, INC.   v. ITC

Drug Administration is charged with the administration of
the FDCA.” J.A. 1. As explained below, we agree.
    As relevant here, the FDCA authorizes the FDA to reg-
ulate drugs and dietary supplements. Introducing a “new
drug,” 21 U.S.C. § 321(p), into interstate commerce re-
quires FDA approval, id. § 355(a). Dietary supplements,
however, do not require pre-market approval.
     The FDCA provides the United States with “nearly ex-
clusive enforcement authority.” POM Wonderful LLC v.
Coca-Cola Co., 573 U.S. 102, 109 (2014); see also 21 U.S.C.
§ 337(a) (“Except as provided in subsection (b), all such pro-
ceedings for the enforcement, or to restrain violations, of
this chapter shall be by and in the name of the United
States.”); Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S.
341, 349 n.4 (2001) (“The FDCA leaves no doubt that it is
the Federal Government rather than private litigants who
are authorized to file suit for noncompliance with the med-
ical device provisions . . . .”). Private parties may not bring
suits to enforce the FDCA. POM Wonderful, 573 U.S. at
109 (citing 21 U.S.C. § 337).
    Given the lack of a private right to enforce the FDCA,
other circuit courts have grappled with the extent to which
private parties’ claims under § 43(a) of the Lanham Act are
limited by the FDCA. See PhotoMedex, Inc. v. Irwin, 601
F.3d 919 (9th Cir. 2010); Alpharma, Inc. v. Pennfield Oil
Co., 411 F.3d 934 (8th Cir. 2005); cf. Sandoz Pharm. Corp.
v. Richardson-Vicks, Inc., 902 F.2d 222 (3d Cir. 1990).
    For example, in PhotoMedex, the Ninth Circuit af-
firmed a grant of summary judgment in favor of a defend-
ant as to a Lanham Act false advertising claim based on
allegations that the defendant misrepresented that its
product had received FDA clearance. 601 F.3d at 922.
That case involved the FDCA’s 510(k) clearance process,
and the court focused heavily on the details of that statu-
tory scheme in reaching its holding. In short, the defend-
ant had received 510(k) clearance for its earlier device, but
AMARIN PHARMA, INC.   v. ITC                               13

the plaintiff argued that based on significant changes to
the device, the defendant should have made a new 510(k)
submission to obtain market clearance for the updated
product. Id. at 926. In reaching its conclusion, the court
emphasized that “[i]t is significant that under the regula-
tory structure established by the FDA for the medical de-
vices at issue in this case, clearance to market a given
device did not necessarily require an affirmative statement
of approval by the FDA.” Id. Further, the court explained
that even though the FDA had been aware of the alleged
need for a new clearance, the FDA had never taken the po-
sition that the products had not been properly cleared. In
sum, the court held that “[b]ecause the FDCA forbids pri-
vate rights of action under that statute, a private action
brought under the Lanham Act may not be pursued when,
as here, the claim would require litigation of the alleged un-
derlying FDCA violation in a circumstance where the FDA
has not itself concluded that there was such a violation.” Id.
at 924 (emphasis added). 5
    The Eighth Circuit employed similar reasoning in Al-
pharma. 411 F.3d at 939–41. There, the district court
granted a defendant’s motion to dismiss a plaintiff’s Lan-
ham Act claim that was based on alleged misrepresenta-
tion of the uses for which a drug had been approved. Id. at
935–36. The Eighth Circuit reversed, reasoning that

    5   The court limited its holding, reasoning that “we do
not suggest that the Lanham Act can never support private
party claims involving FDA approval or clearance of drugs
or medical devices.” Id. at 924. Giving an example, the
court stated that if “it was clear that an affirmative state-
ment of approval by the FDA was required before a given
product could be marketed and that no such FDA approval
had been granted, a Lanham Act claim could be pursued
for injuries suffered by a competitor as a result of a false
assertion that approval had been granted.” Id. at 924–25.
14                                AMARIN PHARMA, INC.   v. ITC

because the FDA had given guidance on the precise dispute
between the parties, the plaintiff’s claim in this particular
case did not require a “preemptive determination” of how
the FDA would interpret and enforce its own regulations.
Id. at 940; see also PhotoMedex, 601 F.3d at 929 (summa-
rizing Alpharma and noting that, there, “FDA explicitly
made clear that it had not given the defendant’s product
the affirmative approval required for expanding its list of
permissible uses” and thus “the plaintiff could bring a Lan-
ham Act claim based on the defendant’s false statements
in its advertisement that the uses had been approved”).
    In its complaint, Amarin includes two separate bases
for its § 337 claims. First, Amarin alleges that respond-
ents’ labeling or advertisements about the articles is false
or misleading, in violation of § 43(a) of the Lanham Act,
such that importation of those articles is an “unfair act”
under § 337 of the Tariff Act. See J.A. 31–56 ¶¶ 53–105
(Compl.). This claim is based on the allegation that label-
ing the products as “dietary supplements” is literally false
because the products “cannot meet the definition of ‘dietary
supplement’ in Section 201(ff) of the FDCA.” J.A. 33 ¶ 60
(Compl.). And, the claim is further based on the allegation
that the products “are actually unapproved ‘new drugs’ un-
der the FDCA.” J.A. 47 (Compl.). Amarin’s complaint re-
lies on these alleged FDCA violations to support key
elements of its Lanham Act false-advertising claim. See
J.A. 55 ¶¶ 102–03 (applying these allegations to the ele-
ments of a false advertising claim). In other words, proving
the Lanham Act claim in this case requires proving viola-
tions of the FDCA.
    The second claim in Amarin’s complaint alleges that
the respondents’ importation and sale of the products con-
stitute unfair acts or unfair methods of competition under
§ 337 based on the standards set forth in the FDCA.
J.A. 56 ¶ 106; see J.A. 56–59 (Compl.). For example, Ama-
rin alleges that the products are “misbranded drugs in vio-
lation of the standards set forth in Section 502 of the
AMARIN PHARMA, INC.   v. ITC                                15

FDCA, [21 U.S.C.] § 352, and adulterated drugs, in viola-
tion of Section 501 of the FDCA, id. § 351.” J.A. 57 ¶ 107.
Every allegation supporting this claim rests on an alleged
violation of the FDCA.
    In sum, Amarin’s two § 337 claims are based on the
same factual allegations—that respondents’ products do
not meet the definition of “dietary supplement” in the
FDCA, see 21 U.S.C. § 321(ff), and are instead unapproved
“new drugs” under the FDCA. E.g., J.A. 33–34 ¶¶ 60–61;
J.A. 47–49 ¶¶ 84–87; J.A. 56 ¶ 106.
     The case before us bears much resemblance to Pho-
toMedex, and we consider the Ninth Circuit’s reasoning in
that case persuasive. In our case, the alleged violations of
§ 337 are based entirely on—and could not exist without—
the FDCA. Because private parties are prohibited from en-
forcing the FDCA, the same concerns expressed in Pho-
toMedex apply here. See PhotoMedex, 601 F.3d at 924. We
note, however, that a major concern of the court in Pho-
toMedex was that proceeding with the Lanham Act claim
would “require litigation of the alleged underlying FDCA
violation in a circumstance where the FDA has not itself
concluded that there was such a violation.” Id. The court
in PhotoMedex appears to have been concerned with adju-
dicating FDCA violations for the first time via a Lanham
Act claim, rather than via the FDA. See id.; id. at 928 (not-
ing that the court’s decision was consistent with other de-
cisions “refusing to allow private actions under the
Lanham Act premised on enforcement determinations that
the FDA and other regulatory agencies did not themselves
make” (emphasis added)); see also Alpharma, 411 F.3d at
935–37; Sandoz, 902 F.2d at 231 (noting that what the
FDCA “do[es] not create directly, the Lanham Act does not
create indirectly, at least not in cases requiring original in-
terpretation of these Acts or their accompanying regula-
tions”).
16                                AMARIN PHARMA, INC.   v. ITC

     As in PhotoMedex (and unlike in Alpharma), affirma-
tive FDA approval is not required in the dietary supple-
ment context. Instead, manufacturers self-police. And as
in PhotoMedex (and unlike in Alpharma), the FDA has not
provided guidance as to whether the products at issue in
this case should be considered “new drugs” that require ap-
proval. Given this lack of guidance, we see no need to go
further than the court in PhotoMedex did. We therefore
hold that a complainant fails to state a cognizable claim
under § 337 where that claim is based on proving violations
of the FDCA and where the FDA has not taken the position
that the articles at issue do, indeed, violate the FDCA.
Such claims are precluded by the FDCA.
    We note that this limited holding is consistent with the
Commission’s arguments in its briefing, which indicated
that Amarin’s claims are precluded at least until the FDA
has provided guidance as to whether the products at issue
are dietary supplements. See, e.g., Commission’s Br. 58
(suggesting that “Amarin is free to file a new complaint
once the FDA issues sufficient guidance with respect to the
accused products such that the Commission is not required
to interpret the FDCA in the first instance and Amarin’s
claims are otherwise no longer precluded by the FDCA”).
We also note that the United States, as amicus, appears to
seek a broader ruling—that all such claims are precluded
regardless of whether the FDA has provided guidance. As
explained above, we need not address that broader ques-
tion here, as the FDA has not provided guidance as to
whether the products at issue properly qualify as “dietary
supplements.”
     Despite Amarin’s heavy reliance on POM Wonderful
LLC v. Coca-Cola Co., 573 U.S. 102 (2014), that recent de-
cision does not alter our analysis. There, the plaintiff sued
a competitor under § 43 of the Lanham Act, alleging that
the label on one of the defendant’s products was deceptive
and misleading. Id. at 106. The product at issue was a
juice blend sold with a label featuring the words
AMARIN PHARMA, INC.   v. ITC                             17

“pomegranate blueberry” more prominently than the words
“flavored blend of 5 juices.” Id. at 106, 110. Despite the
prominence of the names of those two juices, the product
actually contained just 0.3% pomegranate juice and 0.2%
blueberry juice. Id. at 110. The plaintiff alleged that this
labeling (and other features) mislead consumers into
thinking that the juice blend contained primarily pome-
granate and blueberry juices. Id. The issue in the case was
whether a private party could bring a Lanham Act claim
challenging a food label as misleading, where that food la-
bel was regulated by the FDCA. The Ninth Circuit held
that the plaintiff’s Lanham Act claim was precluded by the
FDCA, which forbids misbranding of food, including by
misleading labeling. Id. The Supreme Court reversed,
holding instead that the Lanham Act claim in that case was
not precluded.
     Amarin views POM Wonderful as rejecting the view
that the FDCA precludes Lanham Act claims. But this
reads POM Wonderful too broadly. Although POM Won-
derful held that the FDCA does not categorically preclude
a Lanham Act claim based on a product (e.g., a label) that
is regulated by the FDCA, the court did not open the door
to Lanham Act claims that are based on proving FDCA vi-
olations. The allegations underlying the Lanham Act claim
in POM Wonderful did not require proving a violation of
the FDCA itself. See id. at 117 (“But POM seeks to enforce
the Lanham Act, not the FDCA or its regulations.”). This
stands in stark contrast to the allegations in our case,
which are based solely on alleged violations of the FDCA’s
requirements.
    Amarin also relies on this court’s decision in Allergan,
Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir.
2013). But Allergan was a pre-emption case—not a preclu-
sion case. As the Supreme Court explained in POM Won-
derful, “[i]n pre-emption cases, the question is whether
state law is pre-empted by a federal statute, or in some in-
stances, a federal agency action.” POM Wonderful, 573
18                                  AMARIN PHARMA, INC.   v. ITC

U.S. at 111. Meanwhile, in cases where a cause of action
under one federal statute is alleged to be precluded by the
provisions of another federal statute, “the state-federal bal-
ance does not frame the inquiry,” and the “‘presumption
against pre-emption’ has no force.” Id. (internal citation
omitted). In Allergan, we simply held that the FDCA did
not preempt certain state law claims based on violations of
state law requirements that paralleled FDCA require-
ments. Allergan, 738 F.3d at 1354–56. That analysis has
no bearing on this case.
    In short, although Amarin presents its claims as viola-
tions of the Tariff Act, in reality those claims constitute an
attempt to enforce requirements of the FDCA through the
remedies provided under the Tariff Act. Because private
parties have no such enforcement authority, Amarin’s alle-
gations fail to state a cognizable claim for relief. 6
                              III
    For the foregoing reasons, we hold that we have appel-
late jurisdiction to review the Commission’s decision not to
institute an investigation in this case. Exercising that ju-
risdiction, we hold that the Commission correctly held that
Amarin’s complaint fails to present a cognizable claim un-
der § 337. The decision is therefore affirmed and the peti-
tion for mandamus is denied as moot.
                        AFFIRMED

     6  Although the Intervenors argue that the Commis-
sion should receive Chevron deference for its interpretation
of § 337 with respect to the preclusion issue in this case, see
Intervenors’ Br. 54–68, the Commission does not. The
United States, as amicus, also does not argue in favor of
Chevron deference.
   United States Court of Appeals
       for the Federal Circuit
                        ______________________

           AMARIN PHARMA, INC., AMARIN
          PHARMACEUTICALS IRELAND LTD.,
                    Appellants

                                       v.

       INTERNATIONAL TRADE COMMISSION,
                   Appellee

  ROYAL DSM NV, DSM MARINE LIPIDS PERU
S.A.C., DSM NUTRITIONAL PRODUCTS LLC, DSM
    NUTRITIONAL PRODUCTS CANADA, INC.,
 PHARMAVITE LLC, NORDIC NATURALS, INC.,
            NORDIC PHARMA, INC.,
                    Intervenors
              ______________________

                              2018-1247
                        ______________________

   Appeal from the United States International Trade
Commission in Investigation No. 337-TA-3247.

---------------------------------------------------------------------------------

        IN RE: AMARIN PHARMA, INC., AMARIN
         PHARMACEUTICALS IRELAND LTD.,
                       Petitioners
                 ______________________

                               2018-114
                        ______________________
2                                  AMARIN PHARMA, INC.   v. ITC

    On Petition for Writ of Mandamus to the United States
International Trade Commission in No. 337-TA-3247.
                  ______________________
WALLACH, Circuit Judge, dissenting.
    It is axiomatic that “the power which [C]ongress pos-
sess[es] to create [c]ourts of inferior jurisdiction, neces-
sarily implies the power to limit the jurisdiction of those
[c]ourts to particular objects.” United States v. Hudson, 11
U.S. (7 Cranch) 32, 33 (1812); see Lockerty v. Phillips, 319
U.S. 182, 187 (1943) (explaining that Congress may “with-
hold[] jurisdiction from [lower courts] in the exact degrees
and character which to Congress may seem proper for the
public good” (emphasis added) (internal quotation marks
and citations omitted)). The statute is clear: Congress lim-
ited our subject-matter jurisdiction “to review the final de-
terminations of the United States International Trade
Commission [(‘ITC’)] . . . made under [19 U.S.C. § 1337
(2012)1],” 28 U.S.C. § 1295(a)(6) (2012) (emphasis added),
by defining an ITC “final determination” as a determina-
tion made “under subsection (d), (e), (f), or (g) of [§ 1337],”
19 U.S.C. § 1337(c) (emphasis added).
     Although I agree with the majority’s conclusion that
the ITC did not err in declining to institute an investigation
into the complaint under § 1337 brought by Appellants-Pe-
titioners Amarin Pharma, Inc. and Amarin Pharmaceuti-
cals Ireland Ltd. (together, “Amarin”), see J.A. 4–114
(Complaint), I disagree with the majority’s approach, for it

    1     Section 1337 addresses, inter alia, “[u]nfair meth-
ods of competition and unfair acts in the importation of ar-
ticles . . . into the United States.”            19 U.S.C.
§ 1337(a)(1)(A). Section 1337 is part of the Tariff Act of
1930 (“Tariff Act”). See Pub. L. No. 71-361, § 337, 46 Stat.
590, 703–04 (codified at 19 U.S.C. §§ 1304 et seq.).
AMARIN PHARMA, INC.   v. ITC                                  3

fails to give due respect to Congress’s choice to limit our
appellate jurisdiction. As the ITC’s decision not to institute
was made pursuant to § 1337(b), I believe that we lack ap-
pellate jurisdiction; however, I would instead exercise man-
damus jurisdiction and conclude that Amarin has not
demonstrated that the “extraordinary remedy” of issuing a
writ of mandamus is appropriate. Gulfstream Aerospace
Corp. v. Mayacamas Corp., 485 U.S. 271, 289 (1988). Be-
cause I would dismiss Amarin’s appeal and deny its peti-
tion for a writ of mandamus, I respectfully dissent.
                         DISCUSSION
      I. Congress Limited Our Appellate Jurisdiction
    Congress conferred upon us exclusive jurisdiction “to
review the final determinations of the [ITC] relating to un-
fair practices in import trade, made under [§ 1337].” 28
U.S.C. § 1295(a)(6). Relevant here, § 1337(c) employs the
term “final determination” and states that “[a]ny person
adversely affected by a final determination of the [ITC] un-
der subsection (d), (e), (f), or (g) of [§ 1337] may appeal such
determination . . . to the United States Court of Appeals for
the Federal Circuit.” In interpreting these statutes, we
have said that “[f]inal determinations appealable under
§ 1295(a)(6) are specified in § 1337(c).” Crucible Materials
Corp. v. U.S. Int’l Trade Comm’n, 127 F.3d 1057, 1060
(Fed. Cir. 1997).
  II. We Lack Appellate Jurisdiction to Review the ITC’s
        Decision Not to Institute an Investigation
    Amarin filed its Complaint, which alleges, inter alia,
that Royal DSM NV et al. (“Intervenors”) have “falsely la-
beled[] and/or promoted for use” synthetically produced
omega-3 products (“the Accused Products”), labelled “as di-
etary supplements,” even though they “are actually unap-
proved new drugs under the Federal Food, Drug and
Cosmetic Act (‘FDCA’),” 21 U.S.C. §§ 301 et seq. (2012),
thereby violating “Section 43(a) of the Lanham Act, 15
4                                 AMARIN PHARMA, INC.   v. ITC

U.S.C. § 1125(a) [(2012)], and the standards established by
the FDCA,” J.A. 9 (internal quotation marks omitted). The
Commissioners of the ITC voted not to institute an investi-
gation, see J.A. 681, and sent a letter to Amarin’s counsel
notifying it of that decision, J.A. 1–2; see 19 C.F.R.
§ 210.10(c) (2018) (“If the [ITC] determines not to institute
an investigation on the basis of the complaint, the com-
plaint shall be dismissed, and the complainant and all pro-
posed respondents will receive written notice of the [ITC]’s
action and the reason(s) therefor.”). The ITC stated it “has
determined not to institute an investigation based on the
[C]omplaint . . . and has dismissed the [C]omplaint.”
J.A. 1. According to the ITC, the “[C]omplaint does not al-
lege an unfair method of competition or an unfair act cog-
nizable under . . . § 1337(a)(1)(A), as required by the
statute and the [ITC]’s rules.” J.A. 1. The ITC reasoned
“that the Lanham Act allegations in this case are precluded
by the [FDCA],” and that “the Food and Drug Administra-
tion [(‘FDA’)] is charged with the administration of the
FDCA.” J.A. 1.
    The ITC’s Decision Not to Institute is not an appealable
final determination. An appealable final determination is
an ITC determination made “under subsection (d), (e), (f),
or (g) of [§ 1337].” 19 U.S.C. § 1337(c). Subsections (d)–(g)
pertain to determinations on exclusion orders, see id.
§ 1337(d)–(e), (g), and cease-and-desist orders, see id.
§ 1337(f)–(g). 2 Amarin contends that the ITC’s Decision
Not to Institute is a final determination under either
§ 1337(d) or (f). See Appellants’ Br. 20; see Oral Arg. at
1:37–55,      http://oralarguments.cafc.uscourts.gov/default.
aspx?fl=2018-1247.mp3 (disclaiming reliance on § 1337(e)

    2  Section 1337(g) governs determinations rendered
pursuant to a default and thereby relates to both exclusion
and cease-and-desist orders. See 19 U.S.C. § 1337(g)(1)–
(2).
AMARIN PHARMA, INC.   v. ITC                                 5

or (g)). Each subsection contemplates determinations
made by the ITC post-initiation of an investigation. Sub-
section (d) explicitly provides that the ITC’s determination
to exclude articles will be made “as a result of an investi-
gation.” 19 U.S.C. § 1337(d)(1) (emphasis added); see id.
§ 1337(c) (directing that a “determination under subsection
(d) or (e) . . . shall be made on the record after notice and
opportunity for a hearing”). Subsection (f) sets forth that
the ITC’s determination to issue a cease-and-desist order
is “[i]n addition to, or in lieu of, taking action” pursuant to
other statutory provisions that involve an initiated inves-
tigation, i.e., taking action “under subsection (d),” which in-
volves a completed investigation, “or [subsection] (e),” id.
§ 1337(f)(1), which covers the ITC’s determination to ex-
clude articles made “during the course of an investigation,”
id. § 1337(e)(1).
     Here, the ITC neither initiated an investigation, de-
cided whether a violation of § 1337 occurred, nor deter-
mined whether to issue an exclusion or cease-and-desist
order. See J.A. 1–2. In Block v. United States International
Trade Commission, we held that the “ITC’s decision to ter-
minate its investigation as ‘abated’ [was not] an appealable
‘final determination.’” 777 F.2d 1568, 1570 (Fed. Cir.
1985); see id. at 1571. The ITC terminated the investiga-
tion because, following the U.S. Patent and Trademark Of-
fice’s reexamination relating to an allegedly-infringed
patent, the reexamined claims were substantively
changed. Id. at 1570. There, the ITC’s termination deci-
sion “did not rule on the merits,” so its “action could not
intrinsically be a final determination within the meaning
of . . . § 1337(c) because it was not a decision to exclude or
refuse to exclude articles from entry under . . . § 1337(d),
(e), or (f).” Id. at 1571 (emphasis added). Similarly, the
Decision Not to Institute did not render a decision on
whether to exclude the allegedly mislabeled products or is-
sue a cease-and-desist order. See J.A. 1–2. The ITC re-
fused institution of an investigation and dismissed the
6                                   AMARIN PHARMA, INC.    v. ITC

Complaint, without reaching the requested relief.            See
J.A. 1–2.
    Rather than placing the ITC’s authority to investigate
in subsections (d), (e), (f), or (g), of § 1337, Congress located
that authority in subsection (b). Section 1337(b) authorizes
the ITC to “investigate any alleged violation of [§ 1337] on
complaint under oath or upon its initiative,” 19 U.S.C.
§ 1337(b)(1), and contemplates instances where the ITC
“shall terminate, or not institute, any investigation” or
“suspend its investigation,” id. § 1337(b)(3) (emphasis
added); see VastFame Camera, Ltd. v. Int’l Trade Comm’n,
386 F.3d 1108, 1112, 1113 (Fed. Cir. 2004) (explaining that
§ 1337(b) “gives the [ITC] general authority to investigate
violations of the statute”). Congress indicated its intent to
make § 1337(b) determinations, such as the Decision Not
to Institute, non-appealable through its exclusion of sub-
section (b) from the list of final determinations in § 1337(c).
See Marx v. Gen. Revenue Corp., 568 U.S. 371, 392 (2013)
(“[T]he expressio unius, exclusio alterius canon, . . . in-
structs that when Congress includes one possibility in a
statute, it excludes another by implication.”); cf. United
States v. Erika, 456 U.S. 201, 207 (1982) (“In the context of
the statute’s precisely drawn provisions, this omission pro-
vides persuasive evidence that Congress deliberately in-
tended to foreclose further review of such claims.”
(emphasis added)). 3 Had Congress intended to make non-

    3    Case law, while not expressly deciding the issue,
supports this conclusion. See BASR P’ship v. United
States, 795 F.3d 1338, 1342 (Fed. Cir. 2015) (consulting
case law to construe a statute). In Syntex Agribusiness,
Inc. v. United States International Trade Commission, the
ITC decided not to institute an investigation pursuant to
§ 1337 and accordingly dismissed a complaint. See 659
F.2d 1038, 1040 (CCPA 1981). The complainant first peti-
tioned our predecessor court for a writ of mandamus based
AMARIN PHARMA, INC.   v. ITC                                7

institution decisions appealable, it merely needed to in-
clude them in its list of determinations that would be con-
sidered final in § 1337(c). Given that Congress decided not
to adopt this “obvious alternative,” “the natural implication
is that [it] did not intend” for such decisions under
§ 1337(b) to be appealable. Lozano v. Montoya Alvarez, 572
U.S. 1, 16 (2014). “We cannot revisit that choice.” Id.
     The statutory context further reveals that Congress did
not contemplate appealability of an ITC non-institution de-
cision. See Digital Realty Tr., Inc. v. Somers, 138 S. Ct.
767, 777 (2018) (acknowledging that courts may rely upon
a statute’s “purpose and design” to “corroborate” their un-
derstanding of the statutory text); Block v. Cmty. Nutrition
Inst., 467 U.S. 340, 349 (1984) (“[T]he presumption favor-
ing judicial review of administrative action may be over-
come by inferences of intent drawn from the statutory
scheme as a whole.”). In fact, § 1337(b)(1) covers the pro-
cedures for commencing and conducting an investigation,
and details that, “[u]pon commencing any such investiga-
tion, the [ITC] shall publish notice thereof in the Federal
Register.” Moreover, “the [ITC] shall, within 45 days after
an investigation is initiated, establish a target date for its
final determination.” 19 U.S.C. § 1337(b)(1) (emphases
added). Through this language, Congress established two
separate types of ITC determinations—a decision whether
to institute an investigation and, separately, a final deter-
mination, i.e., those made under subsections (d), (e), (f), or
(g)—and clarified that a final determination is rendered af-
ter an institution decision. See id.

on the ITC’s refusal to investigate and later filed an appeal
from the ITC’s decision. Id. at 1041. Our predecessor
court, by separate order, “dismissed [the complain-
ant’s] . . . appeal on the ground that there had been no final
determination by [the] ITC, which is essential for jurisdic-
tion of the court.” Id. (emphases added).
8                                    AMARIN PHARMA, INC.     v. ITC

     Similarly, § 1337(j) provides that, when the ITC “deter-
mines that there is a violation of [§ 1337] . . . or . . . [ha]s
reason to believe that there is such a violation,” it shall,
inter alia, “transmit to the President a copy of such deter-
mination and the action taken under subsection (d), (e), (f),
(g), or (i)[4] of [§ 1337].” Id. § 1337(j)(1), (j)(1)(B). The Pres-
ident then has the option “for policy reasons” to “disap-
prove[ of] such determination” within sixty days, id.
§ 1337(j)(2), and, if not disapproved or if approved, the “de-
termination shall become final,” id. § 1337(j)(4) (emphasis
added). Such determinations that are submitted to the
President become final well after an investigation is com-
plete. See id. § 1337(b), (j). Tellingly, Congress has con-
ferred jurisdiction explicitly over certain administrative
decisions not to institute an investigation, elsewhere in the
Tariff Act.         Congress explained that “an interested
party . . . may commence an action in the United States
Court of International Trade [(‘CIT’)]” challenging “a deter-
mination by [the U.S. Department of Commerce] . . . not to
initiate an investigation” related to antidumping and coun-
tervailing duty proceedings. 19 U.S.C. § 1516a(a)(1),
(a)(1)(A) (emphasis added); see 28 U.S.C. § 1581(c) (confer-
ring the CIT with “exclusive jurisdiction” over actions com-
menced pursuant to § 1516a). Congress did not confer such
jurisdiction in § 1337.
    The legislative history does not support the majority’s
conclusion. See Thunder Basin Coal Co. v. Reich, 510 U.S.
200, 207, 209–12 (1994) (consulting legislative history for
statutory interpretation). Although the original version of
§ 1337 did not define an ITC final determination by

    4   Section 1337(i) authorizes the ITC, “[i]n addition to
taking action under subsection (d),” to “issue an order
providing that any article imported in violation of the pro-
visions of [§ 1337] be seized and forfeited to the United
States” in certain situations.
AMARIN PHARMA, INC.   v. ITC                               9

reference to specific subsections, see Tariff Act § 337, 46
Stat. at 703–04, Congress amended § 1337(c) and added
that “[a]ny person adversely affected by a final determina-
tion of the [ITC] under subsection (d) or (e) may appeal
such determination,” Trade Act of 1974, Pub. L. No. 93-618,
§ 341(a), 88 Stat. 1978, 2054. 5 When Congress inserted
this language, the Senate Finance Committee recognized it
was “extend[ing] the right to judicial review of final [ITC]
determinations.” S. Rep. No. 93-1298, at 197 (1974) (Conf.
Rep.). It provided that “[b]y final determination, as used in
this section, the Committee means a[n ITC] determination
which has been referred to the President under [the prede-
cessor to current § 1337(j)], and has been approved by the
President or has not been disapproved . . . after referral of
the determination.” Id. (emphases added). This appears
to be the only time in the legislative history Congress ex-
pounded its understanding of the term final determination
in § 1337. Nowhere does Congress equate a non-institution
decision to a final determination. See id.
    While this court has acknowledged that § 1337 “pro-
vides for judicial review of both positive and negative de-
terminations,” we should be careful not to expand the scope
of the term final determination to include determinations
beyond those contemplated by Congress. Amgen, Inc. v.
U.S. Int’l Trade Comm’n, 902 F.2d 1532, 1535 (Fed. Cir.
1990) (footnote omitted); see Imp. Motors, Ltd. v. U.S. Int’l
Trade Comm’n, 530 F.2d 940, 945 (CCPA 1976) (explaining
that § 1337(c) “indicate[s] an intent to provide appeal of
such an unfavorable decision”). I find no support for the
proposition that Congress intended a non-institution

    5   Congress later amended this language to include
additional subsections under the definition of an ITC final
determination. See, e.g., Trade Agreements Act of 1979,
Pub. L. No. 96-39, § 1105(c), 93 Stat. 144, 311 (adding sub-
section (f)).
10                                  AMARIN PHARMA, INC.    v. ITC

decision to be an appealable final determination. Accord-
ingly, I do not believe that the ITC’s Decision Not to Insti-
tute is a final determination under § 1337(c).
    Apparently recognizing that it is not a final determina-
tion as defined by § 1337(c), the majority sweeps the ITC’s
Decision Not to Institute under our jurisdiction by holding
that it is intrinsically a final determination, based on
Amgen. See Maj. Op. 6–9. In Amgen, the ITC dismissed a
complaint for lack of subject-matter jurisdiction because
the patent-at-issue did “not contain any process patent
claims,” which the ITC considered “a jurisdictional prereq-
uisite.” 902 F.2d at 1535. We exercised appellate jurisdic-
tion and vacated and remanded the ITC’s dismissal,
determining that the dismissal “should have been phrased
as a dismissal on the merits.” Id. at 1537. 6 There, the
ITC’s determination that the patent’s claims “do not, in
fact, cover a process [as required by statute] . . . clearly

     6   Amgen’s statement that “when a decision is intrin-
sically a final determination, i.e., a determination on the
merits, then that decision is appealable under [§] 1337(c),”
traces back to our predecessor court’s decision in Import
Motors. Amgen, 902 F.2d at 1535 (emphasis omitted) (cit-
ing, inter alia, 530 F.2d at 944). Even under this interpre-
tation of “final determination,” the ITC’s determination
must be made “under subsection (d), (e), (f), or (g)” because
the statutory language cabins the types of final determina-
tions that are appealable. 19 U.S.C. § 1337(c); see Import
Motors, 530 F.2d at 944 (recounting that an earlier version
of § 1337, “[s]trictly interpreted[,] . . . refers to a final ad-
ministrative decision on the merits, excluding or refusing
to exclude articles from entry under subsection (d) or (e)”).
Amgen does not expand our jurisdiction to determinations
made under different subsections of § 1337, nor could it.
See Lozano, 572 U.S. at 16 (recognizing that we are bound
by Congress’s choice).
AMARIN PHARMA, INC.   v. ITC                                11

reache[d] the merits of [the] complaint and determinatively
decide[d the complainant’s] right to proceed in a [§] 1337
action.” Id. at 1535. The court recognized that “the juris-
dictional requirements of [§] 1337 mesh with the factual re-
quirements necessary to prevail on the merits,” and
explained that “the fact that [the complainant] was later
unable to sustain these allegations [regarding whether its
patent covered a process] is not material to the issue of ju-
risdiction.” Id. at 1536.
    The majority’s reliance on Amgen is misplaced. Amgen
did not involve a determination made pursuant to
§ 1337(b); instead, the ITC in that case “conduct[ed] a full
investigation” before dismissing the complaint. Id. at 1534.
The majority dismisses this fact by stating “the court’s rea-
soning in [Amgen] was not based on that procedural detail”
but “focused on the operative effect of the [ITC] decision.”
Maj. Op. 8. That is hardly a procedural detail; this fact,
coupled with § 1337(c)’s precise definition of a final deter-
mination, fundamentally limits Amgen’s holding. See 19
U.S.C. § 1337(c). The majority criticizes “this approach [as]
elevat[ing] form over substance.” Maj. Op. 9. There is a
“general principle that agencies with statutory enforce-
ment responsibilities enjoy broad discretion in allocating
investigative and enforcement resources.” Torrington Co.
v. United States, 68 F.3d 1347, 1351 (Fed. Cir. 1995). The
majority fails to give due respect to Congress’s choice,
thereby placing “this court in the position of routinely sec-
ond-guessing the [ITC]’s decisions [on non-institution] . . . ,
a role for which [we] are ill-suited and one that could be
quite disruptive of [the ITC]’s effort to establish enforce-
ment priorities.” Id.
    In addition, Amgen determined that the ITC improp-
erly characterized its dismissal as jurisdictional on the pro-
cess patent claim issue, but we explained that the
substance of its analysis meant it “should have dismissed
on the merits.” 902 F.2d at 1536 (footnote omitted). By
contrast, the ITC’s two-page Decision Not to Institute,
12                                 AMARIN PHARMA, INC.   v. ITC

which dismissed on jurisdictional grounds, does not pur-
port to, nor in fact does, reach the merits of Amarin’s Com-
plaint; rather, it recognizes that the FDCA vests the FDA
with primacy over such claims. See J.A. 1–2. Amarin is
not barred from seeking relief; for instance, the ITC did not
find that Amarin failed to “pro[ve] . . . an element of the
cause of action,” such as finding the Intervenors did not
falsely label their accused products and therefore did not
commit an unfair act under § 1337(a). Engage Learning,
Inc. v. Salazar, 660 F.3d 1346, 1354 (Fed. Cir. 2011) (cita-
tion omitted); see Block, 777 F.2d at 1571 (dismissing for
lack of appellate jurisdiction where the ITC did not make a
“finding as to whether . . . § 1337 was violated”); J.A. 1–2.
As in Block, the ITC’s Decision Not to Institute is not “the
equivalent of a final determination,” as it was “without
prejudice,” because it did not make findings on the merits,
and Amarin is “free to” file another complaint. 777 F.2d at
1571; see id. (rejecting the argument that the ITC’s “or-
der . . . involved the denial of substantive rights”); Amgen,
902 F.2d at 1535 (distinguishing Block and recognizing
there that the court “found the lack of any findings by the
[ITC] to be critical; nothing in the termination [o]rder prej-
udiced the [ITC] or any private party in a future proceed-
ing” (emphasis added) (citation omitted)). Indeed, the ITC
represents, on appeal, that its dismissal is “without preju-
dice.” Appellee’s Br. 57. The ITC notes that “Amarin is
free to file a new complaint once the FDA issues sufficient
guidance with respect to the [A]ccused [P]roducts such that
the [ITC] is not required to interpret the FDCA in the first
instance and Amarin’s claims are otherwise no longer pre-
cluded by the FDCA.” Id. at 58 (footnote omitted); see Imp.
Motors, 530 F.2d at 947 & n.13 (relying on an ITC repre-
sentation made on appeal regarding whether a party could
participate in the second stage of a § 1337 investigation).
The majority implicitly recognizes that Amarin may even-
tually re-file. See Maj. Op. 7–8 (“[A]s long as Amarin’s
[C]omplaint is based on proving violations of the FDCA (at
least where the FDA has not provided guidance as to
AMARIN PHARMA, INC.   v. ITC                                13

whether the articles violate the FDCA), Amarin’s claims will
be precluded.” (emphasis added)). 7 Accordingly, I conclude
that the ITC’s Decision Not to Institute is not an appeala-
ble final determination within the meaning of § 1337(c).
III. We Should Exercise Mandamus Jurisdiction and Deny
                   Amarin’s Petition
    Intervenors argue that we lack mandamus jurisdiction
to review Amarin’s Petition, see Intervenors’ Br. 34–37, be-
cause we may not “use mandamus to obtain jurisdiction
over agency decisions otherwise beyond [our] reach,” id. at
36. Amarin and the ITC contend that we have mandamus
jurisdiction. See Appellants’ Br. 25–27; Appellee’s Br. 51–
52. I agree with Amarin and the ITC.
    Pursuant to the All Writs Act, we “may issue all writs
necessary or appropriate in aid of” our jurisdiction. 28
U.S.C. § 1651(a). Therefore, our “authority to issue writs
of mandamus is restricted by statute to those cases in
which the writ is in aid of [appellate] jurisdiction.” Roche
v. Evaporated Milk Ass’n, 319 U.S. 21, 25 (1943). “The au-
thority is not limited to issuance of the writ where the court
already had jurisdiction on appeal; rather, the authority
extends to those cases which are within its appellate juris-
diction although no appeal has been perfected.” In re
Princo Corp., 478 F.3d 1345, 1351 (Fed. Cir. 2007) (internal
quotation marks and citation omitted).
     I believe we have jurisdiction to consider Amarin’s Pe-
tition, which seeks mandamus relief. Section 1295(a) gives
us “exclusive jurisdiction . . . (6) to review the final deter-
minations of the [ITC] . . . made under [§ 1337].” See 19

    7     Because the dismissal is without prejudice and
Amarin can re-file, the majority need not be concerned that
the ITC would unnecessarily be required “to formally insti-
tute . . . just long enough . . . to issue the same dismissal
order it already issued in this case.” Maj. Op. 9.
14                                   AMARIN PHARMA, INC.    v. ITC

U.S.C. § 1337(c) (defining “a final determination”). If the
ITC were to erroneously refuse to initiate an investigation,
we might consequently be divested of appellate jurisdiction
over a matter which we should have had jurisdiction fol-
lowing ITC’s institution and final determination. See id.;
28 U.S.C. § 1295(a)(6). Review over such matters is neces-
sary as an exercise of “limited judicial power to preserve
th[is] court’s jurisdiction.” FTC v. Dean Foods Co., 384 U.S.
597, 604 (1966). Amarin’s Petition asks whether the ITC
is required to initiate an investigation under the governing
statute. See, e.g., Appellants’ Br. 38 (“The Tariff Act im-
poses a non-discretionary duty on the [ITC] to institute in-
vestigations into alleged unfair trade practices and
methods of competition.”); see id. at 39 (relying on
§ 1337(b)). Accordingly, we retain mandamus jurisdiction,
which, under these circumstances, is “necessary to protect
[our] prospective jurisdiction.” Telecomms. Research & Ac-
tion Ctr. v. FCC, 750 F.2d 70, 76 (D.C. Cir. 1984); see, e.g.,
Syntex, 659 F.2d at 1041 (considering, but ultimately deny-
ing, a petition for writ of mandamus where petitioner
sought “to compel [the] ITC to institute an investigation”);
cf. In re Cypress Semiconductor Corp., 321 F. App’x 964,
965 (Fed. Cir. 2009) (exercising jurisdiction over, but ulti-
mately denying, a petition for writ of mandamus seeking to
compel the ITC “to halt its investigation”).
     Heckler v. Chaney does not require a different result.
See 470 U.S. 821 (1985); see also Intervenors’ Br. 26–27, 35
(citing Heckler to argue the ITC’s Decision Not to Institute
is immune from judicial review). Although Heckler held
that “an agency’s decision not to take enforcement action
should be presumed immune from judicial review,” 470
U.S. at 832, the Supreme Court did not address “a refusal
by the agency to institute proceedings based solely on the
belief that it lacks jurisdiction,” id. at 833 n.4, or a “decision
[that] is predicated solely on the agency’s interpretation of
a statute,” Int’l Union, United Auto., Aerospace & Agric.
Implement Workers of Am. v. Brock, 783 F.2d 237, 245 n.10
AMARIN PHARMA, INC.   v. ITC                                   15

(D.C. Cir. 1986). However, as discussed above, the Petition
challenges the ITC’s interpretation of § 1337 and the
FDCA, see Appellants’ Br. 38–39, 50, and the ITC refused
to institute because it lacked jurisdiction over Amarin’s
Complaint, see J.A. 1. Thus, I would exercise mandamus
jurisdiction over Amarin’s Petition, but agree with the ma-
jority’s conclusion that Amarin has failed to demonstrate
that it is entitled to the extraordinary relief of mandamus.
See Maj. Op. 9 n.3, 9–18. 8

    8      To the extent there remains a question about
whether we have mandamus jurisdiction, the ITC’s failure
to institute an investigation would not evade judicial re-
view. Instead, the Administrative Procedure Act (“APA”),
60 Stat. 237 (1946) (codified in scattered sections of 5
U.S.C. (2012)), provides that “[a] person . . . adversely af-
fected” by “final agency action[s] for which there is no other
adequate remedy in a court” may seek review of that ac-
tion, 5 U.S.C. §§ 702, 704. Under this type of action, a re-
viewing court may “compel agency action unlawfully
withheld,” id. § 706(1), for example the ITC’s failure to in-
stitute an investigation. Therefore, if appellate and man-
damus jurisdiction are lacking in this court, Amarin may
be able to raise an APA challenge in district court. See Nor-
ton v. S. Utah Wilderness All., 542 U.S. 55, 64 (2004) (hold-
ing “a claim under § 706(1) can proceed only where a
plaintiff asserts that an agency failed to take a discrete
agency action that it is required to take”). It is useful to
note that § 1337(c) expressly contemplates APA review of
certain types of determinations. See 19 U.S.C. § 1337(c)
(stating that ITC “determinations under subsections (d),
(e), (f), and (g) . . . with respect to its findings on the public
health and welfare, competitive conditions in the United
States economy, the production of like or directly competi-
tive articles in the United States, and United States con-
sumers, the amount and nature of bond, or the appropriate
16                                 AMARIN PHARMA, INC.   v. ITC

                        CONCLUSION
    Through § 1337(c), Congress expressly defined a final
determination of the ITC and thereby precisely drew the
limits of our appellate jurisdiction. The majority disre-
gards the text of the statute and Congress’s intent by hold-
ing that a § 1337(b) non-institution determination is
appealable, even though Congress expressly defined a final
determination as one made under § 1337(d)–(g). Because I
believe we must follow Congress’s directive, I respectfully
dissent.

remedy shall be reviewable in accordance with [§] 706” and
“[d]eterminations . . . under subsections (e), (f), and
(j) . . . with respect to forfeiture of bonds and under subsec-
tion (h) . . . with respect to the imposition of sanctions for
abuse of discovery or abuse of process shall also be review-
able in accordance with [§] 706”).