Amarin Pharma, Inc. v. Int'l Trade Comm'n (In re Amarin Pharma, Inc.)

• Decision Date: 01 May 2019
• Docket Number: 2018-1247,2018-114
• Citation: 923 F.3d 959
• Parties: 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 In re: Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Ltd., Petitioners
• Court: U.S. Court of Appeals — Federal Circuit

923 F.3d 959

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

In re: Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Ltd., Petitioners

2018-1247

2018-114

United States Court of Appeals, Federal Circuit.

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 Products LLC, DSM Nutritional Products Canada, Inc., Pharmavite 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, argued 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 & Schaumberg, LLP, Washington, DC, for amici curiae Council for Responsible Nutrition, Global Organization for EPA and DHA Omega-3S. Also represented by Asha Allam, Paul M. Bartkowski, Paulina Maria Starostka.

Before Prost, Chief Judge, Wallach and Hughes, Circuit Judges.

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, accordingly, 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 capsule. The EPA in Vascepa® is in ethyl ester form and is synthetically produced from fish oil. Amarin obtained approval from the Food and Drug Administration ("FDA") to market and sell Vascepa®, which is designed to reduce triglyceride

levels in adult patients with severe hypertriglyceridemia. 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 complaint alleging violations under § 337 of the Tariff Act of 1930, as amended. J.A. 4–114 (Compl.). The complaint alleges that certain companies were falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as (or for use in) "dietary 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 complaint: (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 importation 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 proposed respondents from importing, using, or selling synthetically 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 investigation and instead to dismiss Amarin's complaint. J.A. 627–37. In the FDA's view, the FDCA prohibits private enforcement 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 decision 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, 134 S.Ct. 2228, 189 L.Ed.2d 141 (2014) ("Private parties may not bring [FDCA] enforcement suits." (citing 21 U.S.C. § 337 )).

In December 2017, Amarin filed in this court a petition for review and, separately, a petition for a writ of mandamus. 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 Nordic Natural, Inc. and Nordic Pharma, Inc. (collectively, "Nordic") (both, "the Intervenors") intervened in the appeal. ECF Nos. 14, 23, 25, 49.

II

At the outset, we begin by confirming that we have jurisdiction 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 investigation when presented with a complaint under oath. Finally, we address whether the Commission correctly determined 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 jurisdiction "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; Commission's Br. 52–56. And these decisions, according to the Intervenors, can only be made "as a result of an investigation." Intervenors' Br. 19.

The question as to our jurisdiction in this case is resolved 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 patented process. See 19 U.S.C. § 1337(a)(1)(B)(ii). The Commission 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 process claim, which the Commission considered to be a jurisdictional prerequisite for an investigation under § 1337(a)(1)(B)(ii). Id. at 1535.

On appeal in Amgen , we first addressed our jurisdiction under 28 U.S.C. § 1295(a)(6). Interpreting 19 U.S.C. § 1337(c), we recognized that § 1337(c)"has been interpreted 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 "intrinsically 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 holding in Block , a case in which we held that a Commission order was not a final determination. In Block , the Commission 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 , however, 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 action." Id. We further explained that "any future action 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 determination 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 cognizable 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) (analyzing the right to appeal a Commission order by asking whether the order "has the operative effect of a ‘final determination under subsection (d) or (e)’ " and noting that "[s]ubstance, not form, must control"). Any future complaint brought by Amarin alleging these same facts "would necessarily raise the same issue" and...