Amarin Pharma, Inc. et al. v. International Trade Commission (ITC) (Appellee) and Royal DSM NV, et al. (Intervenors)

Docket Nos. 2018-1247 and 2018-114

May 1, 2019

Brief summary: ITC decision “that Amarin’s allegations are precluded by the FDCA” affirmed since, e.g., “[p]rivate parties may not bring [FDCA] enforcement suits.”

Summary: Amarin, which markets Vascepa fish oil capsules (“the only purified ethyl ester E-EPA product sold in the [US] as an FDA-approved drug” (E-EPA being the ethyl ester form of eicosapentaenoic acid)), appealed the ITC decision not to institute an unfair competition or unfair act investigation under 19 USC § 1337(a)(1)(A). Amarin filed a complaint under § 337 of the Tariff Act of 1930 alleging “that certain companies” (Royal DSM, Nordic Naturals (the Intervenors)) “were falsely labelling and deceptively advertising their imported synthetically produced omega-3 produces 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” US. Amarin sought “an order under § 337(d) that would exclude synthetically produced omega-3 products from entry into the [US], as well as a cease-and-desist order under § 337(f) to prohibit the respondents from importing, using, or selling synthetically produced omega-3 products.” In declining to institute an investigation and dismissing the complain, the ITC “reasoned that Amarin’s allegations are precluded by the FDCA” and, therefore, “failed to state a cognizable claim under § 337” (as urged by the FDA in a letter to the ITC; POM Wonderful, US 2014 regarding an allegedly mislabeled juice (“Private parties may not bring [FDCA] enforcement suits.”)) The FC panel first explained that it has jurisdiction over the appeal (as argued by Amarin) since the ITC’s “decision ‘clearly reach[ed] the merits of [the] complaint and determinatively decide[d] [Amarin’s] right to proceed in a section 1337 action” (Amgen, FC 1990 (“decision not to institute…is ‘intrinsically a final determination, i.e., a determination on the merits’”); Block, FC 1985 (“order was not a final determination”); Import Motors, CCPA 1976). Amarin also argued that the ITC “had a mandatory duty to institute an investigation” under § 1337(b)(1) as Amarin presented “ a complaint under oath” but the FC panel disagreed since “[t]he facts alleged as the basis for Amarin’s complaint demonstrate” those “are based entirely on violations of the FDCA” and, therefore, “Amarin’s complaint fails to state a cognizable claim for relief” (Syntex, CCPA 1981 (proper to dismiss “where the complain contained insufficient factual allegations”)). The FC panel next explained its agreement with the ITC that the FDA “is charged with administration of the FDCA”, not the ITC, since “the FDCA authorizes the FDA to regulate drugs and dietary supplements” (which “do not require pre-market approval”) and “proving the Lanham Act” (false advertising as “dietary supplement[s]”) “claim in this case requires providing violations of the FDCA” (POM “did not open the door to Lanham Act claims that are based on proving FDCA violations:; Buckman, US 2001; PhotoMedex, 9th Cir. 2010 (FDA has not provided guidance as to whether the products at issue…should be considered ‘new drugs’ that require approval)). Thus, the ITC’s decision not to investigate was affirmed. Judge Wallach dissented, writing that the non-institution decision should not be appealable, and that the case should have been decided under a mandamus jurisdiction (and still denied).

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