Amarin Pharma, Inc. v. Int'l Trade Comm'n (In Re Amarin Pharma, Inc.)
923 F.3d 959
Fed. Cir.2019Background
- Amarin markets Vascepa®, an FDA‑approved prescription drug containing purified ethyl ester eicosapentaenoic acid (E‑EPA); it alleged competing imported synthetically produced omega‑3 products were being labeled and sold as "dietary supplements" but were actually unapproved "new drugs."
- Amarin filed a sworn § 337 complaint at the ITC alleging (1) unfair acts under § 337 via Lanham Act § 43(a) false‑advertising and (2) violations of standards set by the FDCA, seeking exclusion and cease‑and‑desist relief.
- The FDA submitted a letter urging dismissal, arguing private parties may not enforce the FDCA and the ITC should avoid interpreting/enforcing the FDCA or act contrary to FDA primacy.
- The ITC declined to institute an investigation and dismissed Amarin's complaint, holding the Lanham Act‑based allegations were precluded by the FDCA and that the FDCA/FDA controls enforcement in this area.
- Amarin appealed to the Federal Circuit and sought mandamus; the court considered (A) its jurisdiction to review the ITC non‑institution decision, (B) whether institution is mandatory, and (C) whether the complaint was precluded by the FDCA.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Jurisdiction: Can the Federal Circuit review an ITC decision not to institute? | Amarin: §1295(a)(6) covers final ITC determinations and this non‑institution decision is reviewable. | ITC/Intervenors: §1337(c) limits review to determinations made under subsections (d),(e),(f),(g) resulting from investigations; non‑institution decisions are not final. | The court held it has jurisdiction: the ITC's dismissal was “intrinsically a final determination” on the merits and thus appealable. |
| Duty to institute: Is the ITC required to institute an investigation on a sworn complaint? | Amarin: §1337(b)(1) says the Commission "shall investigate" complaints under oath, implying a non‑discretionary duty. | ITC: Rules and statute permit examinations for sufficiency and permit dismissal where complaints fail to state a cognizable claim. | The court held the ITC may decline to institute where a complaint fails to state a cognizable §337 claim; no mandatory duty here. |
| Preclusion: Does the FDCA bar Amarin's Lanham Act/§337 claims premised on proving FDCA violations when FDA has not taken a position? | Amarin: POM Wonderful and precedent allow Lanham Act claims even when subject matter is FDCA‑regulated. | ITC/Intervenors: Private enforcement of the FDCA is prohibited; Lanham claims that require adjudicating FDCA violations are precluded unless FDA has already concluded there is a violation or provided guidance. | Held: Claims that depend on proving FDCA violations are precluded where the FDA has not taken a position/given guidance; Amarin's complaint failed to state a cognizable §337 claim and dismissal affirmed. |
| Scope of POM Wonderful: Does POM Wonderful permit Amarin's claim despite FDCA primacy? | Amarin: POM Wonderful permits Lanham Act suits challenging FDA‑regulated labels. | ITC: POM does not allow Lanham claims that would require first‑time adjudication of FDCA violations by a private party. | Held: POM Wonderful is not controlling here; it does not permit Lanham claims that necessarily require proving FDCA violations where FDA has not acted. |
Key Cases Cited
- POM Wonderful LLC v. Coca‑Cola Co., 573 U.S. 102 (Lanham Act claim not categorically precluded by FDCA)
- Amgen Inc. v. U.S. Int'l Trade Comm'n, 902 F.2d 1532 (Fed. Cir.) (agency dismissal that is "intrinsically a final determination" may be appealable)
- PhotoMedex, Inc. v. Irwin, 601 F.3d 919 (9th Cir.) (Lanham Act claims barred where resolution would require litigation of underlying FDCA violation absent FDA conclusion)
- Syntex Agribusiness, Inc. v. U.S. Int'l Trade Comm'n, 659 F.2d 1038 (CCPA) (ITC may dismiss complaint lacking sufficient factual allegations to be a proper §337 complaint)
- Block v. U.S. Int'l Trade Comm'n, 777 F.2d 1568 (Fed. Cir.) (ITC termination/abatement not appealable where no merits ruling; substance must operate as final determination)
- Import Motors, Ltd. v. U.S. Int'l Trade Comm'n, 530 F.2d 940 (CCPA) ("substance, not form" controls whether an ITC action is functionally a final determination)
- Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (private suits to enforce FDCA are precluded)