The US Court of Appeals for the Federal Circuit affirmed an International Trade Commission (ITC) decision not to institute an investigation where the underlying statutory scheme precluded a private right of action. Amarin Pharma, Inc. v. ITC, Case Nos. 18-1247, -114 (Fed. Cir. May 1, 2019) (Prost, CJ) (Wallach, J, dissenting). The Federal Circuit’s decision solidified precedent giving the Court jurisdiction over ITC decisions not to institute where such decisions intrinsically represent a decision on the merits.

Amarin markets the prescription drug Vascepa®, which uses an ethyl ester synthetically produced fish oil to lower triglyceride levels. Amarin’s product is the only US Food and Drug Administration (FDA) approved drug in the United States made from a purified ethyl ester omega-3 acid. In 2017, Amarin filed a verified complaint with the ITC alleging that several other companies were falsely advertising and labeling their omega-3 products as dietary supplements in contravention of the Food, Drug, and Cosmetic Act (FDCA). Amarin alleged that this conduct constituted an unfair act or unfair method of competition under § 337 of the Tariff Act, because it contained false statements in violation of § 43(a) of the Lanham Act and the standards set forth in the FDCA. The FDCA, however, does not authorize private rights of action. Accordingly, the ITC issued a decision letter declining to institute an investigation and dismissing the complaint. Amarin appealed.

The Federal Circuit first addressed whether it had jurisdiction over the appeal. The ITC and FDA contended that the Court lacked jurisdiction because the ITC’s decision not to institute did not constitute a “final determination” under § 337. Citing its own precedent, the Court found that it had jurisdiction over the appeal because the ITC’s decision is “intrinsically a final determination, i.e., a determination on the merits.” The Court reasoned that because the ITC found that the claims were precluded by the FDCA and the complaint failed to state a claim, the ITC de facto reached the merits of the complaint and decided whether Amarin’s claims could proceed. Any future complaint alleging the same facts would have failed on the same basis. The Federal Circuit rejected the ITC and FDA’s argument that such a “final determination” could only be made after institution of an investigation. On this issue, Judge Wallach dissented, siding with the ITC and FDA. Judge Wallach argued that the statutory text indicated that Congress intended to make determinations not to institute final and non-appealable by excluding them from the list of “final determinations” in the statutory scheme. The majority criticized the dissent for elevating form over substance when neither statutory text nor congressional intent intended such inflexible formality.

Turning to whether the ITC had a mandatory duty to institute an investigation on Amarin’s verified complaint, the Federal Circuit reasoned that where a complaint lacks sufficient allegations to support a particular claim, it does not constitute a complaint within the meaning of § 337.

The Federal Circuit next considered the ITC’s holding that the specific complaint in issue failed to state a claim for an unfair method of competition or unfair act. Although Amarin packaged its claims under the Tariff Act and the Lanham Act, both claims effectively relied on alleged violations of the FDCA and required the ITC to adjudicate the underlying FDCA claims to address the complaint before it. The FDCA lacks a private right of enforcement. Since Amarin was precluded from bringing FDCA claims, the Court reasoned that its complaint failed to state a claim on which relief could be granted, and concluded that the ITC properly dismissed the complaint.