Federal Circuit Asserts Jurisdiction To Review ITC's Non-Institution Decision

Author:Mr Yury Kalish Ph.D. and Vishal V. Khatri
Profession:Jones Day

In a long-awaited decision, a split panel of the Federal Circuit confirmed on May 1, 2019, that the Court has jurisdiction to review the ITC's decision not to institute an investigation. Amarin Pharma, Inc. v. Int'l Trade Comm'n, No. 2018-114, 2019 WL 1925649 (Fed. Cir. May 1, 2019). The appeal arose from Amarin's petition for review pursuant to 28 U.S.C. § 1295(a)(6) and its simultaneously-filed mandamus petition, and in the majority opinion authored by Chief Judge Prost and joined by Judge Hughes, the Court held that it had ordinary appellate jurisdiction to review the non-institution decision as a "final decision" by the ITC under § 1295(a)(6) and did not reach Amarin's mandamus arguments. In dissent, Judge Wallach would have declined to find appellate jurisdiction under § 1295(a)(6) but would have granted mandamus review. On the merits, the panel unanimously agreed that the ITC did not err in declining to institute an investigation.

Amarin's Section 337 complaint related to its omega-3 based prescription drug Vascepa®, for which Amarin had obtained FDA approval. Amarin's complaint, filed August 30, 2017, alleged that other companies were importing omega-3 products falsely labeled as "dietary supplements" rather than "new drugs," in violation of the Food, Drug, and Cosmetic Act (FDCA) and the Lanham Act. On October 27, 2017, the ITC determined not to institute an investigation and dismissed the complaint. In December 2017, Amarin filed its appeal and mandamus petition to the Federal Circuit.

Nearly eighteen months later, the Federal Circuit issued its decision, answering in the affirmative the threshold question of whether it has ordinary appellate jurisdiction pursuant to § 1295(a)(6) to review ITC non-institution decisions. The appellate jurisdiction statute, 28 U.S.C. § 1295(a)(6), provides the Federal Circuit with exclusive jurisdiction to "review the final determinations of the United States International Trade Commission . . . " Opposing judicial review, both the Commission and the intervenors argued that final determinations are only those made "as a result of an investigation." The Court disagreed, explaining that the provision governing ITC "final determinations"— 19 U.S.C. § 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)." Accordingly, he ITC's non-institution decision was such a final...

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