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 determination decision on the merits and thus subject to appeal under § 1295(a)(6).
The Court's analysis compared two of its precedents – Amgen and Block. In Amgen, which, according to the majority, "resolved" the issue in this case, the Court found it had jurisdiction and affirmed the ITC's dismissal of a complaint which alleged a 337 violation by importation of articles made by a patented process where the patent at issue did not contain any process claims. Amgen v. ITC, 902 F.2d 1532 (Fed. Cir. 1990). Amgen concluded that the Commission's decision was intrinsically a final determination, i.e., a determination on the merits, because the Commission "clearly reached the merits of the complaint and determinatively decided the complainant's right to proceed in a section 1337 action." According to Amgen, "any future action brought by the complainant would necessarily raise the same issue, and would presumably be dismissed for the same reason." In Block, on the other hand, the Federal Circuit concluded that it did not have jurisdiction to review the ITC's termination of an investigation where the Commission initiated an investigation on its own motion and later terminated that investigation after the patent at issue was amended during reexamination. Block v. ITC, 777 F.2d 1568 (Fed. Cir. 1985). Block determined that nothing prejudiced the Commission or any private party in a future proceeding, and therefore the Commission's termination was not a final determination.
The majority in Amarin found the facts of this case to be more analogous to Amgen. 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. As in Amgen, this decision clearly reached the merits of the complaint and conclusively decided Amarin's right to proceed in a section 1337 action. Any future complaint brought by Amarin alleging these same facts would necessarily raise the same issue and would presumably be dismissed for the same reason—i.e., for lack of a private right of action to enforce the FDCA. Accordingly, the Amarin majority concluded the Commission's decision is intrinsically a final determination that effectively denies Amarin's request for relief under § 337(d) and (f) and thus was subject to appeal under § 1295(a)(6).
In reaching its conclusion, the Amarin majority also considered and dismissed the arguments raised by Judge Wallach in dissent. The essence of the dissent's argument was that a final determination can be made only after institution. But the majority explained that, even though its decision in Amgen occurred after institution, it was not based on that "procedural detail" and such an approach would "elevate form over substance."
While decisions not to institute ITC investigations are rare, this opinion by the Federal Circuit opens the door for complainants to appeal such decisions. The Federal Circuit explained that a Commission's decision not to institute was a final decision on the merits because any future complaint brought by the same complainant alleging the same facts would necessarily raise the same issue and would presumably be dismissed for the same reason.
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