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Amarin Pharma, Inc. v. International Trade Commission

ITC Non-Institution Decision Held Reviewable on Appeal

Amarin Pharma, Inc. v. International Trade Commission, __ F.3d __, 2019 WL 1925649 (Fed. Cir. May 1, 2019) (PROST, Wallach (dissenting), Hughes) (USITC) (3 of 5 stars)

Fed Cir affirms ITC decision not to institute § 337 investigation and dismissal of Amarin’s complaint, and denies as moot mandamus petition on the same issue. The complaint had alleged false labeling and deceptive advertising by certain companies relating to imported synthetically produced omega-3 products sold as “dietary supplements.” Amarin’s contention was that such labeling/advertising was unlawful under the Food, Drug and Cosmetic Act (“FDCA”), as the proposed respondents’ products were not approved drugs. The Fed Cir has jurisdiction to review the non-institution decision and dismissal per Amgen, 902 F.2d 1532 (Fed. Cir. 1990). The opinion reasons that a decision not to institute is “intrinsically a final determination, i.e., a determination on the merits.” Op. 7. It rejects the argument (presented by the ITC and proposed respondents) that final determinations can come only after institution. “Although the decision in Amgen occurred after institution, the court’s reasoning in that case was not based on that procedural detail.” Id. at 8.

The ITC has at least some discretion to decide not to institute when presented with a complaint under oath. The opinion notes that per Syntex, 659 F.2d 1938 (CCPA 1981), the ITC need not institute on a complaint lacking sufficient factual allegations to state a claim. In this appeal, the ITC did not err in determining that the FDCA precluded Amarin’s Lanham Act claims. The opinion discusses POM Wonderful, 573 U.S. 102 (2014), and Buckman, 531 U.S. 341 (2001), reasoning that there is no private right to enforce the FDCA. It discusses decisions from regional circuit courts describing how the absence of a private enforcement right limits Lanham Act claims. Analyzing Amarin’s claims, the opinion reasons that to prevail, Amarin would have to prove that the proposed respondents’ sale of “dietary supplements” violated the FDCA, but the FDA has not yet expressed a position on that issue. Because the FDA has provided no guidance, in this appeal Amarin’s claims are precluded. The opinion does not reach the question of whether the claims would be precluded had the FDA given guidance.

Dissent: Judge Wallach would have found that the Fed Cir lacks appellate jurisdiction over the ITC’s decision not to institute, but would have exercised mandamus jurisdiction to reach the issue of whether Amarin had demonstrated the necessity of a mandamus writ. Ultimately, he would have held that Amarin had failed to show that such an extraordinary remedy was appropriate.

KEYWORDS: INTERNATIONAL TRADE COMMISSION; INSTITUTION DECISION