Amarin Pharma petitions Supreme Court to review lower court decision on omega-3 supplements

July 31, 2019
Sebastian Krawiec

Amarin Pharma has filed a petition for certiorari asking the Supreme Court to review a decision made by the U.S. Court of Appeals for the Federal Circuit to uphold a 2017 decision of the International Trade Commission (ITC) not to investigate Amarin’s complaints against manufacturers of omega-3 EPA concentrates. 

Amarin Pharma, maker of the omega-3 drug Vascepa, has filed a petition for certiorari asking the Supreme Court to review a decision made by the U.S. Court of Appeals for the Federal Circuit to uphold a 2017 decision of the International Trade Commission (ITC) not to investigate Amarin’s complaints against companies like omega-3 oils supplier DSM Nutritional Products and omega-3 supplement brands such as Pharmavite LLC and Nordic Naturals Inc.

In its September 2017 lawsuit against ITC, Amarin alleged that the omega-3 eicosapentaenoic acid (EPA) fatty acid concentrates, in either ethyl ester or re-esterified form, manufactured by these companies, are synthetic and therefore not considered dietary ingredients and not allowed in dietary supplements according to the Federal Food Drug and Cosmetic Act (FD&C Act). ITC decided not to investigate, and the Federal Circuit’s upheld ITC’s decision because it is up to the FDA to decide whether a product is in violation of the FD&C Act, and therefore, Amarin’s complaint of false advertising did not hold up under the Tariff Act of 1930 and the Lanham Act of 1946, which prohibit unfair trade practices, trademark infringement, and false advertising.

In its petition to the Supreme Court, Amarin argues that the Federal Circuit’s decision eliminates a private right to action that Congress grants to parties in the Tariff Act, and cites precedent that in POM Wonderful LLC v. Coca-Cola Co., the courts held that Congress did not intend the FD&C Act to preclude Lanham Act claims alleging false and misleading advertising for products subject to regulation by FDA. Despite this precedent, the Federal Circuit was divided on how to apply it to Amarin’s case because this particular Lanham Act claim requires applying the meaning of terms defined in the FD&C Act. Because FDA has not made a decision about whether EPA concentrates are in violation of the FD&C Act, the lower court decided Amarin was precluded from taking action.

Amarin hopes that the Supreme Court can address the split in lower court authority, citing cases in which lower courts held that claims can be adjudicated regardless of whether FDA has taken action, contrary to its own case. The petition also argues that the Federal Circuit is giving FDA constitutionally prohibited power by putting FDA’s authority before the private right to take legal action, and misunderstands FDA’s role, explaining that FDA’s lack of action/enforcement is the product of limited resources, and the agency does not have the expertise nor the authority to enforce the nation’s trade laws.

Amarin expects the Supreme Court to consider its petition in the Fall, and to hear the court’s decision about whether or not to grant review by the end of 2019 or early 2020. In July, Amarin also stated its intentions to file a citizen’s petition to FDA urging the agency to rule that omega-3 EPA concentrates, in either ethyl ester or re-esterified form, are not dietary supplements.

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