Federal Circuit backs ITC’s decision to not investigate Amarin Pharma’s omega-3 complaint

In a court decision dated May 1, 2019, the Federal Circuit judges for the US Court of Appeals affirmed the International Trade Commission (ITC)’s dismissal of Amarin Pharma’s complaint, stating that the complaint failed to “allege a cognizable claim based on an unfair method of competition or unfair act” as outlined in 19 U.S.C. § 1337 (a)(1)(A).

This is the latest development of Amarin Pharma’s complaint, filed in August 2017, stating that some synthetically produced omega-3 products were actually “’new drugs’ as defined in the Food, Drug, and Cosmetic Act,” further alleging that certain suppliers and supplement brands were “falsely labeling and deceptively advertising their imported synthetically produced omega-3 products as (or for use in) ‘dietary supplements’,” according to the court document.

Amarin markets Vascepa capsules, a prescription drug containing 1 g of the omega-3 eicosapentaenoic acid (or EPA). The company obtained approval from the Food and Drug Administration (FDA) to market and sell Vascepa to reduce triglyceride levels in adult patients with high cholesterol.

It is the only purified ethyl ester E-EPA product sold in the US as an FDA-approved drug, according to the court document.

Amarin Pharma brought the complaint to the ITC on the basis of the Lanham Act, the primary federal statute of laws governing trademarks. However, the court ruled that the complaints brought forth by Amarin relied on alleged violations of the Food, Drug, and Cosmetic Act (FDCA), therefore “proving the Lanham Act claim in this case requires proving violations of the FDCA.”

Trade groups CRN & GOED applaud the court’s decision

Supplement industry members saw the court decision as a win. The Council for Responsible Nutrition applauded the decision in a press release:

“This decision is significant and beneficial for the dietary supplement industry as it confirmed FDA’s exclusive jurisdiction to interpret and enforce the provisions of the Food, Drug and Cosmetic Act,” said Steve Mister, president and CEO of CRN.

“CRN welcomes the decision of the U.S. Court of Appeals for the Federal Circuit in Amarin Pharma, Inc. v. ITC, affirming the International Trade Commission’s decision not to investigate Amarin’s complaint that alleged certain types of concentrated omega-3 fish oil products were not dietary ingredients and therefore could not be imported as dietary supplements.”

The trade group has been involved in challenging Amarin’s actions since 2017.

“CRN recognized that Amarin was seeking to impose restrictions that could have created a market monopoly for pharmaceutical companies over a subset of omega-3 products, hindered responsible manufacturers from selling beneficial fish oil supplements and removed consumers’ abilities to buy affordable products that benefit their health and well-being,” Mister added.

“We continue to be committed to fight for our member companies in this space and for proper jurisdiction of FDA.”

Ellen Schutt, executive director of the trade group Global Organization for EPA and DHA Omega-3 (GOED), also applauded the decision.

"Given GOED's long-standing position that the ingredients in question are old dietary ingredients, GOED is pleased the U.S. Court of Appeals for the Federal Circuit affirmed the prior decision by the International Trade Commission not to institute the investigation requested by Amarin,” she told us via email.

In March last year, CRN and GOED filed a joint brief asking court to deny Amarin appeal in fish oils case.