Establishing important protections for the dietary supplement industry in the International Trade Commission, Orrick’s appellate and IP litigators won a major ruling today in the Federal Circuit on behalf of clients Pharmavite and Royal DSM. The Federal Circuit, in a published decision, rejected efforts by Amarin Corp. to revive its claims in the ITC against Pharmavite and DSM, major manufacturers of omega-3 fatty acid fish oil dietary supplements.
The ruling stems from a 2017 lawsuit filed by Amarin, which asserted that the fish oil pills are actually “drugs” that must be approved by the FDA before being sold – a potential threat to the industry because many such pills are sold as dietary supplements not subject to preapproval from the FDA. Amarin attempted to assert jurisdiction in the ITC under the theory that the fish-oil manufacturers had engaged in an unfair method of competition under the Tariff Act, which is enforced by the ITC, by falsely labeling their products as “supplements” rather than “drugs.”
An Orrick Litigation and IP team successfully persuaded the ITC to swiftly dismiss Amarin’s lawsuit on the grounds there is no ability for private parties to sue for a violation of the FDCA and that there is no cognizable claim for such violations under the Tariff Act. This was a rare outcome in the ITC, which rejects less than one percent of all complaints.
The Federal Circuit today affirmed the ITC’s decision.
“In short, although Amarin presents its claims as violations of the Tariff Act, in reality those claims constitute an attempt to enforce requirements of the FDCA through the remedies provided under the Tariff Act,” the majority wrote. “Because private parties have no such enforcement authority, Amarin’s allegations fail to state a cognizable claim for relief.”
The ruling was a critical win for the companies, which otherwise faced the threat that all the over-the-counter fish oil pills in stores would have to be taken off the shelf and submitted to years of FDA testing before they could be approved to be sold.
The Orrick team was led by partner Mark Davies, who argued the case in the Federal Circuit, and partners Annette Hurst, Rob Shwarts, Andrew Silverman and Jordan Coyle, along with Of Counsel Patrick Herman and associate Thomas Fu and former associate Alec Schierenbeck.
Media coverage of the decision includes this Law.com story.