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IP Litigator Examines Federal Circuit Ruling in Trade Fight Over False Advertising Claims

Practices: Intellectual Property, Intellectual Property Litigation, Patent Strategy, Appellate & Supreme Court, Life Sciences

Capital Insights.

IP litigation partner Matt Rizzolo (Washington, D.C.) examined the Federal Circuit ruling in Amarin Pharma Inc. v. International Trade Commission. The Federal Circuit affirmed a prior decision by the International Trade Commission not to investigate a false advertising complaint, ruling the ITC can refuse to probe allegations that do not state a proper claim for relief. Mr. Rizzolo was quoted in Reuters, The National Law Journal and Law360 on the decision.

In its complaint, Amarin sought to ban the importation, marketing and sales of fish-oil supplements which, like its product Vascepa, are derived from an Omega-3 acid called EPA. Amarin argued that the supplements are actually "unapproved prescription drugs" under the Food, Drug and Cosmetics Act and that marketing and selling them as supplements amounted to an unfair and deceptive trade practice. The ITC dismissed the complaint and the Federal Circuit affirmed, saying that Amarin's complaint to the ITC was a private action to enforce the FDCA.

Mr. Rizzolo explained that over the last few years there have been several cases either raising FDCA violations as a predicate act for a Section 337 violation, or raising false advertising claims based on FDCA-related labeling or marketing issues. The Federal Circuit's decision establishes that such a claim "is precluded" if it would force the ITC to interpret an FDCA provision for which the U.S. Food and Drug Administration has not already provided definitive guidance.

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