Amarin Fails in Bid to Push Unfair Competition Claim to ITC Prior to FDA Guidance
The court ruled that private parties may not enforce unfair competition claims based on the Food, Drug and Cosmetic Act at the ITC—at least not until the Food and Drug Administration has provided guidance on the precise issue in dispute.
May 02, 2019 at 05:00 PM
5 minute read
The original version of this story was published on National Law Journal
In a case brought by a New Jersey-based pharmaceutical company, the U.S. Court of Appeals for the Federal Circuit ruled that private parties may not enforce unfair competition claims based on the Food, Drug and Cosmetic Act at the ITC—at least not until the Food and Drug Administration has provided guidance on the precise issue in dispute.
“Such claims are precluded by the FDCA,” Chief Judge Sharon Prost wrote in Amarin Pharma v. ITC.
The ruling decision is a win for the ITC, Dutch nutrition company Royal DSM N.V. and its counsel at Orrick Herrington & Sutcliffe. It's a split decision for the Justice Department and a loss for Bedminster-based Amarin Pharma Inc. and its King & Spalding counsel.
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