Majority opinion by Federal Circuit upheld International Trade Commission's decision and denied as moot Amarin's petition for order to compel a judicial or government officer or agency to perform a duty. Dissenting opinion not only agrees ITC acted correctly denying the firm's complaint, but also says the commission's decision wasn't appealable. Ropes & Gray attorneys suggest ruling provides guidance for additional fair trade complaints about FDA-regulated products.

FDA says Newton Laboratories sells unapproved Rx homeopathics because its products are labeled to treat diseases and conditions including allergies, chicken pox and “suicidal tendency.” Warning letter says firm also has repeatedly violated same GMPs across more than a decade of inspections.