Also known as: Amarin Pharma
Amarin is an Irish-American biopharmaceutical company focused on cardiovascular disease therapies, best known for Vascepa. Founded in 1993, it is headquartered in Dublin with U.S. operations in New Jersey. The company is publicly traded on Nasdaq under AMRN.
A paper in the New England Journal of Medicine argues the Supreme Court should reject FDA-required drug labels as standalone evidence of patent infringement in Hikma Pharmaceuticals USA v. Amarin Pharma. The paper says lower-court guidance raises liability risk for generic-drug manufacturers complying with FDA rules and could hamper competition.
Legal scholars argue FDA-required drug labels should not serve as evidence in patent infringement cases against generic manufacturers. The Supreme Court will hear a case involving this "infringement by label" theory, which could clarify that regulatory compliance alone doesn't prove patent violation. This approach threatens affordable generic drug access by creating liability for companies following FDA rules.
