US Supreme Court Sides With Generic Drugmaker Hikma in ‘Skinny Label’ Patent Case

The FDA in 2020 approved Hikma’s generic version of Vascepa with a skinny label that covered only the non-patented indication.

The Supreme Court in Washington on May 21, 2026. Madalina Kilroy/The Epoch Times

The U.S. Supreme Court on June 4 ruled that drugmaker Hikma Pharmaceuticals’ generic version of Amarin Pharma’s cardiovascular medication Vascepa did not infringe Amarin’s patents, in a case that centered on the use of “skinny labels” for generic drugs.

Pharmaceuticals can be protected by patents covering both the drug’s ​active ingredient and specific methods of using it. “Skinny labels,” meant to encourage generic competition, are intended to allow generic drugmakers to avoid patent ⁠lawsuits if the label of their generic omits infringing uses of the brand-name drug it replicates.