The manufacture and distribution of generic pharmaceutical drugs is a polarizing topic in the political and legal world. The manufacturing and marketing of generic versions of brand-name drugs are allowed in the United States if (1) the generic company obtains approval from the Food and Drug Administration and (2) the generic company does not infringe on or induce infringement of patents owned by the branded company. One strategy generic companies use to avoid infringement is the use of so-called skinny labels. These skinny labels list uses of generic drugs that do not overlap with patented uses that belong to the brand company. This skinny-label practice has proven to be a battleground between generic manufacturers and patent owners who often assert that skinny labels induce medical practitioners to infringe on patented uses.
In a recent U.S. Supreme Court case, a branded company, Amarin Pharma, alleged that Hikma Pharmaceuticals actively induced doctors and pharmacists to infringe Amarin’s patented use of its brand-name drug, VASCEPA®. Amarin had an earlier patent on VASCEPA for use in treating severe hypertriglyceridemia, a condition characterized by abnormally high levels of fat (triglycerides) in the blood. After that earlier patent was invalidated, Amarin patented VASCEPA for reducing cardiovascular risk in hypertriglyceridemia patients. Hikma, however, sells the generic version of the drug specifically for the treatment of severe hypertriglyceridemia, a use no longer covered by the patent. In its suit, Amarin alleged in its complaint that the totality of Hikma’s statements, including the skinny label, patient leaflet, and Hikma’s press releases describing its product as “generic Vascepa,” actively induced doctors to prescribe the drug for the patented use (i.e., reducing cardiovascular risk). In defense, Hikma moved to dismiss Amarin’s complaint for failure to state a claim for induced infringement. The trial court granted Hikma’s motion, but the court of appeals reversed, holding that it is “at least plausible that a physician could read” all the statements from Hikma as an encouragement to prescribe the generic drug for its patented use.
In its ruling, the Supreme Court unanimously reversed the court of appeals decision, tightening the requirements for pleading induced infringement based on a generic’s “skinny label.” The Court held that a complaint must plausibly allege “active steps” that affirmatively encourage the patented use. In the Court’s words, the key question is whether the defendant “actively encouraged infringing uses,” not merely whether doctors “could plausibly read the alleged statements as instructions to infringe.”
For branded companies, pleading inducement against skinny-labeled generics now faces a higher bar. But as is usually the case in arms races and in the battle between branded companies and generics, the branded companies will likely find new strategies for alleging inducement and the generic companies will find new defenses.
The case is Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., Case No. 24-889 (US June 4, 2026).
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