Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., 24-889
2026-06-04
Read full decision. Summary prepared by Alan Macek:
"Federal law allows pharmaceutical manufacturers to market generic versions of brand-name drugs, so long as they obtain approval from the Food and Drug Administration (FDA) and do not infringe on any patented uses. … Such substitution is allowed (and sometimes required) by state laws across the Nation, but generic manufacturers may be subject to liability under federal law if they “actively induc[e] infringement of [the brand manufacturer’s] patent.” … The central question is whether Amarin plausibly alleged that Hikma actively encouraged infringing uses, not merely whether doctors could plausibly read the alleged statements as instructions to infringe. … In other words, the skinny label may not give instructions for uses that would infringe the patented methods of use. … Amarin’s allegations, whether viewed together or separately, fail to establish that Hikma took any affirmative steps to encourage infringement. First, several of the relevant statements have an “obvious alternative explanation,”: Hikma was just complying with the law or with standard industry practice."