The U.S. Supreme Court is set to hear Hikma Pharmaceuticals USA v Amarin Pharma, a case delving into the intricacies of pharmaceutical patent law. The dispute centers on the interactions between Amarin, the manufacturer of the cardiovascular medication Vascepa, and Hikma Pharmaceuticals, which produces a generic substitute. At its core, this case questions the threshold of liability for Hikma when its generic product is dispensed for patented uses without its direct involvement.
Vascepa is a drug approved by the FDA for multiple uses—some of which are patented and others that are not. The challenge arises when generic versions like Hikma’s are prescribed for uses still under patent protection. The statutory framework, particularly the Hatch-Waxman Act, allows for FDA approval of generics with a “skinny label,” indicating they are approved solely for non-patented applications. Still, this does not prevent pharmacies from dispensing these generics for off-label, on-patent uses due to factors like prescription practices and state laws enabling pharmacy substitutions for cost efficiency.
Amarin’s lawsuit is predicated not on a direct infringement by Hikma, but on the notion of secondary liability as per the Patent Act. Under this statute, the key legal question for the justices is to determine whether Hikma’s actions actively induce infringement through pharmacies and customers.
The lower courts previously ruled in favor of Amarin, stating there was sufficient evidence for the infringement claims to proceed. The upcoming hearing will focus on Hikma’s appeal for overturning this decision, positing a significant discussion on the scope of liability and responsibilities of generic manufacturers.