Justices to consider thorny dispute between manufacturers of medication and its generic substitute

Hikma Pharmaceuticals USA v Amarin Pharma presents a complex dispute between Amarin, the manufacturer of Vascepa, a prescription medication to reduce heart disease, and Hikma, which markets a generic substitute for Vascepa. With a great deal of simplification, the general topic is how hard it should be to hold Hikma responsible when pharmacists dispense Hikma’s substitute to patients who have been prescribed Vascepa for a use that infringes Amarin’s patents. The lower courts held that the evidence was enough for Amarin to proceed on that infringement claim and Hikma is asking the justices to overturn that ruling.

The problem arises because Vascepa, like many pharmaceuticals, has some uses that are patented and some that are not. The FDA has approved multiple uses of Vascepa. For the on-patent uses, it would infringe patents held by Amarin for doctors in those situations to prescribe, pharmacies to dispense, or patients to use the generic version. But the FDA also has approved Vascepa for some uses that are off-patent, which is to say that no patent protects Amarin from the competition of generics for patients that have those conditions.

The statutory framework for generics, the Hatch-Waxman Act, addresses the situation, offering the generic manufacturer seeking approval of its pharmaceutical the option to submit a certification asking approval of its drug on the premise that it will market the pharmaceutical only for the off-patent use. If the FDA approves that, as it did here, the generic manufacturer uses a so-called “skinny label,” which describes use of the generic only for the off-patent uses.

In reality, whatever those labels might say, it is quite common for pharmacies to dispense the generic for the on-patent use. That is true in part because of the reality of prescription writing – prescriptions typically identify the pharmaceutical but not the reason for the prescription, so it is impossible for the pharmacy to know whether dispensing the generic would infringe the branded manufacturer’s patents. It also reflects state generic substitution laws, which allow (if not command) pharmacists to substitute generics whenever they are less expensive for the customer than the branded pharmaceutical.

Against that backdrop, the branded manufacturer here (Amarin) is suing Hikma (the generics manufacturer) contending that Hikma is responsible for the dispensing and use of its generic product in settings protected by Amarin’s patents. Because even Amarin acknowledges that Hikma itself has not infringed Amarin’s patents, the suit arises under a provision of the Patent Act imposing secondary liability on Hikma for infringement by others. Crucially, that statute permits liability only if Hikma “actively induces” the infringement by the pharmacies and customers. So the key question for the justices is whether the activities of Hikma are enough to justify liability under that standard.

Recommended Citation: Ronald Mann, Justices to consider thorny dispute between manufacturers of medication and its generic substitute, SCOTUSblog (Apr. 24, 2026, 10:00 AM), https://www.scotusblog.com/2026/04/justices-to-consider-thorny-dispute-between-manufacturers-of-medication-and-its-generic-substitu/