Dr David Eyre

February 2026

This case is important because it allows the Supreme Court to define the point of balance between enforcement of patent rights for medical uses and the competition in the market place for generic pharmaceuticals. Consequently, the ruling of the Supreme Court will have consequences industry-wide for pharmaceutical labelling, marketing practices, and practice regarding inducement of patent infringement.  

Turning to the pharmaceutical products on the market that are the background to this case:  

• Amarin markets Vascepa® (icosapent ethyl), approved by the FDA for:  

• Severe hypertriglyceridemia (unpatented), and 

• Cardiovascular risk reduction (laterapproved, patented methodofuse).  

• Hikma launched a generic Vascepa with a Section viii carveout, omitting the patented cardiovascular indication from its FDA label.  

Hikma’s generic version of Amarin’s Vascepa (icosapent ethyl) received FDA approval only for severe hypertriglyceridemia, with the more valuable cardiovascular risk reduction indication carved out pursuant to section viii. 

This case centres on whether or not there has been “induced infringement” of the patented use by the sale of the generic drug. Induced infringement occurs when a party encourages patented use. To assess this the US courts will examine evidence including marketing materials, press releases, and public statements. For example, evidence of marketing generic versions of brand name drugs without clarifying the excluded (patent protected) indication; removing disclaimers from labels that discourage the patented use; and/or sales data or prescribing patterns showing the use of the generic drug for the carved-out medical indication.  

Based on such evidence, to establish induced infringement a plaintiff must prove that:  

1. there has been direct infringement by a third party (e.g., prescribing a drug for patented uses),  
2. the defendant knew about the patent,  
3. the defendant knew or should have known that the induced acts constitute infringement,  
4. the defendant specifically intended to encourage another’s infringement, and  
5. the defendant took an affirmative step to encourage infringement (e.g., through marketing, labelling or public statements). 

At first instance (before the District Court, Delaware) the court dismissed Amarin’s complaint against Hikma for induced patent infringement and held that a fully carved-out skinny label and the alleged statements of Hikma did not plausibly yield the “active steps” required for inducement.  

Amarin appealed this decision to the Courts of Appeal for the Federal Circuit (CAFC) where the decision was reversed and CAFC held that although the skinny label alone did not instruct infringement, the totality of Hikma’s alleged conduct beyond the content of the label plausibly suggested encouragement of the use of Hikma’s generic drug for the use patented by Amarin.  

Thus, in turn, Hikma petitioned for review of this decision by the Supreme Court and argued that the CAFC’s ruling: (i) undermines decades of reliance on skinny labelling by generics; and (ii) conflicts with Supreme Court precedent requiring affirmative, intentional acts to induce infringement.  

Interestingly the Supreme Court invited the U.S. Solicitor General to give their opinion on these proceedings. In response, the government urged the Supreme Court to review this matter and criticized CAFC’s approach as inconsistent with inducement doctrine and policy arising from the Hatch–Waxman act. 

Thus, on 16 January 2026, the Supreme Court agreed to decide two core questions, which, in Hikma’s words, are: 

1. When a generic drug label fully carves out a patented use, are allegations that the generic drugmaker calls its product a “generic version” and cites public information about the branded drug (e.g., sales) enough to plead induced infringement of the patented use? 
2. Does a complaint state a claim for induced infringement of a patented method if it does not allege any instruction or other statement by the defendant that encourages, or even mentions, the patented use? 

This case is thus very important with respect to patent rights and the marketplace for generic vs patented pharmaceuticals. For generic manufactures the decision of the Supreme Court might determine whether long standing practice and skinny label strategies will still protect against liability for inducement in the context of ordinary marketing or investor communications. For pharmaceutical patent rights holders this will affect how patent protection for further medical indications can be enforced in the context of generic pharmaceuticals being on sale in the marketplace. Furthermore, for patent law generally this case may clarify the requirements for “active inducement”. 

We are therefore watching this case with great interest and with a view to the clarity in this area that Supreme Court’s decision might provide and the global impact on the pharmaceuticals sector that it might have.