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AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case

Files Amicus Brief In Support Of Hikma Over Amarin Induced Infringement Claims

 
• By Dave Wallace

By allowing Amarin’s allegation of induced infringement against Hikma over its generic version of Vascepa to proceed, a US court is jeopardizing the ‘skinny label’ system that allows generics to carve out patented indications from their labels under the Hatch-Waxman framework, according to the AAM.

Carved out speech bubble wood
The AAM has aired its views over carve-outs and induced infringement • Source: Alamy

The US Association for Accessible Medicines has intervened in litigation involving Hikma and Amarin over the generics firm’s version of the originator’s Vascepa (icosapent ethyl) brand, criticizing the court for allowing the lawsuit to proceed and claiming that the move could jeopardize generic competition and the use of labelling carve-outs under the US Hatch-Waxman framework.

Having defeated Amarin in litigation over Vascepa patents covering methods of treating hypertriglyceridemia last year, Hikma launched the first US generic. (Also see "Hikma Launches US Vascepa Rival As Amarin Appeal Denied" - Generics Bulletin, 5 November, 2020.) But soon after, Amarin launched a fresh legal attack accusing the firm of inducing infringement of three other Vascepa patents covering cardiovascular indications, which Hikma had carved out of its generic label

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