AAM Warns Of Dangerous Precedent In Vascepa 'Skinny Label' Case
Files Amicus Brief In Support Of Hikma Over Amarin Induced Infringement Claims
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.
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An induced-infringement attack on Hikma’s skinny-label generic version of Vascepa had been cited as evidence of the potential harm that would be caused by controversial rulings in separate litigation involving GSK and Teva. However, these fears may now appear overstated after the claim against Hikma was dismissed.
In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.
An attack on Hikma’s skinny-label generic version of Vascepa by originator Amarin, claiming induced infringement of patents protecting a cardiovascular indication, has been dismissed in the US.