‘Totality, Not Piecemeal’: US Federal Circuit Revives Hikma Vascepa Skinny-Label Suit

 
• By Dean Rudge
  
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Reading Hikma’s press releases and other public documents made it “at least plausible” that a physician would look to prescribe Hikma’s generic Vascepa product for any of its indications, including the highly-valued, patent-protected cardiovascular indication, the US Federal Circuit decided, reopening a lawsuit against the generics firm.

Skinny label in jeans
A January 2022 district court ruling was reversed by the US Court of Appeals for the Federal Circuit. • Source: Shutterstock

Hikma will have to defend itself again against claims that it induced infringement of US patents protecting a cardiovascular indication for Amarin’s Vascepa (icosapent ethyl) with its skinny-label generic, after a US appeals court reversed a Delaware district court’s January 2022 decision dismissing the case.

Key Takeaways

  • The Januarry 2022 dismissal of Amarin's patent infringement case against Hikma was overturned by a federal appeals court.

The US Court of Appeals for the Federal Circuit on 25 June concluded that Amarin’s allegations against Hikma plausibly stated...

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