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AAM Warns Hikma Case Risks Narrowing Skinny-Label Path To ‘Vanishing Point’

Association Says Carve-Out Shield Has Become Sword Wielded Against Generics Industry

 
• By Dave Wallace

In an amicus brief filed in support of Hikma over its US skinny-label generic dispute with Amarin, local industry association the AAM warned that the indication carve-out process that “began as a shield” has now “become a sword that is being wielded against the very generics the law was intended to protect.”

Walls closing in, narrowing opportunity
The AAM cautions that the scope of ‘skinny labels’ is narrowing • Source: Shutterstock

A US appeals court decision to revive litigation between Amarin and Hikma, in which the originator is claiming induced infringement of Vascepa (icosapent ethyl) by Hikma’s generic version, “makes it all but impossible to market a generic, ‘section viii’ drug without infringement risk,” according to local generics and biosimilars industry body the Association for Accessible Medicines.

Hikma recently urged the full US Court of Appeals for the Federal Circuit to rehear “en banc” the panel decision from earlier this year that reopened the case, which revolves around a claim of induced infringement by Hikma’s generic of patent-protected indications of Vascepa

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