1. Generics Bulletin

Does Hikma’s Vascepa Litigation Dismissal Suggest Safety For Skinny Labels?

GSK-Teva Rulings Had Been Seen As An Existential Threat To Indication Carve-Outs

 
• By Dave Wallace

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.

Man shielded protected from storm
Will skinny labels be shielded from the fallout of GSK-Teva? • Source: Federico Caputo / Alamy Stock Photo

As the US Court of Appeals for the Federal Circuit continues to consider Teva’s bid to have controversial induced-infringement litigation with GlaxoSmithKline reheard by the full bench, a recent decision in separate proceedings involving Amarin and Hikma may give the generics industry hope that the GSK-Teva case will not compromise skinny-label generics entirely.

Critics of recent decisions in the GSK-Teva saga have pointed to their potentially damaging impact on the US skinny-label regime of carving

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