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Vascepa Infringement Dismissal ‘Resulted In Multiple Errors,’ Amarin Argues

Originator Launches Opening Salvo In Bid To Have Dismissal Overturned

Executive Summary

Amarin is digging deep to take Hikma back before a US district court in its induced infringement case against the generics manufacturer.

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‘That’s A Much Broader Statement’: Hikma Grilled In Amarin Vascepa Skinny-Label Appeal

Hikma may have succeeded in dismissing Amarin’s induced infringement claim against the firm over Hikma’s skinny label generic Vascepa in the US, but a panel of judges for the US Court of Appeals for the Federal Circuit challenged that the generics manufacturer’s public disclosures “sound like an actual statement, encouraging use for the broad sweep of things: that this generic can be used instead of the brand, without any narrowing.”

Amneal Taps Strides To Add More Competition To US Vascepa Market

Amneal has in-licensed Strides’ generic version of Vascepa to compete with the several ANDA products already on the market.

Industry Impact Weighed As US Supreme Court Refuses Skinny-Label Review

Teva has been denied in its attempt to convince the US Supreme Court to re-examine long-running litigation with GSK over skinny-label carve-outs of generic indications. However, the generics firm has vowed to fight on as the case is returned to the district court level, while the wider off-patent industry weighs the impact of the latest decision.

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