Amarin Makes Vascepa Generics Prediction And Questions Supply
Federal Circuit Decision Anticipated Late 2020 Or Early 2021
Amarin – and the industry at large – was stunned in March this year when Hikma and Dr Reddy’s walked away from court with an invalidity ruling against six Vascepa patents in the US. The originator’s CEO gave an impassioned update on the current state of play, including the potential for generics to launch ahead of a Federal Circuit ruling later this year or early in 2021.
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Hikma has won more time to respond to Amarin’s certiorari petition to the US Supreme Court over a Federal Circuit decision invalidating Vascepa intellectual property – but not the 45 days the company was looking for. Meanwhile, Amarin’s CEO John Thero is to stand down later this year.
Amarin has confirmed that it plans to take its legal battle over Vascepa all the way to the US Supreme Court, as it seeks to overturn a ruling that has already allowed Hikma to launch its generic rival.
Hikma has launched its US rival to Vascepa, after the US Court of Appeals for the Federal Circuit refused a request by Amarin for an “en banc” rehearing of key litigation.