Dr Reddy’s And Hikma Win Big On US Vascepa Patents
Hikma Considering At-Risk Launch If Originator Appeals
In a surprise to the market, Dr Reddy’s and Hikma have prevailed in challenging six method-of-use patents shielding Amarin’s Vascepa in the US, opening the door for a potential at-risk launch that would likely be challenged by the originator.
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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.
Hikma and Dr Reddy’s Laboratories are weighing launches of their generics to Amarin’s Vascepa after the US Court of Appeals for the Federal Circuit upheld a favorable lower court ruling. The originator said it would take its appeal to the next level and continued to raise doubts over supply capacity.
In September, Dr Reddy’s and Hikma will brace themselves for the beginning of Amarin’s appeal over its Vascepa (icosapent ethyl) patent-litigation defeat, while the final financial results for the 30 June quarter and year-end will trickle in.