U.S. Supreme Court denies Amarin’s bid to revive Vascepa drug patents

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U.S. Supreme Court denies Amarin’s bid to revive Vascepa drug patents


WASHINGTON, June 21 (Reuters) – The U.S. Supreme Court on Monday rejected a bid by an Amarin Corp PLC (AMRN.O) subsidiary to revive patents on its heart drug Vascepa in a legal battle against generic drugmakers Hikma Pharmaceuticals PLC (HIK.L) and Dr. Reddy’s Laboratories Ltd (REDY.NS).

The justices declined to hear Dublin-based Amarin Pharma’s appeal of a lower court ruling that affirmed that the patents were invalid following a challenge by Hikma and Dr. Reddy’s. The lower court found that the patents were invalid as “obvious” based on “prior art,” which means that earlier publications had already disclosed their innovations.

A federal judge’s decision last year to invalidate the patents cost Amarin Corp nearly 70% of its stock price.

Vascepa is an omega-3 oil used to lower fat levels in patients’ bloodstreams. Amarin sued London-based Hikma and Hyderabad, India-based Dr. Reddy’s in Las Vegas in 2016, alleging that their proposed generic versions of the drug would infringe six of its patents.

Tourists stop outside the U.S. Supreme Court building in Washington, U.S. June 17, 2021. REUTERS/Jonathan Ernst

Nevada-based U.S. District Judge Miranda Du ruled in March 2020 that the patents were obvious and unenforceable, finding that earlier publications including a reference to the omega-3 drug Lovaza previously disclosed the patents’ innovations.

The decision opened the door to generic versions of Vascepa and wiped out $3.5 billion of Amarin’s market capitalization.

The Washington-based U.S. Court of Appeals for the Federal Circuit, which specializes in patent law, affirmed the decision in September.

Hikma launched its generic version of Vascepa in November.

Amarin told the Supreme Court in February that Du failed to consider secondary indications that the patents were not obvious, including Vascepa’s commercial success and its meeting of a long-standing need for a drug to treat severe hypertriglyceridemia – high amounts of a type of fat found in the blood called triglycerides – that does not elevate “bad” cholesterol.

Hikma had urged the court not to hear the appeal, arguing among other things that Amarin “relied exclusively on prior-art studies” to develop Vascepa.

Reporting by Blake Brittain; Editing by Will Dunham

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