(Updates with Amarin's response to a request for comment in the penultimate paragraph.)
The US Supreme Court on Thursday ruled that Amarin (AMRN) failed to prove that a generic-drug manufacturer actively induced other companies to infringe upon two of its Vascepa patents after the generic maker received approval for a so-called "skinny-label" version of the drug.
Vascepa received Food and Drug Administration approval in 2012 for treating severe hypertriglyceridemia before receiving the FDA's go-ahead in 2019 for a second, more common use: lowering cardiovascular risk in hypertriglyceridemia patients who take statins, the so-called CV indication, for which it received two patents, the Supreme Court noted.
Hikma Pharmaceuticals received FDA approval for a generic icosapent ethyl skinny label in 2020 that carves out Vascepa's still-patented CV-indication method of use, the court noted.
"Amarin has failed to state a claim for active inducement in violation of *271(b), so its complaint cannot withstand Hikma's motion to dismiss," the Supreme Court said.
"We are deeply disappointed by the Supreme Court's decision today and are evaluating our next steps," Amarin toldin a statement. "Amarin remains fiercely dedicated to its primary mission: ensuring VASCEPA/VAZKEPA, a groundbreaking, innovative, and cost-effective therapy, reaches patients across the world who would benefit from this life-changing treatment."
Hikma didn't immediately reply to a request for comment from.
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