Amarin vows to challenge Vascepa patent ruling
Amarin has announced it will seek an en banc rehearing of a decision at the US Court of Appeals for the Federal Circuit that failed to revive its patents on heart medicine Vascepa (icosapent ethyl).
The decision handed down yesterday, September 3, without opinion, affirmed a lower court ruling that invalidated six patents on Vascepa, allowing generic competition for the drug to come to market.
During 2019, sales of the drug accounted for nearly all of Amarin’s $429.8 million revenue last year. According to IQVIA, US sales of Vascepa were approximately $1.1 billion in the 12 months ending July 2020.
Vascepa, a synthetic version of fish oil that is used to treat heart disease, was approved by the US Food and Drug Administration (FDA) last year. Generic drugmakers Hikma Pharmaceuticals and Dr Reddy’s Laboratories then challenged Amarin’s patents after they both filed Abbreviated New Drug Applications for Vascepa generics.
In March, the US District Court for the District of Nevada found the six patents covering Vascepa, which are all due to expire in 2030, to be invalid as they were obvious in light of prior art.
Following yesterday’s unsuccessful appeal of the district court’s decision, John Thero, president and CEO of Amarin, said: “We are extremely disappointed with today’s ruling and plan to vigorously pursue available remedies. Importantly, we and our partners are continuing to pursue additional regulatory approvals for Vascepa in China, Europe and the additional countries in the Middle East, and remain confident in the global market potential of Vascepa.”
The FDA granted regulatory approval for a Vascepa generic to London-based Hikma in May, and to India’s Dr Reddy’s last month.
“We are very pleased with the Federal Circuit's swift decision and to be one step closer to launching a generic version of this important medicine for US patients and healthcare providers, helping us to continue putting better health, within reach, every day,” said Brian Hoffmann, president of Hikma Generics.
He added: “Today's decision demonstrates Hikma's ability to successfully challenge patents on important medicines and to provide value to our customers and millions of patients across the US.”
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