US pharmaceutical company Amarin has lost its patent appeal for its fish oil fatty acid pill Vascepa, Fierce Pharma reported on 3 September.
The US Court of Appeals for the Federal Circuit upheld a March ruling that patents protecting Amarin’s purified fatty acid pill Vascepa from generic challengers were invalid.
The decision followed a recommendation in December 2019 by the US Food and Drug Administration (FDA) for the fish oil-derived product’s benefits in patients with abnormally high triglyceride levels.
In a statement, Amarin said it was reviewing its legal options and planned to file for an ‘en banc’ session before a 12-judge appeals panel within 30 days.
The company was expected to continue promotional efforts for Vascepa and was seeking additional global regulatory approvals, Fierce Pharma said.
“We are extremely disappointed with today’s ruling and plan to vigorously pursue available remedies,” Amarin president and chief executive officer John Thero said on the company’s website.
“Importantly, we and our partners are continuing to pursue additional regulatory approvals for Vascepa in China, Europe and additional countries in the Middle East, and remain confident in the global market potential of Vascepa.”
Amarin was also looking for commercial opportunities in Europe for Vascepa as it anticipated its approval and launch in early 2021, Thero added.
The court’s decision would open up opportunities to challengers to launch their generic versions of Vascepa, Fierce Pharma said.
Vascepa gained US approval in 2012 to lower higher levels of triglycerides and is available on prescription in the USA, Canada, Lebanon and the United Arab Emirates.
In the USA, the number of deaths attributed to cardiovascular disease continues to rise resulting in 859,000 deaths/year.