SCOTUS won’t resuscitate Amarin’s Vascepa patents

Amarin has failed to persuade the US Supreme Court to consider reviving six patents on the heart medicine Vascepa (icosapent ethyl), allowing generic drugmakers Hikma Pharmaceuticals and Dr. Reddy’s Laboratories to roll out copycat products.

SCOTUS handed down its decision rejecting the Dublin-based pharmaceutical company’s petition yesterday, June 21.

The ruling is a blow for Amarin as the omega-3 oil based drug Vascepa, used to lower fat levels in patients’ bloodstreams,is its only product. According to IQVIA, US sales of Vascepa were approximately $1.1 billion in the 12 months ending July 2020.

In its petition, Amarin had argued that District Judge Miranda Du of the District Court of Nevada was mistaken when she ruled that the patents were invalid because they were “obvious” based on “prior art” in March 2020. The patents were due to expire in 2030.

The US Court of Appeals for the Federal Circuit later affirmed Du’s opinion in September.

In February, Amarin claimed in a petition to SCOTUS that the Federal Circuit’s ruling to deny the revival resulted in an “over-invalidation of patents through hindsight bias and the suppression of innovation”.

“The Federal Circuit’s refusal to correct its error will broadly invalidate patents on inventions whose validity is established by real-world evidence of ingenuity simply because that evidence is ignored until the court has already formed an opinion of ‘prima facie’ obviousness,” said the Dublin-based company.

Hikma had countered that Amarin had “relied exclusively on prior-art studies” to develop Vascepa, in its successful bid to convince SCOTUS to reject the appeal.

Did you enjoy reading this story?  Sign up to our free daily newsletters and get stories sent like this straight to your inbox