Amarin appeals ‘skinny label’ loss
Generic heart drug was found to not infringe Amarin’s blockbuster treatment earlier this year | Health insurer Health Net also tied to the original case after allegedly promoting use of the generic.
Biopharmaceutical company Amarin has urged the US Court of Appeals for the Federal Circuit to revive its dispute with UK-headquartered Hikma Pharmaceuticals over ‘skinny labelling’.
Amarin’s appeal against a US District Court for the District of Delaware ruling was filed on 14 November and docketed on Monday, 21 November at the Federal Circuit.
In January, Judge Richard Andrews of the Delaware court held that Hikma’s generic heart drug does not infringe three Amarin patents related to its blockbuster Vascepa (icosapent ethyl) treatment.
The dispute dates back a few years—in March 2020, the US District Court for the District of Nevada cancelled six Amarin patents, previously set to last until 2030, after a challenge from Hikma and Indian drugmaker Dr Reddy’s.
Later that same year, Hikma received approval from the US Food and Drug Administration (FDA) to sell a generic version of Vascepa for the severe hypertriglyceridemia indication under a “skinny” label that “carves out” other indications.
However, Amarin sued Hikma, claiming that Hikma’s label for its generic drug was “not-skinny enough”.
According to Amarin, Hikma’s label, as well as public statements made by the company, infringed three of its patents relating to methods of using icosapent ethyl for the reduction of cardiovascular risk.
Hikma responded with a motion to dismiss in January 2021 and followed up with another motion to dismiss after Amarin had filed an amended complaint.
Despite a magistrate judge’s recommendation that the court should deny all motions to dismiss, Andrews allowed Hikma’s bid for dismissal of the complaint.
Andrews also denied a motion to dismiss filed by Health Net, a health insurance company which had been added as a defendant to the lawsuit with Amarin's amended complaint, with Amarin claiming that it had encouraged the use of the Hikma generic to treat cardiovascular risk.
In Andrews ruling, the judge refers to the recent “authoritative” ruling on skinny labelling, GlaxoSmithKline v Teva Pharmaceuticals US (2021).
In that case, the Federal Circuit ruling found that Teva’s “partial label” induced infringement of GSKs patent as it “did not successfully carve out the patented use, and thus, Teva was selling its generic with a label which infringed the method claim”.
Two Teva press releases also supported the jury’s infringement verdict, according to the court.
Despite the seeming similarities of the case, Andrews ruled that neither Hikma’s labelling, nor its public statements, instructed using its generic Vascepa could reduce cardiovascular risk.
Did you enjoy reading this story? Sign up to our free daily newsletters and get stories sent like this straight to your inbox.
