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6 January 2022GenericsMuireann Bolger

Hikma ‘skinny’ label does not infringe Amarin patents

Hikma Pharmaceuticals has secured a win in its “skinny label” patent suit with Amarin Pharmaceuticals, following a ruling handed down by a federal court in the state of Delaware.

In his opinion issued on Tuesday, January 4, Judge Richard Andrews held that Hikma’s generic heart drug does not infringe three Amarin patents related to its blockbuster Vascepa (icosapent ethyl) treatment.

He granted Hikma’s motion to dismiss despite a recommendation by US magistrate judge Jennifer Hall that the motion should be denied.

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.

Amarin first sued Hikma at the US District Court for the District of Delaware in November 2020, claiming that the label was “not-skinny enough”.

The complaint alleged that 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.

Health insurance company Health Net was eventually added as a defendant to the lawsuit with the amended complaint, with Amarin claiming that it had encouraged the use of the Hikma generic to treat cardiovascular risk. Health Net responded with its own motion to dismiss the amended complaint.

Judge Andrews referred this case to Judge Hall, who wrote a report and recommendation, urging Andrews to deny all motions to dismiss.

But Andrews decided to grant Hikma’s motion to dismiss Amarin’s first amended complaint, but  he agreed to deny Health Net’s motion.

Comparing to GSK v Teva

Throughout the opinion, Andrews refers to the recent “authoritative” ruling on skinny labelling, GlaxoSmithKline v Teva Pharmaceuticals US (2021).

Here, 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 that Teva was selling its generic with a label which infringed the method claim”.

The Federal Circuit also pointed towards two Teva press releases as evidence to support the jury’s infringement verdict.

However, despite the similarities of the case, Andrews ruled that neither Hikma’s labelling, nor its public statements, instructed using its generic Vascepa could reduce cardiovascular risk.

Regarding Health Net’s motion to dismiss, Andrews ruled that there were still “factual questions” regarding whether Health Net took “affirmative action” to recommend the drug for the infringing indication.

Health Net argued that it was “just a payer, not the physician writing the prescription nor the pharmacist making the substitution” but Andrews agreed with Hall’s recommendation that Amarin could proceed with its case against Health Net.

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More on this story

Americas
7 April 2017   Hikma Pharmaceuticals has entered into a settlement agreement with Jazz Pharmaceuticals, following a patent infringement dispute related to Jazz’s drug Xyrem.
Americas
23 November 2022   Generic heart drug was found to not infringe Amarin’s blockbuster treatment earlier this year | Health insurer Health Net tied to case after allegedly promoting use of the generic.
Big Pharma
23 March 2023   Hikma label and public statements encouraged infringement, Amarin says | Delaware District Court had dismissed claims label was ‘not skinny enough’.

More on this story

Americas
7 April 2017   Hikma Pharmaceuticals has entered into a settlement agreement with Jazz Pharmaceuticals, following a patent infringement dispute related to Jazz’s drug Xyrem.
Americas
23 November 2022   Generic heart drug was found to not infringe Amarin’s blockbuster treatment earlier this year | Health insurer Health Net tied to case after allegedly promoting use of the generic.
Big Pharma
23 March 2023   Hikma label and public statements encouraged infringement, Amarin says | Delaware District Court had dismissed claims label was ‘not skinny enough’.