Amarin launches Fed Circ bid to prove Hikma generic infringed heart drug

Hikma label and public statements encouraged infringement, Amarin says | Delaware District Court had dismissed claims label was ‘not skinny enough’.

Amarin has taken its patent fight with rival Hikma to the US Federal Circuit Appeals Court, claiming that the Delaware District Court erred in its judgment that Hikma’s generic heart medication did not infringe Amarin’s blockbuster drug Vascepa.

In January last year, a federal judge in Delaware held that Hikma’s generic did not infringe three Amarin patents covering Vascepa (icosapent ethyl). However, Amarin has now contested, in a complaint filed on Tuesday (March 21), that the court misapplied the plausibility pleading standard, made improper factual determinations and incorrectly applied case law in its decision.

Background to the case

Vascepa is a prescription drug used, among other things, to lower certain fats once they get to harmful levels. It was initially approved by the US Food and Drug Administration (FDA) to reduce triglyceride levels in adult patients with severe hypertriglyceridemia. In 2019, the FDA approved a second indication to reduce the risk of myocardial infarction, stroke, coronary revascularisation, and unstable angina.

Amarin has enjoyed significant success with the drug, and told investors in 2020 that Vascepa had been prescribed over eight million times from its launch in 2012 to that year.

In May 2020, UK pharma firm Hikma was granted FDA approval to launch a generic version of Vascepa. Amarin sued Hikma at the Delware District Court in November 2020, claiming that the label on the generic was “not skinny enough”. However, Judge Richard Andrews granted Hikma’s motion to dismiss.

Amarin appeals

In its latest complaint, Dublin-headquartered Amarin claimed that Hikma “through multiple modes and media outside the label, encouraged prescribing physicians to replace Amarin’s brand-name medication with Hikma’s generic version for the patented use—the use for which Hikma’s generic version was not approved”.

The firm said that its allegations are based not just on Hikma’s label, but on public statements made in press releases and on Hikma’s website that “encouraged physicians to prescribe Hikma’s generic drug for an off-label use patented by Amarin”.

Amarin says the district court failed to consider whether Hikma’s label, together with its public statements, collectively encouraged infringement. Furthermore, it claims that the court misapplied skinny-label precedent in its decision, by relying on Grunenthal, a “label-only case where the asserted patent covered a use narrower than the generic label instructed, whereas Amarin alleged extra-label inducement activity by Hikma in the context of Amarin’s patents, which are directed to a use broader than Hikma’s approved use”, the firm said.

'Anti-competitive' allegations

In a separate lawsuit filed last month (February 21) in New Jersey District Court, Hikma accused Amarin of anticompetitive conduct “to prevent, delay and frustrate generic competition to its branded Vascepa (icosapent ethyl) product”.

Hikma claims that Amarin “locked up” the supply of active pharmaceutical ingredient (API) icosapent ethyl to thwart generic competitors, by entering into exclusive or de facto exclusive agreements with API suppliers.

Sales of Vascepa have fallen as generics have entered the market, Reuters reported, forcing Amarin to cut its workforce last year.

LSIPR has approached Amarin and Hikma for comment.

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