U.S. Appeals Court Revives Amarin's Drug Patent Lawsuit Against Hikma Pharmaceuticals

U.S. Appeals Court Revives Amarin's Drug Patent Lawsuit Against Hikma Pharmaceuticals

A U.S. appeals court revived a Patent Infringement Lawsuit on Tuesday brought by Amarin Pharma against Hikma Pharmaceuticals over its generic version of Amarin's cardiovascular drug Vascepa.

The U.S. Court of Appeals for the Federal Circuit determined that Hikma's drug label, along with its press releases and marketing materials, potentially influenced doctors to prescribe the generic drug in a manner that infringed upon Amarin's patents.

This ruling is the Federal Circuit's latest effort to address the issue of "skinny labels," which permit generic drug manufacturers to avoid patent litigation by omitting infringing uses of the brand-name drug they replicate.

A spokesperson for Amarin declined to comment on the decision, while attorneys and representatives for Hikma did not respond immediately to requests for comment.

Vascepa, derived from fish oil, is approved by the U.S. Food and Drug Administration (FDA) to lower "bad" cholesterol and reduce cardiovascular disease risk in general. It currently stands as Amarin's sole product.

In 2020, Vascepa generated $598 million in revenue for Amarin, but sales have declined due to the entry of generic alternatives into the market.

Initially approved by the FDA in 2012 for treating severe hypertriglyceridemia, Vascepa gained expanded approval for additional uses in 2019. Hikma's generic version received FDA approval solely for treating hypertriglyceridemia, necessitating a "skinny label" that excludes other uses of the drug.

Amarin filed a lawsuit against Hikma in Delaware federal court in 2020, alleging that Hikma's label, combined with statements in press releases and on its website, encouraged doctors to prescribe the generic for off-label uses that infringe on Amarin's patents related to Vascepa's broader cardiovascular risk reduction capabilities. The case was initially dismissed by U.S. District Judge Richard Andrews in 2022.

The Federal Circuit's decision to revive the lawsuit on Tuesday cited Hikma's public references to its product as "generic Vascepa" without clearly indicating its limited approved use, which, in conjunction with its labelling and promotional materials, may have prompted doctors to prescribe it for unauthorised off-label purposes.

In a separate ongoing case, Hikma has sued Amarin, alleging improper tactics to delay generic versions of Vascepa.