Amarin Pharma convinced a U.S. appeals court on Tuesday to resurrect a patent infringement lawsuit over Hikma Pharmaceuticals’ generic version of Amarin’s cardiovascular drug Vascepa.
The U.S. Court of Appeals for the Federal Circuit said that Hikma’s drug label for the generic, combined with its press releases and marketing materials, may have induced doctors to prescribe its drug in a way that infringed Amarin’s patents.
The decision is the Federal Circuit’s latest to grapple with “skinny labels,” which allow generic drugmakers to avoid patent lawsuits if their drug’s label omits infringing uses of the brand-name drug it replicates.
An Amarin spokesperson declined to comment on the decision. Hikma’s attorney and spokespeople did not immediately respond to requests for comment.
Vascepa, derived from fish oil, is approved by the U.S. Food and Drug Administration to lower so-called “bad” cholesterol and reduce the risk of cardiovascular disease generally. It is currently Amarin’s only product.
The drug brought Amarin $598 million in 2020, but its sales have fallen as generics have entered the market.
The FDA approved Vascepa to treat severe hypertriglyceridemia in 2012 before approving it for other uses in 2019. Hikma received FDA approval for its generic solely to treat hypertriglyceridemia, requiring it to create a skinny label that did not include the drug’s other uses.
Amarin sued Hikma in Delaware federal court in 2020, arguing Hikma’s label combined with statements in its press releases and on its website encouraged doctors to prescribe the generic in ways that infringed Amarin’s patents covering the use of Vascepa to lower general cardiovascular risks. U.S. District Judge Richard Andrews dismissed the case in 2022.
The Federal Circuit revived the lawsuit on Tuesday. The appeals court said that Hikma publicly referred to its drug as “generic Vascepa” without clarifying that it was only approved for a specific use, which combined with its label and marketing materials could have encouraged doctors to prescribe it for infringing off-label uses.
Hikma has separately sued Amarin for allegedly using illegal tactics to delay generic versions of Vascepa, in a case that is still ongoing.
The case is Amarin Pharma Inc v. Hikma Pharmaceuticals USA Inc, U.S. Court of Appeals for the Federal Circuit, No. 23-1169.
For Amarin: Nathan Kelley of Perkins Coie
For Hikma: Charles Klein of Winston & Strawn
