Jeremiah Helm and Sean Murray Discuss Generic Drug Case in Law360 Column

In the latest installment of their Law360 column on recent noteworthy Federal Circuit decisions, partners Jeremiah Helm and Sean Murray analyze the outcome of Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc.

The case centered around Hikma’s abbreviated new drug application (ANDA) process and subsequent marketing of a generic version of Amarin’s drug called Vascepa. Upon FDA approval, Hikma launched their generic drug using a “skinny label” which did not exactly mimic Amarin’s label for Vascepa. As a result, Amarin sued Hikma, alleging induced infringement. Following the U.S. District Court granting Hikma's motion to dismiss the lawsuit, the Federal Circuit overturned the dismissal on appeal.

Helm and Murray maintain that the Federal Circuit’s decision has potentially important consequences for how generic drugs are marketed, and induced infringement in general. They argue that the Federal Circuit’s decision, which drew a distinction between the ANDA approval process and post-ANDA approval marketing, could have a far-reaching impact in pharmaceutical litigation as it “creates uncertainty in the sale and marketing of generic drugs postapproval.”

The authors explore the Federal Circuit’s reasoning behind the decision, and suggest that Amarin could impact litigation in other industries. “The ultimate result from Amarin is a very permissive pleading standard for induced infringement,” they write. “While Amarin was decided in the context of FDA-approved drugs and generic equivalents, the court expressly noted its decision applied a run-of-the-mill inducement analysis not limited to the specific pharmaceutical regulatory situation.”

Read the full article here.