Following April 29 oral arguments in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., the closely watched Supreme Court case on whether a generic drug manufacturer can be held liable for induced patent infringement despite using an FDA-approved “skinny label”, Knobbe Martens partner Jeremiah Helm shared his analysis of the arguments with Bloomberg Law and Stat News.
The dispute revolves around Amarin’s claim that Hikma induced physicians to prescribe its generic version of Vascepa for a patented cardiovascular use that Hikma had carved out of its FDA-approved label. The case raises the question of whether marketing statements and public disclosures made alongside a skinny label can give rise to induced infringement liability under the Hatch-Waxman Act. The Court’s decision could ultimately have far-reaching impacts on competition and patent strategy in the pharmaceuticals industry.
Helm explained that while a portion of the arguments narrowly focused on whether Hikma’s skinny label for the drug at issue could itself serve as evidence of induced infringement, an issue specific to these types of cases, the justices “had no interest” in pursuing a more general patent-specific approach to inducement. Instead, Helm noted, the Court’s questioning focused on how to apply the broader inducement standard—specifically, the line between a generic manufacturer’s intent and its conduct—which suggests the decision could reach beyond the facts of the immediate case.
Prior to the arguments, Helm spoke with Law360 and MLex on the key issues at play in the case.
Read Helm’s full comments in Bloomberg Law and Stat News [subscriptions may be required].
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