Knobbe Martens partner Jeremiah Helm was quoted by Bloomberg Law, Law360, and MLex on the U.S. Supreme Court’s unanimous ruling in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., which held that a generic drug manufacturer’s FDA-approved skinny label and related marketing statements were insufficient to plead induced patent infringement. The June 4 decision raises the bar for branded pharmaceutical companies seeking to bring inducement claims against generic competitors using skinny labels.
Helm, who previously shared his analysis of the case following oral arguments, opined on the ruling’s significance for the generic drug industry and for induced infringement law more broadly. He called the decision “very positive” for generic companies, noting that it clarifies the types of marketing statements that will not give rise to inducement liability.
Helm noted that the ruling will make it easier for generic manufacturers to avoid the type of costly litigation seen in Hikma v. Amarin, and to resolve such disputes earlier, reducing the expense and risk of bringing generic products to market with skinny labels. “There’s a fundamental tension in wanting to announce your business successes in the broadest terms possible and to the largest audiences possible” while in-house counsel want to speak “more cautiously,” he explained. He added that the ruling gives generic manufacturers more room for investor communications, provided those communications are not designed to encourage infringement.
Finally, Helm noted that the Court’s inducement standard is not limited to generic drug cases under the Hatch-Waxman Act. “This opinion, even though it’s written in the skinny label context, will absolutely be cited by parties fighting over inducement pleadings in other areas as well, correctly so,” he said. Still, he observed that while the decision provides relatively clear guidance within the ANDA context, its broader impact on inducement law remains to be seen.
Read Helm’s full comments in Bloomberg Law, Law360, and MLex (subscriptions may be required).
Subscribe for News and Updates
