Dinsmore’s intellectual property team has filed a brief with the Supreme Court of the United States as amicus curiae on behalf of the Licensing Executives Society (USA & Canada), Inc. (LES). The brief was submitted in the case Hikma Pharmaceuticals USA Inc., et al. v. Amarin Pharma, Inc., et al., now before the Court on issues involving induced patent infringement and pharmaceutical labeling.
LES is an independent, non-partisan, non-profit professional society, regularly convening conversations among global leaders in intellectual property management. LES participates as a neutral party in the case. Its brief highlights the broader, practical implications this decision will have for innovators, investors and technology implementers across all industries.
The Court’s ruling will clarify what plaintiffs must plead to allege induced infringement, a critical tool that allows patent holders to enforce their rights when direct infringement is difficult to pursue. The brief explains that clear and flexible pleading standards are essential to ensuring the reliability of U.S. patent rights, which serve as the backbone of investment in research and development.
Because this case arises in the context of generic drug approval, the brief also emphasizes that FDA labeling decisions do not determine patent liability. Regulatory approval and patent law serve different purposes, and the FDA lacks authority to decide issues of infringement.
The brief was prepared by a Dinsmore team of Brian O’Shaughnessy as counsel of record, Christopher VanDeusen, and Oleg Khariton.