Kelsey J. McElveen

Kelsey is a trial attorney who focuses on intellectual property matters, with significant experience representing clients in life sciences industries.

As a member of the firm’s Intellectual Property Litigation group, Kelsey focuses her practice on patent litigation under the Hatch-Waxman Act. After nearly a decade of experience working on Abbreviated New Drug Application (ANDA) cases, she is well-versed in the intricacies of the pharmaceutical industry and the legal and regulatory framework that governs it. Kelsey's expertise in patent litigation, particularly in the context of drug development and approval, enables her to provide clients with comprehensive legal representation throughout the entire product life cycle. She understands the challenges pharmaceutical companies face and the importance of navigating the complex regulations and legal issues that surround the ANDA process. With a deep understanding of the science, law, and business of the pharmaceutical industry, Kelsey is well-equipped to provide her clients with the guidance they need to succeed in this complex and constantly evolving field.

• Trial counsel to a nationwide class of contact lens purchasers in Disposable Contact Lens Antitrust Litigation, which alleged antitrust conspiracies by five major contact lens manufacturers and distributors. The case settled on the eve of trial. Total settlements in the case exceed $118 million.
• Trial counsel to Collegium Pharmaceutical in Collegium Pharmaceutical Inc. v. Teva Pharmaceuticals USA, a Hatch-Waxman litigation matter involving 14 Orange Book-listed patents for the oxycodone product Xtampza ER. The case resulted in a settlement in which defendant Teva agreed to a consent judgment confirming that its proposed generic products infringe on Collegium’s asserted patents. Under the settlement, Collegium will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033.
• Trial counsel to Amneal Pharmaceuticals in Amgen v. Amneal, a four-day Hatch-Waxman patent infringement trial before Judge Goldberg, sitting specially for the Federal District Court in Delaware. Obtained a defense finding of non-infringement on Amneal’s unique non-infringement defense that its proposed formulation of the drug Sensipar does not infringe Markush limitations of the asserted patent. The trial order and memorandum were issued on July 27, 2018. Amgen Inc. v. Amneal Pharmaceuticals LLC, 16-0853-GMS (consolidated) (D. Del.).
• Represented Amneal Pharmaceuticals in Genentech, Inc. v. Amneal Pharmaceuticals LLC, 1-19-cv-190-RGA (D. Del.), a Hatch-Waxman patent litigation concerning Genentech’s Esbriet (pirfenidone).
• Represented Hikma Pharmaceuticals in Astellas US LLC v. Hikma Pharmaceuticals USA Inc., 1-21-cv-1785-CFC (D. Del.), a Hatch-Waxman patent litigation concerning Astellas’s Lexiscan (regadenoson).
• Represented Collegium Pharmaceutical, Inc. in a Hatch-Waxman patent litigation concerning a Section 505(b)(2) application for extended-release oxycodone. Purdue Pharma, L.P. v. Collegium Pharm., Inc., No. 15-13099-FDS (D. Mass.).
• Represented device manufacturer Ypsomed AG as a third-party in a Hatch-Waxman patent litigation. Sanofi-Aventis U.S. LLC v. Merck, Sharp & Dohme Corp., 16-0812-RGA (D. Del.).
• Trial counsel for Amneal Pharmaceuticals LLC in multiple Hatch-Waxman patent litigations concerning oxymorphone. Endo Pharms. Inc. v. Amneal Pharms. LLC, No. 15-2023 (Fed. Cir.); Endo Pharms. Inc. v. Amneal Pharms. LLC, No. 17-1094 (Fed. Cir.).
• Represented Amneal Pharmaceuticals in Genzyme Corp. et al. v. Amneal Pharms., 2-16-cv-3892-SRC (D.N.J.), a Hatch-Waxman patent litigation concerning Sanofi/Genzyme’s Clolar (clofarabine injection).
• Represented Amneal Pharmaceuticals in Alza Corp. v. Amneal Pharmaceuticals of New York, LLC, 16-0914-RGA (D. Del.), a Hatch-Waxman patent litigation concerning Alza’s Concerta (methylphenidate hydrochloride).

Education

• University of Minnesota Law School, 2014, magna cum laude
• College of Saint Benedict, B.A., 2011, magna cum laude

Admissions

• Minnesota, 2014
• U.S. Court of Appeals for the Federal Circuit
• U.S. District Court for the District of Minnesota
• U.S. Patent & Trademark Office

• Best Lawyers: Ones to Watch, Litigation-Intellectual Property, 2023-2024 Litigation-Patent, 2023-2024
• Minnesota Super Lawyers Rising Star, Intellectual Property Litigation, 2023

Professional Activities

• Minnesota Justice Foundation, Board Member, 2018-2022
• Fund for Mid-Minnesota Legal Aid, Board Member, 2020-2022
• One Hour of Sharing Campaign, Mid-Minnesota Legal Aid, 2014-2022