A team of Crowell & Moring attorneys recently authored a chapter in the American Bar Association’s first edition of Biosimilars Litigation and Client Counseling. The book “provides attorneys, judges, and pharmaceutical corporation managers with an in-depth and valuable analysis of the Biologics Price Competition and Innovation Act (BPCIA).” It also includes litigation tactics and a guide to best serve clients operating in the biologics field.
The chapter, entitled “BLA Applicant Counseling and Strategies,” was written by Laura Lydigsen, Shannon Lentz and Deborah Yellin, partners in the Patents Group; Joanna Fuller, senior counsel in the Antitrust & Competition Group; and Kent Walker, who recently retired as senior counsel from the Patents Group. April Barnard, an associate in the Patents Group, assisted with editing.
The chapter walks Abbreviated Biologics License Application (aBLA) applicants through the practical and strategic considerations for preparing an aBLA with an eye toward future litigation under the BPCIA, including options for labeling carve-outs, the impact of interchangeability, approaches for addressing various patent landscapes, guidance on detailed statement preparation, discussion of early litigation issues such as venue and personal jurisdiction, and settlement considerations.
The chapter is the result of a collaborative effort from attorneys in the firm’s Chicago, Washington, D.C., and Orange County offices, which includes members of the former Brinks, Gilson & Lione team that combined with Crowell in 2021. The group blends deep technical experience with biologics and extensive litigation experience with the BPCIA and related areas, such as the Hatch-Waxman Act.
To learn more about the book and to purchase a copy, click here.
About Crowell & Moring LLP
Crowell & Moring is an international law firm with operations in the United States, Europe, MENA, and Asia. Drawing on significant government, business, industry and legal experience, the firm helps clients capitalize on opportunities and provides creative solutions to complex litigation and arbitration, regulatory and policy, and corporate and transactional issues. The firm is consistently recognized for its commitment to pro bono service as well as its programs and initiatives to advance diversity, equity, and inclusion.
