WATCH: Defending market exclusivity through Hatch-Waxman and BPCIA litigation strategies

Ha Kung Wong, Partner at Venable, is joined by Sarah Fendrick, Vice President and Head of Intellectual Property at Alnylam Pharmaceuticals; Abby Markeson, Executive Director and Associate General Counsel - Intellectual Property at Arcutis Biotherapeutics; and Eberle Schultz, Intellectual Property Attorney at Sumitomo Pharma America.The panel examines the tactical dynamics of the BPCIA patent dance for biologics and evaluates current trends in Hatch-Waxman Paragraph IV litigation for small molecules. They also delve into post-Teva v. Amneal strategies for Orange Book listings, with a specific focus on method patents and drug-device combinations.The discussion rounds out with a look at coordinating district court litigation with PTAB proceedings, assessing timing advantages, and navigating complex settlement negotiations that balance litigation risk with regulatory approval pathways.