Hatch-Waxman case outcomes are often decided by early choices that shape risk, cost, and leverage long before trial. This session offers a structured review of how companies are building and defending Hatch-Waxman cases, from the first Paragraph IV notice through to final judgement.
- Identify strategic decision points from Paragraph IV notice to trial, and where early decisions most influence outcomes.
- Review recent key Hatch-Waxman cases, such as Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (Fed. Cir. 2025), and Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC (Fed. Cir. 2025); examine how their outcomes have influenced litigation strategy.
- Managing evidence, discovery scope, and expert strategy.
- Compare US Hatch-Waxman litigation strategy to parallel approaches in Canada and other key jurisdictions, including differences in timing, remedies and leverage.
Speaker(s):
Jim Harrington
Chief Intellectual Property Counsel
Vera Therapeutics
Laura Chubb
Director – Global IP Litigation
Organon
Time:
12:20pm – 13:05pm
Agenda Track No.:
Track 3
Session Type:
Track
Force Inline Description:
0