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Overview
Explore the latest developments in Hatch-Waxman litigation, with a deep dive into the legal and regulatory complexities surrounding Orange Book listings and the evolving obviousness standard in pharmaceutical patent law.
Join Jason A. Lief, Partner, at Windels Marx Lane & Mittendorf, LLP and Max H. Yusem, Of Counsel, Litigation Department, at Paul Hastings, LLP as they provide expert analysis and practical guidance based on recent court decisions, FDA actions, and real-world case studies. From Purdue v. Accord to Teva v. Amneal, this program will help attorneys and regulatory professionals navigate the shifting landscape of ANDA litigation, Orange Book strategy, and exclusivity protections.
Key Topics:
- Key legal standards for obviousness in pharmaceutical patent cases, including KSR and Purdue v. Accord
- Strategies for Orange Book listings, delisting requests, and managing Paragraph III/IV certifications
- Recent FDA guidance and Federal Circuit rulings impacting Hatch-Waxman litigation