Explore Hatch-Waxman litigation developments, diving into legal and regulatory complexities of Orange Book listings and the evolving obviousness standard in pharma patent law.
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 in the 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.
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Partner at Windels Marx Lane & Mittendorf, LLP
Jason Lief is a premier patent trial lawyer with 25 years of experience. He has litigated and tried dozens of major patent and other intellectual property cases on behalf of some of the world’s most innovative and dynamic companies, often involving billion-dollar products. Applying his legal and scientific training, Jason has established a reputation for winning outcomes and courtroom excellence. Beyond litigation, Jason also counsels clients on various intellectual property issues. Jason’s approach is to partner with clients to comprehensively understand the scientific, legal and business concerns they face. Listening to clients and asking the right questions is the key to winning. As Jason often says, “litigation is the art of the question.
Of Counsel, Litigation Department at Paul Hastings, LLP
Max Yusem is an of counsel in the Litigation practice of Paul Hastings and is based in the firm’s New York office. His practice focuses on complex litigation with an emphasis on intellectual property matters in the fields of pharmaceuticals and biotechnology. Mr. Yusem has experience litigating cases arising under the Hatch-Waxman Act on behalf of innovator companies and the Biologics Price Competition and Innovation Act (BPCIA). He has represented leading life science companies in high-stakes disputes in district court litigations, patent office proceedings, and arbitrations involving pharmaceutical compounds, formulations, and methods of treatment, which involved a wide variety of therapeutics, covering areas such as cardiovascular, diabetes, oncology, central and peripheral nervous systems, hormone replacement, and hemoglobinopathy.
