IP Due Diligence in the Pharmaceutical Industry: Evaluating Hatch-Waxman Litigation

Leason Ellis Partners Yuval Marcus and Jordan Garner have written an article identifying the benefits of conducting IP due diligence when evaluating debt and equity investments in the pharmaceutical industry, particularly in the context of Hatch-Waxman litigation. The article, published in CorporateLiveWire Intellectual Property Expert Guide 2025, explores the complexities of evaluating Orange Book-listed patents, the role of regulatory exclusivities, and the impact of litigation on business transactions. The article also touches on how patent validity, enforceability, exclusivity and a comprehensive understanding of Hatch-Waxman litigation is crucial for managing and handicapping risk when considering strategic investments in the pharmaceutical industry.