All pharmaceutical companies, whether they are an innovator or a generic, must navigate the same complex legal and regulatory framework to bring a product to market and fend off competition. Now completely updated, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Second Edition, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.
Baker Botts contributing authors include:
Chapter 11: Post-marketing Regulatory Requirements and Life Cycle Management: Stephen M. Hash, Margaret J. Sampson, and Jeremy Merling
Chapter 12: Continued Patent Portfolio Development before the Patent Office: Justine A. Gozzi and Sandra S. Lee
Chapter 14: Pre-Litigation Investigations and Due Diligence: Matthew Avery, Paul A. Ragusa, and Jennifer C. Tempesta
Click HERE for a copy of the full publication.