Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition

Deepro Mukerjee, partner and chair of Katten's global Intellectual Property practice, and Lance Soderstrom, partner and national co-chair of the firm's Patent Litigation practice, were among several practitioners who served as editors for the third edition of "Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio."

ANDA patent litigations and strategies are complex and require the patent professional to be able to explain complex technical and legal issues to lay persons, both within the organization and to judges and juries. This compendium provides lawyers with invaluable and in-depth tactics and counsel so that any pharmaceutical litigant wanting to increase market share, whether as an innovator or a generic, can plan early and be ready to alter plans as new events occur. Topics include:

• coordinating new drug application (NDA) and patent portfolio strategy;
• preclinical and patent considerations;
• clinical trials and regulatory considerations;
• trademark (TM) and nonproprietary name considerations;
• acquiring and in-licensing pharmaceutical products;
• pre-litigation investigations and due diligence; and
• market entry business considerations for generic companies.

"Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition," ABA Book Publishing, July 15, 2022