Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio - 3rd Edition - Kenneth Laurence Dorsney

Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio 3rd Edition Kenneth Laurence Dorsney ISBN 9781639051144

All pharmaceutical companies—whether innovator or generic—must operate within the same intricate legal and regulatory landscape to bring products to market and compete effectively. Fully updated, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition offers a comprehensive and practical guide to understanding, planning for, and navigating ANDA litigation, as well as the many strategic paths pharmaceutical litigants may pursue.

From the innovator’s perspective, patents are essential to protecting new drug products, recouping development investments, and supporting future innovation. Patent owners must therefore understand the vulnerabilities of their intellectual property and be prepared to respond proactively to patent challenges. At the same time, generic manufacturers face their own strategic considerations when evaluating market entry and litigation risk. This resource equips both innovators and generics with the tools needed to develop sound strategies well before litigation begins.

ANDA patent litigation is highly technical and legally complex, often requiring counsel to translate sophisticated scientific and legal concepts for business teams, judges, and juries. This authoritative compendium provides in-depth guidance, practical tactics, and strategic insight to help pharmaceutical litigants anticipate challenges, adapt to changing circumstances, and position themselves for success—whether defending market exclusivity or seeking competitive entry.

Topics covered include:

• Coordinating New Drug Application (NDA) strategy with patent portfolio development

• Preclinical research and patent considerations

• Clinical trial and regulatory strategy

• Trademark and nonproprietary name issues

• Acquiring and in-licensing pharmaceutical products

• Pre-litigation investigations and due diligence

• Market-entry and business considerations for generic manufacturers

An essential reference for pharmaceutical lawyers and industry professionals, this guide enables early, informed planning and strategic flexibility in the high-stakes world of Pre-ANDA and ANDA litigation.

Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio 3rd Edition Kenneth Laurence Dorsney ISBN 9781639051144, 978-1639051144 & 9781639051151

Editor
Kenneth Laurence Dorsney