Pre-ANDA Litigation Strategies and Tactics for Developing a Drug Product and Patent Portfolio

by Dorsney, Kenneth L.

• ISBN13: 9781627227315
• ISBN10: 1627227318
• Format: Hardcover
• Copyright: 2015-08-07
• Publisher: American Bar Association

Summary

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. Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow.

Topics include, but are not limited to:

• Coordinating new drug application (NDA)and patent portfolio strategy
• Preclinical R&D 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
• Market Entry Business Considerations for Generic Companies

Author Biography

Kenneth L. Dorsney, a registered patent attorney, maintains an active practice representing corporate clients and the interests of outside counsel in a wide variety of complex commercial matters, including patent, trademark, trade secret, and copyright litigation, mediation, and dispute resolution in the Wilmington, Delaware.