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
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
Sprache
Verlagsort
Zielgruppe
Maße
Höhe: 262 mm
Breite: 187 mm
Dicke: 46 mm
Gewicht
ISBN-13
978-1-62722-731-5 (9781627227315)
Copyright in bibliographic data and cover images is held by Nielsen Book Services Limited or by the publishers or by their respective licensors: all rights reserved.
Schweitzer Klassifikation
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.
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.
Chefredakteur*in / Cheflektor*in