xxiii, 796 pages : illustrations ; 27 cm
Bibliography, etc. Note
Includes bibliographical references and index.
Formatted Contents Note
Coordinating new drug application (NDA) and patent portfolio strategy Preclinical R&D Preclinical patent considerations Clinical trials and regulatory considerations Clinical trial-patent considerations Trademark (TM) and nonproprietary name considerations Investigational new drug (IND) and new drug applications (NDA) Regulatory exclusivity Overview of the NDA review process Orange book listable patents Postmarketing regulatory requirements and life cycle management Patent prosecution Acquiring and in-licensing pharmaceutical products : due diligence issues Pre-litigation investigations and due diligence Market entry business considerations for generic companies Intellectual property considerations for generic product opportunities Preparation of noninfringement/invalidity legal opinions ANDA preparation (with an eye toward approval and litigation) and the FDA review Obtaining ANDA approval and right to market Providing notice to the NDA holder Evaluating scenarios for launch, including marketing, and manufacturing developments Citizen petitions Expedited regulatory pathways Biologic drugs and the Biologics Price Competition and Innovation Act Pharmaceutical regulation and approval in foreign countries.
KF3133.D78 P74 2014
Chicago, Illinois : ABA Section of Intellectual Property Law,