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 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 -- Continued patent portfolio development before the Patent Office -- Acquiring and in-licensing pharmaceutical products : due diligence issues -- Pre-litigation investigations and due diligence -- Market entry business considerations for generic companies -- Selection of generic drug candidates -- Intellectual property considerations related to generic products -- Preparation of noninfringement/invalidity legal opinions -- Preparing your ANDA with an eye toward approval and litigation -- Section VIII carve-outs -- Obtaining ANDA approval and right to market -- Providing notice to the NDA holder -- Pharmaceutical supply chain : patent considerations -- Evaluating scenarios for launch, including marketing and manufacturing developments -- Interplay between inter partes review (IPR) and ANDA litigation -- Citizen petitions -- Expedited regulatory pathways -- REMS 101 for ANDA litigators and counselors -- Regulatory compliance : inspections and their consequences -- Biologic drugs and the Biologics Price Competition and Innovation Act -- Drug approval considerations and patent linkage system in China -- Pharmaceutical regulation and approval in foreign countries.
Summary:
"This book, 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 the pharmaceutical litigants could follow"-- Provided by publisher.
This resource is supported by the Institute of Museum and Library Services under the provisions of the Library Services and Technology Act as administered by State Library of Iowa.