Pre-ANDA litigation : strategies and tactics for developing a drug product and patent portfolio

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  • Includes bibliographical references and index.


  • 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 -- 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 -- 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 -- Pharmaceutical regulation and approval in foreign countries
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