Pre-ANDA litigation : strategies and tactics for developing a drug product and patent portfolio / Kenneth L. Dorsney, editor-in-chief.
Contributor(s): Dorsney, Kenneth L [editor.] | American Bar Association. Section of Intellectual Property Law [sponsoring body.]Material type: TextPublisher: Chicago, Illinois : ABA Section of Intellectual Property Law, Description: xxiii, 796 pages : illustrations ; 27 cmContent type: text Media type: unmediated Carrier type: volumeISBN: 1627227318; 9781627227315Other title: Pre-Abbreviated New Drug Application litigationUniform titles: ANDA litigation. Subject(s): Biotechnology -- United States -- Patents | Drug approval -- United States | Drug development -- United States | Drugs -- Law and legislation -- United States | Drugs -- United States -- Patents | Patent laws and legislation -- United States | Pharmaceutical industry -- United States | Pharmacy -- Law and legislation -- United StatesGenre/Form: Patents.
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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 -- 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.