Pre-ANDA litigation
Subtitle: strategies and tactics for developing a drug product and patent portfolio
By: Kenneth L. Dorsney, editor-in-chief
Contributors: American Bar Association. Section of Intellectual Property Law
Publisher: ABA Section of Intellectual Property Law; American Bar Association
Published: 2014
Place of publication: Chicago, Illinois
Language: eng
Number of pages: 796
ISBN-13: 9781627227315
Subjects: Drugs; Law and legislation; Patents; Patent laws and legislation; Drug approval; Drug development; Pharmacy; Pharmaceutical industry; Biotechnology
Other titles: ANDA litigation.
Notes: Includes bibliographical references and index.
Table of contents: title: Coordinating new drug application (NDA) and patent portfolio strategy; title: Preclinical R&D; title: Preclinical patent considerations; title: Clinical trials and regulatory considerations; title: Clinical trial-patent considerations; title: Trademark (TM) and nonproprietary name considerations; title: Investigational new drug (IND) and new drug applications (NDA); title: Regulatory exclusivity; title: Overview of the NDA review process; title: Orange book listable patents; title: Postmarketing regulatory requirements and life cycle management; title: Patent prosecution; title: Acquiring and in-licensing pharmaceutical products : due diligence issues; title: Pre-litigation investigations and due diligence; title: Market entry business considerations for generic companies; title: Intellectual property considerations for generic product opportunities; title: Preparation of noninfringement/invalidity legal opinions; title: ANDA preparation (with an eye toward approval and litigation) and the FDA review; title: Obtaining ANDA approval and right to market; title: Providing notice to the NDA holder; title: Evaluating scenarios for launch, including marketing, and manufacturing developments; title: Citizen petitions; title: Expedited regulatory pathways; title: Biologic drugs and the Biologics Price Competition and Innovation Act; title: Pharmaceutical regulation and approval in foreign countries.