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Biosimilars Litigation and Client Counseling.
- Format:
- Book
- Author/Creator:
- Dorsney, Kenneth Laurence.
- Language:
- English
- Subjects (All):
- United States. Biologics Price Competition and Innovation Act of 2009--Legislative history.
- United States.
- United States. Food and Drug Administration--Rules and practice.
- Patent laws and legislation.
- Intellectual property.
- Physical Description:
- 1 online resource (396 pages)
- Edition:
- 1st ed.
- Place of Publication:
- La Vergne : American Bar Association, 2024.
- Summary:
- This book provides a comprehensive analysis of the Biologics Price Competition and Innovation Act (BPCIA), exploring its history, provisions, and implications for patent litigation in the biopharmaceutical industry. It examines the regulatory processes for FDA approval of biologics and biosimilars, the intricacies of the 'patent dance', and differences between BPCIA and Hatch-Waxman litigation. It also covers strategies for litigation management, client relations, and future trends in biosimilars. The book is intended for legal professionals, policymakers, and industry stakeholders involved in intellectual property and biopharmaceuticals. Generated by AI.
- Contents:
- Cover
- Title Page
- Copyright Page
- Contents
- Board of Editors
- Chapter Authors
- Preface
- Foreword
- Chapter 1 Introduction
- I. The Biologics Price Competition and Innovation Act
- II. A Need for Alternative Biological Products
- III. Brief Summary of the BPCIA
- IV. Patent Litigation under the BPCIA
- V. Patents of Biological Products
- VI. Litigation Management and Client Relations
- VII. Future of Biosimilars and the BPCIA
- Part I
- Chapter 2 BPCIA History and Overview
- I. History Leading Up to BPCIA Passage
- II. Overview of Key Provisions of the BPCIA
- A. The Patent Dance
- B. Impact of the BPCIA
- Chapter 3 FDA Approval and Regulatory Process
- I. Background
- II. Types of Biological Products
- A. Protein
- B. Analogous Product
- III. Licensure of Biologics, Biosimilars, and Interchangeables
- A. BLAs
- B. Biosimilars and aBLAs Generated by AI.
- Notes:
- Description based on publisher supplied metadata and other sources.
- Part of the metadata in this record was created by AI, based on the text of the resource.
- ISBN:
- 9781639054664
- 1639054669
- OCLC:
- 1460463497
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