ANDA litigation: strategies and tactics for pharmaceutical patent litigators. Second edition

Index

• Preliminary sections
• Board of editors
• Chapter authors
• Contents
• Foreword
• Preface
• The Statutory and Regulatory Scheme
• The Drug Approval Process - An Overview
• Notice and Prefiling Considerations
• The Litigation Timeline
• Initiating Litigation
• Use of Reissue Proceedings in Hatch-Waxman Litigation
• Inter Partes Review in ANDA Litigation
• Examining Subject-Matter Jurisdiction over Declaratory Judgment Claims Filed in Combination with Patent Infringement Claims under Section 271(e)(2)(A)
• Responding to the Complaint
• Discovery
• Experts
• Claim Construction
• Summary Judgment
• Remedies
• Settlement
• Antitrust
• Pretrial Preparation
• Trial
• Posttrial
• Appeals to the Court of Appeals for the Federal Circuit
• Hatch-Waxman Practice in the Supreme Court of the United States
• Managing an ANDA Litigation
• Pharmaceutical Regulation and Litigation in Foreign Countries
• Appendix Table
• Appendix
• Appendix A-1 Paragraph IV Notice Letter
• Appendix A-2 Section vii 'Carve Out' Certification
• Appendix A-3 Complaint
• Appendix A-4 ANDA Form
• Appendix A-5 Complaint for Declaratory Judgment
• Appendix A-6 Answer, Defenses, and Counterclaims
• Appendix A-7 Covenant Not to Sue
• Appendix A-8 Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) and (6)
• Appendix A-9 Brief in Opposition to Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) and (6)
• Appendix A-10 Scheduling Order
• Appendix A-11 Infringement Contentions
• Appendix A-12 Invalidity Contentions
• Appendix A-13 Plaintiff's Document Requests
• Appendix A-14 Defendant's Document Requests
• Appendix A-15 Plaintiff's Interrogatories
• Appendix A-16 Defendant's Interrogatories
• Appendix A-17 Plaintiff's Requests for Admissions
• Appendix A-18 Defendant's Requests for Admissions
• Appendix A-19 Document Authenticity Stipulation
• Appendix A-20 Plaintiff's Notice of Deposition with Schedule A
• Appendix A-21 Defendant's Notice of Deposition with Schedule A
• Appendix A-22 Subpoena for Documents
• Appendix A-23 Protective Order
• Appendix A-24 Expert Undertaking
• Appendix A-25 Expert Report
• Appendix A-26 Joint Claim Construction and Prehearing Statement
• Appendix A-27 Plaintiff's Claim Construction Brief
• Appendix A-28 Defendant's Claim Construction Brief
• Appendix A-29 Expert Declaration in Support of Claim Construction
• Appendix A-30 Responsive Expert Declaration in Support of Claim Construction
• Appendix A-31 Motion for Summary Judgment and Request for Oral Argument
• Appendix A-32 Summary Judgment Brief on Invalidity and Obviousness
• Appendix A-33 Summary Judgment Brief on Nonobviousness
• Appendix A-34 Summary Judgment Brief on Noninfringement
• Appendix A-35 Summary Judgment Brief on Infringement
• Appendix A-36 Motion for Preliminary Injunction and Temporary Restraining Order
• Appendix A-37 Opening Memorandum of Law in Support of Motion for Temporary Restraining Order and Preliminary Injunction
• Appendix A-38 Order Granting Motion for Temporary Restraining Order and Preliminary Injunction
• Appendix A-39 Motion to Extend the Stay of FDA Approval
• Appendix A-40 Opening Memorandum of Law in Support of Motion to Extend the Stay of FDA Approval
• Appendix A-41 Order Granting Motion to Extend the Stay of FDA Approval
• Appendix A-42 Unopposed Motion for Entry of Consent Judgment and Permanent Injunction as to Defendant
• Appendix A-43 Petition to Request a Change from a Listed Drug
• Appendix A-44 Trial Preparation Checklist
• Appendix A-45 Joint Pretrial Order, Consent Judgment, and Permanent Injunction as to Defendant
• Appendix A-46 Joint Pretrial Order
• Appendix A-47 Brief in Support of Motion in Limine - Person of Ordinary Skill in the Art
• Appendix A-48 Brief in Support of Motion in Limine - Exclude Expert Testimony
• Appendix A-49 Stipulation and Order of Infringement
• Appendix A-50 Useful Links
• Index
• About the ABA Section of Intellectual Property Law
• ABA-IPL Books Editorial Board 2015-16
• ABA Section of Intellectual Property Law (ABA-IPL)