ANDA litigation: strategies and tactics for pharmaceutical patent litigators

Index

• 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
• Paragraph IV Notice Letter
• Section vii 'Carve Out' Certification
• Complaint
• ANDA Form
• Complaint for Declaratory Judgment
• Answer, Defenses, and Counterclaims
• Covenant Not to Sue
• Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) and (6)
• Brief in Opposition to Motion to Dismiss Pursuant to Fed. R. Civ. P. 12(b)(1) and (6)
• Scheduling Order
• Infringement Contentions
• Invalidity Contentions
• Plaintiff's Document Requests
• Defendant's Document Requests
• Plaintiff's Interrogatories
• Defendant's Interrogatories
• Plaintiff's Requests for Admissions
• Defendant's Requests for Admissions
• Document Authenticity Stipulation
• Plaintiff's Notice of Deposition with Schedule A
• Defendant's Notice of Deposition with Schedule A
• Subpoena for Documents
• Protective Order
• Expert Undertaking
• Expert Report
• Joint Claim Construction and Prehearing Statement
• Plaintiff's Claim Construction Brief
• Defendant's Claim Construction Brief
• Expert Declaration in Support of Claim Construction
• Responsive Expert Declaration in Support of Claim Construction
• Motion for Summary Judgment and Request for Oral Argument
• Summary Judgment Brief on Invalidity and Obviousness
• Summary Judgment Brief on Nonobviousness
• Summary Judgment Brief on Noninfringement
• Summary Judgment Brief on Infringement
• Motion for Preliminary Injunction and Temporary Restraining Order
• Opening Memorandum of Law in Support of Motion for Temporary Restraining Order and Preliminary Injunction
• Order Granting Motion for Temporary Restraining Order and Preliminary Injunction
• Motion to Extend the Stay of FDA Approval
• Opening Memorandum of Law in Support of Motion to Extend the Stay of FDA Approval
• Order Granting Motion to Extend the Stay of FDA Approval
• Unopposed Motion for Entry of Consent Judgment and Permanent Injunction as to Defendant
• Petition to Request a Change from a Listed Drug
• Trial Preparation Checklist
• Joint Pretrial Order, Consent Judgment, and Permanent Injunction as to Defendant
• Joint Pretrial Order
• Brief in Support of Motion in Limine?Person of Ordinary Skill in the Art
• Brief in Support of Motion in Limine?Exclude Expert Testimony
• Stipulation and Order of Infringement
• Useful Links