ANDA litigation: strategies and tactics for pharmaceutical patent litigators
- Publisher:
- American Bar Association
- Publication date:
- 2016-06-02
- Authors:
- Kenneth L. Dorsney
- ISBN:
- 9781634254588
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