Pre-ANDA Litigation : Strategies and Tactics for Developing a Drug Product and Patent Portfolio / edited by Kenneth Laurence Dorsney.

Format:

Book

Author/Creator:

Dorsney, Kenneth L.

Language:

English

Subjects (All):

Drugs--United States--Patents.

Drugs.

Patent laws and legislation--United States.

Patent laws and legislation.

Drug approval--United States.

Drug approval.

Pharmacy--Law and legislation--United States.

Pharmacy.

Biotechnology--United States--Patents.

Biotechnology.

Physical Description:

1 online resource (1112 pages)

Edition:

Third edition.

Place of Publication:

Cleveland : American Bar Association, 2018.

Chicago, Illinois : ABA Publishing, [2022]

Summary:

All pharmaceutical companies, whether they are an innovator or a generic, must navigate the same complex legal and regulatory framework to bring a product to market and fend off competition. Now completely updated, Pre-ANDA Litigation: Strategies and Tactics for Developing a Drug Product and Patent Portfolio, Third Edition is an in-depth resource for learning about and planning for ANDA litigations and all the different avenues that pharmaceutical litigants could follow. From the perspective of an innovator company, patents are vital to protect new drug products both to recoup the initial investment and for future investments. For the innovator and patent owner, the patentee must be aware of the risk to those intellectual property rights and be prepared for any patent challenge. Both entities can use Pre-ANDA Litigation as a resource to help formulate a strategy before patent litigation begins. ANDA Patent litigations and strategies are complex and require the patent professional to be able to explain complex technical and legal issues to lay persons, both within the organization and to judges and juries. This compendium provides lawyers with invaluable and in-depth tactics and advice so that any pharmaceutical litigant wanting to increase market share, whether as an innovator or a generic, can plan early and be ready to alter plans as new events occur. Topics include: Coordinating new drug application (NDA) and patent portfolio strategy Preclinical and patent considerations Clinical trials and regulatory considerations Trademark (TM) and nonproprietary name considerations Acquiring and in-licensing pharmaceutical products Pre-litigation investigations and due diligence Market entry business considerations for generic companies

Contents:

Intro

Title Page

Copyright Page

BOARD OF EDITORS

CHAPTER AUTHORS

Contents

Foreword

Preface

Chapter 1 Coordinating New Drug Application (NDA) and Patent Portfolio Strategy

I. Introduction

II. A Changing Landscape

A. The Impact of Portfolio Planning

B. Looking Back at the Cliff

III. Strategic Portfolio Planning

A. Enacting a Team-Based Approach

IV. Building the Portfolio

A. Research and Development

B. Cost/Benefit of Filing

C. Timing of Filing

D. Acquisitions

E. Reassessing Existing Portfolios

V. Managing the Portfolio

VI. Utilizing the Portfolio

VII. Conclusion

Chapter 2 Preclinical R&amp

D

I. Lead Compounds

A. Identification

II. Pharmacokinetics

A. Safety and Efficacy

B. Toxicology

C. Drug Supply and Scale-Up

III. Summary

Chapter 3 Preclinical Patent Considerations

I. Identifying Intellectual Property (IP) Opportunities and Ensuring Freedom to Operate (FTO)

A. Identifying IP Opportunities

B. Ensuring Freedom to Operate

II. Patent Application Filing Strategies

A. Invention and Patent

B. Timing

C. Scope of Offensive and Defensive Filings

D. Optimal Patent Protection

III. Conclusion

Chapter 4 Clinical Trials and Regulatory Considerations

A. Code of Federal Regulations (CFR)

II. Drug Development Process

A. Preclinical Stage of Drug Development

B. Clinical Stage of Drug Development

C. Regulatory Stage of Drug Development

D. Commercial Stage of Drug Development

III. Types of Clinical Trials

A. Human Pharmacology Studies

B. Therapeutic Exploratory Studies

C. Therapeutic Confirmatory Studies

D. Therapeutic Use Studies

E. Classification According to Phases

IV. ICH Guidelines

A. General Principles

B. Regulatory Benefits

C. GCP Guidelines

D. ClinicalTrials.gov.

V. Summary

Chapter 5 Clinical Trial-Patent Considerations

II. Public Use, On Sale, or Otherwise Available to the Public

A. Public Accessibility

B. Commercial Exploitation

C. The On-Sale Bar

D. Experimental Use

E. The Grace Period under 35 U.S.C. 102

III. Government Funding and Disclosure

IV. Expected and Unexpected Results for Patent Considerations

A. Repurposing Compounds

B. Rebutting a Prima Facie Case of Obviousness

C. Compliance with 35 U.S.C. 112, First Paragraph

V. Conclusion

Chapter 6 Trademark™ and Nonproprietary Name Considerations

I. Introduction: The Headache of Pharmaceutical Naming

II. Pharmaceutical Trademarks

A. The USPTO's Role: The Benefits of Federal Trademark Registration

B. The FDA's Role: Regulating Direct to Consumer Advertising

C. Considerations in Selecting Pharmaceutical Trademarks

D. The Approval Process for Pharmaceutical Trademarks

III. Nonproprietary Names

A. Selecting Nonproprietary Names

B. USAN Application and Approval Process

IV. Conclusion

Chapter 7 Investigational New Drug (IND) and New Drug Applications (NDA)

II. Investigational New Drug Applications: Types and Requirements

III. New Drug Applications: Types and Requirements

A. The 505(b)(1) Application

B. The 505(b)(2) Application

C. The FDA Draft Guidance

D. The Mechanics of Preparing and Submitting an NDA

E. Negotiating the Label

F. Changing the Label after Approval: Section 505(o)(4)

G. Changing the Label after Approval: Section 506A

IV. Prescription Drug User Fee Act

Chapter 8 Regulatory Exclusivity

I. Regulatory Exclusivity and Requirements

A. New Chemical Entities

B. New Clinical Investigation

C. Orphan Drug

D. Pediatric

E. Miscellaneous Exclusivity Provisions.

II. Challenges to Exclusivity Determinations

A. Procedural Considerations

B. New Chemical Entity Challenges

C. New Clinical Data Challenges

D. Orphan Drug Challenges

E. Pediatric Exclusivity Challenges

III. Patent Term Extension

A. Background

B. Application

Chapter 9 Overview of the NDA Review Process

II. Governance and Guidance Regarding NDA Procedures

A. Laws and Regulations Governing NDA Review

B. Code of Federal Regulations (C.F.R.)

III. NDA Review Policy, Procedure, and Guidance Documents

A. CDER's Manual of Policies and Procedures (MaPPs)

B. CDER 21st Century Review Process Desk Reference Guide (DRG)

C. Other FDA Published Guidance

IV. Primary Steps of the NDA Pre-Submission Process

A. Pre-Submission Meeting to Ensure Application Readiness

B. Recommended Contents of Pre-Submission Meeting Request

C. Pre-Submission Meeting Participants

D. Conducting the Pre-Submission Meeting

V. Receiving and Processing the NDA Submission

A. Receipt Marks Beginning of Review

B. Determination of Regulatory Compliance

C. Assessing and Assigning Reviewers

VI. Filing Determination and Review Planning Phase

A. Fileability Determination and Start of "Filing Clock"

B. Planning a Review of the Filed Application

VII. Conducting the Scientific and Regulatory Review of the NDA

A. The Review Process

VIII. Taking Official Action on the Disposition of the NDA

IX. Providing Post-Action Feedback to the NDA Applicant/Sponsor

A. Disputes

X. Conclusion

Chapter 10 Orange Book Listable Patents

I. Requirements for Orange Book Listing

II. Completion of Forms 3542 and 3542a

A. Section 1-General

B. Section 2-Drug Substance (Active Ingredient)

C. Section 3-Drug Product (Composition/Formulation)

D. Section 4-Method of Use.

E. Section 5-No Relevant Patents

F. Section 6-Declaration Certification

III. Confirming or Obtaining Protective Claim Scope

A. Protecting Approved Indications

B. Challenges to Listings under 21 C.F.R. 314.53(f)

C. Challenges to Listings under 21 U.S.C. 355(j)

D. Coordinating Patent Prosecution and Regulatory Strategies and Submissions

E. Non-Orange Book Listable Patent Protection

F. Delisting

G. Nuances of Challenges to Listed Patents

Chapter 11 Postmarketing Regulatory Requirements and Life Cycle Management

I. Postmarketing Regulatory Requirements

A. Mandatory Adverse Drug Experience Monitoring and Reporting

B. Drug Product Labeling

C. Risk Evaluation and Mitigation Strategies

D. Postmarketing Studies and Clinical Trials

E. Additional Postapproval Regulatory Requirements-Annual Reports

II. Life Cycle Management in the Regulatory Context

A. Postapproval Changes to an NDA

B. Data and Marketing Exclusivities

C. Strategies to Forestall Generic Competition

Chapter 12 Continued Patent Portfolio Development before the Patent Office

I. Patent Portfolio Strategies

A. Approved Products and Indications

B. Alternative Formulations

C. New Indications and Target Populations

D. Combination Compositions and Alternative Dosing Strategies

II. Patent Prosecution Strategies

A. Continuing Patent Applications

B. Reissue Patent

C. Reexamination Practice

D. Post Grant Review, Inter Partes Review

E. Expedited Prosecution

Chapter 13 Acquiring and In-Licensing Pharmaceutical Products: Due Diligence Issues

I. Chain of Title/Scope of Rights

A. Inventorship

B. Transfer of Intellectual Property Rights to the Company

C. License and Co-Development Agreements

D. Formalities in Order

II. Asset Evaluation

A. Evaluation Process.

B. Sharing Information with Seller and Licensor

C. Privilege of Counterparty Communications

III. Patent Due Diligence

A. Intellectual Property Rights to Be Transferred

B. Patents Covering Product

C. Validity

D. Patentability Searches

E. Freedom to Operate (FTO)

F. Design-Around Issues

G. PTE Decision for Multi-Patent Families

H. Life Cycle Management

IV. Trademarks

A. Traditional and Nontraditional

B. Validity

C. Scope of Protection

D. Ownership

V. Trade Secrets

A. Enforceability

B. Process

C. Know How

D. Valuation

VI. Standing to Enforce Intellectual Property Rights

A. Necessary Parties

B. Acquirer Rights

VII. Regulatory Considerations

A. PTE Candidates

B. Mapping of Market Exclusivity

C. Timing of Potential ANDA Filings

Chapter 14 Pre-Litigation Investigations and Due Diligence

II. Fact Investigation

A. Document Preservation

B. Invention Story

C. Secondary Considerations

D. Initial Disclosures

III. Patent Evaluations

A. Claim Construction

B. Validity/Enforceability

C. Infringement

D. Ownership and Standing

IV. Receiving Paragraph IV Notices

A. What to Look For

B. Evaluation of Concerns

Chapter 15 Market Entry Business Considerations for Generic Companies

I. Brand-Name Drug Markets and Patent Expiry

II. First-Filer and Early Entrant Advantage

III. Generic Entry's Effect on Branded and Generic Prices

IV. Key Generic Manufacturer Costs

V. Competitive Advantage: Prior Experience and Branding

Chapter 16 Selection of Generic Drug Candidates

I. Selection Based on Therapeutic Category

II. Selection Based on Markets

III. Preparation of a Master List of Potential Products

IV. Preparation of Product Profiles.

V. Circulation of the Product Profiles to a Group of Custodians within the Organization.

Notes:

Title from eBook information screen..

Includes bibliographical references and index.

Description based on print version record.

Other Format:

Print version: Dorsney, Kenneth Laurence Pre-ANDA Litigation

ISBN:

1-63905-115-5