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Contents

Disclaimer

Acknowledgments

About the Author

Preface to the Fifth Edition

Preface to the First Edition

Introduction

Chapter 1 Overview of Patents

Origins of U.S. Patents

Is a Patent a Legal Monopoly?

Edison Patent for the Electric Light Bulb

What is a Product or Process?

A Patent is a Sword, Not a Shield!

Basic Term of a Patent

Harmonization

Submarine Patents

Patent Term Adjustments and Extensions

How are Patents Obtained?

First-to-invent v. First-to-file

Provisional Applications

Foreign Filings

Patent Cooperation Treaty (PCT)

Costs of Filing

Patent Contents

Specification

Claims Define the Scope of the Invention

What is Not Patentable?

Laws of Nature

Natural Substances

Inherency

Story of Aspirin

Basic Requirements for Patentability

New

Useful

Novel

Experimental Use Exception

Non-Obvious

Inventorship

Proof of Invention

America Invents Act

Inter Partes Review (IPR)

Post-expiration Patent Royalties

Take Home Message

Chapter 2

Patent Enforcement and Infringement

Patent Enforcement

Burden of Proof

Trials in the U.S.

Trials outside the U.S.

Patent Infringement

Infringement and Validity Opinions

To Litigate or Not to Litigate

Patent Strategies

Damages and Injunctions

Inducement of Infringement

Off-label Use Patent Infringement

Defenses to a Claim of Infringement

FDA Safe Harbor

Patent Exhaustion

Inequitable Conduct

Take Home Message

Chapter 3

Pharmaceutical, Biologic and Medical Device Patents

Pharmaceutical Patents Generally

Hierarchy of Pharmaceutical Patents

Compound Patents

Medical Use Patents

Formulation Patents

Biologics Patents

Medical Device Patents

Take Home Message

Chapter 4

Overview of FDA

FDA Generally

Origins of FDA

Current FDA

OGD

PDUFA

FDASIA

Pediatric PRVs

OPDP

FDAMA

FDA Off-label Use Issues

FDA Orange Book

Drug Industry Regulation

Drug Development

Pre-clinical Development

Clinical Development: Phases I–IV

Well-controlled Studies

Accelerating NDA Approvals

Types of Drug Filings

Biologically Derived Drugs

Antibiotics

Medical Devices

Right-to-try State Laws

Drug Agencies Outside the U.S.

Europe

Japan

Take Home Message

Chapter 5

Exclusivity for Brand Name Innovative Drug Products

Exclusivity in General

Patent Exclusivity

Regulatory Exclusivity

Orphan Drug Exclusivity

New Chemical Entity (NCE) Exclusivity

New Use/Condition of Use/Formulation Exclusivity

Pediatric Exclusivity

Qualified Infectious Disease Products (QIDP)

Other Forms of Exclusivity

Litigation Exclusivity

Exclusivity outside the U.S.

European Union

Japan

China, Australia, New Zealand and Canada

India

Take Home Message

Chapter 6

Generic Drugs: Hatch Waxman Act

Historical Background

The Law Today

FDA Orange Book

Patents Listed in the Orange Book

Patent Certifications

Suits Following Patent Certification

Therapeutic Equivalence Rating

Patent Use Codes

Litigation on Scope of Patent Use Codes

180-day Generic Product Exclusivity

Authorized Generics

Medicare Act Amendments

Declaratory Judgment Actions

Counterclaim to De-list from the Orange Book

Agreements between Innovators and Generics

Settlement Agreements in Europe

Orphan Exclusivity to Block Generic Approval?

ANDA Backlog

Patent Challenges on the Increase

Inter Partes Review in Hatch Waxman Cases

Canada

In General

Paragraph IV Type Letters

Listing Requirements

NAFTA Challenge

Exclusivity

PMPRB

Take Home Message

Chapter 7

Generics for Biologic Drugs

Introduction

The Purple Book

Story of Erythropoietin (EPO)

Early Approvals of Biologic Generics

BPCIA

Biosimilars and Interchangeables

Exclusivity for Branded Biologics (BLAs)

Patent Dispute Procedures for Biosimilars

Biosimilar Litigation under BPCIA

FDA Guidance on Biosimilar Development

European Regulation of Biosimilars

Biosimilars in India and Canada

Take Home Message

Chapter 8

Putting it All Together: Product Life-Cycle Management

In General

FTC View: “Product Hopping”

Patents

Development Stage

Clinical Stage

Pre-approval Stage

Extending the Life of Patents

U.S. Patent Term Adjustments and Extensions

Litigation over Patent Term Extensions

Scope of Patent Term Extensions

Product Improvements

Active Drug Combinations

Single Isomers

New Dosage Forms/Delivery/Conditions of Use

Orange Book Listing and De-listing

Original Product Replacement

Over-The-Counter (OTC) Strategy

FDA Citizen’s Petitions

Authorized Generics

Examples of Life-Cycle Management

The Acular (ketorolac) Story

The Alphagan (brimonidine) Story

Take Home Message

Chapter 9

Conclusions and Final Thoughts

Drug Policy v. Industrial Policy

Longer Exclusivity Terms

Uniform International Approval Standards

Price Controls and “free ride” Issues

Prescribing Generic Drugs Even More Often

Glossary of Terms