The Generic Challenge

Disclaimer xv
Acknowledgments xvii
About the Author xix
Preface to the Sixth Edition xxi
Preface to the First Edition xxv
Introduction 1
Chapter 1 Overview of Patents 7
Origins of U.S. Patents 7
Is a Patent a Legal Monopoly? 8
Edison Patent for the Electric Light Bulb 9
What is a Product or Process? 9
A Patent is a Sword, Not a Shield! 14
Basic Term of a Patent 15
Harmonization 16
Submarine Patents 17
Patent Term Adjustments and Extensions 18
How are Patents Obtained? 20
First-to-invent v. First-to-file 20
Provisional Applications 22
Foreign Filings 22
Patent Cooperation Treaty (PCT) 25
Costs of Filing 26
Patent Contents 27
Specification 28
Claims Define the Scope of the Invention 28

What is Not Patentable? 32
Laws of Nature 32
Natural Substances 34
Inherency 36
Story of Aspirin 38
Basic Requirements for Patentability 38
Chapter 8 Putting it All Together:
Product Life-Cycle Management 165
In General 165
FTC View: “Product Hopping” 166
Patents 168
Development Stage 168
Clinical Stage 168
Pre-approval Stage 169
Extending the Life of Patents 170
U.S. Patent Term Adjustments and Extensions 170
Litigation over Patent Term Extensions 171
Scope of Patent Term Extensions 172
Product Improvements 172
Active Drug Combinations 173
Single Isomers 173
New Dosage Forms/Delivery/Conditions of Use 174
Orange Book Listing and De-listing 175
Original Product Replacement 176
Over-The-Counter (OTC) Strategy 177
FDA Citizen’s Petitions 177
Authorized Generics 178
Examples of Life-Cycle Management 179
The Acular (ketorolac) Story 179
The Alphagan (brimonidine) Story 184
Combigan 190
Take Home Message 192
Chapter 9 Conclusions and Final Thoughts 193
Drug Policy v. Industrial Policy 193
Longer Exclusivity Terms 194
Uniform International Approval Standards 194
Price Controls and “free ride” Issues 195
Prescribing Generic Drugs Even More Often 196
Glossary of Terms 199