Optimizing Patent Protection

Business Wire, August 31, 2007

FARMINGTON, Conn. -- The Infoshop (http://www.the-infoshop.com/ee/55103) has announced the addition of Business Insights' product Patent Protection Strategies: Maximizing Product Revenues to its online catalog.

In a market environment where competition from generics companies is becoming increasingly aggressive, and the patenting of therapeutics is continually subject to impending legislative change, understanding how to effectively reassess, develop and exploit patent protection strategies is essential in facilitating enhanced market exclusivity and revenue returns over the lifecycles of new drugs. Patent Protection Strategies: Maximizing product revenues is a new report that examines the need for optimizing and sustaining the patent protection of novel products. The best methods of exploiting legislation to maximize revenue generation and protecting the considerable investments associated with innovations are also explored. It will also investigate both the offensive and defensive tactics that can develop product lifecycle strategies, through the refinery of organizational patent protection in tandem to encumbering the market entry of generic substitutes.

Table of Contents

Executive Summary

* The need for patent protection

* Current patent protection mechanisms

* Offensive strategies

* Case Histories

* Optimizing Revenue Returns

* Future outlook

Chapter 1 The need for patent protection

* Summary

* Introduction

* The costs of drug development

* The drug lifecycle

* The need to optimize returns from successful drugs

* The dependence on blockbuster revenues

* The impact of generics

* Aggressive generic companies

Chapter 2 Current patent protection mechanisms

* Summary

* Introduction

* Patent basics

* Requirements for a therapeutic patent

* Four types of pharmaceutical patent

* Legal patent frameworks

* United States

* Europe/PCT

* Japan

* Other markets

* Patent term extensions

* US patent term extensions

* Supplementary Protection Certificates

* Japanese Patent term extensions

* Pediatric exclusivity

* Orphan Drug legislation

* Regulations for market entry of generics

* United States

* Hatch Waxman

* ANDAs

* Paragraph IV challenges

* Europe

* Japan

* Biological Products and Biosimilars

* United States

* Europe

* Freedom to operate

Chapter 3 Offensive strategies

* Summary

* Introduction

* Filing strategies

* Early or late filing?

* Overlapping claims

* Broad claims or narrow claims?

* Exploitation of term extension legislation

* Product patents

* Subsidiary patents

* Crystalline form patents

* Salt and solvate patents

* Enantiomer patents

* Prodrug and antedrug patents

* Process patents

* Formulation patents

* Improved formulations

* Drug Combinations

* "Obvious" antihypertensive combinations

* Advair

* Antidiabetic agents

* New delivery routes

* Method of Use patents

Chapter 4 Defensive strategies

* Summary

* Introduction

* Patent infringement suits

* Mechanism

* Authorized generics

* OTC switches

* Orange Book delisting

* Research Disclosures

Chapter 5 Case Histories

* Summary

* Introduction

* Prozac

* Losec and Nexium

* Epogen v Dynepo

* Plavix

* Legal challenges

* Impact of generic clopidogrel

Chapter 6 Optimizing Revenue Returns

* Summary

* Introduction

* Lifecycle initiatives

* Franchise development

* Follow on products

* Secondary patents

* Prodrugs

* Portfolio development

* Competing with generics

Chapter 7 Future outlook 138

* Summary

* Introduction

* Changes in drug development

* Impact of technology

* Tougher project goals

* Legislative issues

* KSR International Co. v. Teleflex Inc (US Supreme Court)

* Biologicals

Appendix

* Glossary

* References

* Index

For more information visit http://www.the-infoshop.com/ee/55103