Abstract
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: Maximising product revenues is a new report published by Business Insights that examines the need for optimising and sustaining the patent protection of novel products. The best methods of exploiting legislation to maximise 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 organisational patent protection in tandem to encumbering the market entry of generic substitutes. Develop and apply successful patent protection strategies, exploit legislation effectively and secure the lifecycles of your innovations with this new report...
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
List of Figures
- Figure 1.1: Novel Therapeutic Entities Approved by the FDA, 2000-2006
- Figure 1.2: Schematic drug revenue life cycle
- Figure 1.3: Dependence of major companies' 2006 revenues on blockbuster products
- Figure 1.4: US Sales of Prozac and generic fluoxetine, 2000 - 2006
- Figure 1.5: Quarterly US sales of Zocor 2005-2006
- Figure 1.6: Quarterly US sales of Plavix 2005-2007
- Figure 1.7: US sales of OTC and Prescription Claritin, 2000-2006
- Figure 2.8: Variation in number of SPCs granted in EU countries, 2003
- Figure 2.9: Variation in number of SPCs granted in EU countries, 2003
- Figure 3.10: Impact of offensive strategies on drug revenue life cycle
- Figure 3.11: Primary claims of two key patents relating to paroxetine
- Figure 4.12: Impact of defensive strategies on drug revenue life cycle
- Figure 4.13: Timeline for Paragraph IV ANDA filing
- Figure 4.14: US sales of Paxil, an authorized generic and a competing generic August 2003- June 2004
- Figure 4.15: US Sales revenues of Schering-Plough' s major anti-histamines 2000-2006
- Figure 5.16: Revenues from AstraZeneca' s antiulcer franchise 1999-2006
- Figure 6.17: US Sales of Wellbutrin and generic bupropion 1999-2006
- Figure 6.18: Global sales of Adalat formulations 1975-2000
List of Tables
- Table 1.1: Drugs generating 2006 revenues in excess of $3 billion
- Table 2.2: Possible term extensions in major markets
- Table 2.3: Selected high revenue generating Orphan drugs
- Table 2.4: Orphan drug legislation in the major markets
- Table 5.5: Amgen' s key Epogen patents
