Patent Protection Strategies: Maximising product Revenues

Table of Contents

• The need for patent protection
• Current patent protection mechanisms
• Offensive strategies
• Case Histories
• Optimizing Revenue Returns
• Future outlook

• 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

• 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

• 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

• Summary
• Introduction
• Patent infringement suits
• Mechanism
• Authorized generics
• OTC switches
• Orange Book delisting
• Research Disclosures

• Summary
• Introduction
• Prozac
• Losec and Nexium
• Epogen v Dynepo
• Plavix
  • Legal challenges
  • Impact of generic clopidogrel

• Summary
• Introduction
• Lifecycle initiatives
• Franchise development
  • Follow on products
  • Secondary patents
  • Prodrugs
• Portfolio development
• Competing with generics

• Summary
• Introduction
• Changes in drug development
• Impact of technology
• Tougher project goals
• Legislative issues
• KSR International Co. v. Teleflex Inc (US Supreme Court)
• Biologicals

• Glossary
• References
• Index

• 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

• 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