Intellectual Property Rights Issues in Vaccine Development offers a timely exploration of the evolving role of intellectual property (IP) in shaping global vaccine research, innovation, and accessibility. As the world continues to grapple with public health challenges like the COVID-19 pandemic-this book provides a critical lens on how patents, trade secrets, and international agreements influence vaccine development and distribution.
The contents of the book explore the historical evolution of IP in vaccinology, the debate over patent protection, the intersection of legal frameworks and ethical concerns, and the tension between innovation and equitable access. Special attention is given to global case studies, the impact of international agreements, and recommendations for stakeholders across policy, industry, and healthcare sectors.
Key features:
- Traces the history and legal evolution of vaccine-related IP
- Analyzes global access challenges and equity concerns
- Explores the role of IP during the COVID-19 pandemic
- Examines real-world case studies of vaccine IP dynamics
- Offers actionable policy and industry recommendations
Table of Contents
PREFACE
LIST OF CONTRIBUTORS
CHAPTER 1: INTRODUCTION OF INTELLECTUAL PROPERTY RIGHTS AND VACCINES
Gurpreet Bawa and Ashish Jain
INTRODUCTION
Applying IP Protection to Vaccines
Types of IP Protection
Patents
Trademark
Copyright
Plant Breeders’ Rights
Trade Secret
Why Protect Vaccines with IP Rights?
IP Considerations for Vaccines
When to File a Patent Application and Sound Prediction
Vaccine IP and Accessibility in the Developing World
TRIPs and LDCs
Vaccines and Humanitarian Purposes
Protection of Public Health
Links between Patent and Drug Legislation
CONCLUSION
REFERENCES
CHAPTER 2: HISTORICAL PERSPECTIVE ON VACCINES AND IP RIGHTS
Sandhya Bagde, Ruchi Shivhare, Ashwini Ingole, Gayatri Tiwaskar and Sachin
Kumar Jain
INTRODUCTION
ANCIENT PRACTICES AND VARIOLATION
EARLY HISTORY OF VACCINES
Edward Jenner and the Smallpox Vaccine
Global Efforts in Smallpox Eradication:
KEY ELEMENTS OF THE SMALLPOX ERADICATION CAMPAIGN INCLUDED
Surveillance
Vaccination
Containment
GLOBAL VACCINE INITIATIVES IN THE 21ST CENTURY
VACCINE AND THE PHARMACEUTICAL INDUSTRY
THE ROLE OF IP IN THE PHARMACEUTICAL INDUSTRY
TYPES OF INTELLECTUAL PROPERTIES AND THEIR DESCRIPTION
IP RIGHTS INCENTIVE INNOVATION AND INVESTMENT IN VACCINE RESEARCH
Challenges in Encouraging Vaccine Production
THE TRIPS AGREEMENT'S EFFECT
TRIPS IMPACT ON VACCINES
Patent Protection and its Access
Access to Medicine and Public Health
Global Health Crises
ACCESS TO VACCINES AND GLOBAL HEALTH
VACCINATION'S IMPACT ON GLOBAL HEALTH: PAST, PRESENT, AND FUTURE
THE VACCINATIONS OF THE FUTURE GENERATION
The Vaccination's long-term Prospects
CONTROVERSIES AND CHALLENGES
Restricted Accessibility of Intellectual Property Rights (IPR) understanding:
RECENT DEVELOPMENTS AND TRENDS
THE COVID-19 PANDEMIC AND VACCINE IP
CONCLUSION
REFERENCES
CHAPTER 3: INTELLECTUAL PROPERTY RIGHTS AND VACCINE INNOVATION
Dolly Rani and Megha Jha
INTRODUCTION
Overview of Vaccine Innovation-
Vaccine Innovation
Antigen Identification
Technological Platforms
mRNA
Viral Vectors
Subunit Vaccines
Inactivated Vaccines
Adjuvants and Delivery Systems
Personalized Vaccines
Vaccine Thermostability
Reverse Vaccinology and Computational Approaches
Global Collaboration and Data Sharing
Disease Eradication and Elimination
Vaccine Safety Monitoring
Next-Generation Vaccines
IPR and Vaccine Innovation
Technology Transfer and Collaboration
Balancing Access and Affordability
Global Health Challenges
Biopiracy Concerns
Incentivizing Research in Neglected Diseases
Regulatory Exclusivity
Challenges of Monopolies
CONCLUSION
REFERENCES
CHAPTER 4 : THE DEBATE ON PATENT PROTECTION FOR VACCINES
Nitin G. Dumore and Manasi M. Choudhari
INTRODUCTION
SIGNIFICANCE OF VACCINES IN PUBLIC HEALTH
BRIEF HISTORY OF VACCINE DEVELOPMENT
HEALTH BENEFITS OF VACCINATION
ECONOMIC BENEFITS
SOCIAL BENEFITS
OVERVIEW OF THE PATENT SYSTEM FOR PHARMACEUTICAL
TERM OF INTELLECTUAL PROPERTY RIGHTS
OBJECTIVE AND ROLE OF INTERNATIONAL AND NATIONAL GOVERNING
BODIES
WHAT IS A PATENT?
CRITERIA FOR PATENTABILITY
TYPES OF PATENT APPLICATIONS
INVENTIONS NOT PATENTABLE
CONTENT OF A PATENT
PROCEDURE FOR FILING A PATENT APPLICATION
PROCEDURE INVOLVED AT THE PATENT OFFICE
HISTORIC CONTEXT
The Role of Patents in Encouraging Innovations
Past Instances of Patent Disputes in the Pharmaceutical Industry
Patent Infringement Allegations
Patent Validity Challenges
Market Exclusivity
Regulatory Approval and Market Entry
Technology Transfer and Licensing Disputes
Evergreening and Secondary Patents
Global Competition
Counterclaims and Defensive Litigation
Anticompetitive Practices
Emergence of Global Health Crisis and Needs for Vaccines
ROLE OF TECHNOLOGY TRANSFER IN COVID-19
THE CURRENT DEBATE
Arguments in Favour of Patent Protection
Encouraging Research and Development
Incentive for Innovation
Securing Funding for R&D
Technology Transfer and Collaboration
Protection of R&D Investments
Encouraging Disclosure of Knowledge
Providing Incentives for Innovation
Protecting Intellectual Property Rights
ARGUMENTS AGAINST PATENT PROTECTION
Access to Medicine in Low-income Countries
Affordability and Accessibility
Public Health Impact
Intellectual Property Barriers
Compulsory Licensing and Flexibilities
Ethical Considerations
ACCELERATING VACCINE DISTRIBUTION DURING PANDEMIC
MORAL AND ETHICAL CONSIDERATIONS
IMPACT ON GLOBAL ACCESS TO VACCINES
High Prices and Limited Access in Developing Countries
Role of Intellectual Property Right in Vaccine Distribution
Calls for Waiving Patents Rights During Public Health Emergencies
ALTERNATIVES TO TRADITIONAL PATENT MODELS
Open-source Approaches to Vaccine Development
Public-private Partnerships & Collaborations
Voluntary Licensing Agreement
Implementation of Voluntary License Over Compulsory License
RECENT DEVELOPMENT
International Efforts to Address Vaccine Inequity
Proposals for Patent Waivers and Technology Transfer
Industry Response and Adaptation
VFUTURE IMPLICATIONS
Potential Changes in Patent Policies for Pharmaceuticals
Lessons Learned from the COVID-19 Pandemic
CONCLUSION
REFERENCES
CHAPTER 5: ACCESS TO VACCINES AND INTELLECTUAL PROPERTY
Aarti K. Thakre, Nitin G. Dumore and Monali N. Dumore
INTRODUCTION
Effect of Technology Transfer on Access to Vaccines
Source: MS/SVS/COVER
The Functions of Patent
The World Trade Organisation (WTO) (TRIPS) Agreement
Patent
International Patent
Intellectual Property and Development in WIPO
Validity of Patent
Minimum Standards of Patent Protection
Patent Protection Strategies
Patent and Access to Essential Medicines in Africa
Impact of Waiver of Intellectual Property Rights on the Pharmaceutical Industry
Public health, the Doha Declaration, and TRIPS
TRIPS Flexibilities
Criteria of Patentability
Compulsory Licences
Government Laws
Examples of Government Use
Principles of Patent Law
Indian Principles Law
Novelty
Non-obviousness
Utility
Limitations to Patent Rights
Different Limitations of Patent Rights
TRIPS Agreement
CONCLUSION
REFERENCES
CHAPTER 6: INTERNATIONAL AGREEMENTS AND VACCINE IP
Vikas K. Jain, Himanshu Vishwakarma, Khushi Jain and Sachin Kumar Jain
INTRODUCTION
TREATY PERSUASION
Bilateral Treaties
Multilateral Treaties
Regional Treaties
Trade Agreements
World Trade Organization (WTO)
Trade-Related Aspects of Intellectual Property Rights (TRIPS)
REGULATORY APPROVAL FOR VACCINES
Preclinical Development
Clinical Development
