CONTENT

Particulars Page
No

 Declaration
 Certificate
 Acknowledgement
 List of Tables
 List of Cases

CHAPTER-I 01-29
INTRODUCTION
1.1. Introduction
1.2. Statement of the Problem
1.3. Objectives of the Study
1.4. Review of Literature
1.5. Scope of the Study
1.6. Sources of Data
1.7. Methodology
1.8. Hypothesis of the Study
1.9. Conceptual Framework
1.10. Research Design
1.10.1 Introduction
1.10.2 The Indian Patents Act - An Overview
1.10.3 The TRIPs Agreement and other International Agreements
1.10.4 The Indian Patents Act on Drugs and Medicines
1.10.5 The Impact of Product Patent Regime on Prices of Drugs and their accessibility
1.10.6 The Role of Government in Framing and Protecting the Public Health Policy
1.10.7 Conclusions and Suggestions

CHAPTER-II 30-67
INDIAN PATENTS ACT: AN OVERVIEW
2.1 Introduction
2.2 Knowledge and Property
2.3 India’s Patent Policy
2.3.1 India’s Patent Policy in pre-TRIPs Period
2.4 The main features of the original Indian Patents Act, 1970
2.5 Provisions of TRIPs
2.6 The influence of England on Indian Patent Law
2.7 History of Indian Patent Law
2.8 Patent Amendments in India after TRIPs Agreement
2.9 The Indian Patent Act (Post-TRIPs amendments)
2.9.1 Patents Amendment Act, 1999
2.9.2 The Patents (Amendment) Act, 2002
2.9.3 The Patents (Amendment) Act, 2005
2.9.4 Main Provisions of Patents (Amendment) Act, 2005
2.9.5 Compulsory License as flexibility in Indian Patents Act.
2.10 Conclusion
CHAPTER-III 68-176
THE TRIPs AGREEMENT AND OTHER INTERNATIONAL
AGREEMENTS
3.1 Introduction
3.2 The Formation of WTO
3.3 Type of Agreements
3.3.1 Bilateral (Plurilateral) Agreements
3.3.2 Multilateral Agreements
3.4 The main differences between the GATT and the WTO
3.5 Objectives of the WTO
3.6 Functions of the WTO
3.7 Structure of WTO
3.8 Principles of the WTO Trading System
3.9 Major agreements of WTO
3.10 TRIPs Agreement
3.11 The nature and role of Intellectual Property
3.12 Legal Protection of Intellectual Property Rights
3.12.1 Meaning of IPRs and their protection
3.12.2 The Traditional Concept of IPRs
3.12.3 General Provisions and Basic Principles of IPR under TRIPs Agreement
3.13 Patents in the TRIPs Agreement
3.14 Basic Patent Obligations of TRIPs
3.15 TRIPs Agreement and Patents on Medicines and Drugs
3.16 The Doha Declaration flexibilities to protect public health
3.17 Policy Option: Flexibility in the TRIPs Agreement
3.18 Doha Analysis
3.19 Classification of Flexibilities
3.20 Limited Flexibilities in the Paragraph 6 (Implementation Agreement)
3.20.1 Patentable subject matter (Article 27)
3.20.2 Research and experimental use exception (Article 30)
3.20.3 Compulsory licensing (Article 31)
3.20.4 Conditions for Compulsory Licenses
3.20.5 The possibilities of structuring the grant of CL arising from TRIPs and
Paris Convention
3.20.6 Parallel Imports
3.20.7 Bolar provision/regular exception
3.20.8 Regulatory (bolar) exception (Article 30)
3.20.9 Pharmaceutical test data protection (Article 39.3)
3.21 Intellectual Property and Development
3.22 Transition periods (Articles 65.2; 65.4; and 66.1)
3.23 Differential Pricing
3.24 The “Special 301” and access to medicine
3.25 Overview of International Development in the Field of Patent and Other
Intellectual properties
3.26 Paris Convention
3.27 The Berne Convention
3.28 Role of WIPO in Harmonizing Patent protection
3.29 The Patent Cooperation Treaty (PCT)
3.30 Patent Law Treaty
3.31 Conclusions
CHAPTER-IV 177-262
THE INDIAN PATENT ACT ON DRUGS AND MEDICINES
4.1 Introduction
4.2 Dispute on Contentious issues in implementation of TRIPs Agreement
4.3 Main Provisions of Indian Patent Amendment act on Pharmaceutical Products
and chemicals
4.4 Current Position of Indian Patent Law on granting patents in the field of Drugs
and medicines
4.5 Unique requirements of the Indian Patent System
4.6 Issues over Indian position on Drug Patent
4.7 Analysis of the case in relation to sec 3
4.8 Difficulty in utilizing the TRIPs flexibility
4.9 Utilization of Compulsory Licensing in Indian Scenario to make drugs Affordable
4.10 India questioned by WTO as to the issue of utilizing Compulsory Licensing and
granting patent u/s 3(d)
4.11 Conclusions

CHAPTER-V 263-434
THE IMPACT OF PRODUCT PATENT REGIME ON PRICES OF
DRUGS AND THEIR ACCESSIBILITY
5.1 Introduction
5.2 Hypothesis Tested
5.3 There is conflict in Product Patent protection and Protection of Public Health
5.3.1 Human Rights Provisions in the Patent as Exceptions
5.3.2 TRIPs do not Include Anything Protecting Health as a Right to Health
5.3.3 Flexibilities in the TRIPs are not sufficient to meet the Requirements of the
Indian People
5.3.4 Findings
5.4 The Product Patent Regime in the field of medicines and drugs has a Negative
Impact on Public Health Policy
5.4.1 Variation of Drug Prices – Evidence of Profiteering
5.4.2 Comparison of Generic and Brand Name Drugs
5.4.3 There is a Poor Access to Pain-relieving Cancer Drugs in India due to High
Prices
5.4.4 Findings
5.5 The Product Regime in the field of medicines and drugs has Increased the non-
affordability of the life saving drugs for the common Man due to high tendencies
of monopoly
5.5.1 Trends in access to medicines in India
5.5.2 Findings
5.6 Priority to the health is not given in Indian Patents Act in utilizing the
flexibilities to regulate the effect of prices of Product Patents in the Field of
medicines and drugs after its amendments in 1999, 2002 and 2005
5.6.1 Flexibilities which India can use under its Patents Law
5.6.2 Compulsory Licensing in India’s Patent Act: General Provisions
5.6.3 Findings
5.7 Diseases Sufferers right to have access to medicines and drugs is Inefficiently
addressed under the existing laws such as Indian Patents Act.
5.7.1 Right to Health under Indian Constitution
5.7.2 Right to Health at International Level
 5.7.3 Provisions that is included in Indian Constitution recognizing Right to Health
5.7.4 Judiciary recognizing Right to Life as an inclusive right including Right to Health
5.7.5 Welfare State has a Duty to Protect its Subjects
5.7.6 Various Policies of the Government in Promoting Health Policies in
Support of Right to Health
5.7.7 Regulation in Pharmaceuticals
5.7.8 Principles for Drugs Price Control and Determination in NPPP-2012
5.7.9 Findings
5.8 There is a need to amend the existing national and international laws and policies
to extend the fundamental right to health on par with the fundamental right to
education
5.8.1 Relation between TRIPs and Public Health
5.8.2 TRIPs Agreement, Human Rights and Consumers Rights
5.8.3 Human Rights to Health
5.8.4 Findings

CHAPTER-VI 435-548
THE ROLE OF GOVERNMENT IN FRAMING AND PROTECTING
THE PUBLIC HEALTH POLICY
6.1 Introduction
6.2 Health Legislation in India
6.3 Analysis of Governments expenditure on public health
6.3.1 Annual government budget for urban healthcare
6.3.2 Social Health Initiatives
6.3.3 Funding by International donor Agencies
6.4 Pattern of Access to medicines
6.5 Pre-HLEG recommendations on Health for all
6.6 Access to Health Services provided by the Government
6.7 Drugs industry protecting ‘morally unacceptable’ patent system hindering
Access to medicines
6.8 Pharmaceutical Industry
6.8.1 Pharmaceutical Policy Importance of Price Regulation
6.8.2 Drug Policy Formulation in India
6.8.3 Overview of Forty Five Years of Price Controls in India
6.8.4 Criteria for Selection of Drugs for Price Control
6.8.5 Functioning of the National Pharmaceutical Pricing Authority (NPPA)
6.8.6 Pharmaceutical Advisory Forum
6.8.7 Price Control measures taken by the Government
6.8.8 Drug Regulatory System of India
6.8.9 Lack of will to implement laws to regulate price of drugs and medicines
6.8.10 Drug Prices Equalisation Account (DPEA)
6.8.11 The Policy on Pricing Patented Drugs
6.8.12 The Policy to control and Regulate prices are not efficient
6.9 Duties and taxes on retail medicines
6.10 Conclusions
CHAPTER-VII 549-577
CONCLUSIONS AND SUGGESTIONS
7.1 TRIPs and IPR protection is motivated by profit, not health
7.2 The amendment to the patents act
7.3 TRIPs flexibilities incorporated in India’s patent law is not sufficient to meet the
requirements of its people in access to medicines.
7.4 No links between patent status and marketing approvals
7.5 Lack of clarity in the new law for utilization of flexibilities
7.6 The Dracula effect of the product patent regime
7.7 Unfinished agenda - non communicable diseases and injuries
7.8 The right to health is not properly addressed in India
7.9 Factors affecting access to medicines in India
7.10 Stringent product patent regime and failure to enact a separate law recognizing
‘right to health’
7.11 Access to health services
7.12 Suggestions

BIBLIOGRAPHY 578-588

ANNEXURES