Title Page
ABSTRACT
Contents
INTRODUCTION 14
1. Overview 14
2. Aim and Objective of the Study 18
3. Research Methodology 19
4. Structure of the Dissertation 19
4. Limitation of Problem 20
5. Legal Issues 20
6. Purpose of Research 21
CHAPTER ONE: GENERAL INTRODUCTION OF PHARMACEUTICAL PATENT AND GENERIC DRUGS 22
1.1. Definition 22
1.1.1. Pharmaceutical Patent 22
1.1.2. Generic Drug 24
1.2. History of Pharmaceutical Patent 25
1.2.1. Uruguay Round Discussion 25
1.2.2. TRIPS Agreement 26
1.2.3. Generic Drug 27
1.3. Issues Which Leads to the Enforcing Pharmaceutical Patent 28
1.4. Fundamental Objectives of Pharmaceutical Patent 29
1.5. Fundamental Objective of the Allowance of Generic Drugs Production 32
1.6. World Issue Aroused from the Pharmaceutical Patent 34
1.7. Controversy Around National Pharmaceutical Law 36
CHAPTER TWO: INTERNATIONAL LAW AND THE PRACTICE OF INTELLECTUAL PROPERTY LAW REGARDING PHARMACEUTICAL PATENT 40
2.1. International Law of Pharmaceutical Patent Law 40
2.1.1. The Paris Convention and Priority Period 40
2.1.2. Uruguay Round Discussion Result 41
2.1.3. Doha Round Discussion Result 43
2.1.4. TRIPS Agreement Analysis 45
2.2. International Pharmaceutical Patent Practice 49
2.2.1. The Pharmaceutical Patent Law Practice in Europe 49
2.2.2. The Pharmaceutical Law Practice in the United States 54
CHAPTER THREE: INTELLECTUAL PROPERTY LAW AND THE PRACTICE OF PHARMACEUTICAL PATENT LAW IN INDIA 58
3.1. The History of Indian Pharmaceutical Patent Law 58
3.1.1. Indian Pharmaceutical Patent Law before the TRIPS Agreement 58
3.1.2. Indian Pharmaceutical Patent Law after the TRIPS Agreement 63
3.2. The Discussion on Indian Pharmaceutical Patent Law 67
3.2.1. The Alignment of Indian Pharmaceutical Patent Law with TRIPS Agreement 67
3.2.2. The Analysis of Indian Pharmaceutical Patent Law 68
3.2.3. The Analysis of Indian Pharmaceutical Industry Status before and after TRIPS 69
3.3. Generic Drug Industries in India 71
3.3.1. The Development of Generic Drug Industries in India 71
3.3.2. Government Involvement in Generic Drug Industries Development 72
3.3.2. The Legal For Manufacturing Generic Drugs in India 73
CHAPTER FOUR: INDIAN PHARMACEUTICAL PATENT LAW PRACTICE 75
4.1. The Gleevec (Glivec) Case Study between Novartis AG v Union of India & Others 75
4.1.1. Fact Analysis 75
4.1.2. Issue 78
4.1.3. The Court Judgement 79
4.2. Discussion and Overall View on the Court Judgement 80
4.2.1. The International View and Discussion on Indian Court Judgement 80
4.2.2. Consequences of the Court Judgement 81
4.3. The Discussion on Section 3(d) of Indian Pharmaceutical Patent Law 82
4.3.1. Indian Patent Law Section 3(d) Interpretation 82
4.3.2. The Primary Objective of Indian Pharmaceutical Patent Law Section 3(d) 85
4.3.3. Section 3(d) Constitutional Analysis 86
4.3.4. The Discussion of the International View on Section 3(d) 87
4.3.5. Debate on the Motive of section 3(d) of Indian Patent Law 89
4.3.5. Similarity provision of other countries with section 3(d) 91
4.4. The Discussion of Pharmaceutical Cases in India and other Countries 92
4.4.1. Other Pharmaceutical Cases in India 92
4.4.2. The comparison of Gleevec case with other cases in India 101
4.5. The Application of France and the United States Patent Law on Gleevec case 102
4.5.1. Gleevec Case Fact Summary 102
4.5.2. The Application of France Patent Law on the Gleevec Case 103
4.5.3. The Application of the United States Law on the Gleevec Case 105
CHAPTER FIVE: RECOMMENDATIONS AND CONCLUSION 108
5.1. Recommendations 108
5.1.1. Recommendation on Indian Pharmaceutical Patent Law 108
5.1.2. Recommendation on Cambodian Pharmaceutical Patent Law 111
5.2. Conclusion 114
REFERENCES 118