Compulsory Licensing with Reference to Health in Developing Countries
- Bangalore NLSIU, Bangalore 2019
- 382p.
TABLE OF CONTENTS LIST OF ABBREVIATIONS; LIST OF CASES; CHAPTER 1: INTRODUCTION; 1.0. INTRODUCTION; 1.1. INTERPLAY BETWEEN RIGHT TO HEALTH AND PATENT; 1.2. COMPULSORY LICENSING: BALANCING RIGHT TO HEALTH AND PATENT RIGHT; 1.3. STATEMENT OF PROBLEM; 1.4. RESEARCH OBJECTIVES; 1.5. RESEARCH QUESTIONS; 1.6. RESEARCH HYPOTHESES; 1.7. RESEARCH DESIGN; 1.8. CHAPTERISATION; CHAPTER 2: COMPULSORY LICENSING: ORIGIN AND EVOLUTION; 2.0. INTRODUCTION; 2.1. MEANING AND FORMS OF COMPULSORY LICENSING; 2.2. HISTORICAL BACKGROUND OF COMPULSORY LICENSING; 2.3. COMPULSORY LICENSING PROVISIONS IN INDIA &USA; 2.4. CONCLUSION; CHAPTER 3: LOCAL WORKING, NATIONAL EMERGENCY/EXTREME URGENCY AND PUBLIC NON-COMMERCIAL USE: TRIPS COMPATIBILITY; 3.0. INTRODUCTION; 3.1. LOCAL WORKING REQUIREMENT; 3.1.1.Local Working of the Patent: An Anecdote; 3.1.2. Interpretation of Article 27.1; 3.1.2.A. Vienna Convention on the Law of Treaties (VCLT), 1969; 3.1.3. Article 31 and 30 Based Interpretations; 3.1.3.A. Article 31 and Local Working; 3.1.3.B. Article 30 and Local Working: The Three Step Test; 3.1.4. Local Working Requirement in India & USA; 3.1.5. Conclusion; 3.2. NATIONAL EMERGENCY, EXTREME URGENCY AND PUBLIC NON-COMMERCIAL USE; 3.2.1.National Emergency and Extreme urgency: Meaning; 3.2.2. Instances of Compulsory License for National Emergency; 3.2.3.Public Non-commercial Use; 3.3. CONCLUSION; CHAPTER 4: PRACTICES UNDERMINING COMPULSORY LICENSING; 4.0. INTRODUCTION; 4.1. INTERNATIONAL/TRIPS PLUS PRESSURE ON COMPULSORY LICENSE; 4.1.1.Special 301 Report; 4.1.1.A. The Special 301 and Compulsory Licensing; 4.1.1.A.i. Pre TRIPS Era; 4.1.1.A.ii. The TRIPS Epoch; 4.1.1.B. Special 301 for Compulsory Licensing: An Analysis; 4.1.2. Conclusion; 4.1.3.TRIPS Plus Free Trade Agreements; 4.1.3.A. FTA’s and Compulsory License; 4.1.3.A.i. Restrictions on the Grounds of compulsory license; 4.1.3.A.ii. Data Exclusivity and Patent Linkage; 4.1.3.A.iii. Patent Term Extension; 4.1.3.B. United States - Jordan Free Trade Agreement; 4.1.4.Conclusion; 4.1.5. Price Regulation of Patented Drugs: An Indian Perspective; 4.2. OTHER CHALLENGES TO COMPULSORY LICENSING; 4.3. CONCLUSION; CHAPTER 5: EFFECTS OF COMPULSORY LICENSING FOR PUBLIC HEALTH 200-294 5.0. INTRODUCTION; 5.1. PATENTS AND INNOVATION; 5.1.1.Patent Law and India; 5.2. EFFECT OF COMPULSORY LICENSING ON RESEARCH &DEVELOPMENT; 5.3. EFFECT ON FOREIGN DIRECT INVESTMENT; 5.3.1.Key Determinants of FDI; 5.3.2.FDI Inflow in Pharmaceutical Sector and Compulsory Licensing; 5.3.3.Conclusion; 5.4. EFFECT ON AVAILABILITY, ACCESSIBILITY AND AFFORDABILITY OF MEDICINES; 5.4.1.Patent Monopoly and Price of the Drugs; 5.4.2.Conclusion; 5.5. CONCLUSION; CHAPTER 6: ADEQUATE REMUNERATION: AN EQUALIZER; 6.0. INTRODUCTION; 6.1. ADEQUATE REMUNERATION: EVOLUTION; 6.2. ADEQUATE REMUNERATION:MEANING AND DEFINITION; 6.2.1. Adequate Remuneration; 6.2.2. Circumstances of each case; 6.2.3. Economic value of the authorization; 6.3. LEGISLATIVE ADOPTION OF ‘ADEQUATE REMUNERATION; 6.4. OTHER SIGNIFICANT CONSIDERATIONS IN DETERMINING THE ADEQUACY OF REMUNERATION; 6.4.1. Royalty Calculation in Voluntary License; 6.4.2.Calculation of Compensation in Cases of Expropriation of Property; 6.4.3. Remuneration Guidelines for Pharmaceutical Products; 6.4.3.A. 2001 UNDP/HDR Guidelines; 6.4.3.B. JPO Royalty Guidelines 1998; 6.4.3.C. 2005 Canadian Royalty Guidelines; 6.4.3.D. Tiered Royalty Method (TRM); 6.4.4. Calculation of Adequate Remuneration: Case Study; 6.5. CONCLUSION; CHAPTER 7: CONCLUSIONS AND RECOMMENDATIONS; 7.0. CONCLUSIONS; 7.1. RECOMMENDATIONS; ANNEXURE ; BIBLIOGRAPHY; LIST OF BOOKS; LIST OF ARTICLES; LIST OF CONSTITUTIONS AND LEGISLATIONS; LIST OF DICTIONARIES; LIST OF INTERNATIONAL AGREEMENTS AND INTERNATIONAL DOCUMENTS; LIST OF REPORTS; LIST OF WORKING PAPERS AND STUDY REPORTS; MISCELLANEOUS.
Compulsory license Patent monopoly Patent right Right to health & patent