Compulsory Licensing with Reference to Health in Developing Countries

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.