By Thaddeus Nkum Manu a THESIS SUBMITTED in PARTIAL
Total Page:16
File Type:pdf, Size:1020Kb
COMPULSORY LICENSING FOR PHARMACEUTICAL PATENTS: EXAMINING THE CONSISTENCY OF THE LOCAL WORKING REQUIREMENTS UNDER SECTION 84 OF THE INDIAN PATENT ACT WITH THE TRIPS AGREEMENT AS A MODEL FOR GHANA By Thaddeus Nkum Manu A THESIS SUBMITTED IN PARTIAL FULFILMENT OF THE REQUIREMENTS FOR THE DEGREE OF DOCTOR OF PHILOSOPHY in THE CENTRE FOR COMMERCIAL LAW STUDIES - QUEEN MARY UNIVERSITY OF LONDON 2017 I. Statement of Originality I, Thaddeus Nkum Manu, confirm that the research included within this thesis is my own work or that where it has been carried out in collaboration with, or supported by others, that this is duly acknowledged below and my contribution indicated. Previously published material is also acknowledged below. I attest that I have exercised reasonable care to ensure that the work is original, and does not to the best of my knowledge break any UK law, infringe any third party’s copyright or other Intellectual Property Right, or contain any confidential material. I accept that the College has the right to use plagiarism detection software to check the electronic version of the thesis. I confirm that this thesis has not been previously submitted for the award of a degree by this or any other university. The copyright of this thesis rests with the author and no quotation from it or information derived from it may be published without the prior written consent of the author. Signature: Thaddeus N. Manu Date: 27 December 2017 2 II. Abstract Compulsory licensing would offer Ghana a practical means to mitigate the high costs and shortages of medicines resulting from the failure of patentees to work their patented medicines locally. Article 5(A) of the Paris Convention as incorporated into Article 2 of TRIPS is consistent with Section 84 of the Indian Patents Act allows for the granting of compulsory licences to remedy failure to work. Where national laws permit, Article 31 of TRIPS allows the use of compulsory licences on any grounds subject to certain conditions. Although, the Doha Declaration on TRIPS and Public Health confirmed this position, there are contradictory opinions that the non-discrimination principle under Article 27(1) of TRIPS prohibits the granting of compulsory licences for failure to work. To the extent that Article 2 of TRIPS incorporates Article 5(A) of the Paris Convention provision, which is consistent with Section 84, the question that arises is whether Section 84 is consistent with TRIPS. Therefore, the aim of this thesis is to draw on applicable sources of law in an attempt to examine the consistency of Section 84 with TRIPS. This work is based on the hypothesis that Section 84, which allows the granting of a compulsory licence provided that the patented invention has not been worked in the territory of India, is consistent with TRIPS and would therefore provide a suitable model for Ghana. This argument is enhanced by the fact that in 2012 India invoked Section 84 in granting a compulsory licence to Natco and to date the consistency of this decision with TRIPS remains unchallenged within the World Trade Organisation Dispute Settlement system. The overriding implication is that if India got away with this decision, then it is probable that Ghana could implement a model similar to Section 84 to obtain affordable medicines without any legal challenge. 3 III. Acknowledgements I would like to extend my earnest gratitude to many people who generously contributed to the work presented in this thesis. Foremost, special appreciation goes to my primary supervisor, Professor Gail Evans. This study has been an amazing experience, and I thank Professor Evans unreservedly for her patience, motivation, immense knowledge, and also for providing me with so many wonderful opportunities. I would like to thank my second supervisor, Professor Spiros Maniatis for his tremendous academic support. Finally, but by no means least, I would like to thank my family for their unbelievable support. My parents, particularly my mother, Akua Kunadu whose love and guidance are with me in whatever I pursue. Most importantly, I wish to thank my loving and supportive wife, Linda, and my two wonderful children, Akua Kunadu-Taku and Afia Tafoa-Ansua, who provide unending inspiration. I dedicate this thesis to them. 4 IV. Table of Contents I. Statement of Originality……………………………………………………………………..2 II. Abstract…………………………………………………………………………..................3 III. Acknowledgements…………………………………………………………………..........4 IV. Table of Contents….…………………………………………………………….................5 Chapter 1: Ghana’s Essential Medicines Need and the Legal Difficulties in using Compulsory Licensing 1.1. Aim of the Chapter……………………………………………………………………….9 1.2. Introduction to the Work…………………………………………………………………9 1.3. The Context: Ghana’s Essential Medicines Need…………………….…….……….......21 1.4. Legal Difficulties of Ghana Using Compulsory Licensing………………………………22 1.5. The Aim of this work and Research Questions………………………………………….24 1.6. Hypothesis of the Work………………………………………………………………......25 1.7. Methodology………………….…………….....................................................................25 1.8. Research Scope…….………………………….................................................................27 1.8.1. Why Ghana?…………………………………………………………………...27 1.8.2. Why India?..........................................................................................................27 1.9. Limitation……………………………………………………...………………………...29 1.10. Structure of the Thesis…………………………….........................................................30 Chapter 2: Section 84 of the Indian Patent Act: Working of Patents and the Grant of Compulsory Licences 2.1. Aim of the Chapter………………………………………………………………………32 2.2. Introduction to the Chapter………………………………………………………………32 2.3. Section 84: A Legal Obligation to Work Patents in the Territory of India……..………..33 2.4. Utilisation of Section 84: The Compulsory Licensing Decision in Bayer v Natco….……......................................................................................................37 2.5. IPAB’s Interpretation of Section 84: Reasonable Requirements of the Public for Patents to be Worked Locally in the Territory of India………………………………39 2.6. The IPAB’s Interpretation of Section 84: The Requirement for Patented Inventions to be Reasonably Affordable to the Public of the Public…………………….45 5 2.7. Conclusion…………………………………………………………………………….....48 Chapter 3: Consistency of Section 84 of the Indian Patent Act with TRIPS 3.1. Aim of the Chapter……………………………………………………….........................49 3.2. Introduction to the Chapter………………………...…………………………………….49 3.3. Consistency of Section 84 with Article 5(A) of the Paris Convention …………………..51 3.4. Consistency of Section 84 with Article 31: Substantive Conditions and Procedural Requirements for the Granting of Compulsory Licences under TRIPS……..57 3.5. Consistency of Section 84 with the Objectives of TRIPS……………………………….60 3.6. Consistency of Section 84 with the Principles of TRIPS………………………………. ..64 3.7. Conclusion ……………………………………………………………………………....69 Chapter 4: Section 84: Non-Discrimination, Article 27 of the TRIPS Agreement and the Local Working Requirement 4.1. Aim of the Chapter……………………………………………….....................................71 4.2. Introduction to the Chapter………………………………………………………………71 4.3. Non-Discrimination and Article 27(1) of TRIPS..............................….…………………73 4.4. Non-Discrimination and Article 27(1) of TRIPS: Canada – Patent Protection of Pharmaceutical Products’ Case ………………………………………………………76 4.5. Non-Discrimination under Article 27(1) of TRIPS and the General Exception in Article 30 …………………………………………………………………83 4.6. Consistency of Local Working with TRIPS: The United States v Brazil Dispute………87 4.7. The Approach to Interpreting the Consistency of Local Working with Article 27(1) of TRIPS …………………………………………...……………….90 4.8. Implementation of Local Working by WTO Members’ and the Negotiation History of TRIPS………………………………………………………..95 4.9. Section 84 Model: Compatibility Article 5(A) of the Paris Convention with Article 27(1) of TRIPS ………………………………………………………….99 4.9. Conclusion………………………………………………………………………...........106 Chapter 5: Section 84: A Feasible Option to the Complex Restrictions Imposed by Article 31 of TRIPS and the Doha Solution 5.1. Aim of the Chapter……………………………………………………….…..................109 6 5.2. Introduction to the Chapter………………………………………………………...…...109 5.3. Complex Conditions and the Procedural Requirements under Article 31 of TRIPS…….114 5.4. The Right of WTO Ghana and other WTO Members to Determine the Grounds to Grant Compulsory Licences……………………………….……………………..116 5.5. Difficulties of Ghana and other WTO Members Satisfying the Conditions and the Procedural Requirements in Article 31 of TRIPS.........................................119 5.6. Doha Declaration: Confirmation of Ghana and other WTO Members’ Right to Grant Compulsory Licences ………………………………………………………………….123 5.7. 2003 Waiver Decision and the Amendment of Article 31 of TRIPS to Allow Ghana and other WTO Members to Grant Compulsory Licences…………………..131 5.8. The Doha Declaration and the Right to Health……………………………….................132 5.9. Procedural Restrictions Imposed by the Doha Solution on the Use of Compulsory Licences………………………………………………………..140 5.10. Conclusion……………………………………………………………………….........145 Chapter 6: Would Implementation of the Section 84 Model Threatens the Attainment of Socio-Economic Objectives in Ghana? 6.1. Aim of the Chapter……………………………………………………….…..................148 6.2. Introduction to the Chapter………………………………………………………...…...148