Patent Exhaustion and International Trade Regulation

Santanu Mukherjee, M.I.L.E., Ph.D. (WTI, Bern University), is an Advocate & Accredited Mediator in India, and the Head of Ex Lege Chambers, a boutique Law Office. He specializes in IPR, International Trade Policy and Technology Laws.

Foreword


Preface


Acknowledgments


List of Figures and Table


Abbreviations and Acronyms


Introduction


Part 1

Patents and Exhaustion

1 Intellectual Property Rights and Patents: Introduction to Intellectual Property Rights

1.1 Brief History of Patents


1.2 Rationale for Patents

1.2.1 Libertarian


1.2.2 Self-expression


1.2.3 Utilitarian


1.2.4 Human Rights


1.2.5 Distributive Justice


1.2.6 Privacy


1.2.7 Egalitarian




1.3 Specific Characteristics of Intellectual Property Rights




2 Ubiquity and Exhaustion Doctrine: Ubiquity in Patents

2.1 Doctrine of Implied License


2.2 Doctrine of First Sale


2.3 Exhaustion of Patent Rights




3 Economics of Patents and Economic Rationale for Exhaustion in Relation to International Trade

3.1 

3.1.1 The Economics of Patents


3.1.2 The Economic Arguments for Free Trade in Relation to Exhaustion of Patents




3.2 The Economic Reasoning for Patent Exhaustion

3.2.1 Economic Reasoning for ‘National Exhaustion’ of Patent Rights


3.2.2 Economic Reasoning for ‘International Exhaustion’ of Patent Rights


3.2.3 Economic Reasoning for ‘Regional Exhaustion’ of Patent Rights


3.2.4 Ideal Mode of Patent Exhaustion among the Three Modes




4 Evolution of Exhaustion: Patent Exhaustion in Different Jurisdictions

4.1 The United Kingdom and the Doctrine of ‘Implied License’


4.2 Patent Exhaustion in Germany and Some Countries in Continental Europe


4.3 Patent Exhaustion in the United States of America


4.4 Patent Exhaustion in Japan


4.5 Patent Exhaustion in Some Developing Countries

4.5.1 Brazil


4.5.2 China


4.5.3 India


4.5.4 South Africa


4.5.5 Indonesia


4.5.6 Malaysia


4.5.7 Singapore


4.5.8 Thailand


4.5.9 The Philippines


4.5.10 Vietnam




5 Exhaustion and Parallel Trade: Patent Exhaustion

5.1 The Effect of Patent Exhaustion on Parallel Trade


5.2 The Effect of Exhaustion of Other ipr s on Parallel Trade

5.2.1 Exhaustion of Trademarks


5.2.2 Exhaustion of Copyrights


5.2.3 Exhaustion of Trademarks and Copyrights in Relation to Patent Exhaustion and Effect on Parallel Trade





Part 2

Multilateral and Regional Trade Regulations and Patent Exhaustion

6 trips Agreement: The Negotiating History of the trips Agreement and Patent Exhaustion

6.1 Intellectual Property Rights under the gatt and the Negotiating History of trips


6.2 The Negotiating History of Exhaustion


6.3 Exhaustion under trips / wto: Analysis from the Multilateral Trade Perspective

6.3.1 Patent Exhaustion under the trips Agreement




7 gatt 1994 and Exhaustion

7.1 Preamble to the gatt 1994


7.2 Article i – Most Favoured Nation


7.3 Article iii – National Treatment


7.4 Article xx – General Exceptions


7.5 Article xi: 1 – General Elimination of Quantitative Restrictions


7.6 Article xxiv – In Light of the Most Favoured Nation Principle


7.7 Article xxiii: 1 – Non-discrimination of Quantitative Restrictions




8 General Agreement on Trade in Services and Its Interface with Patent Exhaustion

8.1 gats and Patent Exhaustion


8.2 Article ii and Article xvii in gats and Its Impact on Patent Exhaustion


8.3 Exceptions to Most Favoured Nation and National Treatment and Its Impact on Patent Exhaustion under Article v and Article xiv




9 Free Trade Agreements and Exhaustion: Different Regional Trade Agreements

9.1 

9.1.1 Regionalism and Its Relationship with Multilateralism


9.1.2 Development of Regionalism in Different Parts of the World


9.1.3 Relation between Regionalism and Multilateralism with Reference to Articles xiv and xxiv of the gatt / wto Agreement




9.2 The European Union, European Free Trade Association, European Economic Area and Patent Exhaustion


9.3 North American Free Trade Area (nafta), United States Canada Mexico Agreement (usmca) and Patent Exhaustion

9.3.1 nafta: Historical Perspective and Evolution


9.3.2 nafta: Legal rules on Intellectual Property Rights and Patent Exhaustion


 9.3.3 usmca: Background and Evolution




9.4 Association of Southeast Asian Nations (asean) and Patent Exhaustion


9.5 Gulf Cooperation Council (gcc) and Patent Exhaustion


9.6 Common Market of the South (mercosur) and Patent Exhaustion


9.7 Comprehensive and Progressive Agreement for Trans-pacific Partnership (cptpp), ipr s and Patent Exhaustion


9.8 Comprehensive Economic and Trade Agreement (ceta) and Patent Exhaustion




Part 3

Policy Dimensions of Patent Exhaustion

10 Patents and Public Health: Patents and Access to Medicines – The Exhaustion Dimension

10.1 Historical Perspective of Patents, Public Health Concerns and Access to Medicines: The Indian Experience


10.2 Post-trips Scenario: Patents, Public Health Concerns and Access to Medicines


10.3 Public Policy Implications of Public Health Crisis Leading to trips Amendment


10.4 trips Amendment: Patent Exhaustion Enabling Parallel Trade




11 Exhaustion and Competition Policy: Patent Exhaustion and Its Relation with Competition Law and Policy

11.1 Competition Law and Policy in the Multilateral Trading System


11.2 Competition Law/Policy and ipr s within the gatt/wto Regime


11.3 Competition Law/Policy trips and Parallel Imports




Conclusion and Final Remarks

12 Conclusion and Recommendation: Adoption of International Exhaustion of Patents, Globally

12.1. Purpose of Patent Protection, Ubiquity and Need for Balance


12.2 Patent Exhaustion in Different Countries: Need for Uniform International Exhaustion


12.3 Patent Exhaustion and Multilateral Trade: Need for Removal of Non-Tariff Barriers


12.4 International Exhaustion of Patents – Balancing ipr Protection and Consumer Welfare through Competition Policy


12.5 Addressing Parallel Imports under State Control and Restraints on Intellectual Property Rights

12.5.1 Restraint on Parallel Imports Due to Non-existence of Patents in Country of Export or Patents being Subject to Compulsory Licenses and Other Controls


12.5.2 Restraint on Parallel Imports due to Inferior Quality of Products




12.6 Amendment of the trips Agreement: Proposed Draft Amended Text for Article 6, trips




Bibliography


Legal Texts and wto Documents


List of Cases


Websites


Index