1
General Overview
I.INTRODUCTION
THIS BOOK CHRONICLES the complex relationship of pharmaceutical patents and access to medicines within the limiting space of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).1 It does so by suggesting that to obtain a fuller understanding of this complex relationship, one should factor in three phenomena. First, the history and origins of patent law, bearing in mind various theories and understanding of patents that have emerged and developed through specific historical conjunctures, and how these affect the way a country understands the utility and importance of patents in achieving overall nationalistic goals. Second, the role of local politics (including the presence of state and non-state actors) in influencing and shaping pharmaceutical patent law-making and processes. Third, the power of international politics and political actors to exert pressure on the other to influence patent law and policy outcomes. The third point is truer for the developing country context than for developed or advanced economies.
Patent Games in the Global South explores the contours of that complex relationship by taking as examples Brazil, India, and Nigeria, and tells the story of patent law-making within each of them. In doing so, this book puts forward the hypothesis that for countries in the Global South keen on building a human-focused patent regime, the presence and participation of a strong indigenous pharmaceutical manufacturing sector and even stronger civil society activism are imperative. This is because the presence of these actors is paramount in the mobilisation of knowledge, cognitive-shaping of public discourse, creation of expertise, and participation in the politics and games required in building a pharmaceutical patent regulatory framework. Regrettably, as we shall see in these chapters, the contestation, presence and participation of these actors are asymmetrical.
At a fundamental level, this book attempts to explore pharmaceutical patent law-making in Nigeria. Specifically, how do patents affect, if at all, access to essential medicines in Nigeria? How is patent conceptualised into law and policy vis-Ć -vis the TRIPS Agreement among policy-making circles in Nigeria? How do ideas regarding patents circulate? That is, what influences the way in which particular policy options are constructed ā and, by extension, how do others get extinguished with regard to patent law and policy in Nigeria? How do non-state actors ā private sector and civil society groups ā challenge and/or influence this understanding and conceptualisation of patents into Nigerian law and policy? I focus on Nigeria because aside from it being my home country, it is also the largest economy in Africa with a growing population and an expanding industrial sector. The choice of Nigeria as a case study on the intersection between patent law, development, and access to medicine discourse is informed by two factors. First, the prominent position of the country within the continent affords it the power to influence and set policy agenda on norms governing patent law and public policy discourse in sub-Saharan Africa. Second, the country has always been a significant interlocutor for Africa and the Global South at various international forums. At the onset and in the course of the Uruguay Round negotiations that established the WTO, especially during the TRIPS Agreement negotiations, Nigeria was outspoken in its objection to the inclusion of an intellectual property (IP) regime within the multilateral trade framework. Nevertheless, there is a sharp disconnect between government rhetoric at international forums and government actions at the local level. This is in stark contrast to the prevailing situation in traditional āTRIPS opponentā countries such as Brazil and India, whose stance at international forums is usually reflective of their IP policies at home.
But in the course of undertaking this research, it became urgent to widen the discourse to include Brazil and India ā countries different from Nigeria and yet similar in many ways. Both countries are the focus of attention when it comes to balancing a patent regime with each respective countryās needs and aspirations, even as they continue to face so many hurdles as they seek to balance protecting the IP of inventors, on one hand, and fulfilling the social contract needs of their citizens on the other. Still, their inclusion in this book provides a toolbox, and not a fixed roadmap, for Nigeria in assessing the value to be promoted or protected as the country designs and develops its IP rules in fulfilment of its TRIPS Agreement obligations.2 Further, the experiences of Brazil and India, as the chapters in this book show, are relevant in raising awareness and increasing the knowledge of Nigerian law-makers on legal norms, debates, and cases in other jurisdictions to make better informed decisions on laws to adopt and discard based on the distinct circumstance(s) and needs of Nigeria.
At a more general level, this book investigates the growing Third World resistance against hegemonic IP rules. It is an exercise in the quest for legal re-ordering of patent law in the Third World ā a sort of unmasking of alternative approaches to patent law-making and un-making. Such approaches are alternative in the sense that the IP law-making engaged in this book moves away from the dominant EuropeanāUS models to a development-oriented IP regime. Through an empirical study of the Brazilian and Indian patent regimes, this book maps out the broad interpretations and domestication of international law in the Third World, and the ways these interpretations widen the aperture on international norms and rules governing IP whilst also being āTRIPS compliantā in that challenges at the WTO have failed to materialise.
Consequently, this book pays particular attention to how the local politics between the subaltern state, non-state actors, and transnational capital, as well as the factions within subaltern states ā often ignored in debates surrounding intellectual property rights (IPRs) and their relation to access to health ā are involved in the game of recalibration of global IP norms and discourses. This book also exposes some of the contradictions involved in this emerging subaltern jurisprudence on IP law. These contradictions are not surprising. While both Brazil and India are making huge strides in designing patent regime systems that best meet their needs, their respective regimes are still flawed as certain policies and actors inadvertently promote IP practices that impede development and public health management. As analyses in this book show, protectionist interests are fighting back. These actions do not mean a failure of these regimes. Instead, they show that the IP ecosystem is complex, does not exist in isolation, and the presence of various actors means it will continue to calibrate and recalibrate the global IP regime.
Thirdly, this work also highlights the changes in ways postcolonial states engage and interact with international law in general and IP in particular, which can no longer be analysed within the statist paradigm alone. The presence of transnational civil society groups, mobilising across state boundaries and operating in forums previously thought as the exclusive turf of nation-states, is rapidly expanding and shaping laws and practices in the field of international IP law. In this regard, the discoveries and overall findings provided in this book form part of emergent discourse on new constitutionalism in the Global South.
Over the years, subaltern jurisdictions have become the battleground for the promotion of global ideals of human, social, economic, and environmental development. The struggles on access to medicines (A2M) have somewhat shifted from WTO forum disputes to local or national courts in the Global South. This is due to a prevailing perception in contemporary international legal discourse where the developing world has often been seen as the āotherā. In this view, Third World countries are usually the importer of international regulations, from the European civilising missions, International Monetary Fund (IMF) fiscal conditionalities and the World Bank development programmes, to many other such stipulations by donor states and organisations usually located in the Global North.
Within this narrative, international law discourses have the tendency to reduce the Global South to what Upendra Baxi calls the āgeographies of injusticeā.3 That is, the use of international law ā be it in human rights, investment, trade, or others ā as an instrument for social change, with its applications based on Eurocentric ideals to provide solutions to the needs and concerns of the Third World. One of the consequences of this is a reproduction of patterns of silence and the erasure of significant legal, institutional, and socio-political development and law-making in the Third World. This book, however, shows emerging critical legal trends from the Global South, particularly the anti-evergreening provisions in Indian patent law such as sections 3(d)(e) and (i). These laws, as this book shows, are visibly altering āreceived geographies of core-and-periphery, relocating southward some of the most innovative and energetic modes of producing valueā.4
At a theoretical level, this book builds heavily on critical legal theory (CLT), although it touches on insight by postcolonial theory and critical development theory. CLT challenges and overturns accepted norms and standards in legal theory and practice.5 According to this school of thought, the failings in the international law project are not marginal or exceptional, but are endemic, consistent and structural.6 As a result, this school of thought uses a broad array of techniques to address separate but interrelated failings perceived in the international legal project to show the cruelty of the current systems of law.7 Though CLT constitutes various strands, its unifying stance is the need to rethink the foundations of international law and create space for an emancipatory and inclusive international legal project.8 It is this rationale and its philosophical assumptions that underlie this research project.
Within CLT, this book builds on critical Third World scholarship, specifically Third World Approaches to International Law (TWAIL). TWAIL is an intellectual movement devoted to providing an alternative narrative of international law that has developed to perpetuate the domination and subordination of the Third World. Within this oppositional space, TWAIL performs both deconstructive and reformative functions.9
As a deconstructive tool, TWAIL identifies, unpacks and challenges the history, oppressive structures and processes of international law.10 As a reformative tool, it reconstructs international law to be cognisant and responsive to the needs and aspirations of peoples of the Third World.11 It is this particular understanding of twailian theory ā the gradual unpacking, deconstruction and inclusion of legal projects operating at the margins of the mainstream discipline ā that underpins the critical engagement of this research with the pharmaceutical patent regime.12 By focusing on domestic jurisprudential experiences in detail, this research examines the ways international law āunfolds on the mundane and quotidian plane through sites and objects which appear unrelated to the internationalā.13 By focusing on domestic phenomenon that is not ostensibly international but in actuality is, the research expands twailian materiality by delving into āthe everyday life of international [IP] lawā14 through the examination of practices that occur, not only through typical international legal IP practices, but also through many other sites and objects in which international law operates today.
In order to explore this issue, I engaged in multi-sited ethnography from 2014 to 2015, conducting over 50 interviews with actors in access to medicines and patent discourses in Brazil, India and Nigeria, and again in July 2016 to interview pharmaceutical companies in Nigeria. These actors include government officials, pharmaceutical manufacturing companies or their representatives, civil society groups, legal scholars, lawyers and judges. The reason for multi-sited ethnography is that it allows for the objective study of social phenomena that cannot be accounted for by focusing on a single site. This is important as this method aims to give voice to marginalised groups, in the sense of following people, connections, associations and relationships across space. While seeking to be inclusive as much as possible by presenting varying perspectives, I am also mindful that some of the views may make some of the interviewees susceptible to attack, retaliation, or possibly government sanctions. Therefore, in cases in which the opinions expressed by respondents have the potential to draw such attacks or inflame existing tensions among different groups with an interest in patent law, I do not reveal the speakersā identities unless the views concerned are already a matter of public record. In 2014, I accessed the archives of the Working Group of Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/REBRIP) in Brazil for historical records while in 2015, I observed meetings on trade policy organised by the WTO Desk at the Ministry of Trade and Investment to gauge the views on and awareness of patents as a development policy tool among government officials. Finally, I drew on secondary data, including legislation and policy documents, for theoretical and contextual analysis.
In excavating patent law-making and governance within the countries under focus in this book, the following key points are underscored. First, the innovative interpretation of global patent rules in the local forums of the countries under study was inspired by and made po...