International Intellectual Property Regime Research Articles

From defending the “opposite of property” to the fundamental right to property, the case for the application of human rights law and philosophy to the international intellectual property regime.

International intellectual property law has extended so far in scope, both substantially and geographically, that it plays a role in aggravating poverty, creating crises in access to medicine and in the exploitation of indigenous peoples’ resources, to cite a few of its impacts. This expansion of intellectual property law has been extensively criticised, most famously by “cultural environmentalists”, who compare the public domain to a natural resource which is being depleted by intellectual property rights. While this criticism aptly brings into question the international intellectual property regime, the binary it relies on, between the public domain and intellectual property, does little to address the nefarious human impacts of the regime. Instead, bringing intellectual property law within the ambit of international human rights law allows for a more comprehensive evaluation of ethical concerns and human consequences, bringing nuance that the cultural environmentalists’ public domain rhetoric lacks.

(Il)legitimacy of international intellectual property regime?

AbstractThe recent Covid-19 global health crisis not only brings into sharp relief the current problems afflicting the international intellectual property regime (IIPR) but also calls into question its legitimacy as an international authority. Against this backdrop, the article aims to launch an investigation into the legitimacy of the IIPR, as an international co-ordinative authority, designed to protect IP rights without prejudice to international trade norms. Drawing on Raz’s service conception of authority, it explores whether the IIPR lives up to its promises by enabling co-ordination between states over IP rights without undermining the initial balance on which it is founded, struck between developing and developed countries, as well as between international protection of IP- cum-trade rights and domestic regulatory autonomy. It does so by classifying the historical evolution of the IIPR under three different phases: (i) its foundation, (ii) before, and (iii) after the TRIPS-plus. Upon showing the legitimacy challenges inherent in its undemocratic foundation, the article points to the success of the regime in finding a balance between conflicting interests before the TRIPS-plus era. Later, it underlines the many challenges that come with linking the IIPR to the investment regime and argues that the FTAs and frequent regime-shifting activities put further pressure on the authority and legitimacy of the regime. Stressing the importance of democratic participation for the legitimacy of any co-ordinative authority, the article casts doubt on the IIPR’s legitimacy and concludes by raising some points to overcome the ongoing legitimacy challenges.

The Jurisprudence of Patentable and Non-patentable Inventions: Nigerian in Perspective

Patent is an industrial property right granted by the government of a state to a patentee. It is an intangible, incorporeal and exclusive right granted under the Law to an invention. While an invention is something that has never been made or existed before. Patents are granted to inventions, but not every invention qualify for grant of patent, hence there are patentable and non-patentable inventions. An invention is patentable if it is new, results from an inventive activity and is capable of industrial application (s.1(1) of the Patent and Designs Act 2004). Several textbooks, case laws, statutes(local and International), internet sources reveal that Nigerian legislation inadequately granted patent to inventions, wherein it did not grant patent to some inventions which International intellectual property regime stated patent should be granted. The Laws of developed countries like USA have wider protection of inventions than Laws of developing countries like Nigeria. Hence the Nigerian Law is narrow in the inventions that should be patentable as against the International Intellectual Property Regime.

Intellectual Property's Territorial Framework and the Macro-Level Contradiction with Tax Policy

Many large intellectual property owning firms have not paid "fair taxes" in the territories where they achieve sales and licences of their products. Rather, they tend to utilise regimes where they pay as little tax as possible. The international taxation system has allowed this to happen extensively. This is currently under challenge from some governments and the OECD. In this tribute to renowned tax scholar, John Prebble, the territorial nature of intellectual property is explained. Territoriality is a key organising principle of the existence of intellectual property rights, their exploitation and enforcement. At a high-level the territorial nature of intellectual property is not consistent with what happens to the profits of its exploitation, rather at a macro-level the frameworks of the international intellectual property regime and the international tax regimes are in contradiction.

The protection of cultural heritage: common heritage of humankind, national cultural ‘patrimony’ or private property?

Starting from an argument about the relationship between cultural heritage and national and/or community identity, this article considers the different ways in which both the international law regime for the protection of cultural heritage and the international intellectual property regime tend to appropriate cultural heritage. The article argues that, in the postcolonial context, both these forms of appropriation continue to interfere with the demands for justice and for the recognition of historical wrongs made both by indigenous peoples and by many developing countries. At the same time, the article suggests that these claims are undermined by the misappropriation of the postcolonial discourse with respect to restitution of cultural heritage, particularly in the intra-European context. The article advocates the need for a regime for the protection of cultural heritage that is strong enough to resist its private appropriation through the use of intellectual property rights and nuanced enough to recognise significant differences in the political context of local and national claims to cultural heritage.

Remarks by Ana Santos Rutschman

Good afternoon—and in some cases, good evening. I am very grateful to the American Society of International Law, the Vagts family, our convener, Professor Rochelle Dreyfuss, and the panelists on this roundtable for the opportunity to reflect on the interplay between our international and global intellectual property (IP) regime and the determinants of health, which I discuss in a piece scheduled to be published by the Vanderbilt Journal of Transnational Law in early 2021.

Sweetening a Bitter Pill: Of Drug Prices, Drug Delays and Data Exclusivity

Commentators and social activists vehemently demonize data exclusivity for increasing the price of essential pharmaceuticals beyond the purchasing power of developing countries’ citizens, whereas R&D industries defend it as a necessary instrument for bringing new medicines into the market. The present work adds to the ongoing debate by addressing the topic under the light of the empirical evidence suggesting that low-income countries significantly lag behind Western economies in the introduction of new drugs. Under a policy perspective, the paper reviews in a unitary and comprehensive framework the stance that data exclusivity has a role to play in reducing the international drug lag in developing countries. This paper concludes that empirical evidence does not offer compelling arguments to either uphold or discard drug lag driven data exclusivity claims and there is no room to advocate for data exclusivity as a generalized solution to the international drug lag. In spite of this, developing countries tend to give in to the pressures of their western counterparts and have already accepted data exclusivity in more than 30 bilateral and multilateral free trade agreements. As such, anytime data exclusivity is accepted as a bargaining chip to strike a more favourable trade deal, a health-oriented precautionary approach demands to safeguard those flexibilities that are best fit to strike a balance between intellectual property, affordable medicines and prompt drug introductions. The paper will, therefore, analyse and defend the consistency of six data exclusivity flexibilities with the international intellectual property regime and in particular with the TRIPS Agreement. In doing so, the paper provides developing countries’ governments with some legal and policy arguments in support of data exclusivity flexibilities, with the goal of best protecting the health interests of their populations in the process of implementation and/or negotiation of international data exclusivity provisions.

The role of national intellectual property laws in promoting innovation, scientific and technological development

This paper examines the role which intellectual property rights can play in stimulating innovation for sustainable development. It provides an overview of the international intellectual property regime and its relevance to innovation, technological and scientific development. It considers the role of national intellectual property laws in the context of innovation by focusing on a number of key areas, including the protection of traditional knowledge and genetic resources, and the diffusion of environmentally sound technologies. The paper highlights areas of intellectual property law and system reform and strengthening that may be a focus for Commonwealth member countries.

Intellectual Property: How Much Room is Left for Industrial Policy?

The early industrialization process in developed countries took place under flexible frameworks of intellectual property (IP) protection. Those countries, however, proposed and obtained in trade negotiations the adoption of an international IP regime that expanded and strengthened such protection. While the role of this regime, especially patents, in promoting innovation is controversial, it may effectively limit the ability of developing countries to implement industrial policies. These countries can preserve some room to implement such policies by using certain flexibilities, such as applying rigorous standards of patentability and granting compulsory licenses to broaden the space for local production.

Challenging Compliance with International Intellectual Property Norms in Investor–state Dispute Settlement

Enforcing intellectual property (IP) rights abroad is not easy—not least because international IP treaties do not create global rights that can be invoked in national courts. International investment law offers potential routes for overcoming these hurdles. Whenever investment treaties include IP rights as an investment and allow for investor–state dispute settlement (ISDS), investors can challenge host state measures affecting their IP rights in ISDS proceedings. As this article will show, this in turn offers a unique opportunity for invoking the standards of protection under international investment agreements (IIAs) to challenge host state compliance with international IP treaties. While challenging national IP regimes is an attractive option for right holders, these challenges potentially amount to a sea change for the international IP regime and cause serious concern for host states. I, however, argue that most of the routes pursued by right holders under IIAs are unlikely to be successful. Investment protection standards such as fair and equitable treatment, umbrella clauses, and most-favoured nation treatment should not be construed to allow invoking alleged breaches of international IP norms in ISDS. Some IIAs, however, contain clauses that subject expropriation claims against compulsory licenses and other IP limitations to a test of consistency with the international IP rules governing these limitations. As they offer the only feasible route for investors to challenge host state compliance with international IP treaties, I review the implications of these clauses, recent reform proposals, and suggest alternative mechanisms for aligning international IP and investment protection based on general international law.

Twenty years of TRIPS agreement and access to medicine: a development perspective

The Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS) changed the landscape of international Intellectual Property (IP) regime by setting a common minimum standard for the protection and enforcement of IP. In the context of 20 years of the entry into force of the TRIPS Agreement and completion of 11 years of implementation of product patent protection in many developing countries, this paper examines the challenges faced by developing countries with regard to patent and access to medicines. The paper argues that the Agreement is a classic case of corporate capture of international law making and it spearheaded a new chapter of struggle for access to medicines. It provides a brief survey of experiences of developing countries with regard to access to patented medicines as well as research and development (R&D), foreign direct investment (FDI) and technology transfer in the pharmaceutical sector during the post TRIPS period. It analyses major challenges faced by developing countries in the actual use of TRIPS flexibilities to address access to medicines and thereby meeting the developmental and public health needs. The paper focuses on the need to restructure the TRIPS and TRIPS plus IP regime, which not only prevent access to affordable medicine, but also failed to deliver access to R&D needs of developing countries. It emphasises providing enough policy space for countries to design their patent laws, especially to address product access to medicine, and scrapping of the compulsory product patent protection under the TRIPS Agreement as critical to serve this purpose.

Discursive Intervention in International Intellectual Property Policymaking: How Developing Countries and Civil Society Employ Text to Challenge and Change the Status Quo

This study looks at discursive instabilities or tensions in intellectual property (IP) policymaking and their role in efforts by developing country representatives and civil society actors struggling to mobilize alternative agendas. I address 2 research questions: (1) How are discursive strategies of policy framing employed to challenge the international IP regime status quo and its underlying rationale? and (2) How does a discursive approach to policy analysis expand our understanding of how ideas about IP governance evolve, and what are the implications of this understanding for actors seeking to intervene in the debate? This study finds the production and distribution of texts to be a central site of ongoing contestation against normative conventions and narratives that reproduce the hegemonic order.

Origins and Limitations of State-based Advocacy

Brazil has occupied a central role in the access to medicines movement, especially with respect to drugs used to treat those with the human immunodeficiency virus (HIV) that causes the acquired immune deficiency syndrome (AIDS). Contrary to previous literature centered on the role of the domestic pharmaceutical industry, politicians seeking electoral gains, and civil society activists, I argue that the state, especially the National AIDS Program, led the struggle in contesting a corporate-driven international intellectual property regime. After reviewing the origins of Brazil’s treatment policies and patent reforms, I trace the actions and relationships between the state, civil society, transnational corporations (TNCs), and local industry in three instances when Brazilian officials used compulsory licenses to reduce the price of medicines. Coalition-building and “naming and shaming” tactics contributed to Brazil’s success, while changing pharmaceutical capabilities limited more aggressive actions.

The Human Rights Paradox: Intellectual Property Rights and Rights of Access to Science

The right of everyone to share in the benefits of science has been enshrined in human rights instruments since the last century, originally in Article 27 of the Universal Declaration of Human Rights (UDHR) and subsequently in Article 15 of the International Covenant on Economic, Social and Cultural Rights (ICESCR). The right was generally perceived as "obscure" and its interpretation widely neglected until the expansion of the international intellectual property (IP) regime under the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS) prompted an upsurge of legal scholarship and reports from international organizations seeking to address the "human rights paradox." The paradox is claimed to arise from the juxtaposition in human rights instruments of individual rights over intellectual creations against the rights of everyone to "share in scientific advancement and its benefits." This article draws on archived documentation to show that the paradox rests on a conceptual obfuscation of human rights and IP rights and is at odds both with the historical record on the aims of the drafters of the UDHR and the philosophical and legal foundations of human rights and IP rights. The drafting history of Article 27 shows that delegations from South American socialist countries backed the French initiative to include rights of authors and inventors to the protection of their intellectual creations, while the US, UK, and former Anglo-Saxon colonies opposed the proposal to the very end. Yet, behind the paradoxical political alignments there are important areas of convergence on the underlying philosophies and moral rationales which led to the adoption of Article 27 of the UDHR.

Raising the Right to Health Concerns within the Framework of International Intellectual Property Law

Balancing the trade-off between the pursuits for economic interests (from the protection of the intellectual property rights) and public health (from promotion of human rights to health) is always a complicated issue and sometimes a tragic choice. Even though international trade laws afford member countries the flexibility to impose restrictions on intellectual property rights to protect public health, individuals’ rights to health (especially the right to access affordable medicines) are still frequently sacrificed. This article proposes that applying the human rights approach to the international intellectual property regime would provide the state an objective and monitorable standard to balance the conflicts between the intellectual property right and the right to health. Furthermore, by defining the scope of the right to health protection, this article develops an independent assessment mechanism (the right to health impact assessment for intellectual property policies) to provide both developing and developed countries legal grounds to refuse unjustified intellectual property protection (when fundamental rights to health are at stake) and to prevent the TRIPS-exemptions from being misused (when only some vague notion of public health is at stake).

International Trade, Public Health, and Intellectual Property Maximalism: The Case of European Border Enforcement and Trade in Generic Pharmaceuticals

Even as the world witnesses another pandemic, industrialized nations and their industries continue their efforts to ‘rachet-up’ levels of intellectual property (IP) protection. Such a maximalist agenda drives another paradigm shift in the international IP regime today. While maximalists employ several methods to promote their agenda, this work seeks to study the case of European border enforcement law (Council Regulation (EC) No. 1383/2003 of 22 Jul. 2003, Concerning Customs Action Against Goods Suspected of Infringing Certain Intellectual Property Rights and the Measures to be Taken Against Goods Found to Have Infringed Such Rights [hereinafter ‘EC Regulation 1383’]) and its effects on international trade in generic drugs. Triggered by several incidents involving ‘seizure’ of in transit generic drugs by European customs, the issue continues to be ‘hotly debated’ on at the international level and is of immense contemporary relevance to larger issue of global justice. After a discussion on the evolution of European border enforcement law and its interpretation by European courts to determine its scope, this work seeks to study the effect of EC Regulation 1383 on international trade in generic pharmaceuticals by studying several instances of ‘seizure’ of generic pharmaceuticals in transit between developing nations and the international debate it has generated at the World Trade Organization (WTO). The discussion highlights the maximalist (and ‘TRIPS-Plus- Plus’) nature of the European law and raises important issues concerning the interpretation of Agreement on Trade-Related Aspect of IP Rights (TRIPS), public health, World Trade Organization, Ministerial Declaration of 14 Nov. 2001 (hereinafter ‘Doha Declaration’), and the possibility of a future WTO dispute. The discussion concludes with some comments on broader issues of global justice and the WTO that are raised by the European law and its enforcement affecting access to medicines in developing countries.

The symbiotic relationship between global contracts and the international IP regime

This article examines the increasing use of contracts and licensing agreements in relation to intellectual property (IP) and information on a global level and whether contract law will spell the ultimate demise of the international IP regime.

A 'Calibrated Approach': Pharmaceutical FDI and Evolution of the Patent Law in India

India has charted its own intellectual property (IP) path over the last 35 years, attempting to foster the growth of a domestic pharmaceutical industry and access to medicine while, more recently, also addressing the requirements of the international IP regime. Multinational companies (MNCs) have responded to India's movement towards compliance with WTO intellectual property agreement, TRIPS, by increasing the quantity and quality of foreign direct investment (FDI) in the areas of pharmaceutical research and development (R&D) and manufacturing. By contrast, MNCs have adopted a more cautious attitude toward the patenting and commercialization of new pharmaceutical products in India, waiting to see how Indian courts and patent offices interpret the new laws, and awaiting the enactment of long-debated data protection legislation. The ultimate success of India's calibrated approach to fostering the domestic industry and access to medicine while also addressing international IP requirements remains to be seen.

From information to property and back again

The paper traces the ascendance of intellectual property law to the summit of economic life in all countries from the 1960s onwards before a backlash started to emerge in recent years in courtrooms, parliaments and public forums particularly in the US and Europe, among NGOs, public interest groups and international organizations. It argues that the widespread feeling that the international intellectual property regime has only benefited the multinational corporations and not the broader public in the developing and developed countries may generate problems which no amount of military power will be able to mitigate. The paper therefore calls for global justice and a return to the balance between encouraging innovation and fostering public benefit in intellectual property law.

A dilemma for developing countries in intellectual property strategy? Lessons from a case study of software piracy and Microsoft in China

This paper examines the dilemmas faced by developing countries (DCs) in determining their response to the global harmonisation of intellectual property (IP) protection. It focuses on two key questions: will a weak IP regime in DCs deter inward investment/technology transfer and hamper technology development?; and can DCs build up their technology capabilities and thereby overcome the projected negative impacts of global IP harmonisation by a strategy of delaying compliance with the international IP regime? This paper reviews these debates and dilemmas, applying an analytical framework based on technology studies. It uses a case study of the software industry in China to advance the argument that the effects of an IP regime are extremely complex, depending on particular industrial, technological and social factors. The key question is not whether to enforce the global IP regime; rather, policymaking needs to be informed by a more detailed approach. Imposition of the global IP regime may not be effective and may not per se promote innovation. Copyright , Beech Tree Publishing.