Trade-Related Intellectual Property Rights Agreement Research Articles

Holding Up a Mirror to the World Trade Organization: Lessons from the COVID-19 Pandemic

Holding Up a Mirror to the World Trade Organization: Lessons from the COVID-19 Pandemic

US–China Trade War An Impetus for New Norms on Technology Transfer

This article argues that the trade dispute between United States (US) and China should be an impetus for new rules and norms regarding technology transfer at the World Trade Organization (WTO). Technology transfer is a desirable outcome under WTO rules, including the Trade-Related Intellectual property Rights Agreement. However, Trade-Related Aspects of Intellectual Property Rights (TRIPs) have failed to effectively promote and facilitate technology transfer. The problem lies in the nature of the intellectual property rights that TRIPs are intended to protect and enforce. Though necessary, by conferring exclusive rights to its holder, intellectual property rights have the unintended consequences of inhibiting competition and technology transfer. Furthermore, it may impede the transfer of technology from developed countries to developing countries where firms often lack the capacity to further innovate the technology it has acquired. This article proposes new norms at the WTO, in particular the TRIPs and SCM Agreement, to improve its efficacy in promoting and facilitating technology transfer.

Parallel Trade of Patented Pharmaceuticals: A Discussion from Developing Country Perspective

Although the legitimacy of parallel trade was established in the Trade-Related Intellectual Property Rights Agreement 1994 (TRIPS Agreement) and re-affirmed in the Doha Declaration on TRIPS Agreement and Public Health 2001 (Doha Declaration) , parallel trade in patented pharmaceuticals has so far been one of the most heatedly debated topics. Multi-national pharmaceutical companies complain that parallel trade of patented pharmaceuticals denies them adequate protection of their patent rights and prevents them from recouping the costs of pharmaceutical development including research and development (R&D), regulatory approval and amortization of the cost of unsuccessful drug development. In contrast, the developing (and least developed) countries, suffering from the burdens of high disease levels and lack of resources to pay for high priced medicines, support liberalization of the parallel trade in patented pharmaceuticals to fulfil basic human needs. In addition, developing countries have a greater focus on consumer interests, social welfare and health care policy concerns. The puzzle, therefore, is how to fully understand the differences and how to harmonize the interests of the multi-national pharmaceutical companies with those of developing countries. This article, discusses the rationale of developing countries’ arguments in favour of parallel trade in pharmaceuticals in conjunction with an analysis of international and national legal frameworks of parallel trade in pharmaceuticals and its two-sided effects of on developing countries. The article also compares the counter-arguments of multi-national pharmaceutical companies as well as the applicable legal treatment of parallel trade in developed countries, particularly the United States (US) and the European Union (EU). The article ends with proposals for developing countries to utilize the parallel trade of pharmaceuticals as a useful tool for access to essential medicines in order to combat the devastation resulting from epidemic diseases, and for building up national pharmaceutical industries. In particular, the questions of how to lessen any negative effects of parallel trade in pharmaceuticals and why it should be combined with the compulsory licensing of pharmaceutical-related patents as well as technology transfer in the field of pharmaceuticals are mentioned in the set of proposals.

The role of intellectual property rights in treatment access

The purpose of this study is to review relevant literature published from January 2011 to July 2012 that specifically addresses the impact of intellectual property protection on access to antiretroviral drugs. The articles reviewed discussed the relation of intellectual property protection and access to medicines. For most authors, the World Trade Organization (WTO) Trade-Related Intellectual Property Rights Agreement (TRIPS) and the 10-year anniversary of the 2001 WTO Doha Declaration on TRIPS and Public Health formed an important background for the review of the current state of play. Intellectual property plays an important role in implementing policies to ensure HIV treatment and care programmes. From the review, three main themes emerged: the implementation of the Doha Declaration, the role of generic competition in antiretroviral treatment scale-up and innovative licensing mechanisms. The attention for the effects of intellectual property on access to HIV medicines opened the path for new initiatives for the management of patents using public health objectives as the key driver such as the UNITAID-backed Medicines Patent Pool. Some of the literature addressed the question whether more fundamental changes in the intellectual property architecture were necessary.

A Firm-level Analysis of the Vulnerability of the Bangladeshi Pharmaceutical Industry to the TRIPS Agreement: Implications for R&D Capability and Technology Transfer

This study measures the different types of vulnerability experienced by Bangladeshi pharmaceutical firms since 2005, consequent upon the Agreement on Trade Related Intellectual Property Rights (TRIPS) of the World Trade Organisation (WTO). We find that that R&D-related vulnerability was the highest in the pharmaceutical sector in Bangladesh. Cluster analysis supports this proposition as 79.8% of the sampled firms had below average levels of innovativeness. We argue that the TRIPS transition period (which began in 2005 and is to end in 2015) has not been used effectively used by Bang- ladesh, the most technologically advanced LDC to create a strong technological platform for the pharmaceutical industry. Also, the expected process of transfer of technology has not taken place. We recommend that the post-TRIPS industrial policy for the pharmaceutical industry in Bangladesh should be designed and delivered with a key focus to improve the R&D and innovation capabilities of the domestic firms. Moreover, the WTO must evaluate the current mechanisms un- derpinning developed countries-LDCs technology transfer.

Parallel imports and unparallel laws: an examination of the exhaustion doctrine through the lens of pharmaceutical products

Parallel imports, the natural consequence of exhaustion doctrine, represent a complex interaction between the issue of free flow of international trade and the protection of intellectual property rights. There is considerable divergence among scholars, both economic and legal, about the need for harmonisation of principles of exhaustion, and consequently parallel import laws. In this article, we examine the need for harmonisation of parallel import laws through the lens of pharmaceutical products. We highlight the necessity for the affirmative norm of exhaustion doctrine in the Trade Related Intellectual Property Rights (TRIPS) Agreement and suggest amendment to TRIPS Agreement Article 6 mandating international exhaustion doctrine as international legal standard with limited exceptions as an intermediate approach to strike a balance between the interests of the IP owners and consumers, and concurrently addressing the concerns of developed and developing countries.

Patenting of microorganisms: Systems and concerns

The Government of India permitted patenting of microorganisms in India under the Patents (Second Amendment) Bill, 2002, which was passed by the Parliament on 14 May 2002. The Government has so far granted very few patents for microorganisms, mainly on directives from courts. With the law permitting patenting of microorganisms, several private sector pharmaceutical companies and research institutions have filed applications for patenting microorganisms including fungi, bacteria and viruses. But there is still much debate on the advisability of allowing patenting of microorganisms in India. While the existing provisions in the patents bill permit patenting of certain life forms in line with the Trade-related Intellectual Property Rights Agreement, there is still sufficient controversy regarding the term ‘microorganism’, which has not been clearly defined. This article discusses the evolution of the patenting systems in relation to microorganisms. The article also explores the feasibility of offering statutory protection to microorganisms that are genetically altered with significant human intervention on harmonized global patent systems and also elaborating on the need for a well-accepted definition of the term ‘microorganism’.

Exploitative and Explorative Learning as a Response to the TRIPS Agreement in Indian Pharmaceutical Firms

The intellectual property regime forms an important part of any government's economic and industrial policies. It is an important regulatory instrument not only affecting industry and market structure but also influencing firm‐level learning strategies, especially in knowledge‐based industries like pharmaceuticals. Given its crucial role, the strengthening of patent laws as a result of the Trade Related Intellectual Property Rights (TRIPS) agreement presents a significant institutional change for developing country industry. This paper analyses Indian pharmaceutical firms' strategic response to the strengthening of patent law. The research in this paper shows that Indian pharmaceutical firms responded to anticipated disruptive regulatory change by developing competencies incrementally as well as radically. Ambidextrous capability development involved explorative investment in R&D to develop innovative product R&D competencies and in parallel also involved exploitative use of existing process R&D capabilities. This ambidextrous capability development has enabled Indian pharmaceutical firms to survive and compete with multinational corporation (MNC) pharmaceutical firms, showing other catch‐up firms a different path of capability development.

Strategic Value-Chain Analysis of Indian Pharmaceutical Alliances

A number of firms around the world have been using strategic alliances to become more competitive globally. The reasons attributed to such alliances vary from economies of scale, increased revenue, cross selling, synergy, tax write-offs, diversification and resource transfers among others. After the liberalization of Indian economy in 1991, Indian companies have used these strategic alliances to expand into other markets and prepare for increased competition at home. But after joining the World Trade Organization in 1995, India had to change its patent laws by 1 January 2005 to meet its commitments under the WTO's agreement on Trade Related Intellectual Property Rights (TRIPS). In the post-2005 scenario, the pharmaceutical industry has undergone a significant change due to the TRIPS agreement. Though a number of reasons are attributed to these strategic alliances in literature, there is no particular pattern that can be observed in these alliances. This study aims at analyzing the Indian Pharmaceutical Industry and the strategic alliances in the recent past and what drives these alliances. A value chain framework has been proposed that analyses the critical capabilities needed along the value chain in the Pharmaceutical Industry, the existing capabilities of the firms and how these alliances are supposed to bridge the capability gap.

Patently obvious: Intellectual property rights and nanotechnology

Rapid technological advances and commercialisation of the emerging field of nanotechnology will challenge traditional international and domestic regulatory regimes, including intellectual property rights. This article examines the role of the World Trade Organisation's Trade-Related Intellectual Property Rights Agreement as a global regulatory device for nanotechnology, and questions the applicability of the Agreement with respect to current and future nanotechnology applications. With the commercialisation of nanotechnology already occurring, exploration of the international intellectual property and nanotechnology interface is timely. Early recognition of uncertainties will enable policy makers the ability to balance the needs of commercial investors and innovation against the broader objectives and ideals promised by nanotechnology.

Foreign patent rights and high-tech exports: evidence from Taiwan

This paper conducts a consecutive pooled data analysis from 1989 to 2000 to investigate the relationship between foreign patent rights (FPRs) and the exports of three high-tech industries in Taiwan: the semiconductor, the information and the communication equipment industries. Following Smith's model setup, empirical results indicate that both market expansion and market power effects do exist in Taiwan's case. In addition, this paper proposes a new hypothesis in which the importing country may exhibit a stronger R&D ability than the exporting country, a case that has not been considered in earlier empirical work. Finally, a test is made to determine if a TRIPS (Trade-related Intellectual Property Rights) agreement has any impact on the FPRs–exports relationship, and no evidence is found of a structural change after the implementation of TRIPS.

Intellectual property rights and global capitalism: the political economy of the TRIPS Agreement

This is an examination of the origins and impact of the agreement on Trade-Related Intellectual Property Rights (TRIPS) negotiated during the Uruguay Round of GATT talks. The principal theme is that the TRIPS agreement is not in the best interests of the poorer countries, and that its imposition on them by the richer countries has more to do with the exercise of political and economic power than with the positive economic benefits the agreement's supporters claim it can deliver. To support this assertion the book critically examines the economic evidence regarding the impact of intellectual property rights on such important variables as export performance, foreign investment, and economic growth. The author provides a political economic analysis of why the poorer countries acceded to the TRIPS agreement, illustrated with case studies of two important industries where the struggle over intellectual property is especially strong: pharmaceutical and agricultural biotechnology sectors. Designed for use in advanced undergraduate and graduate courses in international political economy and international relations theory, the book offer a radical view of the process of globalization.

INFORMATIONAL CAPITALISM AND U.S. ECONOMIC HEGEMONY: Resistance and Adaptations in East Asia

This article promotes a “cultural international political economy” approach to globalization in East Asia in the so-called information age. It emphasizes the inherently discursive as well as material character of economic relations and their embedding in a complex web of different scales of action from local to global. Thus it introduces the policy discourses related to two major components in recent efforts to renew U.S. hegemony: promotion of the Global Information Infrastructure and the global expansion of intellectual property rights through the Trade-Related Intellectual Property Rights agreement. This initiative has enabled the emergence of a hegemonic GII-IPR-TRIPs complex supported by transnational informational capital, trade-related committees, and state agencies. This complex has triggered several forms of resistance and adaptation in East Asia. Targets of this resistance have been the Internet Corporation for Assigned Names and Numbers and the GII-IPR-TRIPs complex itself. Modes of counterhegemonic resistance have included state strategic support for the Linux movement as well as everyday tactics of software piracy. In addition, subhegemonic forces (e.g., APEC and national governments) have been acting as translating centers that help shape responses to efforts to consolidate the hegemony of the GII-IPR-TRIPs complex at regional levels.

The right to a living in the international economy

Since the arrival of the World Trade Organization (WTO) in 1995 a number of side agreements have also been negotiated that seek further rationalization of the emerging global economy. Prominent among these is the agreement on trade‐related intellectual property rights (TRIPS). Enforcement of the TRIPS agreement would involve the multilateral trade sanctions mechanism of the WTO. By contrast, proponents advocating a parallel international agreement guaranteeing adequate protections for workers – trade‐related international labor standards (TRILS) – have not met with success. This paper examines how traditional justificatory arguments for the property rights might apply to the question of workers’ rights in the international economy. It is found that such arguments apply quite well to the right of access to a “decent living”. It is then investigated how a TRILS agreement administered and enforced by the WTO's disputes settlements mechanism might advance these rights.

The TRIPS Agreement: Implications for Access to Drugs in Developing Countries

Globalisation will have an adverse effect on access to drugs as far as developing countries are concerned because when the Trade Related Intellectual Property Rights (TRIPS) Agreement comes into operation in 2005 the prices of drugs for which patents are in place will increase. However, this effect can be reduced if timely steps are taken to aggressively introduce programmes of rational use of drugs and the country enacts legislation to take advantage of the possible safe guards that have been incorporated into the TRIPS Agreement.

Patenting of microorganisms: Systems and concerns

The Government of India permitted patenting of microorganisms in India under the Patents (Second Amendment) Bill, 2002, which was passed by the Parliament on 14 May 2002. The Government has so far granted very few patents for microorganisms, mainly on directives from courts. With the law permitting patenting of microorganisms, several private sector pharmaceutical companies and research institutions have filed applications for patenting microorganisms including fungi, bacteria and viruses. But there is still much debate on the advisability of allowing patenting of microorganisms in India. While the existing provisions in the patents bill permit patenting of certain life forms in line with the Trade-related Intellectual Property Rights Agreement, there is still sufficient controversy regarding the term ‘microorganism’, which has not been clearly defined. This article discusses the evolution of the patenting systems in relation to microorganisms. The article also explores the feasibility of offering statutory protection to microorganisms that are genetically altered with significant human intervention on harmonized global patent systems and also elaborating on the need for a well-accepted definition of the term ‘microorganism’.