Intellectual Property Provisions Research Articles

Intellectual Property and the Politics of Public Good during COVID-19: Framing Law, Institutions, and Ideas during TRIPS Waiver Negotiations at the WTO.

To facilitate the manufacturing of COVID-19 medical products, in October 2020 India and South Africa proposed a waiver of certain intellectual property (IP) provisions of a World Trade Organization (WTO) agreement. After nearly two years, a narrow waiver agreement that did little for vaccine access passed the ministerial despite the pandemic's impact on global trade, which the WTO is mandated to safeguard. The authors conducted a content analysis of WTO legal texts, key-actor statements, media reporting, and the WTO's procedural framework to explore legal, institutional, and ideational explanations for the delay. IP waivers are neither legally complex nor unprecedented within WTO law, yet these waiver negotiations exceeded their mandated 90-day negotiation period by approximately 18 months. Waiver opponents and supporters engaged in escalating strategic framing that justified and eventually secured political attention at head-of-state level, sidelining other pandemic solutions. The frames deployed discouraged consensus on a meaningful waiver, which ultimately favored the status quo that opponents preferred. WTO institutional design encouraged drawn-out negotiation while limiting legitimate players in the debate to trade ministers, empowering narrow interest group politics. Despite global political attention, the WTO process contributed little to emergency vaccine production, suggesting a pressing need for reforms aimed at more efficient and equitable multilateral processes.

Implementing Intellectual Property Provisions in New-Generation Free Trade Agreements in the EU

The inclusion of chapters that introduce a high standard of intellectual property protection in free trade agreements has become an essential feature of the international commercial policy of developed countries. Based on the analysis of the legal policies and practices of entering into and implementing commitments on intellectual property in the new generation of free trade agreements of the European Union (EU), this article points out that there are two prominent legal aspects of implementing intellectual property provisions in the new generation of free trade agreements. On the one hand, in comparison to partners being developing countries, the EU has always been in the position of a negotiating party with a superior intellectual property protection system; therefore, the goal of these agreements is to provide “sticks and carrots” to push the developing countries to change their laws, policies, and standards. From the perspective of comparative law theory, the implementation of agreements will lead to the “transplantation and transformation” of intellectual property legislations from the EU to partner countries. On the other hand, in some typical cases related to i) the protection of genetic resources, traditional knowledge, and ii) technology transfer, the developing countries have also gained certain achievements in including the above issues in the agreements; and thereby imposing obligations on the EU to implement these commitments.

The Social Costs of Success: The Impact of World Trade Organization Rules on Insulin Prices in Bangladesh upon Graduation from Least Developed Country Status

In 2021, the United Nations Committee on Development Policy adopted a resolution that Bangladesh would graduate from least developed country (LDC) status after a period of 5 years. This means that in 2026 Bangladesh would have to forego its exemption to intellectual property (IP) provisions of the World Trade Organization (WTO). Bangladesh has taken advantage of the policy space it was granted under the LDC exemption to build a generic medicines industry that not only serves Bangladesh but also other LDCs. We examine how IP provisions in the WTO will impact the price of insulin in Bangladesh and the subsequent impacts on welfare and poverty. We find that LDC graduation will trigger a significant jump in insulin prices that could cause about a 15% decline in the welfare of households in Bangladesh with one or more members living with diabetes, increasing the poverty rate of such households unless policy adjustments are carried out.

Critical Examination of the Intellectual Property Regimes in the Gulf-Co-operation Council (GCC) States

The research focuses on the intellectual property developments made by the member states of the GCC and how intellectual property development and subsequent deployment, can act as a catalyst for financial prosperity. The main purpose of the research is to analyse and examine the intellectual property provisions currently in existence within the states of the GCC. The aim is to provide recommendations to improve the current level of intellectual property protection at both a national level and at a state level in the GCC through an integrated intellectual property protection model. There have been three main stages in the development of intellectual property in the Gulf states; a pre Trade Related Aspects of Intellectual Property Rights (TRIPS) stage, the current level of TRIPS compliance and a push towards TRIPS Plus. To date, each individual Gulf state has developed its intellectual property laws at varying rates. Post 2000, the Gulf states all display a set of intellectual property laws that are largely compliant with TRIPS. Therefore a question arises as to how much scope there is in the current laws to accede to more stringent intellectual property provisions. The research will show this is a key question for the GCC, its international partners and the wider trading communities of the WTO. The findings of the research are that the GCC does not have the capacity to take on TRIPS Plus provisions without compromising its sharia laws and value and that instead an integrated intellectual property protection model is needed.

Intellectual Property Rights, Technology Transfer and International Trade

I study the short- and long-term effects of regional trade agreements (RTA) with strict intellectual property (IP) provisions. An empirical analysis using gravity methods suggests that regions signing these agreements share more technology in the form of technology licensing following the year of enforcement. I set up a multi-country model with endogenous productivity through innovation and adoption to quantify the effect of such agreements on innovation, growth and welfare. Adopters pay royalties to innovators for the use of their technology; the model allows for various degrees of IP rights enforcement ranging from pure imitation to perfect enforcement of IP rights. An improvement of IP protection in exchange for market access increases welfare, growth and innovation in the world. Developed countries benefit from a higher return to innovation and a lower home trade share, accruing welfare gains both in the short and long term. Developing countries are impacted through three channels: (i) internal IP reforms increase the return to domestic innovators,(ii) lower trade costs increase profits from exports, and (ii) higher royalty payments reduce the return to adopters. A counterfactual exercise shows that while the first two forces dominate in the long run, there are short-term losses from a lower return to adoption.

Suatu Analisis Terhadap Perlindungan Hukum Indikasi Geografis Di Propinsi Riau

That actually Intellectual Property is a material right that has commercial value with great potential. Today’s global trade is dominated by various forms of products from the intellectual property of various countries. In principle, countries that have many of these products, and strong Intellectual Property provisions will dominate business competition. The study here intends to analyze policies and barriers to protection of Intellectual Property Rights (IPR) especially in the field of Geographical Indications in Riau Province. This paper is more dominant using the type of normative juridical research. To complete this paper, empirical research forms are also used, by gathering data from survey results in the field. Based on the research results, it is known that the Riau Provincial Government’s policy in providing legal protection against IG’s did not proceed as expected. Proven that there are no Regional Regulations in the Province or regencies and cities that regulate IG. The inhibiting factors in protecting IG’s in Riau Province are the absence of Regional Regulations governing IG’s, the low legal awareness of the people of Riau Province against IG’s, the absence of an entrepreneurial spirit among Riau Provincial Government officials, and insufficient expertise in controlling products Quality IG.

Biologics Under a New NAFTA

Scientific developments, such as biologics and personalized medicine, have created an entirely new category of pharmaceutical drugs that were not considered when the North American Free Trade Agreement (“NAFTA”) was adopted in 1994. However, the rise of biologics has increased demand for a reconfigured NAFTA, particularly with respect to Chapter 17, which outlines NAFTA’s robust intellectual property standards, as well as Chapter 11, which both lays out the framework for foreign investment under NAFTA and introduces a controversial mechanism referred to as the investor-state dispute settlement mechanism (“ISDS”). The intellectual property provisions of the original NAFTA should be revised to mirror the similar provisions of the Trans-Pacific Partnership (“TPP”) Agreement, which better accommodates new medical advances. However, despite criticism of their lack of transparency, the investment provisions of the original NAFTA are likely sufficient to grant medical patent-rights holders the investment protection that they seek because they strengthen transparency, which is ultimately good for business.

Mapping the New Frontier of International IP Law: Introducing a TRIPs-plus Dataset

AbstractThis article introduces a new dataset on the intellectual property (IP) provisions included in preferential trade agreements (PTAs) and makes it available for research and policy communities alike. Several PTAs include IP commitments that go well beyond the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). A sound knowledge of these TRIPs-plus commitments is essential in order to improve our understanding of what drives them and of their legal, social, and economic consequences. Yet, until now, these provisions have not been mapped in a comprehensive and systematic way. The T + PTA dataset fills this gap by documenting the existence of 90 types of IP provisions in 126 agreements signed between 1991 and 2016. We show that, even for like-minded countries, significant variations exist in their reliance on TRIPs-plus provisions, their degree of consistency across PTAs, and their preferences for some IP rights. We also find that strong TRIPs-Plus provisions are correlated with the depth of PTAs, the asymmetry between trade partners, and the strength of their domestic IP law. By making the T + PTA dataset available, we hope to create the opportunity for a new generation of research on TRIPs-plus agreements.

Using Intellectual Property Flexibilities to Accelerate Progress Against Micronutrient Deficiencies

Ever since the adoption of TRIPS, it has become increasingly clear that the intellectual property provisions of the WTO do not effectively support the needs of developing countries. Instead, they principally serve transnational corporate interests disproportionately. We discuss some pathologies of the system for public health, especially the challenge of effectively overcoming micronutrient deficiencies. We discuss the use of public health exceptions in WTO law and argue for greater use of tools such as compulsory licensing, especially with regard to affordably addressing malnutrition.

Intellectual property rights, trade agreements, and international trade

The global process of strengthening and harmonization of intellectual property rights (IPRs) systems has been intensified in the last twenty five years by the signing of trade agreements (TAs) that include chapters with intellectual property (IP) provisions and other trade-related issues. This paper provides a first exploration of whether and how the signing of TAs with IP chapters influences bilateral trade flows for a balanced panel of 110 countries and the period 1995–2013. We address methodological issues related to the assessment of the effect of TAs on bilateral trade. We use matching econometrics to evaluate the treatment of TAs with and without IP chapters. In addition, we estimate the effects of TAs on bilateral trade in a more dynamic fashion using a panel data approach based on the gravity model. Also, we perform our analysis for trade in low- and high-IP intensive products. We found that both types of TAs increase bilateral trade but TAs with no IPRs chapters have a stronger positive effect on trade. However, if we include lags to consider that TAs with IP chapters might need a longer implementation time, the net expected increase on trade is similar for both types of TAs. We also found that the effects depend on the development level of countries and on the IP intensity of products. We found a clear positive effect for developed countries, but we do not observe important gains for developing countries in all sectors and to all destinations derived from TAs with IP chapters. This raises the question of whether trade gains can compensate the effort related with IP reforms.

Ensuring Expeditious Entry: Korea and the U.S. Regulatory Pathway for Bringing Biosimilars to Market

Biosimilar products are expected to encounter substantial barriers in their efforts to compete with branded biologics. Current biosimilar regulatory regimes in both Korea and the U.S. raise questions about the viability of successfully bringing competition, innovation, and affordability into the biological products market as intended. Thus, bringing a biologic to market presents significant challenges that necessitate complex situations and subsequent legal regimes. This article will discuss the bilateral implications of each respective biosimilar regulatory pathway and the procedures each regime uses to resolve patent disputes. In particular, key amendments in pharmaceutical intellectual property provisions pursuant to the Korea-U.S. Free Trade Agreement suggest that select bilateral regulatory principles can enhance biosimilar market involvement. As a corollary, Korea's first invalidation action and several related cases in the U.S. in which courts interpreted some of the important provisions of the Korean Pharmaceutical Affairs Act and the Biologics Price Competition and Innovation Act of 2009 are analyzed using a comparative approach. Finally, future developments and exogenous factors that may impact the expeditious entry of the future first biosimilars into the two countries are applied to these legal regimes.

The Copyright Law Framework and Its Interaction with Open Access Repositories in Europe

The paper examines the European copyright framework and its interaction with open access repositories. Access to information resources has become a modern necessity that needs to be met to share equitably the wealth of the European society. The Directives with intellectual property provisions to enhance copyright law policy makers are the foundation of the European copyright regime. This statement helps me to clarify the design and assumptions underlying open access practice in Europe. The paper analyses strengths and short-comings of these Directives in relation to copyright protection and open access practice among European member states.

The Trans Pacific Partnership Agreement, intellectual property and medicines: Differential outcomes for developed and developing countries.

The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delaying the introduction of low-cost generics. While developing nations negotiated transition periods for implementing some obligations, all parties would have eventually been expected to meet the same standards had the TPP come into force. While the TPP has stalled following US withdrawal, there are moves by some of the remaining countries to reinvigorate the agreement without the United States. The proponents may seek to retain as much as possible of the original text in the hope that the United States will re-join the accord in future. This article presents a comparative analysis of the impact the final 2016 TPP intellectual property chapter could be expected to have (if implemented in its current form) on the intellectual property laws and regulatory regimes for medicines in the TPP countries. Drawing on the published literature, it traces the likely impact on access to medicines. It focuses particularly on the differential impact on regulatory frameworks for developed and developing nations (in terms of whether or not legislative action would have been required to implement the agreement). The article also explores the political and economic dynamics that contributed to these differential outcomes.

Do Developing Countries Have a Say? Bilateral and Regional Intellectual Property Negotiations with the EU

Bilateral and regional agreements concluded with the European Union (EU) and the United States are extensive and include high levels of IP protection and enforcement standards. Such protection is crucial to enhance their competitiveness, but it does not seem to be a priority for developing countries (DCs). This paper analyses how DCs should best address trade negotiations in which high standards of IP protection and enforcement are sought and few balancing (safeguard and flexibility) provisions, or such that can stimulate technology transfer, are on offer. The Max Planck Institute for Innovation and Competition’s “Principles for Intellectual Property Provisions in Bilateral and Regional Agreements” cover many issues that are worth discussing as to how these can be incorporated in the negotiating process. Data collected from the CARIFORUM region when negotiating the EU-CARIFORUM Economic Partnership Agreement reconfirm the Principles’ main recommendations; so do the experiences from India, Central American countries, Colombia and Peru in negotiations with the EU. The argument made here, however, is that a crucial factor in achieving more favourable outcomes for DCs is through an increase of their bargaining power. It will be examined what structural factors influence bargaining power and how this impacts the use of negotiating strategies.

Intellectual Property Rights, Trade Agreements, and International Trade

The global process of strengthening and harmonization of intellectual property rights (IPRs) systems has been intensified in the last twenty five years by the signing of trade agreements (TAs) that include chapters with intellectual property (IP) provisions and other non-trade-related issues. This paper provides a first exploration of whether and how the signing of TAs with IP chapters influences bilateral trade flows for a panel of 122 countries and the period 1995-2013. We address methodological issues related to the assessment of the effect of TAs on bilateral trade. We use matching econometrics to evaluate the treatment of TAs with and without IP chapters. In addition, we estimate the effects of TAs on bilateral trade in a more dynamic fashion using a panel data approach based on the gravity model. We perform our analysis for trade in low- and high-IP intensive products. We found that both types of TAs increase bilateral trade. However, TAs with no IPRs chapters have a stronger positive effect on trade, while TAs with IP chapters have a stronger effect if we include lags to consider that they might need a longer implementation time. We also found that the effects depend on the development level of countries and, to a lesser extent, on the IP intensity of products. We found a clear positive effect for developed countries, but we do not observe gains for developing countries in all sectors and to all destinations derived from TAs with IP chapters. This raises the question of whether trade gains can compensate the effort related with IP reforms.

Intellectual property provisions and support for US trade agreements

Intellectual property rights are a key piece of the expanded trade agenda, and the United States has pushed hard to strengthen protections beyond WTO standards in its trade agreements. While agreement provisions governing intellectual property are commonly thought to be an important driver of corporate preferences over US trade policy, systematic empirical evidence for this proposition, especially in comparison to other determinants of trade policy, is generally lacking. To fill this void, this paper examines variation in reliance on intellectual property across US industries to explain attitudes and lobbying on US trade agreements. The effects of IP provisions on support for US trade agreements are politically substantial, though trade remains the primary determinant of preferences over trade agreements.

Free Trade Agreements and Regulatory Change: Examples from the Generic and Biosimilar Sectors

Comprehensive free trade agreements (FTAs) have increasing importance and impact on domestic legislation and significantly affect regulated industries, such as pharmaceuticals. Recent FTAs include provisions on regulatory cooperation and convergence, as well as intellectual property provisions going well beyond the scope of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPs). These rules have particular importance for the generic and biosimilar medicines’ sectors and have important links to public health objectives. A growing number of sectors are covered by the substantive provisions of FTAs, often by means of dedicated and sector-specific rules and chapters catering to country- and/or industry-specific needs and interests. The article provides the relevant background in terms of trade law, trade negotiations and FTA trends, particularly as they relate to intellectual property rights and pharmaceuticals. The article places its core emphasis on the domestic impact of FTAs. Examples are drawn from the pharmaceutical sector of generic and biosimilar medicines. The potentially decisive impact of FTAs implies the necessity that all interested parties be more pro-actively involved in order to shape the future of the applicable legal frameworks, internationally and domestically.

Patents, Copyright and Competition: Assessing the Impact of Trade Deals on Canada

The intellectual property (IP) provisions of the Comprehensive Economic and Trade Agreement (CETA) between Canada and the European Union, and of the Trans-Pacific Partnership (TPP), were among their most controversial features. Critics focused notably on strengthened protection for pharmaceutical patents in the CETA, and on the extended term of copyright in the TPP. While the TPP as negotiated may have been sunk by the withdrawal in January of the United States’ signature, its IP provisions will very likely resurface in the context of the re-opening of the North American Free Trade Agreement demanded by the new US administration. In this paper, we review in detail the claims that strengthened protection for pharmaceutical patents would result in an increase in health care costs, and provide some estimates of our own. We also examine claims about the cost to Canadians of copyright term extension. In both cases, we find that the cost of these changes is likely to be well under what their critics have claimed, and considerably lower than the net gains for Canada otherwise offered by agreements like CETA and the TPP. Furthermore, we note that some changes to Canadian law under CETA actually support competition in the pharmaceutical industry. The cost of the IP provisions examined here could be reduced or offset by a variety of government policies: speeding up patent approval, promoting competition in the pharmaceutical industry, negotiating lower prices for drugs or, in the case of copyright, promoting the public domain or the accessibility of copyrighted material. There is little, in other words, suggesting insuperable costs to Canada from these provisions. Meanwhile, harmonizing basic IP rules with those of our trade partners and increasing our access to these large markets, is expected to have a positive effect on domestic innovators and copyright holders. Canada is a net importer of intellectual property, and in that sense, will incur some short-term costs as a result of higher net payments to patents and rights holders abroad. Yet Canada is also a net exporter of research and, increasingly, of culture. This indicates the potential for Canadians in the long term to become more active exporters of IP, and in that sense benefit from stronger IP protection themselves.

The Trans Pacific Partnership Agreement and access to HIV treatment in Vietnam

ABSTRACTIn the Trans Pacific Partnership (TPP) Agreement negotiations, the USA successfully pursued intellectual property (IP) provisions that will affect the affordability of medicines, including anti-retrovirals (ARV) for HIV. Vietnam has the lowest GDP per capita of the 12 TPP countries and in 2013 provided ARVs for only 68% of eligible people living with HIV. Using the current Vietnamese IP regime as our base case, we analysed the potential impact of a regime making full use of legal IP flexibilities, and one based on the IP provisions of the final, agreed TPP text. Results indicate that at current funding levels 82% of Vietnam’s eligible people living with HIV would receive ARVs if legal flexibilities were fully utilised, while as few as 30% may have access to ARVs under the TPP Agreement – more than halving the proportion currently treated.

The Regional Comprehensive Economic Partnership, Intellectual Property Protection, and Access to Medicines.

The inclusion of elevated standards of intellectual property (IP) protection in the recently negotiated Trans-Pacific Partnership (TPP) agreement has raised serious public health concerns regarding access to medicines. A lesser-known trade agreement under negotiation in the Asia-Pacific region is the Regional Comprehensive Economic Partnership (RCEP). Framed as an attempt to reassert ASEAN's position in response to the United States-led TPP, RCEP includes key players China and India as well as several low- and middle-income countries (LMICs). Leaked drafts of IP provisions proposed by Japan and South Korea raise similar concerns in the Asia-Pacific region. This article identifies TRIPS (Trade Related Aspects of Intellectual Property Rights agreement)-Plus provisions in leaked negotiating texts and examines their implications for LMICs that are not also parties to the TPP: Cambodia, Indonesia, Laos, Myanmar, the Philippines, Thailand, China, and India. We find that higher levels of IP protection delay the market entry of generic medicines, giving rise to increased costs to governments and reduced access to essential medicines. The article concludes that the public health community should recognize risks inherent in trade agreements that promote expansions of IP rights and engage with governments to ensure that public health is adequately and explicitly protected in trade and investment negotiations.