TRIPS Agreement Research Articles

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

Examining the legality of abuse by failure to manufacture patents locally as a substantive condition for granting compulsory licences pursuant to the TRIPS Agreement

This article assesses whether abuse by failure to manufacture patents locally remains a valid condition for granting compulsory licences under TRIPS. The author examines Article 27(1) of TRIPS, which stipulates that patent rights shall be enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced, and Article 5(A)(2) of the Paris Convention, which recognises failure to manufacture locally as an example of the abuse of patent rights, and argues that the former is incorporated into Article 2 of TRIPS, thus validating the same as a condition for granting compulsory licences under TRIPS. This argument rests on the notion that India has used Section 84(1) of its TRIPS-compliant Patent Act, related to a requirement that patented inventions be manufactured locally, as a condition for granting a compulsory licence to Natco, and this decision remains unchallenged within the WTO DSU system.

The WTO TRIPS Agreement and Global Health Progress

The WTO TRIPS Agreement and Global Health Progress

Trade-Related Aspects of Intellectual Property Rights Waiver at the World Trade Organization: A BIT of a Challenge

To augment the global production and distribution of Covid-19 medical products such as vaccines, drugs and other therapeutics, countries are negotiating for temporarily waiving certain provisions of the TRIPS agreement at the WTO. Depending on the conditions that would govern the waiver, countries would amend their domestic intellectual property (IP) laws to effectively implement the waiver. While the waiver would provide immunity to IP-related regulatory measures from legal claims at the WTO, multinational pharmaceutical companies can use the investor-State dispute settlement (ISDS) mechanism under bilateral investment treaties (BITs) to challenge such IP-related regulatory measures. In case of such a challenge to IP-related regulatory measures, will the host State be able to defend these measures? The paper answers this question by dividing the investment treaty practice into those BITs that contain carve-out for IP and those that don’t. The former set of treaties provides greater regulatory autonomy to implement the TRIPS waiver. However, given the fragmented and incoherent nature of the ISDS mechanism, the final outcome would depend on arbitral discretion.

Technological Self-Sufficiency and the Role of Novelty Traps

The COVID pandemic has demonstrated the tragic consequences of technological dependency. Unable to manufacture vaccines for themselves, developing countries must rely on obtaining supplies from other nations. While strong arguments have been made to waive international obligations under the TRIPS Agreement to permit these countries to freely use of COVID-related patented inventions, it is not clear that this move would produce sufficient vaccine to meet global demand. Considerable scholarship has been devoted to the question of how to help these countries reach the technological frontier and become technologically independent. In this paper, we identify a novel source of their problem: a structural feature of modern patent law traps technologies in a legal limbo, where there are inadequate incentives to invest in the adaptations and efforts needed to make technologies effectively available in low-income countries. Moreover, the current regime deprives potential innovators of an opportunity to protect their intellectual contributions and begin to build robust innovative ecosystems. The paper proposes a modified patent regime designed to break what we call the 'novelty trap' and discusses its compatibility with international intellectual property law.

INCORPORATING ARTICLE 31bis FLEXIBILITIES ON TRIPS PUBLIC HEALTH INTO DOMESTIC PATENT SYSTEM: THE INESCAPABLE WAY FORWARD FOR MALAYSIA

The purpose of this study is to highlight the absence of specific provisions on public health under Article 31bis of the TRIPS Agreement, that were not incorporated into the Patents Act 1983 in Malaysia. The main research question of this study is; why should Malaysia immediately amend its Patents Act 1983 to incorporate these flexibilities? Malaysia must develop effective strategies to implement policies, law and governance in managing the country’s public health system. This is to ensure a balance of rights between intellectual property owners and the public, at all times. This study employs a qualitative research methodology that is based on primary sources such as the TRIPS Agreement and the Patents Act 1983, and is further supported by secondary sources such as journals and the contents of authorities’ websites. This study is limited to the issues related to public health and patents. This study includes a discussion on the provisions related to patents and public health, proposed amendments to the Patents Act 1983 that should incorporate the provisions from Article 31bis, and a conclusion on the importance of immediately amending the Patent Act 1983 to incorporate these provisions, especially during the current Covid-19 pandemic. This study proposes that the amendments be made to Section 84 of the Patents Act 1983 in relation to Rights of Government, and not through the compulsory licence mechanism under Part X of the Patents Act 1983. Thus, this study concludes that currently, Malaysia is unable to implement the provisions under Article 31bis, unless the Patents Act 1983 is amended.

Comparative characteristics of trade secret in the legislation of foreign countries and in international law

The purpose of the article is to investigate the place of trade secrets in regulations, international treaties, foreign legislation, and key means of protecting trade secrets in accordance with these regulations. A comparative analysis of current norms and provisions of the system of legislation of foreign countries in terms of protection of trade secrets. An analysis is performed of international treaties and the legal framework of foreign countries, namely, the Paris Convention for the Protection of Industrial Property, the Stockholm Convention establishing the World Intellectual Property Organization of 1967 in terms of protection of trade secrets in order to improve national legislation in this area. It has been emphasized that the definition of trade secrets is similar in the Civil Code of Ukraine and in the TRIPS Agreement, which enshrines three criteria of trade secrets: secrecy, commercial value and taking adequate measures to ensure secrecy. It is noted that legal protection provides for and requires the owner of the commercial secrecy to take appropriate measures to ensure the protection of relevant information from unfair commercial use. Sometimes the misappropriation of a trade secret is the result of industrial espionage, when a person provides classified information to a competitor for monetary or other remuneration. The main provisions of the North American Free Trade Agreement (NAFTA) on trade secrets are analyzed in comparison with the EU legal system, according to which patent law provides additional incentives for the application of the commercial secrecy regime to protect confidential information. Four approaches to understanding this legal regime in the doctrine of Anglo-Saxon legal systems are analyzed: the theory of contractual obligation, the theory of fiduciary (trust) relations, the theory of misappropriation and the theory of unfair competition. It is concluded that the applied criteria for classifying information as a trade secret are similar, in relation to actions that are not appropriation of a trade secret, in particular, in relation to the ‘legalization’ of reverse development, which is relevant for the information technology industry. Ukraine has the prospect of including in its legislation an important legal act – the Law of Ukraine on Trade Secrets, which will have a positive impact on the business climate, promote investment attractiveness, and meet the needs of businesses and the state.

Kia Tāwharautia Te Mātauranga Māori: Decolonising the Intellectual Property Regime in Aotearoa New Zealand

This article explores ways to decolonise aspects of the intellectual property system in Aotearoa New Zealand, primarily in respect of trade marks. It considers the seminal Wai 262 report of the Waitangi Tribunal and builds upon its findings and recommendations, while also offering new ideas of legal reform for protecting mātauranga Māori (Māori knowledge and expertise) from undue exploitation. This article also measures those ideas against the objectives and principles of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as well as other internationally recognised rights. Essentially, this article maintains that for any mechanism to be effective in recognising and upholding the tino rangatiratanga (unqualified self-determination) of Māori over their own mātauranga, that mechanism must be founded upon the principles of tikanga Māori (Māori laws and customs), which is a notion crystallised within the Treaty of Waitangi/Te Tiriti o Waitangi. It must also find its own meaningful place in the law of New Zealand that surrounds us today. It is only in this way that the extractive and thereby oppressive binds of the western intellectual property regime can be unpicked and put aside and the tapu (high status and associated sanctity) of mātauranga can be upheld. These words are also an honouring of those who spent countless hours on the Wai 262 report. It is hoped this article gives new and much needed life to the issue of protecting mātauranga Māori, which is still as relevant today as it was then. Kei aku rangatira, kei aku tapaeru, kei aku whakaruakākā, tēnei e ngākau whakaiti nei (an acknowledgement of all those who took part in Wai 262).

Pengaturan Impor Paralel dalam Merek (Studi Perbandingan Hukum Indonesia, India dan New Zealand)

Parallel import is a concept for importing and reselling original products from distributors that are legally obtained from producers at lower prices rather than buying directly from producers. These products are placed on the market in one country with the approval from owner and imported to another country without the permission of the owner. Parallel imports are built on the principle of exhaustion of rights. Basically, there are three principles of exhaustion of rights, namely;the principle of international exhaustion of rights, domestic/national exhaustion of rights and regional exhaustion of rights. Based on the TRIPS agreement, each country is given the freedom to determine and regulate the principle of exhaustion of rights to be applied. The issue under discussion is how the parallel import regulation in brands according to Indonesia, Indian, and New Zealand laws what can be adopted in Indonesia law regarding parallel imports based on these comparisons. In this study, the writer used a normative research method. This research also uses legal comparison as part of its analysis with data collection techniques through literature study. Data analysis method used is descriptive qualitative method. The results of the study showed that Indonesia has no regulation regarding parallel imports. While in India and New Zealand there are related regulations. Regarding disputes settlement regarding parallel imports in Indonesia, civil law is adopted, in India with a judge's decision in accordance with existing regulations. What can be adopted by Indonesia in this case is to explicitly reinforce regulations regarding parallel imports in brands.

A Inconstitucionalidade do Artigo 40, Parágrafo Único, da Lei de Propriedade Industrial sob uma Perspectiva Comparada

The research discusses the constitutional aspects of Article 40, sole paragraph, of the Brazilian Industrial Property Law (LPI, from its acronym in Portuguese). This institute establishes a minimum protection period for invention patents, and the Brazilian Supreme Court is now examining its constitutionality in Direct Action for the Declaration of Unconstitutionality no. 5529. The research aims to understand where this Brazilian provision is within the international landscape. For this purpose, the study compares Brazilian law and data on granting pharmaceutical and non-pharmaceutical invention patents for the period between 2010 and 2019 to intellectual property laws and patent granting in twenty-nine jurisdictions. In a nutshell, the research shows no match for Article 40, sole paragraph, of LPI in any other jurisdiction. Although a minority of the nations studied have mechanisms for additional patent protection, these are restricted to specific cases (e.g., for pharmaceutical products) and are guided by a diverse legal-economic rationale of reduced application, which is subject to certain exceptions and limitations. Therefore, one cannot correctly compare these provisions to the Brazilian one. These conclusions are corroborated by the empirical research results, which show that the minimum term institute is responsible for distortions that extend the duration of patents registered in Brazil beyond the deadlines established by the TRIPS Agreement or by the practices adopted by the international community. Finally, the research provides the Brazilian Supreme Court factual and robust material to decide for the unconstitutionality of Article 40, sole paragraph, of LPI. This decision could be an adequate measure to stimulate Brazilian scientific-technological production, amplify access to healthcare by Brazilians, and, consequently, promote the country's socio-economic development.

Building respect for intellectual property—The journey toward balanced intellectual property enforcement

AbstractThis paper provides a succinct history of how multilateral dialogue on intellectual property (IP) enforcement developed since the Agreement on Trade‐related Aspects of Intellectual Property Rights (TRIPS Agreement) came into effect in 1995. The early years of multilateral IP enforcement dialogue were politically volatile and turbulent; while some states strove for a further increased level of international IP enforcement, others requested to extend the transitional period to implement the minimum standards under the TRIPS Agreement. With the adoption of the WIPO Development Agenda in 2007, however, this situation started to change, and international dialogue shifted from a merely punitive conception of IP enforcement to the more holistic concept of building respect for IP. To understand the trajectory of this evolution, this article describes several IP enforcement initiatives that were undertaken somewhat contemporaneously at different international organizations, but which ultimately did not secure consensus. From this point, this paper elaborates on the concept of building respect for IP, examining its origins, its development at WIPO and the profound impact it has had on multilateral dialogue on IP enforcement, demonstrating how a development‐oriented shift in international IP policy has triggered a multilateral transformation in a more balanced, inclusive light.

Letters to the MJM

In response to "TRIPS agreement and public health" by Junaid Subhan.

A Study on the Improvement of TRIPs Agreement regarding Patent on Genetic Resource

A Study on the Improvement of TRIPs Agreement regarding Patent on Genetic Resource

Do changes in patent policy influence firms’ technology strategy? Evidence from manufacturing in India

India made patent policy changes to comply with TRIPs agreement that increased the rights of patent owners. Considering that such policy changes influence both in-house research and development investments and technology licensing from external sources, the firms have to accordingly devise their technology strategy. This study employs a simple and fixed effects multinomial logit regression models to study the impact of policy changes on the technology strategy of 402 firms operating in Indian manufacturing sector from 1999 to 2014. The results show that changes in patent policy have a significant impact on technology strategy of firms.

The South Centre – Max Planck Global Forum on IP, Innovation and Access to Medicines MPI, Munich, 9-10 December 2019

On 9-10 December 2019, the South Centre and the Max Planck Institute (the MPI) for Innovation and Competition jointly organised a ‘Global Forum on Intellectual Property, Innovation and Access to Medicines’ (the Forum), in Munich, Germany. The Forum brought together leading academic figures from around the world and policymakers from Latin America, Africa and Asia to examine how intellectual property policy and law is evolving to incorporate public health considerations. The invited policymakers were government officials from ministries of foreign affairs, health and trade, staff from intellectual property offices, and judges. Discussions centred on the policy choices available to governments and recent experiences. The Forum served to support evidence-based policymaking and the creation of intellectual property regimes in developing countries that are supportive of the goals of public health, in particular the promoting of access to healthcare for all. The Forum made possible dialogue on the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights (the TRIPS Agreement), such as compulsory licensing, exceptions to patentability, the use of rigorous patentability criteria, patent oppositions and parallel imports. The Forum also facilitated discussion on IP-related aspects of emerging gene and cell therapies, the interface between IP and regulations on the access and use of genetic resources and traditional knowledge, the use of competition law to enhance access to medicines, IP rules in free trade agreements and models for research and development (R&D).

Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19

The work is devoted to identifying the main problems of legal regulation of innovations in the medical field and developing the best options for solving them in the context of the Covid-19 pandemic. Thus, the research methodology is based on general and special scientific methods, in particular: formal legal, historical and legal, comparative analysis, and modeling. So, the procedure and issues to be considered are as follows. In the introduction, we will briefly highlight the origins of intellectual property rights issues in the medical field and the overall state of the pharmaceutical industry. In the first subsection of the third section, we will consider the positions of the main players in the pharmaceutical industry and the contradictions between them. In the second subsection, we will highlight the international obligations under TRIPS. In the third subsection, we will consider the consequences of their direct violation. In the fourth subsection, the impact of Covid-19 and the methods of legal regulation of medical innovations and patents under the TRIPS agreement will be discussed. In the fifth subsection, we will propose a way out and a compromise according to the Indian scenario. As a result of the study, contradictions were identified in the aspect of maintaining the balance of private and public interests between states and international pharmaceutical companies in the context of a pandemic and proposed ways to resolve them within the existing legal methods under the TRIPS agreement to achieve an acceptable compromise.

COVID-19 Pandemic, Long-Term Incentives for Developing Vaccines and Infectious Disease Market: IP Law under Stress

Continents are facing an apocalyptic pandemic that pose a mortal danger to millions of its citizens. This paper seeks to address the role of intellectual property law in addressing the problem of COVID-19 pandemic. We suggest that current international IP law regime and TRIPS Agreement do not pose an insurmountable impediment to access to the successful COVID-19 vaccine. Publicly advocated fundamental reform or even the abolishment of the current IP law regime under severe information asymmetries might be counterproductive and distortive. Governments can via existing compulsory licensing, advance purchase agreements and employment of patent-pools, research subsidies, reward mechanisms and reputational sanctions take necessary steps to effectively overcome any IP barriers in ensuring access to crucial medicines/vaccines especially during a COVID-19 pandemic. Moreover, the current rate of medical research on COVID-19 suggests that previous vaccine R&D “failures” were driven by rather limited demand for such vaccines and where not the problem of inadequate IP-incentive stream. Furthermore, paper suggest that the current EU competition law rules on the horizontal exchange of information might be perceived as an impediment to innovate and might be temporary suspended. In addition, paper offers several substantive insights on an improved IP related public policy respond in the war against COVID-19.

ISSUES AND CHALLENGES OF GEOGRAPHICAL INDICATION IN INDIA

In the recent years Geographical Indications have grabbed attention as an important property right issue in a country like India where there is great diversity on cultural and geographical grounds which if utilized wisely can benefit the country a lot. But several challenges and issues are there due to which some states in India are lagging behind when some are really performing well. The objective of this study is to dig out the reasons behind this disparity among states on the grounds of GI registration. For this the study takes help of secondary sources like WIPO, WTO, Manupatra.com, IPI, case studies from literatures, journals, books etc. and explains it by making use of bar graphs and pie charts. The findings of this study will carry significant implications for Central as well as State Government of India in terms of addressing this challenge and developing strategies so that potential benefits ingrained in Geographical Indications can be realized efficiently. KEYWORDS: Geographical Indications, WTO, TRIPS agreement, Challenges, Tag

Twenty-five years since TRIPS: Patent policy and international business

In this introduction to the special issue, we take stock of the impact of the TRIPS agreement on international business in the hyper-globalised world of the late twentieth and early twenty-first century. We begin by providing a brief background on TRIPS, putting it in the historical context of international agreements on intellectual property (IP) and then looking at the logic of national patent policies, examining how policies may vary across countries, in theory, and reviewing literature that discusses the factors driving historical variation, in practice. We review the key issues in the domestic politics of implementation as the new rules migrate from the international to national levels. Lastly, we consider the implications of TRIPS for the governance of innovations in industries based on ICT and where ICT has enabled global value chains (GVCs), where the speed and distributed nature of innovation makes IPR simultaneously less effective and more necessary.

India’s patenting record since TRIPS compliance of her patent regime

ABSTRACT India’s patent regime underwent a major change in 2005 when its various provisions were brought into conformity with the TRIPS Agreement. The expectation was that the patent regime was made stronger from the point of protection of intellectual property leading to an incentivisation of innovation, leading to more production of patents in important technologies and especially by domestic enterprises. The paper undertakes a detailed survey of India’s patenting record to check if domestic enterprises and institutions have been very active in creating this important knowledge asset. Ownership of this intangible asset has become very important as the country is now once again moving to a new policy regime of enhanced technological self-reliance.