Patent suspension on the COVID-19 vaccine in Indonesian patent law perspective

Vaccination patent is associated with exclusive rights that restrict the production, use, and sale of inventions by third parties for a specific period. This factor contributes to the high cost of vaccines, making it challenging to access vaccines in many underdeveloped nations such as Indonesia. The urgency for faster vaccine distribution during the COVID-19 pandemic further highlights this issue. However, the patent provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPs Agreement) may exacerbate the unequal distribution of vaccines worldwide. This study analyzes the implementation of the flexibility feature of the TRIPs Agreement, and Doha Declaration contained in Law Number 13 of 2016 respecting Patent to achieve a pandemic-free era. It is also necessary to examine the Indonesian patent rules and regulations, the TRIPs Agreement, the Doha Declaration, and other legal documents to examine these issues. The results showed that the patent rules and regulations have adopted flexibility under the TRIPs Agreement and the Doha Declaration. However, the effect on the country's sluggish pharmaceutical supply chain has not been improved. A patent suspension system on a global scale is required to hasten the transition to a pandemic-free period since the feature of flexibility cannot handle the slow pace of vaccine procurement. The patent suspension system can be implemented through international agreements, such as the Patent Suspension Proposal filed by South Africa and India in October 2020. The suspension is crucial to accelerate the equitable distribution of vaccines and reduce their price. © 2023 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group.

The WTO and the Covid‐19 "Vaccine Apartheid”: Big Pharma and the Minefield of Patents

Unequal access to vaccines for the Covid‐19 pandemic, also referred to as "vaccine apartheid,” has marginalized low‐income countries again. In October 2020, India and South Africa proposed a temporary waiver from certain provisions of the TRIPS Agreement for the prevention of Covid‐19 at the World Trade Organization (WTO). An agreement was later reached in Geneva on June 17, 2022. The objective of this article is to analyze the negotiation and agreement reached at the WTO. This article explores the difficulties of creating international public good in the field of public health within the milieu of powerful actors, namely big pharmaceutical companies with vested interests. The central argument of this article is that this agreement alone will not solve the vaccine access problem for low‐income countries. It is too restrictive, does not cover trade secrets and know‐how, production capacity, availability of raw materials, and even adds new limitations that did not exist before. The best option to promote the production of quality vaccines in low‐income countries is to share technology and know‐how on a voluntary basis through production agreements. One way to facilitate the cooperation of large pharmaceutical corporation is to make it easier for low‐income countries to use compulsory licenses. Simplifying the use of this mechanism could help encourage pharmaceutical companies to enter into voluntary licensing agreements. © 2023 by the author(s);licensee Cogitatio Press (Lisbon, Portugal).

COVID-19, vaccines and international knowledge governance on trial

The production, distribution and availability of vaccines to combat the COVID-19 pandemic are all impacted by the international rules of knowledge governance. These rules include patents, trade secrets and health and efficacy regulatory approval processes. This article discusses how these intellectual property related mechanisms all interfered with vaccine availability. It analyses the international rules, related exceptions (including compulsory licensing and national security) and the possible waiver of the relevant rules found in the World Trade Organization TRIPS Agreement. Throughout the first two years of the pandemic, vaccines were not available widely enough. Although most of the developed world had enough vaccine doses by late 2021, that was not the position in much of the developing world, where the problem became the distribution of vaccines. Distribution may have always been difficult, but the failures in timely local supply exacerbated the problem of vaccine inequality between the developed and developing world. The inequality had several likely causes including intellectual property rules. The problem was not neces-sarily the existence of patents (or other rules) but the insufficiency of checks and balances that are necessary to address global public health needs. This resulted in private interests, whose primary goal is not public health, wielding too much power. The article concludes that collectively the effect of the international rules enacted in domestic laws supports a regime that was not fit for purpose to address the COVID-19 pandemic and is not fit to address future pandemics. © 2022 The Author.

The Legality of a Trips Waiver for Covid-19 Vaccines under International Investment Law

This article assesses the arguments and challenges that are likely to arise should investors file an investor-State dispute settlement (ISDS) claim over measures taken in response to a waiver of obligations relating to intellectual property rights (IPRs) under the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). After providing an overview of the proposed waiver of IPRs for COVID-19 vaccinations and treatments, it examines the jurisprudence relating to IP and investor-State arbitration and the grounds upon which investors would rely to make a case in ISDS and possible State defences. The analysis, which focuses on fair and equitable treatment and expropriation, concludes that it will be difficult for investors to succeed in claiming that measures taken in response to a TRIPS waiver of IPRs breach any substantive protection provision contained in an international investment agreement. States should, however, seek additional security by revisiting existing treaties and adding additional layers of safeguards to ensure legitimate and non-discriminatory measures taken in response to a TRIPS waiver do not lead to investor claims.

Compulsory Licensing System in Bosnia and Herzegovina: How Pandemic-Proof Is It?

The article examines the relevant provision of the Patent law of Bosnia and Herzegovina governing the conditions and procedures for granting a compulsory licence in light of the Covid-19 pandemic. In the course of this critical analysis, the insufficiencies of the regulatory framework for the application of this mechanism are detected, and improvements to the system proposed. Furthermore, the article also discusses other legislative (e.g., Law on Medicines and Medical Devices) and regulatory obstacles for the production and marketing of generic medicines on the territory of Bosnia and Herzegovina. Finally, it presents a short overview of the pharmaceutical industry in the country and identifies a potential compulsory licensing event. © 2022, The Author(s), under exclusive license to Springer Nature Switzerland AG.

The Doha Declaration at Twenty: Interpretation, Implementation, and Lessons Learned on the Relationship Between the TRIPS Agreement and Global Health

In the two decades since adoption of the Doha Declaration on the TRIPS Agreement and Public Health (“Doha Declaration”), it has been the subject of intense debate. The Declaration sets out WTO Members’ understanding of the relationship between the Agreement on Trade-Related Aspects of Intellectual Property Rights (“TRIPS Agreement”) and global health;recognizes the existence of “flexibilities” in the Agreement;and identifies (in Paragraph 6) a “problem” that required “an expeditious solution.” In line with Paragraph 6, WTO Members ultimately agreed to amend the TRIPS Agreement to enable compulsory licensing for export to countries with insufficient pharmaceutical manufacturing capacities. This article reviews and interprets the language of the Doha Declaration, and considers its legal status. The article then examines practical experiences with the system established pursuant to Paragraph 6, drawing conclusions about that system and, more generally, compulsory licensing. Compulsory licensing is often a deeply flawed means to the critically important end of increasing access to medicines, and may ultimately be counterproductive to a country’s objectives of improving public health. The article also explains how the ongoing development and manufacture of COVID-19 vaccines and therapeutics provides real-world confirmation of the importance of intellectual property protection for incentivizing investments in R&D and fostering voluntary collaborations. It considers that proposals to reduce intellectual property protection in the midst of the COVID-19 pandemic may reduce the pace of collaborations that are essential to producing the billions of vaccine doses needed in the coming months, while leaving the world unprepared for the next pandemic. © Terms and Conditions.

How Can Lower-Income Countries Access COVID-19 Medicines Without Destroying the Patent System? The National Exhaustion Solution

Many scholars argued that improving access to medicine requires major amendments to the patent system, which is structured according to the Agreement on Trade-Related Aspects of Intellectual Property Rights. This article argues that the argument is not necessarily true. Amending Article 6 of the TRIPS Agreement to adopt a national exhaustion rule for pharmaceutical patents would be sufficient to achieve a considerable improvement in access to medicine while simultaneously strengthening patent protection. This proposal encourages the pharmaceutical industry to adopt a price discrimination policy whereby Pharma would lower medicine prices in the lower-income countries. Accordingly, global access to new medicines such as COVID-19 medicines could be increased as these countries have the majority of poor people. At the same time, Pharma can continue to sell the same medicine in higher-income countries at higher prices, generating sufficient profits to incentivize research and development. © 2022, National Institute of Science Communication and Information Resources. All rights reserved.

Historical account of dwindling national flexibilities from the Paris Convention to post-TRIPS era: What implications for access-to-medicines in low-and-middle-income-countries?

It is arguable that the most significant feature of the maiden Paris Convention is the creation of a remarkably broad national policy space which allowed Union members to balance the implementation of required obligations with the need to occasionally attend to national exigencies. Thus, a member may choose not to offer industrial property protection if national interests would be best served by doing so. While subsequent revisions to the Paris Convention chipped away at national flexibilities, the most strident attack to national flexibilities occurs under the Agreement for the Trade-Related Aspects of Intellectual Property Rights and the period after it. This paper puts the almost-unnoticed whittling down of national flexibilities in international patent agreements in historical perspective. It subsequently discusses four ways through which this development could exacerbate access-to-medicines in low-and-middle-income-countries.

Medical Countermeasures for Pandemic Response and Intellectual Property Rights: Articulating and Enabling Community Interests under International Law

The current article addresses the question of whether and under which circumstances access to medical countermeasures against pandemics, such as COVID-19, may constitute a community interest under international law. First, the intertwined concepts of global public goods and community interests are fleshed out. Second, the analysis expounds whether the protection against pandemics, including immunization, can be framed as a community interest, and which obligations would result. Third, the relationship between community interests and intellectual property rights as enshrined in international law is explored. Fourth, the conclusions try to reconcile the goals of international intellectual property rights and the protection against pandemics. Positive obligations to furnish medical countermeasures may not attain the consent of a sufficiently large number of states. Nevertheless, articulating the protection against pandemics as a community interest should entail obligations to refrain from resorting to international intellectual property law to impede developing patent-protected medical countermeasures in other countries. [ FROM AUTHOR] Copyright of International Community Law Review is the property of Brill Academic Publishers and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full . (Copyright applies to all s.)

TRIPS Pluralism

The article explains that the interpretation of the TRIPS Agreement by WTO dispute-settlement panels and the Appellate Body has palpably shifted since the establishment of the WTO in 1995. Some of this shift is also arguably present in disputes concerning other WTO instruments. This progressive shift comes at a time when key debates about TRIPS waivers are taking place on the rue de Lausanne, namely a first for the COVID-19 pandemic and a second possible one for environmental protection measures related to climate change. According to the proposed pluralist analysis of TRIPS, it was less likely as of 2020 that the WTO dispute-settlement system would find unjustifiable inconsistencies between WTO commitments, on the one hand, and measures to protect public health or mitigate climate change, on the other hand. Whether future Appellate Body will follow that jurisprudence is an open question. Though the analysis contained in the article may make the COVID-related TRIPS waivers doctrinally unnecessary and allow Members to take measures now, its main aim is to inform the debates about the waivers and the future interpretation of the TRIPS Agreement, including the three-step test.

To Waive or not to Waive: International Patent Protection and the Covid-19 Pandemic

In 2020, South Africa and India submitted a landmark proposal to the World Trade Organization (WTO) to allow all countries the legal right under international trade rules to choose not to grant or enforce patents and other intellectual property (IP) related to COVID-19 drugs, vaccines, diagnostics and other technologies and materials for the duration of the pandemic. Since then, the proposal for an IP waiver has gained support from 100 WTO members. However, a small number have continued to oppose implementing an IP waiver, maintaining that the current flexibilities under the Agreement on Trade-Related Intellectual Property Rights (TRIPS) provide a sufficient remedy. The TRIPS flexibility most recommended by waiver opponents is the Compulsory Licensing mechanism which allows government the authority to grant permission to itself or domestic producers to make a patented product without the patent owners' consent. This article conducts a comparative analysis of the potential IP waiver and the compulsory licensing mechanism's functioning in relation to facilitating increased production of Covid-19 vaccines by generic pharmaceutical manufacturers.

The Patent System During Global Pandemic and the Access to Medications and Vaccines

The Declaration on Trade-Related Intellectual Property Rights (TRIPS) and Public Health Agreements want to promote the balanced interpretation and implementation of its provisions and promote universal access by assisting WTO members to protect public health rights. Two years will soon pass, and the emergence of new variants of COVID-19 shows that the virus will not stop at national borders. However, vaccines are gradually entering and almost monopolised by industrialised countries. If Jonas Salk thought in the 1950s that patenting his polio vaccine was like patenting the sun, the problem appearing is that today's patent holders do not think so. The COVID-19 vaccine is owned by biotech companies, universities, research institutes or pharmaceutical companies. The purpose of this research is to analyse, through a normative juridical approach, the requirement for patent holders to protect their intellectual property rights if they are to remain competitive in the marketplace. Not to forget that they must pay patent fees as a percentage of the final price of the vaccine, which is a significant benefit to the economies of the countries where they are located. While for developing countries, the best solution would be to produce their vaccines. With industrial property rights, it seems impossible to transfer the vaccine technology on COVID-19. That is why some developing countries (South Africa and India have the support of many other developing countries) have filed a complaint with the WTO, requesting a waiver of property rights under Article 31 of TRIPS in order to produce a COVID-19 vaccine on a large scale and at an affordable price © 2022 Sriwijaya University.