Intellectual Property
This section includes literature on the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).
Abbas, Muhammad Zaheer, ‘Australia Must Support a Temporary Waiver of Intellectual Property Protections in Response to a Future Pandemic’ (SSRN Scholarly Paper No 4664627, 14 December 2023)
Jurisdiction: India
link to book page on publisher website
Open Access e-book on Cambridge Core
Abstract: In times of pandemics, the Australian government must intervene through policy and legislative measures to protect the public interest. In response to the COVID-19 pandemic, the Australian government failed to take a clear position on intellectual property (IP) and access to vaccines, therapeutics, and diagnostics. Instead of fully supporting the TRIPS Waiver proposal aimed at addressing vaccine inequity, Australia remained non-committal in times of serious public health crisis. In response to a future pandemic, the Australian government must take a clear and strong position on IP in favour of equitable and universal access to vaccines, diagnostics, and therapeutics. Recommendations: 1. To safeguard the public interest, Australia needs to appreciate the importance of temporarily waiving IP protections to scale up production and supply of vaccines, diagnostics, and therapeutics in response to a pandemic.2. In the WHO convention, agreement or other international instrument on pandemic prevention, preparedness and response (Pandemic Accord), Australia needs to fully support temporary waivers of IP protections.
Abbas, Muhammad Zaheer, ‘Conflicting Interests, Competing Perspectives and Policy Incoherence: COVID-19 Highlights the Significance of the UN High-Level Panel Report on Access to Medicines’ (SSRN Scholarly Paper No 4524975, 29 July 2023) Abstract: The issue of affordable and equitable access to innovative health technologies has been the subject of a long-standing global debate on intellectual property, trade, and public health. The current COVID-19 has put this problem in the limelight because governments, even in the economically advanced countries, are struggling to meet the health needs of their populations. Patent exclusivities add to the cost of healthcare by allowing supra-competitive prices of protected technologies. The UN High-Level Panel Report on Access to Medicines is a great help in identifying and articulating the nature of the public policy problems faced by countries in response to COVID-19. After analysing the Report and its key recommendations, this paper evaluates the diverging responses to the Report which clearly highlight the conflicting interests of stakeholders. This article concludes that WTO Member States need to revive the spirit of the Doha Declaration which was arguably the best multilateral effort to accommodate the conflicting interests.
Abbas, Muhammad Zaheer, ‘COVID-19 and the Issue of Affordable Access to Innovative Health Technologies: An Analysis of Compulsory Licensing of Patents as a Policy Option’ in Klaus Mathis and Avishalom Tor (eds), Law and Economics of the Coronavirus Crisis (Springer, 2022) 265–294 [link to pre-print chapter on SSRN] Abstract: The conflict between patents and public health has been a long-standing concern. The current COVID-19 crisis has further visualized the complexities of the global issue of availability, accessibility, and affordability of essential health technologies. Compulsory licensing is a policy option, provided under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), to balance the conflicting interests of patent-holder brand-name pharmaceutical industry and low- and middle-income countries requiring access to the patented pharmaceutical drugs in a legal and sustainable way. The Doha Declaration on TRIPS and Public Health recognized the importance of compulsory licensing in addressing the issue of equitable access to medicines. Despite its established legitimacy, this regulatory tool has been the subject of immense controversy. This article evaluates the conflicting views on compulsory licensing to analyse the root causes of this controversy. It argues that compulsory licensing is not only politically sensitive but also procedurally cumbersome. It also considers empirical evidence on the actual use of compulsory licensing since Doha. Finally, it considers the recent compulsory licensing-related legislative measures adopted by different countries in response to COVID-19. It concludes that the compulsory licensing mechanism needs to be revisited and reformed to make it more responsive and practical. It proposes that the actual use of compulsory licensing safeguard should be backed by civil society mobilization to neutralize the pressures exerted by brand-name pharmaceutical corporations and their hosting countries.
Abbas, Muhammad Zaheer, ‘The COVID-19 Crisis: Intellectual Property and Sustainable Development During the Pandemic’ in Caroline Ncube and Matthew Rimmer (eds), Intellectual Property and the Sustainable Development Goals (Edward Elgar, 2024) 559–581 Abstract: This chapter explores the impact of the COVID-19 pandemic on each of the 17 Sustainable Development Goals (SDGs). This chapter then considers the intellectual property law dimensions of the pandemic in the context of three specific issues: online teaching and access to digital collections; the right to repair medical devices; and access to COVID-19 vaccines, therapeutics and diagnostics. It also makes suggestions for a sustainable recovery and calls for policy reforms aimed at building more resilient health systems, food systems, societies and economies. The conclusion maintains that the framework for recovery should be based on the principles of equity, inclusion, solidarity and multilateralism.
Abbas, Muhammad Z, ‘Patent Law and 3D Printing Applications in Response to COVID-19: Exceptions to Inventor Rights’ (2022) 25(2) The Journal of World Intellectual Property 317–334 Abstract: Three-dimensional (3D) printing technology offers promise in relation to much-needed health technologies associated with COVID-19. Additive manufacturing, which allows the rapid conversion of information from digital 3D models into physical objects, is uniquely well-positioned to address the shortage of critical medical devices by enabling the fabrication and repair of medical devices in a timely and cost-effective manner. This paper examines the issue of patent rights being at odds with access to critical 3D printable health technologies during COVID-19 crisis. It undertakes an in-depth analysis of the right to repair and calls for a clearer recognition of the right to repair exemption at the global level. It also evaluates the private and noncommercial use exception and proposes the use of a reasonably broad form of this exception to make it practically significant. It also considers the experimental use exception and calls upon World Trade Organization Member States to provide legislative clarity that a defense of an experimental use extends to repairs. This study is crucial because access to necessary health technologies, in a pandemic context, is a matter of life and death for millions of patients around the globe, especially for underprivileged patients in resource-constrained countries.
Abbas, Muhammad Zaheer, ‘Practical Implications of “Vaccine Nationalism”: A Short-Sighted and Risky Approach in Response to COVID-19’ (SSRN Scholarly Paper No 4536868, 1 November 2020) Abstract: To end the COVID-19 pandemic and ensure a return of normalcy, an effective and safe vaccine is the best hope. The vaccine nationalism approach, adopted by some countries to gain preferential access to emerging COVID-19 vaccines, poses a threat to the fair and equitable distribution of the potential vaccines across the globe. This article critically evaluates the approach of vaccine nationalism and argues that this self-centred political behaviour of leaving others behind is short-sighted, potentially risky, morally indefensible, and practically inefficient in containing the pandemic. This article highlights why it is important for national governments to support the collaborative and coordinated effort of the COVID-19 Vaccines Global Access (COVAX) facility for the timely development and efficient delivery of potential COVID-19 vaccines. It concludes that an effective response to the current health and economic crisis should be guided by values of international solidarity, multilateralism, equality, and global collaboration. It proposes the adoption of an enforceable global framework to address the concerns arising from the combination of vaccine nationalism and intellectual property exclusivities.
Abbas, Muhammad Zaheer, ‘The Proposed TRIPS Waiver and Pharmaceutical Industry’s Concerns About Counterfeit COVID-19 Vaccines’ (SSRN Scholarly Paper No 4525046, 1 August 2021) Abstract: Corporations are expected to pursue profit-maximising strategies. They do not like competition and look for strategies to extract maximum revenue from their patent- protected products. They like to dominate markets by having exclusive rights and by extending their exclusive rights. It is duty of the Australian government to intervene through policy and legislative measures when the public interest is actually or potentially undermined, especially in times of emergencies. The COVID-19 crisis exposed vulnerabilities of supply chains and put global healthcare systems under critical strain. The Australian government’s policy and legislative response is required to address the imbalance between the corporate interest and the public interest in the context of equitable access to COVID-19 vaccines. There is a pressing need to consider policy initiatives that are aimed at expanding equitable access to COVID-19 related health technologies, especially vaccines. Patent rights should not be allowed to stand in the way of saving human lives. Australia needs to support the proposal of temporarily waiving intellectual property protections to scale up production and supply of vaccines and other COVID-19 related treatments and diagnostics. Brand-name pharmaceutical industry’s claim that the proposed TRIPS waiver will result in proliferation of counterfeit vaccines and treatments is not supported by empirical evidence. If there is a tangible risk of counterfeit vaccines, governments have mechanisms in place to curb any malpractices. Governments can further strengthen their existing mechanisms to deal with any issues hypothetically raised by brand-name pharmaceutical industry.
Abbas, Muhammad Zaheer, ‘Revisiting Canada’s Access to Medicines Regime in Response to COVID-19: A Review of the Legislation and Its Underlying Objectives’ (2022) 34(2) Intellectual Property Journal 147–180 [link to pre-print on SSRN] Abstract: The current COVID-19 pandemic has highlighted the significance of the export-oriented compulsory licensing mechanism for countries lacking domestic manufacturing capacity. Article 31bis, the first amendment to the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), is aimed at giving effect to the WTO General Council Decision 2003, which waived the domestic market requirement of compulsory licensing. In 2005, Canada became the first country to amend its patent laws to provide for Canada’s Access to Medicines Regime (CAMR) as enabling legislation to implement the WTO General Council Decision 2003. Canada clearly described its regime as a humanitarian initiative aimed at helping least-developed countries and many developing countries that lack sufficient drug and/or vaccine manufacturing capacity of their own and rely upon imports to address their public health problems. The legislation got compromised by the conflicting goals of protecting the corporate interests of patentee corporations. This research paper argues that the CAMR system is not capable of delivering what was promised. This research paper maintains that Canada unnecessarily added extra layers of complication, restrictions, and regulatory requirements on top of what was required under Article 31bis, which is itself too onerous to invoke for resource-poor countries. This research paper also evaluates Canada’s efforts to reform CAMR and suggests overhauling of export-oriented compulsory licensing mechanism to provide a functional and expeditious one-licence solution workable for importing countries and acceptable to generic drug companies.
Abbas, Muhammad Zaheer, ‘The Right to Repair Medical Equipment in a Health Emergency: Australia Needs to Reform Its Patent Law’ (SSRN Scholarly Paper No 4525042, 1 July 2021) Abstract: The right to repair is not merely a legal concept but is a matter of life or death when it comes to fixing critical medical devices in a health emergency like COVID-19. Time delays in accessing repair information and repair services may result in preventable loss of human lives. Hospitals cannot wait for days or even weeks for an authorized technician because patients cannot be made to wait if a ventilator or defibrillator goes down. In such a situation, healthcare providers, facing life-threatening logistical problems, cannot and should not rely on optional goodwill and benevolence of profit- driven manufacturing corporations. Corporations are expected to pursue profit- maximising strategies. They do not like competition and look for strategies to extract recurring revenue from their patent-protected products. They like to dominate markets by having exclusive rights and by extending their exclusive rights. It is duty of the Australian government to intervene through policy and legislative measures when the public interest is actually or potentially undermined, especially in times of emergencies. The COVID-19 crisis exposed vulnerabilities of supply chains and put global healthcare systems under critical strain. It highlighted the importance of 3D printing and the right to repair medical devices. The Australian government’s policy and legislative response is required to address the imbalance between the corporate interest and the public interest in the context of the right to repair. There are substantial barriers to repairing medical equipment even during a health emergency. There is a pressing need to think about the existing gaps or imbalances in Australia’s patent laws and policies. Patent rights should not be allowed to stand in the way of saving human lives. Australia needs to use the impetus of COVID-19 to reform its patent law. There is a pressing need to legislate a more robust and explicit right to repair and to provide explicit defences or exceptions for the right to repair medical devices in response to the current and future health crisis.
Abbas, Muhammad Zaheer, ‘Treatment of the Novel COVID-19: Why Costa Rica’s Proposal for the Creation of a Global Pooling Mechanism Deserves Serious Consideration?’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa049 Abstract: The COVID-19 is causing not only deaths and fear but also economic and social harm across the globe. Lockdowns, travel restrictions, quarantines, social distancing, and other strict public health measures are playing their part in delaying the spread of infection, but a safe and potent vaccine, effective therapeutics, point-of-care diagnostics, and other health products are desperately needed because it may not be practically possible for governments to extend these measures for an indefinite period of time. On March 23, Costa Rica submitted a proposal to the Director-General of the World Health Organization for the creation of a global pooling mechanism in order to facilitate access to and use of intellectual property, trade-secret know-how, regulatory data, cell lines, product blueprints, and other proprietary data for technologies that are useful for the detection, prevention, control, and treatment of the COVID-19 pandemic. This study critically evaluates Costa Rica’s proposal and endeavors to briefly answer the following questions: Why Costa Rica’s proposal deserves serious consideration? To what extent this proposal addresses some of the key concerns related to the COVID-19? To what extent this proposal is practically feasible?
Abbas, Muhammad Zaheer, ‘Vulnerable Supply Chains in a Health Emergency: Australia, Local Manufacturing and 3D Printing’ (SSRN Scholarly Paper No 4525041, 1 April 2021) Abstract: The response to the COVID-19 crisis highlighted the weaknesses of the free trade system and failures of the traditional supply chains. Public health preparedness for future pandemics demands nation-states to increase their local production of medical supplies in order to reduce their dependence on third countries. Globally connected local production, enabled by digital fabrication tools, is arguably the best policy response to collaboratively address supply-chain vulnerabilities. 3D printing technology, which is the most prominent manifestation of digital fabrication ecosystems, can play a key role in enhancing the local production capacity in a time- and cost-efficient manner. This submission calls upon the Australian Government to increase its focus on local production of personal protective equipment (PPE) and proposes a more systematic and organized use of onshore 3D printing capabilities to address shortages of critical medical equipment in a health emergency. This submission also addresses intellectual property dimensions of local manufacturing with a key focus on compulsory licensing of patents, Crown use, and the right to repair patent protected devices to address shortages of critically needed medical equipment.
Abbott, Frederick M, ‘Intellectual Property and Technology Transfer for COVID-19 Vaccines: Assessment of the Record’ (World Intellectual Property Organization, 2 November 2023) < > Abstract: The World Intellectual Property Organization (WIPO)’s Global Challenges Division commissioned an independent study on the role played by intellectual property (IP) and technology transfer in the development, production and distribution of vaccines used to address the COVID-19 pandemic. The study uses a case-study approach to provide an in-depth analysis of some of the different approaches adopted by ten different global vaccine manufacturers, with respect to their funding, procurement, vaccine development and IP strategies (including licensing, technology transfer and access provisions). These experiences and lessons learnt provide practical insights to guide global policy-making on IP, health and access issues.
Adekola, Tolulope Anthony and Faith O Majekolagbe, ‘Human Rights Law, Intellectual Property and Vaccine Nationalism: Lessons for the Post-COVID-19 World’ [2024] Australian Journal of Human Rights (forthcoming) Abstract: The rollout of COVID-19 vaccines during the pandemic was labeled a ‘parallel pandemic of human rights.’ Occuring simultaneously with the primary public health crisis, the production, distribution, and profiteering that followed the announcement of vaccines were satirically referred to as ‘vaccine nationalism’ or ‘vaccine apartheid’. Against the backdrop of the COVID-19 pandemic and its attendant vaccine inequality, this article examines the extent to which existing international human rights laws provide a framework for equity in global vaccine distribution. The article explores the delicate balance between protecting intellectual property and promoting public health and human rights: the private property rights of vaccine developers and the broader human rights of members of the public to vaccine access. It does this by appraising the decision on the proposed waiver of intellectual property rights for COVID-19 vaccines and treatments under the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights during the pandemic. The article argues that a reform of the WTO multilateral system is needed to ensure that in future global health emergencies, private interests are subordinated to global public health needs and that global action is not conditioned by nationalism and hegemonic positions in international relations.
Adewopo, Adebambo, ‘Access to Pharmaceutical Patents in the COVID-19 Emergency: A Case for Government Use in Nigeria’ (2021) 65(S2) Journal of African Law 259–286 Abstract: The COVID-19 pandemic has continued to exert enormous pressure on public health policies and systems, with far-reaching implications. The race for vaccines has raised important intellectual property rights issues. These are evident in the need to advance the public interest and in the obligation of governments to address the challenge of access to vaccines, especially in sub-Saharan countries like Nigeria with relatively underdeveloped healthcare and innovation ecosystems. While the Nigerian Patents and Designs Act (PDA) establishes a compulsory licence regime that affords access to patented drugs, existing public healthcare is severely challenged in providing access to new medicines. This article examines the framework for patent protection of pharmaceuticals designed to meet public health challenges, such as those presented by the pandemic. It recommends the implementation of a government use provision under the PDA, with a view to addressing the challenge of access to COVID-19 vaccines.
Aerts, Rob J, ‘COVID-19 Vaccines, Patents and an IP Waiver’ (2022) 17(11) Journal of Intellectual Property Law & Practice 940–945 Abstract: On 2 October 2020, a proposal was submitted by India and South Africa to the World Trade Organization (WTO) to broadly waive intellectual property (IP) rights, including patents, for coronavirus disease 2019 (COVID-19) related medical products. The waiver is meant to ensure that such IP rights ‘do not create barriers to the timely access to affordable medical products including vaccines and medicines or to scaling-up of research, development, manufacturing and supply of medical products essential to combat COVID-19’. In a revision of the text of 25 May 2021, the waiving of IP relevant for COVID-19-related health products and technologies is mentioned. After publication of the proposal for an IP waiver, a discussion started about the desirability of such an IP waiver. In this article, it is attempted to summarize and comment the views of various authors on IP-related aspects concerning COVID-19 vaccines and the IP waiver. Overlapping observations by the authors can be identified. First, however, we take a brief look at the technology and patents involved in the production of RNA vaccines.
Afronomicslaw COVID-19 Symposium on International Economic Law in the Global South (May 2020), Symposium II: Intellectual Property, Technology and Agriculture - Caroline Ncube, ‘The Musings of a Copyright Scholar working in South Africa: is Copyright Law Supportive of Emergency Remote Teaching?’
Introduction: As we were reminded on twitter recently, The Statute of Anne, the world’s first copyright law, came into effect on April 10, 1710, three centuries and a decade ago. Its title reads in part, “An Act for the Encouragement of Learning…”. The veritable links between copyright and the right to education have been established by several scholars …The Statute of Anne is a forebear of South African copyright law which has its roots in English copyright law … Against this background, this post asks ‘is copyright still true to its original intent and is it supportive of emergency remote teaching in alignment with the right to education?’
- David Enrique Betancourt Cruz, ‘An Exceptional International Intellectual Property Law Solution for COVID-19: Spurring Innovation to Facilitate Access to Affordable Medicines’
Introduction: There is no doubt about the role international law can play in order to face the current COVID-19 pandemic. The answer is crystal clear: reform the current International Intellectual Property Law regime in order to accelerate innovation and facilitate access to affordable medicines worldwide. This could include examining how to better use the current flexibilities of the patent system so as to allow for more innovation, and effective co-operation/coordination in the scientific world. This unprecedented crisis of international scope offers us a rare opportunity to galvanize support for stronger international co-operation among the World Health Organization (WHO), World Intellectual Property Organization (WIPO), World Trade Organization (WTO), United Nations (UN), G20, and the European Union (EU) – as the top net exporter of pharmaceuticals. Reforming the international patent system and the Trade- Related Aspects of Intellectual Property Rights Agreement (TRIPS) is the type of real and pragmatic solidarity that we need to protect the most vulnerable individuals around the world.
- Jacquelene Mwangi, ‘COVID-19 and the ‘Unlocking’ of Innovation: Reflections on Law and Innovation in sub-Saharan Africa’
Extract from Introduction: I will reflect on the logics that have obscured innovation namely, international intellectual property law and formal organization of innovation through ‘national innovation systems’. These two combine under the banner of legal modernization and economic growth, and have collectively undermined innovation that does not fit into their premises.
Abstract: The spread of SARS-CoV-2 has paused the entire commercial sector except for the pharmaceutical domain. This highly contagious virus has kept the pharmaceutical domain, and publicly funded research institutions dynamically occupied in the R&D process to achieve the vaccine for the treatment and eradication of the COVID-19 virus. The key issues are not the incentives for R&D but the accessibility of such vaccines at the ground level amidst voluntary licensing, elliptically, the dilemma encompassing innovations, patent rights, accessibility, and public health emergencies amidst stakeholders with contrasting interests. The voluntary licensing approach promotes a balance between native generic manufactures and international groups yearning to protect their intellectual property (IP) rights while boosting goodwill via better accessibility of such medicine, and concurrently providing pharmaceutical giants a constructive business strategy to set foot in developing markets. Patent rights and more significantly voluntary licensing might have a consequential impact on the public healthcare niche as it would facilitate a grip of patent holders concerning private governance activities over IP-protected technologies. This paper provides an overview of voluntary licensing and its implications on vaccines in the pandemic.
Aghamohammadi, Akram and Bizhan Hajiazizi, ‘The Legal Aspects of the COVID-19 Vaccine Produced Based on Genetic Modification (Approach of the Legal Systems of the United States of America, the European Union and Iran)’ (2022) 0 Public Law Studies Quarterly (advance article, published online 18 June 2022 Abstract: The spread of COVID-19 disease has now become the biggest health crisis worldwide. Biotechnology research companies have begun a new era in overcoming the disease by using genetic modification techniques. The findings of the present study, which was performed by descriptive-analytical method, indicate that the COVID-19 vaccine based on genetic modification technology faces two main challenges: First, the relatively strict approach regulation to genetically modified organisms that exists to protect the environment and human health, and compliance with these requirements may make the vaccine production process a lengthy evaluation process. Second, companies active in this field seek legal protection for their intellectual achievements: Critics of intellectual property protection, however, believe that this type of protection of the COVID vaccine could potentially affect accessibility and cost-effectiveness. In the legal system of the European Union and the America, special legal actions are prescribed to exit the above challenges. However, due to the emergency situation caused by the spread of the disease in the Iranian legal system, we still face Legal vacuum.
Agrawal, Akshat, ‘Waiving Windfalls: The Socio-Legal and Contextual Justification of a “TRIPS Waiver” during the COVID-19 Pandemic’ (SSRN Scholarly Paper ID 3960967, 10 November 2021 Abstract: Distributive concerns in respect of IP, especially in the context of pharmaceuticals, are nothing new. The histories of inequity in bargaining towards a multilateral agreement as well as in its implementation has been widely documented. However, with the COVID-19 pandemic, and its gruesome, rather focally visible, impact on access to health, there ought to be a shift in conversation beyond IP internalism, questioning the fundamental inequities which come with TRIPS. This paper goes on to highlight aspects of inequity in institutionalizing IP regimes across the world, and focusses on IP Gradualism, and the lack of it. It builds on narratives of capability building, the hypocrisy of transition periods, and its impact on the global political economy of IP institutions across nations. The paper is an attempt to defog the historical realities that have resulted in skewed capabilities, which are clearly being exposed during such a pandemic, leading to a situation where a part of the world, which was clearly not allowed to pursue sovereign self-determination for over centuries, is having to ‘beg’ for a waiver of the same agreement which is the fundamental basis of situating this inequity, albeit to no effect. The paper discusses the prolonged practice of ‘absorption’ and imitative learning practiced by nations currently opposing the waiver, and uses time as a metric, to lay down certain realities that are important and ought not be ignored while debating the waiver, even at a diplomatic level. The primary normative point which the paper makes is that getting rid of this knowledge and capability divide, during these critical times, and in fact De-Colonizing IP, requires an alternate accent - where global trade ought to be looked at from the eyes of geo-historical attentiveness. The essence of distributive justice, especially in the grim situation that we face today, lies in realizing the importance of the historical context, i.e., this context of prolonged inability, not due to controllable forces or complacency or a lack of merit, but rather due to global acts of suppression, accounted for in history. As a corollary to this normative claim, this paper also discusses the practice of grating ‘Waivers’ under the WTO Agreement to show as to how the debate around waiving TRIPS obligations should have a clear favourable outcome, given the historical situations and circumstances in which such waivers have been granted. The legal limelight is on exposing the hypocrisy in the interpretation of ‘Exceptional Circumstances’ under Article IX.3 of the WTO Agreement, further supporting the normative claims of inequity, need for context, and the fundamental restructuring of this global diplomatic regime. The final attempt of this paper is to harp upon the fact that the need of the hour is one of global solidarity, which cannot in fact be pragmatized unless one is forced to face these historical realities to consciously realize the context, and as I might as well say – the reasons, for the inequity that we see today. The context needs to be out there, and this paper is an attempt towards the same.
Akl, Jean, ‘Patent Exceptions in the Time of a Pandemic’ (2020) 55(3) les Nouvelles: Journal of the Licensing Executives Society 204–205 Abstract: The blistering race and competition to find a COVID-19 vaccine is ongoing at a very fast pace. Pharmaceutical companies are scurrying to secure a legal monopoly for the treatment, to control the largest market share, and to ensure a considerable return on their investment, since the demand thereon would be immediate, global, and possibly extending for years and decades to come.Whether it is Gilead’s Remdesivir or any other treatment or vaccine that is ultimately found to have a proven curative or preventive outcome, researchers are ramping up their efforts, all while anticipating that a second wave of coronavirus is expected to swipe the globe again, as the Spanish flu did a century ago.
Akpan, Emaediong and Chinonyerem Ememobong, ‘COVID-19 and the Rebirth of Compulsory Licensing: An Examination of the Right to Health Care’ (SSRN Scholarly Paper ID 3606917, 21 May 2020) Abstract: The COVID-19 epidemic has ravaged nations leaving a high death toll in its wake. This article examines the intellectual property issues that may surround an invention of a vaccine for COVID-19. Chief amongst these issues being compulsory licensing. The compulsory licensing of a COVID-19 vaccine patent was examined with respect to the right to health. International treaties on compulsory licensing and the right to health was discussed as a justification for making vaccines such as that which may be discovered for the COVID-19 available to developing countries like Nigeria. It was discovered that the Nigerian Constitution does not make justiciable the right to health. It was recommended amongst others that the Nigerian State should leave up to its international commitments as contained in treaties signed by making policies that ensure access to health care.
Alnusair, Fayez et al, ‘Intellectual Property Rights and Fair Vaccine Distribution: A New Perspective on the TRIPS Agreement’ (2024) 6(2) Corporate Law & Governance Review 42 Abstract: The COVID-19 pandemic has highlighted inequities concerning global vaccine distribution, as well as issues surrounding patents and intellectual property rights for these vaccines. This paper addresses the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) regarding vaccines. Adhered to by all state members of the World Trade Organization (WTO), the agreement sets minimum regulatory standards for governments on intellectual property, including vaccines. Our contribution is a new analysis of TRIPS Art. 31 Bis concerning flexibilities in its terms of use on global vaccine distribution. We consider existing solutions for fairer vaccine distribution, such as governments enforcing a compulsory vaccine licence, and governmental/individual charitable efforts. We then focus on issues with know-how distribution and access to knowledge in the TRIPS context. We conclude that the enhanced provisions of TRIPS are ill-suited to global pandemics. To ensure fairer global vaccine distribution, we argue that patent pools and further TRIPS amendments are needed to endow less and least-developed countries with the ability to implement government-use compulsory licenses and to negotiate compensation terms later under judicial review. Further, to enable countries lacking the technical manufacturing capabilities to produce vaccines under license, TRIPS needs to be amended to permit technology and know-how transfer.
Andrieansjah, Andrieansjah, ‘The Impact of COVID-19 on Intellectual Property Legal System Related to Public Health in Connection with TRIPS Flexibilities in Indonesia’ (2020) 13(2) Indonesian Law Journal 165–191 Abstract: In early 2020, countries in the world was shocked by a new virus called Coronavirus Disease 2019 (COVID-19) including Indonesia. The COVID-19 pandemic gives impact to the legal system, including intellectual property (IP). Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities on public health in developing countries: Transition Periods, Compulsory License, Government Use, Parallel Imports, Exceptions to Patent Rights, Exemptions from Patentability, Limits on Data Protection, and Implementation of the Paragraph 6 of the Doha Declaration. Research problems: (1) what are the conditions for implementing the flexibilities of TRIPS in facing COVID-19 pandemic in Indonesia and (2) what are the issues that should be anticipated for future IP legal system relating to public health as a lesson from this COVID-19 Pandemic. Government Use is most effective to be used for encounter COVID-19 Pandemic, and voluntary license is recommended tobe promoted for future approach. The study is using a qualitative literature study.
Arewa, Olufunmilayo, ‘COVID-19 Exclusion, Policy Contagion, and Colonial Hangover in Africa’ (SSRN Scholarly Paper No 4996274, Social Science Research Network, 21 October 2024) Abstract: African countries have experienced multiple consequences from the COVID-19 pandemic that extend beyond its immediate impact on human health. In Africa, much like elsewhere in the world, the pandemic has had a significant economic impact, leading to profound global economic distress. African countries have also experienced consequences that are unlike those of much of the rest of the world. The pandemic has contributed to a surge in sovereign debt defaults, including in Zambia in late 2020, Mali in early 2022, Ghana in late 2022, and Ethiopia in 2023. Travel bans and COVID-19 vaccine exclusion have also had a particular impact in Africa. The experiences of African countries during the COVID-19 pandemic highlight key consequences of colonial hangover and fundamental structural impediments and inequalities evident in global and local contexts.
Arup, Christopher and Jagjit Plahe, ‘Patents and Other Conditions of Access to Vaccines’ (2023) 26(1) The Journal of World Intellectual Property 41–62 Abstract: This paper reviews the experience with access to vaccines during the pandemic. Its inquiry is the extent to which pharmaceutical patents have hindered or enhanced access when compared to other factors or conditions like health spending, manufacturing capacity, and regulatory competence. To conduct the review, the paper queries the regulatory governance perspective when it suggests a decentralised field of legal pluralism will maximise access. It recalls the pre-COVID-19 experience with antiretrovirals to provide pointers to the present situation. It then examines the experience with COVID vaccines under the headings of invention, production, procurement, and distribution. The review finds while patents may hinder access to vaccines, other, essential conditions for access, like independent manufacturing capacity and commitment to procurement, are not established. Regulatory governance must now adopt a much more concerted, coordinated approach, mobilising both patent regulation and other key conditions to further access. The review is an opportunity to gather some of the copious commentary on this issue.
Asay, Clark D and Stephanie Plamondon Bair, ‘COVID-19 and Its Impact(s) on Innovation’ (2021) Utah Law Review (forthcoming) Abstract: In previous work, we explored how certain characteristics of adversity are often more conducive to innovation than others. In this Article, prepared as part of the Lee E. Teitelbaum Utah Law Review Symposium—The Law & Ethics of Medical Research, we review some of that work and apply it specifically to the COVID-19 context. We conclude by assessing certain policy implications in light of how the COVID-19 pandemic has both spurred and hindered innovation.
Asay, Clark D and Stephanie Plamondon Bair, ‘Innovation in Adversity’ (2022) 49(4) Florida State University Law Review 825–882 Abstract: Adverse experiences, like long-term poverty, can inhibit innovation. But as much research and many real-world examples show, adversity can also stimulate innovation. Indeed, the COVID-19 pandemic provides a number of recent examples where adverse conditions have led individuals, firms, and governments to innovate in the hope of benefiting society. Despite the fact that some forms of adversity undermine innovation while others stimulate it, legal scholars have largely failed to distinguish between the two forms or even account for adversity’s relationship to innovation when assessing innovation law and policy, including intellectual property (IP) laws. Yet given adversity’s significant role in affecting the pace and direction of innovation, doing so is crucial. In this Article, we undertake that task. Our analysis shows that adversity is most likely to stimulate innovation when it satisfies what we call the Goldilocks principle: the adversity is neither too intense nor too mild, too fleeting nor too enduring, too all-encompassing nor too confined, too commonly experienced nor too isolated, too severe nor too insignificant, but instead is ‘just right.’ Hence, for adversity to have the best chance of stimulating innovation, it should be (1) a relatively discrete experience; (2) of moderate intensity; (3) experienced collectively rather than in isolation; and (4) significant enough that, if left unaddressed, the adversity could result in severe consequences for large groups of people. To be clear, these conditions are not necessary for innovation--adversity, or some other trigger, might spur innovation even if each of these conditions is not met. Neither are they sufficient--innovation will not necessarily occur even if all of these conditions are present. Indeed, individual and organizational characteristics often play a role in determining whether a party will respond to adversity with innovation. But existing research suggests that these are some of the features of adversity most conducive to, and thus most likely to inspire, innovation. Conversely, adverse conditions falling outside of these parameters are more likely to inhibit innovation, or at least fail to stimulate it. We then assess what this means for IP laws and innovation policy more generally. Predominant theories suggest that IP laws are meant to incentivize parties to benefit society through innovation andcreativity. Yet over the years, commentators have pointed out that IP rights are often unnecessary to inspire these activities and thus at times impose unnecessary costs on society by restricting access to those innovations. We contribute to this important discussion by highlighting the role that adverse conditions frequently play in affecting the pace and direction of innovation. First, we argue that the role of certain types of adversity in stimulating innovations provides another reason to doubt the efficacy of IP rights as applied to many of those innovations. Other policy levers, such as grants and prizes, may often be preferable in such cases. Second, we explore possible solutions to innovation-inhibiting adversity, including bolstering IP rights in certain situations and a greater societal commitment to basic research funding. Finally, we examine the role that adversity can play in creating innovation path dependencies, and we briefly explore some possible solutions to this dilemma.
Baachus, James, ‘An Unnecessary Proposal: A WTO Waiver of Intellectual Property Rights for COVID-19 Vaccines’ (Cato Institute, Free Trade Bulletin No 78, 2020) Abstract: In a sign of their increasing frustration with global efforts to ensure that all people everywhere will have access to COVID-19 vaccines, several developing countries have asked other members of the World Trade Organization (WTO) to join them in a sweeping waiver of the intellectual property (IP) rights relating to those vaccines. Their waiver request raises anew the recurring debate within the WTO over the right balance between the protection of IP rights and access in poorer countries to urgently needed medicines. But the last thing the WTO needs is another debate over perceived trade obstacles to public health.Unless WTO members reach a consensus, the multilateral trading system may be further complicated by a delay like that in resolving the two‐decades‐old dispute between developed and developing countries over the compulsory licensing and generic distribution of HIV/AIDS drugs. A new and contentious ‘North‐South’ political struggle definitely would not be in the interest of the developed countries, the developing countries, the pharmaceutical companies, or the WTO. Certainly it would not be in the interest of the victims and potential victims of COVID-19.
Baker, Brook K, ‘Hamstringing the Health Technology Response to Covid-19: The Burdens of Exclusivity and Policy Solutions’ (2021) 13(2) Northeastern University Law Review 689-731 Abstract: The world was unprepared for COVID-19 despite other recent coronavirus outbreaks and despite multiple warnings from the World Health Organization (WHO) and others. Although there was an initial sharing of research among scientists and an unleashing of significant public, charitable, and private funding to develop, test, and expand manufacturing capacity of new COVID-19-related medicines, vaccines, and diagnostics, the status quo of exclusive rights ownership and commercial control by the multinational biopharmaceutical industry continues unabated. Existing intellectual property rules that allow private entities to maintain monopoly rights over the development, clinical testing, regulatory approval, pricing, supply, and distribution of essential medical products have not been altered. And the determination of rich countries to secure preferential and disproportionate access to proven and promising vaccines, medicines, diagnostics, and personal protective equipment remains unchanged. In place of open science and coordinated clinical trials, scientific rigor in regulatory assessment and broad regulatory approval, low-cost pricing and rational expansion of manufacturing capacity, and equitable global access to all needed COVID-19 health products, we have needlessly high prices, inadequate supplies, and nationalistic hoarding, especially, but not exclusively, by the Global North. Fortunately, there are multiple initiatives and proposals to counteract exclusivities, commercial prerogatives, and rich countries’ preferential access to existing and novel COVID-19 health technologies. These initiatives include more radical proposals to waive recognition and enforcement of COVID-19-related intellectual property rights (IPRs) at the global and national level during the pandemic and to extend the general least developed country transition period for enforcement of IPRs. Other proposals focus on both voluntary and compulsory mechanisms to override IPRs, openly license and facilitate technology transfer of coronavirus vaccines, medicines, and diagnostics. Several global partners have established an accelerator to speed the development and marketing of new COVID-19 tools and secure at least some supplies for low- and middle-income countries. Finally, regional cooperation initiatives have been established. Although there have been multiple initiatives and proposals to overcome industry’s exclusive rights and commercial prerogatives, these efforts have not resulted in the needed paradigm shift in global health such that life-saving and enhancing health products are viewed as global public goods rather than as ordinary consumer products. Similarly, rich countries’ hegemonic hoarding of COVID-19 health products and inadequate global coordination mechanisms have left the imperative of equitable distribution of COVID-19 health products disarrayed, with the risk that twice as many people will die from COVID-19 than if vaccines were to be shared globally. We can hope that this dystopian stasis will be overcome, but it will take far more activism from governments, institutions, and civil society to dislodge the current lethargic response and intellectual property and market fundamentalisms that leave our world fractured in responding to this modern-day plague. This global pandemic needs a global response now and as a proving ground for future threats.
Balasubramanian, Sai Smrithi et al, ‘Covid-19 Vaccine vis-à-vis Application of Patent Law During Pandemic’ (2021) 10(2) International Journal of Modern Agriculture 388-394 Abstract: This article aims to study the possibility of a vaccine juxtaposed with the law of patents, to see how best the rights of the creator of the treatment kit may be protected while also not jeopardizing public health and safety. The author seeks to discuss the cost benefit analysis between the drug development process and patent protection of the developed drug, the concept of compulsory licensing which acts as a safety valve to block the creation of monopolies in the market during times of emergencies, and also bring to light the relatively modern idea of patent pooling to achieve equitable results across the globe.
Ballano, Vivencio O, ‘Analyzing the Morality of Owning and Suspending Patent Rights for COVID-19 Vaccines in the Light of Catholic Social Teaching’ [2021] The Linacre Quarterly (advance article, published online 8 December 2021) [pre-print available on SSRN] Abstract: Using the Roman Catholic Church’s set of moral principles on social concerns called Catholic social teaching (CST) and utilizing some secondary data and scientific research literature, this article examines the morality of India and South Africa’s request to the World Trade Organization (WTO) to temporarily suspend the property rights and patents of top pharmaceutical companies to their vaccines to allow low-income countries to locally manufacture them to save the lives of the poor during this COVID-19 pandemic. Applying the theological method of ‘See-Judge-and-Act,’ this article argues that the suspension of patents for COVID vaccines is morally justifiable in the light of CST’s principles on the universal destination of earth’s goods, the common good, and preferential option for the poor. The top pharmaceutical companies cannot claim absolute ownership to their vaccines as they do not totally own and fund the entire development and production process. Furthermore, the right to private ownership and patents has a social dimension and must serve the common good and welfare of the poor, especially in times of global emergency such as the COVID-19 pandemic. Patent holders have a moral obligation to promote the common good and save the lives of the poor which must prevail over their capitalist quest for profit. This article recommends that Catholics and Christians must join this crusade for the suspension of patents as part of their spirituality of social transformation., Summary: Applying the Roman Catholic Church’s set of moral principles on social concerns called CST and utilizing some secondary data and scientific research literature, this article examines the morality of India and South Africa’s request to the World Trade Organization to temporarily suspend the property rights and patents of top pharmaceutical companies to their vaccines to allow low-income countries to locally manufacture them to save the lives of the poor during the current pandemic. Applying the theological method of ‘See-Judge-and-Act,’ this article argues that the suspension of patents for COVID vaccines is morally justifiable in the light of CST’s principles on the universal destination of earth goods, the common good, and preferential option for the poor. It recommends that Catholics and Christians must join this crusade for the suspension of patents as part of their spirituality of social transformation., Short Summary: This article argues that patents of the top pharmaceutical companies to their COVID-19 vaccines must be suspended as requested by India and South Africa in the WTO in the light of CST’s moral principles on the universal destination of earth’s goods, the common good, and preferential option for the poor.
Basheer, SK, ‘Ensuring Innovation and Access in Covid 19 Treatment: Challenges under Saudi Arabian Patent Law’ (2021) 27(2) Journal of Law and Political Sciences 72–100 Abstract: The COVID 19 pandemic has resulted in devastating social and economic impact. Hundreds of thousands of lives have lost and lives of billions more have been spilled. Apart from developing a successful Co-vaccine, the vital challenge is to ensure equitable access by accountability and transparency in vaccine allocation. ‘Nobody wins the race until everyone wins’ because this global infectious threat knows no boundaries. While 90% successful vaccines are set for the pandemic, patent regimes have to be ready with a well balanced mechanism promoting innovation and ensuring access to COVID 19 treatment. Call for ‘patent waver’ on COVID 19 was also a miserable failure. Equally alarming is pandemic profiteering by institutions like Vanderbilt University and AstraZeneca. Challenge before the international community is not simply the vaccine development;real threat is vaccine nationalization and patent monopolization. In this context the patent law of the kingdom has a critical role in spurring innovation on COVID 19 treatments and also it in ensuring equitable access of the vaccine to the developing countries.
Beemsterboer, Stephen, ‘Fahrenheit 2020: Torching the Internet’s Library of Alexandria at the Height of a Global Pandemic’ (2021) 2021(2) Journal of Law, Technology & Policy 387–517 Abstract: As the pandemic’s deadly grip took hold of the world, the need for a widely accessible universal library became more apparent than ever. Responding to the exigencies of the pandemic, Internet Archives suspended its limits on concurrent loans, effectively untethering its lending practices from one of the primary legal justifications that imputed legitimacy to the controlled digital lending (CDL) model. But four of the country’s largest publishers decided to take aim at not only the National Emergency Library, but the concept of CDL generally. This Note endeavors to introduce additional perspectives to the legal analysis and comprehensively address some of the most pernicious rhetoric that permeates the discourse with respect to this case.
de Beer, Jeremy and E Richard Gold, ‘International Trade, Intellectual Property, and Innovation Policy: Lessons from a Pandemic’ in Colleen M Flood et al (eds), Vulnerable: The Law, Policy and Ethics of COVID-19 (University of Ottawa Press, 2020) 579 Abstract: This chapter addresses intersections among international trade law, intellectual property rights, and domestic innovation policies to prevent, detect, and treat pandemics. Structural issues with Canada’s innovation system affected preparedness for this pandemic and, unless remedied, will impede responses to future crises. In this chapter, we suggest aligning domestic and international policy measures to nuance Canada’s approach to intellectual property and accelerate Canada’s global contributions through open science.
Bennett, Belinda, Ian Freckelton and Gabrielle Wolf, ‘Development of COVID-19 Treatments and Vaccines’ in COVID-19, Law, and Regulation: Rights, Freedoms, and Obligations in a Pandemic (Oxford University Press, 2023)
Bhardwaj, Chintan and Sanat Prem, ‘COVID-19 Vaccine: A Case of Compulsory Licensing for Social Utility!’ (SSRN Scholarly Paper ID 3853761, 26 May 2021) Abstract: After a long and tough battle with COVID-19, people were given a ray of hope with the emergence of vaccines across the globe. However, it is safe to say that things have not quite gone according to plan. Vaccine shortages, debates over patents, hoarding, re-infections despite vaccines etc. have taken over the discourse. In this paper, the authors seek to examine one of these aspects: the need to treat vaccines as a ‘social utility’ tool essential for saving lives worldwide. We will delve into the compulsory licensing prospects in India, the debate around the recent patent-waiver calls on vaccines, and the dilemma between IP rights and social utility for COVID-19 vaccines. India and South Africa have led the calls for this waiver based on concerns of supply and price affordability. In this backdrop, we shed light on the process and need for compulsory licensing for the vaccine in India and how, in a sense, India is contradicting its call on the international front and its efforts back home, domestically. ‘Necessity is the mother of innovation’ – but what happens when that innovation does not reach those for whom it is a necessity? The legal dilemma arises when the jurisprudence of public welfare entangles with the jurisprudence of patent law under the principles of Intellectual Property Rights.The epidemic of COVID-19 has led to the development of the COVID-19 vaccine. The pharmaceutical sector has been upfront to develop a cure to bring normalcy back into the world. There have been billions of dollars invested to develop the vaccine and the institutions have secured a patent on the technology and the formula. The conclusive standing shall be observed by understanding the legislative intent under the Indian Patents Act 1970 (hereinafter referred to as ‘the Act’).
Biagioli, Mario, ‘Of Viruses and Licenses: Learning from COVID-19 Patent Debates’ (SSRN Scholarly Paper ID 4028429, 7 February 2022) Abstract: From the White House to the World Trade Organization (WTO), heated debates have flared up around the compulsory licensing of COVID-19 vaccine technologies, producing a flurry of op-eds in all of the major US newspapers. Should patent protections, these op-eds ask, be temporarily relaxed to enable developing countries to produce and distribute cheaper shots to ensure timely global immunization? Can compulsory licenses actually achieve that goal, or would the efforts of developing countries be thwarted by other constraints, like limited production capacity, equipment, and skills? Conversely, would the granting of such licenses stymie medical innovation?
Billette de Villemeur, Etienne, Vianney Dequiedt and Bruno PA Versaevel, ‘Better Than a Compromise, a Third Way: Using Patent Pooling To Accelerate Access to Vaccines and Treatments Against COVID-19’ (SSRN Scholarly Paper No 4492430, 1 December 2021) Abstract: In the debate on intellectual property rights induced by the Covid-19 pandemic vaccines and treatments are typically referred to as simple products whose manufacturing specifications need only to be shared in order to increase production capacity and accelerate access to all, more specifically to low-income populations in the developing world. We contribute to this debate by taking into account the fact that the manufacture of innovative vaccines and treatments can involve multiple technologies whose patents are held by several entities. We propose an economic approach that it is more balanced than the polar options – on which the debate has focused – of either maintaining or suspending patents, without being reduced to a simple compromise between these two extremes. This ‘third way’ is grounded in a model for the characterization of the performance of a patent pool mechanism, whose objective is to maximize access to medicinal products by licensing multiple technologies as a bundle to downstream manufacturers. The outcomes of the nonprofit patent pool are compared with those of two benchmark scenarios where either patent holders license their technologies separately, or where a profit-maximizing patent pool is involved. The analysis highlights the positive role that a non-profit organization such as the Medicines Patent Pool can play in the global governance of responses to the pandemic.
Bin Siddique, Fahad, ‘The Doctrine of Fair Use in the Aspect of COVID-19 Pandemic: Perspective of Copyright Laws in Bangladesh’ (2021) 1(1) University of Asia Pacific (UAP) Law Review 47–57 Abstract: The doctrine of fair use or fair dealing indicates exceptions to the author’s exclusive right under copyright law. This doctrine permits making copies or using copyrighted work in such a way that does not consider copyright infringement. The primary objective behind the doctrine is the benefit of society, which could be through educational institutions, for instance, by allowing photocopies of a book for teaching, which does not amount to infringement of copyright. COVID-19 pandemic and the consequential lockdown worldwide have changed people’s lifestyles, and even educational institutions are now serving their students online. Even though people are adjusting to this new normal situation, issues concerning the uncertainty of how the doctrine of fair use or fair dealing under copyright law will apply to online education have emerged. Does this doctrine of fair use extend to the online education system? This article will scrutinize the position and scope under Bangladeshi law on fair use concerning questions that have arisen in the aftermath of online teaching. Therefore, this article aims to study the status of the doctrine of fair use in the aspect of this pandemic and discover the applicability of this doctrine in terms of the online education system to observe the position and practice of the other jurisdictions in this regard.
Birnhack, Michael, ‘Who Controls COVID-Related Medical Data? Copyright and Personal Data’ (2021) International Review of Intellectual Property and Competition Law (forthcoming) Abstract: Who controls big medical data of relating to COVID-19 vaccines? The January 2021 Real-World Epidemiological Evidence Collaboration Agreement between Pfizer and the Israeli Ministry of Health highlights the interrelationship between two modes of protecting data: data protection law and copyright law. The former provides legal protection to data subjects and limits the data controller, but generally speaking, allows the data to be processed for the benefit of public health; the latter awards the databases’ controller with rights regarding the dataset, a control which may hinder others’ access to highly important data. This editorial unpacks this relationship. Under the Agreement, the Ministry shares ‘aggregate project data’ with Pfizer, meaning ‘any de-identified data.’ ‘Project data’ are owned by the MoH or Israeli Health Maintenance Organizations. The data are about millions of people from a variety of sources and are used as they are collected. Combining copyright law and the obligations imposed by data protection law, pushes the parties to protect data under both copyright law and additional layers of protection, such as trade secret law. This result means that other parties may have access to outcomes but not to raw data. To facilitate broad access to crucial data during a global health crisis, we need to address both bodies of law in an integrated manner.
Bois, Mikhalien Du, ‘State Use Provisions for Patent Law, and Expropriations: Some Comparative Law Guidelines for South Africa during the Covid-19 Crisis and Beyond’ (2020) 23 Potchefstroom Electronic Law Journal 1–35 Abstract: This article views section 4 of the Patents Act 57 of 1978 against section 25 of the Constitution of the Republic of South Africa, 1996 and Article 31 of the Agreement on Trade-Related Aspects of Intellectual Property Rights of 1994 (hereafter TRIPS). The purpose is to find a suitable framework for the state/government use/utilisation of patented products or processes for public purposes. A comparison is done with the Crown use provisions in United Kingdom, Australian and Canadian law to find a suitable approach to questions relating to remuneration for state use, the prior negotiations requirement set by Article 31 of TRIPS, and the public purposes and exclusive patent rights that would be included under state use. The COVID-19 international pandemic has caused a state of national disaster in South Africa, which is exactly the kind of situation of extreme urgency envisioned by the exception in Article 31 of TRIPS, which permits the state use of patents without requiring prior negotiations with the patent owner. In the battle against COVID-19 and its concomitant fallout, the South African government (and authorised private parties) would be permitted to utilise patent rights without explicit authorisation from the patent owner and without prior negotiations, but subject to the payment of reasonable remuneration by the government and other terms and conditions as agreed upon or as determined by a court. This may include making (manufacturing), using, exercising, and importing patented products (for example, personal protective equipment, pharmaceuticals, ventilators and diagnostic tests) deemed necessary in the fight against COVID-19. Foreign jurisdictions considered in this article indicate that section 4 of the Patents Act 57 of 1978 may certainly benefit from an update to provide detailed guidance on the state use of patented products or processes for public purposes. In the interest of a timeous offensive against the COVID-19 virus, the patent provisions need a speedy update to allow state use compliant with TRIPS and the Constitution of the Republic of South Africa, 1996.
Boldrin, Michele and David Levine, ‘Reforming Patent Law: The Case of Covid-19’ (2021) 41(3) Cato Institute 773–784 (Jurisdiction: Reforming Patent Law) Abstract: While vaccination rates are increasing quickly in wealthier countries, rates in Africa, Latin America, India, and elsewhere are not improving much. A short time ago the debate over the proposal to temporarily waive intellectual property rights on Covid‐19 vaccines was raging worldwide; and the suspension of those rights seemed imminent. Public attention reached its peak in May 2021 when the Biden administration endorsed the idea and committed itself to pursuing it under the World Trade Organization–World Intellectual Property Organization (WTO-WIPO) procedural rules for waiving intellectual property (IP) protection. By suspending IP rights, the administration sought to help low‐income countries to start producing vaccines more quickly, reducing the rising and dramatic worldwide vaccine inequality.
Bonadio, Enrico and Andrea Baldini, ‘COVID-19, Patents and the Never-Ending Tension between Proprietary Rights and the Protection of Public Health’ (2020) 11(2) European Journal of Risk Regulation Special Issue-‘Taming COVID-19 by Regulation’ 390-395 Introduction: In January 2020, Chinese researchers at the Wuhan Institute of Virology filed for a patent covering the use of remdesivir, an experimental antiviral drug, to treat COVID-19. Normally, this might be cause for celebration: COVID-19, a deadly pneumonia-like disease caused by the novel coronavirus, has so far killed thousands of people worldwide and sickened many more, sending researchers scrambling to develop an effective treatment.1 Only, the Wuhan Institute of Virology did not develop remdesivir. The drug was researched and produced by Gilead Sciences, a California-based pharmaceutical company, which had filed patent applications at several patent offices, including in China, covering a “method for treating Arenaviridae and coronaviridae virus infection”.
Boschiero, Nerina, ‘COVID-19 Vaccines as Global Common Goods: An Integrated Approach of Ethical, Economic Policy and Intellectual Property Management’ (2022) 22(2) Global Jurist 177–230 Abstract: The article deals with the current debate about COVID-19 Vaccines as global public/common goods. After a brief introduction on the global epidemiological and economic implication of the pandemic, the problem of the correct characterization of either vaccine or immunization/herd immunity as global public/common good, according to the necessary characteristics outlined by the pertinent economic theories, is addressed. The conclusion is that the term ‘global public good’/global common goods” has been extensively used in the last two years by policy makers, political leaders, academics, economists, international organizations, NGOs and others health groups, in a sort of ‘loose way’. Substantially, in order to underscore that equitable access to health products, including vaccines, health and biomedical technologies, medical services, medical devises, whose availability, accessibility, acceptability, affordability to the world is fundamental to tackling the pandemic. The current legal proprietary regime applied to vaccines, extensively covered by IPRs, has transformed an intrinsically non-excludable common/public good (the vaccines, due to their nature and characteristics) in something excludable and rival in consumption. Consequently, the article argues that what is needed is a swift in their legal governance. The current legal discipline of vaccines and health technologies must be changed to bring it into line with the non-excludable nature of these goods. The richest countries in the world, in pursuit of their ‘vaccine nationalisms’, have already collectively preordered 8.8 billion doses of vaccine, far in excess of need, thus obliging billions of people in the Global South to wait years to be vaccinated. In this respect, the article investigates the EU vaccines strategy and analyzes the Advanced Purchase Agreements signed by the European Commission with the major vaccine producers, enlightening the untenable secrecy and opacity with which the European Union’s executive has handled COVID-19 vaccine supply contracts, and how it has simply paid no more than lip-service to the concept of global common/public good by attributing a broad ‘private governance’ to the pharmaceutical companies. Then, the various arguments, for and against, the Waiver Proposal to several sections of the WTO TRIPS agreement, introduced by India and South Africa on the TRIPS Council on October 2020, have been briefly summarized, accounting the current luck of needed consensus among the various members of the WTO. The article however describes an important number of new global and collaborative efforts already put in place by a myriad public and private actors to allow efficient development and production of vaccines in order to enhance a global access to vaccines. The article concludes by stressing the major developments in the U.S. patent’s landscape and in the Biden Administration’s attitude towards the current global health crisis, that leave hope for ‘extraordinary measures’ to be agreed by the international community in near future. The auspice is that the time has finally arrived for the international community to develop reliable and long term solutions to tackle future global pandemic, preferably by the negotiation of a new WHO global health treaty, to secure universal fair access to essential technologies and vaccines and protecting them as global public/common goods.
Calboli, Irene, ‘Trade Mark Licensing and Covid-19: Why Fashion Companies Have a Duty to Comply with Their Legal Obligations’ (2020) 15(7) Journal of Intellectual Property Law & Practice 489–490 Abstract: For the past several months, Covid-19 has dominated the intellectual property (IP) debate. Most discussions have focused on the implications of patent protection on access to treatments against the virus and a hopefully soon to be found vaccine. In these remarks, I would like to focus on another Covid-19 crisis making headlines across the world and partially related to IP: millions of workers in the garment industry in developing countries have been fired or furloughed as fashion companies have cancelled orders due to plunging sales since the pandemic’s beginning. Famous Western groups such as Inditex (Zara), C&A, Target, and Marks & Spencer are among the companies involved in this humanitarian crisis.
Calboli, Irene, ‘Trade Marking “COVID” and “Coronavirus” in the USA: An Empirical Review’ (2021) 16(6) Journal of Intellectual Property Law & Practice 473–483 Abstract: Famous and sensational events often lead to several entities filing trade mark applications that include terms related to these events. The most recent example of this phenomenon is the COVID-19 pandemic, which has led to large numbers of (largely controversial) filings worldwide. In this article, I review the applications including the terms ‘COVID’ and ‘Coronavirus’ filed with the United States Patent and Trademark Office (USPTO) in 2020 based on the data available and recorded by the end of January 2021. These data offer significant information related to the type of products for which the applications were filed, the type of filing entities, the legal basis for filings and the timing of these filings throughout the months of 2020.In particular, the COVID-19 pandemic led not only to a large number of filings for medical and pandemic related products, but also, and even more, for unrelated and promotional products. Individuals and small businesses were the largest groups of filing entities. Moreover, over two-thirds of the filings were submitted based on intent-to-use rather than use in commerce. Not surprisingly, the number of filings closely mirrored the development of the pandemic during the various months of 2020. Perhaps, one of the lessons that could be derived from the COVID-19 pandemic, and this unprecedented number of applications, is the need to further study the phenomenon of ‘sensation-drive’ trade mark filings and the problems that these filings can represent for the trade mark system.
Carney, Todd, ‘Does IP Law Allow for Exploitation during a Pandemic?’ (2021) 4 Wayne State University Journal of Business Law 101
Cartsens, Jan Paul, ‘A Legal Review of the World Trade Organisation’s Applications of the Agreement on Trade-Related Aspects of Intellectual Property Rights to Ensure Equitable Access to Health Care during the COVID-19 Pandemic’ (Master of Laws Thesis, Stellenbosch University, 2023) Abstract: With this in mind, the purpose of this research paper is to conduct a legal review of the WTO’s applications of the TRIPS agreement to ensure equitable access to health care during the COVID-19 pandemic. In this determination, a short review of the establishment of the WTO and TRIPS is done to help identify the role the WTO plays as a facilitator of international trade to ensure equitable access to health care to its member states. Thereafter, a review of the forms of IPR protection provisions in TRIPS is undertaken. Then, a review of the TRIPS flexibilities is conducted to identify what these flexibilities entail and to determine how states can make use of TRIPS to gain access to required IPR’s. A determination is then made if TRIPS is a sufficient instrument for its member states to gain access to IPR’s of health care products of other member states’ during times of a pandemic like COVID-19. Finally, a review of the actions taken by the WTO during the COVID-19 pandemic was conducted, to whether the WTO itself was an obstacle or facilitator in the fight against COVID-19 and if this assisted in preparation for a future pandemic.
Chaudhary, Talat and Arshi Chaudhary, ‘TRIPS Waiver of COVID-19 Vaccines: Impact on Pharmaceutical Industry and What It Means to Developing Countries’ (2021) 24(5–6) The Journal of World Intellectual Property 447–454 Abstract: The WTO was formed in 1995 and since then countries have abide by Trade Related Aspects of Intellectual Property Rights (TRIPS). The agreement provides for comprehensive plan for patenting and protection including those of medical supply units including vaccines and diagnosis. Recently developing countries such as India and South Africa have demanded TRIPS waiver for access to vaccines for all the developing countries The TRIPS waiver demanded, would apply to vaccines, diagnosis, and treatment related to COVID-19. The waiver is important as it would allow member state in researching, manufacturing, and supplying of vaccines. The proposal by the developing countries for temporary waiver of IP rights argues that IP could impede the supply of COVID-19 drugs and vaccines. However, there is no near consensus as most of the developed countries opposed this stance and they even argue that waiving TRIPS is not going to ramp up the manufacturing process. The pharmaceutical industry is also against this stance of developing countries, they put their argument forward that waiving of the IP will inhibit research and development of future prospects.
Chaudhuri, Sudip, ‘Patent Protection and Access to COVID-19 Medical Products in Developing Countries’ (SSRN Scholarly Paper ID 3902314, 30 June 2021) Abstract: Several new vaccines that have been developed for COVID-19 are patent protected. The patentees control the production, supply and pricing of these vaccines. Most people in low-income countries have been unable to access the vaccines. India and South Africa supported by a large number of developing countries have submitted a proposal to the TRIPS Council of the WTO requesting a temporary waiver to eliminate patent and other intellectual property barriers for the development, production and supply of all COVID-19 medical products. Nine months have passed since the proposal was first made in October 2020 but still no decision could be taken because of the opposition from developed countries. The disagreements essentially revolve around four issues: whether suspension of patent rights will act as a disincentive for the development of new medical products; whether patented products can be manufactured in the absence of manufacturing capacities; whether voluntary initiatives are better than a patent waiver; and whether a waiver is necessary in view of compulsory licensing and other measures which TRIPS permits. The paper briefly reviews these issues and also provides some suggestions about what developing countries can do to make COVID-19 medical products affordable and accessible.
Choudhary, Yatindra, ‘Intellectual Property Rights and Competition Law: A Hidden Chemistry Amidst Covid-19 Pandemic’ (2021) 25 Supremo Amicus Journal (unpaginated) Abstract: During the COVID19 pandemic a word ‘Duopoly’ came across us frequently. A duopoly is a market situation that entails two competing companies that share the market. In this market, two brands can collude to set prices or quantity and make customers pay more money. In this context we are talking about Serum Institute of India and Bharat Biotech the manufacturers of covid vaccines Covishield and Covaxin respectively. Also, during this crisis enterprises felt compelled to take aggressive pricing measures to improve revenue collection while government was concerned about determining fair prices for essential commodities. Amid all this, ‘Competition Act, 2002’ came in light, significance of which was not put into much consideration by the government. Along with this the issue of Covid vaccines patent and compulsory licensing also caught the worldwide attention, which failed to reach the finish line. Abandoning the idea of compulsory licensing or patents and maintaining the pharmaceutical duopoly, resulting in creation of market imbalance and price discrimination was all protected by sensitive arguments like public health and emergency vaccination drive. The interface between competition law and IPRs protection is complex and multifaceted. It needs to be handled very carefully. It can be said that the countries including India requires the regulated market as well as free market in such times since both have their advantages and disadvantages and going with the operation of Competition law and IP invention is crucial, price needs to be stable, so that the supplier along with the buyer is able to fulfill their needs. A market without any regulating bodies will cause an unbalanced situation and once it goes out of control it is difficult to restore.
Christabel, Vania Rebecca, ‘The Legal Basis for the Application of Patent Waiver Settlements in the Covid-19 Pandemic’ (2024) 2(1) Economic Military and Geographically Business Review_ _Abstract: The research on the role of the World Trade Organization in solving the vaccine patent waiver problem related to the 2019 coronavirus disease pandemic will address each issue one by one. Seeing the waiver applications that were made from the end of 2020 to 2022, it is necessary to further study the legal basis and enforcement of patents. Coupled with its relation to public health and equality for the global world to achieve. This study aims to provide an understanding of the role of the WTO in the patent waiver application process and the continuity of current and future patent law enforcement. The results of this study are that the WTO has carried out its roles and functions in accordance with applicable international legal instruments. However, this research emphasises further on the principles of the WTO itself which emphasises justice for developing and less developed countries on the other words called Special and Differential Treatment of Developing Countries (SDT). Coupled with the existence of the Doha Declaration which should emphasise that public health should take precedence over intellectual property rights, including patents. Conclusion: Regarding the WTO’s role in resolving vaccine patent issues during the COVID-19 pandemic, it can be concluded that the actions taken by the WTO, including its internal bodies and councils, adhere to applicable legal principles and the TRIPs Agreement. However, the decisions must fully align with the WTO’s principles, particularly the Special and Differential Treatment of Developing Countries (SDT).
Chuma-Okoro, Helen and Ifeoma Ann Oluwasemilore, ‘Intellectual Property Rights, Agricultural Biotechnology and Food Sufficiency: Strengthening the Nigerian Intellectual Property Legal Framework for Food Self-Sufficiency in the Aftermath of a Global Pandemic’ (2022) 36(1) International Review of Law, Computers & Technology 48–67 Abstract: This article focuses on the imperatives of self-sufficiency in food production in Nigeria from the experience of the COVID 19 pandemic, and examines the role of intellectual property rights (IPRS) in boosting productive capacity. While the different types of IPR protection standards remain relevant to the overall goal of food self-sufficiency in respect of the different activities and outputs along the food value chain, the main emphasis of the article is on patent and plant varieties protection (PVP) in connection with agricultural biotechnology. The article is library-based and explains the meaning and import of food self-sufficiency, the factors responsible for the weak capacity for food self-sufficiency in Nigeria in particular, and other African countries vis-à-vis potentially enabling factors. It also examines the strength and weaknesses of the current IP laws in Nigeria, and how Nigeria could repurpose or improve her laws to achieve the objective of food self-sufficiency. The article found that IPRs are relevant in boosting greater efficiency and productivity of Nigerian agriculture to strengthen food self-sufficiency, but the current IPR framework are not designed to circumvent the perils and leverage the benefits of IPRs that would help unlock the potential of the sector for food self-sufficiency.
Contreras, Jorge L, ‘Expanding Access to Patents for COVID-19’ in Scott Burris et al (eds), Assessing Legal Responses to COVID-19 (Public Health Law Watch, 2020) 158–162 Abstract: Two competing and linked sets of goals must be addressed when considering patent policy in response to a public health emergency. First is the allocation of existing resources among potential users (hospitals, patients, etc.); second is the creation of new technologies over time (innovation). Patents provide financial incentives to develop new technologies. Yet shortages of patented products often plague crisis response. In the case of COVID-19, allocative goals, particularly satisfying demand for patented medical products (e.g., vaccines, ventilators, PPE, and test kits), may be achieved through governmental interventions such as march-in and governmental use rights (compulsory licensing). But in cases involving the development of new technologies such as vaccines and therapies, incentive structures must be preserved to ensure that the private sector is appropriately motivated to act. In addition to patents, which reward inventors for financially successful innovations, a range of other incentives such as prizes, grants, and subsidies also exist to motivate technological innovation. Incentives like these, coupled with a requirement that resulting discoveries be made available on a broad and open basis, can achieve a balance between allocation and innovation goals. Governments can encourage such measures using both the incipient threat of compulsory licensing and the reward of procurement preferences and other up-front rewards.
Contreras, Jorge L, ‘The Open COVID Pledge: Design, Implementation and Preliminary Assessment of an Intellectual Property Commons’ [2021] Utah Law Review (forthcoming) Abstract: Early during the COVID-19 pandemic, a number of widely-publicized incidents gave rise to concerns that holders of patents and other intellectual property (IP) rights could hinder the development, manufacture and distribution of essential medical devices, protective equipment and biomedical products. The global response to these concerns was swift and included the issuance of compulsory licensing orders by several national governments, as well as the proposal of a technology pool by the World Health Organization (WHO). Alongside these efforts, a group of scientific, engineering and legal experts created a lightweight, open framework under which IP holders could voluntarily pledge not to assert their rights against those responding to the COVID-19 pandemic. This effort – known as the Open COVID Pledge (OCP) – attracted significant participation from some of the world’s largest IP holders, with nearly 500,000 patents and patent applications, as well as significant copyrighted material, pledged to date. The OCP has also been adopted as part of the framework of the WHO’s COVID Technology Access Pool (C-TAP), a multinational initiative to make particular biomedical innovations more accessible around the world. This article describes the development of the OCP, including the design choices that shaped its legal structure and implementation. It also assesses the adoption of the OCP across market sectors including biopharmaceuticals, diagnostics, medical devices, protective equipment and digital innovations. It finds that while pledges in the biopharmaceutical sector have been infrequent, many other critical technologies in the fight against COVID-19 have been made broadly available to users through this and related pledging mechanisms, creating a favorable environment for open innovation, new market entry and equitable access to technology. As such, the OCP may both help to address the current pandemic and serve as a useful model for IP sharing platforms to address to future public health emergencies.
Contreras, Jorge L, ‘Research and Repair: Expanding Exceptions to Patent Infringement in Response to a Pandemic’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa014 Abstract: While public health emergencies such as the recent COVID-19 coronavirus pandemic strain resources, burden the economy and cause significant human suffering, they also provide opportunities to revisit established legal doctrines and consider them in a fresh light. This phenomenon is as true in patent law as it is in many other areas of law.1 Commentators have been quick to observe the many intersections between patent law and the coronavirus pandemic, often in connection with long-standing complaints and criticisms of the system.2 This essay does not attempt to address every patent law issue raised by the coronavirus pandemic, of which there are many. Rather, it focuses on two discrete areas of patent law through the lens of the current crisis and considers how we might adjust existing doctrine knowing what we know today.
‘Covid Virus Effects on Intellectual Property Rights’ (2022) Journal of Law Research (advance article, published online 5 July 2022) Abstract: The outbreak of Corona or Covid virus has had profound effects on various areas of social life. Legal rules have not been spared from the spread of the virus. As far as intellectual property rights are concerned, these works are evident not only in the field of industrial property rights, but also in the field of literary and artistic property rights. Especially in the field of pharmaceutical inventions, the need for reconciliation between the public health requirements and the exclusive rights of inventors and trade secrets associated with the corona virus has become more apparent than ever. The United Nations and the World Health Organization (WHO) have issued resolutions emphasizing the need for unity in equitable access to health technologies against Covid 19 in all parts of the world through the shared use of knowledge, intellectual property and data. In this regard, some jurists recommend the need to use the mechanism of compulsory exploitation (compulsory license) and other exceptions to the economic rights of inventors and trade secret owners. Other works of Covid 19 on industrial and commercial property rights include extending the deadlines related to industrial property rights and responding to the Patent Office until the state of emergency is resolved . In the field of literary and artistic property, except for software and databases, in addition to using the exceptions of the economic rights of creators, the focus is mainly on dramatic works and financial aid to the performers of these works. Its economics have been deprived.
Cowart, Tammy, Tsuriel Rashi and Gregory L Bock, ‘Should Pharma Companies Waive Their COVID-19 Vaccine Patents? A Legal and Ethical Appraisal’ (2023) 12(3) Laws Article 47 Abstract: Pharmaceutical companies, like many other types of companies, are incentivized to create, manufacture, and distribute new products, in part due to the legal protections of patent law. However, the tension between patent rights and the public good has been heightened as pharma companies developed new vaccines to combat the COVID-19 pandemic. Wealthy governments paid well for vaccines and received ample supplies, while low- and middle-income countries struggled to obtain access to any vaccines. Some countries called for pharmaceutical companies to waive their patent protections for vaccines in order to facilitate the worldwide manufacture and distribution of COVID-19 vaccines. This paper will examine the rationale of patent protection and patent waiver issues, then compare these concepts with ethical constructs and a Jewish perspective.
Craig, Carys and Bob Tarantino, ‘“An Hundred Stories in Ten Days”: COVID-19 Lessons for Culture, Learning, and Copyright Law’ (2021) 57(3) Osgoode Hall Law Journal 567–604 Abstract: In the face of a pandemic, copyright law may seem a frivolous concern; but its importance lies in the ever-expanding role that it plays in either enabling or constraining the kinds of communicative activities that are critical to a flourishing life. In this article, we reflect on how the cultural and educative practices that have burgeoned under quarantine conditions shed new light on a longstanding problem: The need to recalibrate the copyright system to better serve its purposes in the face of changing social and technological circumstances. We begin by discussing how copyright restrictions have manifested in a variety of contexts driven by the coronavirus lockdown, focusing first on creative engagement and then on learning, foregrounding the damage done by encoding a permission-first approach into governance structures and digital platforms. These stories unsettle the common copyright narrative— the one that tells us that copyright encourages learning and the creation and dissemination of works—laying bare its disconnect from the current realities of our digital dependency. Turning to consider the justifications for copyright control, we underscore the critical role of user rights and substantive technological neutrality in crafting a flexible and fair copyright system for the future. The article concludes with some lessons that might be drawn from these tales of copyright in the time of COVID19 to inform the development of new digital copyright norms for whatever ‘new normal’ emerges.
Cruz, David Enrique Betancourt, ‘An Exceptional International Intellectual Property Law Solution for COVID-19: Spurring Innovation to Facilitate Access to Affordable Medicines’ (Afronomicslaw COVID-19 Symposium on International Economic Law in the Global South (May 2020), Symposium II: Intellectual Property, Technology and Agriculture) Introduction: There is no doubt about the role international law can play in order to face the current COVID-19 pandemic. The answer is crystal clear: reform the current International Intellectual Property Law regime in order to accelerate innovation and facilitate access to affordable medicines worldwide. This could include examining how to better use the current flexibilities of the patent system so as to allow for more innovation, and effective co-operation/coordination in the scientific world. This unprecedented crisis of international scope offers us a rare opportunity to galvanize support for stronger international co-operation among the World Health Organization (WHO), World Intellectual Property Organization (WIPO), World Trade Organization (WTO), United Nations (UN), G20, and the European Union (EU) – as the top net exporter of pharmaceuticals. Reforming the international patent system and the Trade- Related Aspects of Intellectual Property Rights Agreement (TRIPS) is the type of real and pragmatic solidarity that we need to protect the most vulnerable individuals around the world.
DaBiere, Ashley, ‘COVID Vaccines and Intellectual Property Rights: Evaluating the Potential for National Legislation Implementing Global Patent Waivers’ (2023) 20(1) Duke Law & Technology Review 68–89 Abstract: Debates over the proper scope of intellectual property protections during the COVID-19 pandemic have occupied newspaper headlines since the first vaccines were developed nearly three years ago. Scholars and key politicians from several nations considered the implementation of a global patent waiver in an effort to make the vaccines more widely available in developing parts of the world. Although the question of whether such a waiver would fulfill this goal remains empirically unanswered and up for debate, the legal structure of United States patent law would make its implementation by Congress difficult given the value placed on intellectual property protections since America’s birth. If lawmakers wish to consider limiting patent rights in an inevitable future pandemic or other national emergency, they would be wise to consider these legal issues ex-ante by revising the Bayh-Dole Act and the existing patent law takings provision.
Davey, Neil, ‘COVID-19 Response in an Alternative America: Legal Tools That the US Government Failed to Invoke’ (2023) 25(1) Minnesota Journal of Law, Science & Technology 1 Abstract: This article begins with a description of the regulatory and patent landscape for various COVID-19 technology types, including testing (diagnostics), drugs (therapeutics), and vaccines. It then describes the COVID-19 crisis response in the United States from the Trump to Biden Administrations. Next, this article details how the government might have invoked other legal tools during this emergency. These include (1) bypassing patent rights in the pharmaceutical industry, (2) leveraging the government’s central authority to contract creatively and drive know-how transfer, and (3) invoking executive authority to commandeer part of the pharmaceutical sector. Unfortunately, the federal government failed to employ any of these three legal tools to increase access to COVID-19 testing, drugs, and vaccines. Understanding the nuances that may exist for different technology types, this article concludes with tailored solutions on what could have been used to end the pandemic more quickly and effectively. Ultimately, some of the core concerns around innovation incentives that exist for one technology type (e.g., compulsory licensing for complex vaccines) may not exist for another, given different market characteristics due to varying regulatory and patent landscapes. Thus, there is ripe ground for greater government intervention during future crises, without undermining needed innovation.
Davies, Lowri, ‘Compulsory Licensing: An Effective Tool for Securing Access to Covid-19 Vaccines for Developing States?’ (2023) 43(1) Legal Studies 86–103 Abstract: A significant issue in combatting the Covid-19 pandemic is the need to enhance developing states’ access to Covid-19 vaccines. The present paper considers the request for a temporary waiver of intellectual property rights in relation to Covid-19 technologies and treatments submitted to the World Trade Organization and analyses a key argument against the proposed waiver: that the compulsory licensing provisions set out in the TRIPS Agreement are sufficiently flexible to help states get access to vaccines. The compulsory licensing flexibilities set out in TRIPS, including the amendment to TRIPS in Article 31bis, are evaluated, to explore whether compulsory licensing could be an effective tool in helping developing states to access Covid-19 vaccines. Key issues are explored from a human rights perspective to examine whether a rights-based approach to the compulsory licensing provisions could offer further insights as to how the provisions could be more workable, to enhance access to medicines and vaccines for developing states.
Deb, Chaarushena, Osman Moneer and W Nicholson Price II, ‘Covid-19, Single-Sourced Diagnostic Tests, and Innovation Policy’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa053 Abstract: The United States’ disastrous response to the onset of the Covid-19 pandemic has arisen in large part by an utter failure to provide adequate diagnostic tests for the presence of SARS-CoV-2. The Centers for Disease Control were the sole testing source authorized by the Food and Drug Administration, and when the CDC failed to provide reliable tests in sufficient volume, it took weeks for other providers to be approved and to ramp up testing. Revised policies should decrease the likelihood of sole-sourcing tests in pandemic contexts, which results in a fragile system. The pandemic sole-sourcing failure, however, not only accelerated the pandemic, but also provides lessons for innovation policy about diagnostic testing more generally. Sole-sourcing hurts clinical practice by limiting confirmatory testing and systemic robustness, whether in a pandemic or in regular practice. We thus argue against relying too heavily on exclusivity-creating patents as innovation incentive for diagnostic tests—including the proposed Coons-Tillis patent reform bill which would increase patentability for many such tests. Instead, we propose the use of reformed reimbursement to create better incentives for diagnostic test innovation. In both pandemics and elsewhere, single-sourcing creates too great a point of failure, but targeted innovation policy can help.
Dhenne, Matthieu, ‘COVID-19, Patents and Access to Healthcare: A French Perspective’ (SSRN Scholarly Paper No ID 3614409, 1 May 2020) Abstract: While the coronavirus 19 (COVID-19) pandemic forced a large part of the world’s population into quarantine, research into treatment and testing intensified. At the same time, patents have rarely been so much in the forefront: how can we ensure that access to care will not be hindered by patents? Should we opt for an ex-officio license, relax the conditions of this license, or even expropriate the patentees? A bill tabled on April 7, 2020 in the French ‘Assemblée Nationale’ launches discussion in France.
Dong, Yupeng and Hong Wu, ‘The Collaborative Innovation between Patents and Standards: A New Path to Solve the Legal Dilemma of COVID-19 Vaccine Patenting’ (SSRN Scholarly Paper No 4373630, 1 March 2023) Abstract: As the COVID-19 pandemic continues, the rapid development and dissemination of safe, effective, and long-lasting vaccines have become global imperatives. Intellectual achievements must be fully respected and protected in order to have an effective and sustainable stimulating effect. Therefore, the granting of a patent on a COVID-19 vaccine is not inconsistent with its public goods status. However, there are many legal risks and conflicts of interest in the process of licensing the rights after patents are granted, and the current solutions to the legal dilemma of COVID-19 vaccine patents are inadequate. What remains promising, however, is that the collaborative innovation between patents and standards in the development of COVID-19 vaccines is a realistic legal and policy basis for promoting the public productization of COVID-19 vaccines. Therefore, this article proposes a synergistic solution to the legal dilemma of patents and standards for COVID-19 vaccines and suggests that both international legal and public policy support are needed to alleviate the dilemma, that efforts should be made to create a chartered innovation community based on contractual industrial alliances, and that the standard-essential patent system should be upgraded in an open innovation pattern.
Dugard, Jackie, Mandivavarira Mudarikwa and Nicola Soekoe, ‘COVID-19, International Trade Law, and the Gendered Dimensions of the Global Vaccine Apartheid: A Rights-Based Analysis’ in The Routledge Companion to Gender and COVID-19 (Routledge, 2024) Abstract: Even as the COVID-19 pandemic retreats into a relatively more manageable phenomenon, the costs of the global failure to overcome ‘vaccine apartheid’—including through expeditiously supporting a waiver proposal at the World Trade Organization (WTO)—are still being counted. This is especially so in the Global South, where inadequate access to COVID-19 vaccines has exacerbated exclusion, marginalization, and invisibility and has resulted in disproportionate burdens and impacts for poor women of color. Providing a gendered analysis of the impacts of vaccine apartheid, this chapter offers some insights into how international human rights can be mobilized in the effort to ensure that trade law is not used to justify the power imbalances and systematic inequalities that COVID-19 has both exposed and entrenched.
Eichensehr, Kristen E (ed), ‘United States Seeks Answers on COVID-19’s Origin While Stepping Up “Vaccine Diplomacy”’ (2021) 115(4) American Journal of International Law 732–739 Abstract: As the COVID-19 pandemic continues to rage across the world, the United States and its allies are pushing for answers about the virus’s origins while China rebuffs inquiry into its early handling of the outbreak. Meanwhile, a growing U.S. stockpile of vaccines has opened new avenues for ‘vaccine diplomacy,’ and the Biden administration has thrown its weight behind an effort to suspend cross-border intellectual property (IP) rules for vaccine manufacturing. In the near term, however, experts expect vaccination rates and access will continue to vary widely between countries depending on their wealth.
‘E-Learning and the Challenges of Copyright Infringement in the Covid 19 Era’ (2022) Journal of Law Research (advance article, published online 5 July 2022) Abstract: With the advent of Covid 19, serious transformations have taken place in various areas of life, including the style of general and specialized education. If in the past, classrooms were held in a physical environment with face-to-face presence of teachers and students, following the Corona era, there was a significant change in school and university education and virtual education in order to continue the education process and not stop the serious matter of education, E-Learning replaced the previous method. In virtual classrooms, instructional content, including videos, music, articles, and instructional slides, is provided by the professor or student for teaching or classroom exercises in the instructional system. In addition; The entire training class will also be recorded and subsequently made available. Each of these topics can be a work protected by the system of literary and artistic property rights (copyright). Therefore, their creators have the right to claim infringement of intellectual property rights and plagiarism in connection with unauthorized publishing and other unauthorized exploitation. The problem of the present study is what are the dimensions and risks of intellectual property rights in e-learning and how can these concerns be managed? The paper concludes with an analytical-descriptive method that the creators of scientific, literary and artistic works in the process of E-Learning can manage the secondary uses by using the technologies resulting from the Digital Rights Management and blockchain. Nevertheless, exceptions to intellectual property rights can impose rights and privileges in the public interest.
Fedorov, Valentyn et al, ‘Theoretical Problems of Legal Regulation of Innovations in the Medical Field: Experience in Counteracting Covid-19' (2020) 9(2) Ius Humani Law Journal 251–289 Abstract: 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.
Fischer, Sara E et al, ‘Intellectual Property and the Politics of Public Good in COVID-19: Framing Law, Institutions, and Ideas during TRIPS Waiver Negotiations at the WTO’ (2023) Journal of Health Politics, Policy and Law (advance article, published online 31 July 2023) Abstract: To facilitate the manufacturing of COVID-19 medical products, in October 2020, India and South Africa proposed a waiver of certain WTO intellectual property (IP) provisions. After 18 months, a narrow 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. FINDINGS: IP waivers are neither legally complex nor unprecedented within WTO law, yet TRIPS waiver negotiations exceeded their mandated 90-day negotiation period by nearly 2 years. Waiver opponents and supporters engaged in escalating strategic framing, which 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 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.
Fitzgerald, Patrick, ‘Why, in Light of COVID-19, Congress Should Legislate E-Book Solutions’ (SSRN Scholarly Paper ID 3850921, 10 January 2021) Abstract: Five months into the 2019 novel coronavirus (COVID-19) pandemic, the American Library Association found forty-seven percent of the United States libraries were closed, and did not plan to reopen soon. COVID-19 has diminished or temporarily ended access to over 650 million physical books in communities across the United States. In response, libraries have offered electronic books (e-books) to the public through different models called pretend it is print (PIP), cost per circulation (CPC), and controlled digital lending (CDL). At the beginning of the pandemic, an organization called Internet Archive decided to offer 1.4 million free, unrestricted e-books to the public. As a result, four of the biggest publishers sued Internet Archive in the Southern District of New York. The publishers argue Internet Archive specifically engaged in copyright infringement, but have also launched an attack on the legality of the CDL model. This note argues that the publishers’ lawsuit against Internet Archive ought to make the CDL model illegal, but Congress also ought to intervene to make e-books more similar to physical books in the PIP and CRC model, by reducing publishers’ pricing and reforming e-books’ current restrictions to make them more similar to physical books. Part II provides a brief overview of United States copyright law, culminating in a discussion of topics that relate specifically to e-books: the first sale doctrine, a potential digital first sale doctrine, the rights and limitations copyright holders have today, and the fair use doctrine. While discussing these concepts, Part II will examine how copyright law applies differently to physical books than e-books. Also included in this section will be important case law like Capitol Records, Ltd. Liab. Co. v. ReDigi Inc., since it has implications on the Hachette Book Group, Inc. v. Internet Archive case. Part III will discuss the ongoing battle between libraries and publishers and how the e-book system is currently constructed. This section will discuss the different types of e-book lending models that libraries and publishers engage in, including the costs and restrictions associated with each model, and why publishers believe e-book lending by libraries unfairly takes away some of publishers’ profits. This section will also address how COVID-19 has impacted libraries and publishers. Part III ends by inspecting the facts around the Internet Archive case, including the controversial model Internet Archive operates in, known as CDL. Part IV will apply copyright law to the facts of Internet Archive. Part IV will conclude Internet Archive engaged in copyright infringement, and its use is not protected by the fair use doctrine. After discussing Internet Archive specifically, Part IV will turn its focus to the model Internet Archive operates in, known as CDL. This part will conclude the model as a whole constitutes copyright infringement, and its use is also not protected by the fair use doctrine. Thus, I will argue the publishers should, and will, prevail on their copyright infringement claim. After predicting the publishers will prevail in their lawsuit against Internet Archive, Part V will discuss solutions to make the remaining models, PIP and CPC, better. I will argue Congress should intervene to regulate the structure of e-book licenses to imitate physical books. However, these solutions are not meant to supplant the technology restrictions already in place by publishers and libraries to prevent piracy, in particular digital rights management (DRM) technology, and the one book, one user limitation. Congress should set e-book licenses to expire based on what type of book the physical version is, mandate the use of advanced technology to limit e-books’ accessibility, and provide that the first sale doctrine does not to apply to digital copyrighted works. By having Congress intervene to make e-books more like physical books, the hope is that publishers will recognize how e-books are similar to physical books, and lower the prices publishers charge libraries for e-books. This would create a more equitable e-book lending market where libraries are able to circulate more e-books through a lower cost, and publishers can to continue to profit off of their works.
Flynn, Sean et al, ‘Implementing User Rights for Research in the Field of Artificial Intelligence: A Call for International Action’ (Joint PIJIP/TLS Research Paper Series No 48, 2020) Abstract: Last year, before the onset of a global pandemic highlighted the critical and urgent need for technology-enabled scientific research, the World Intellectual Property Organization (WIPO) launched an inquiry into issues at the intersection of intellectual property (IP) and artificial intelligence (AI). We contributed comments to that inquiry, with a focus on the application of copyright to the use of text and data mining (TDM) technology. This article describes some of the most salient points of our submission and concludes by stressing the need for international leadership on this important topic. WIPO could help fill the current gap on international leadership, including by providing guidance on the diverse mechanisms that countries may use to authorize TDM research and serving as a forum for the adoption of rules permitting cross-border TDM projects.
Foss-Solbrekk, Katarina, ‘IP Waiver and COVID-19: Reasons for Unwavering Support’ (2021) 16(12) Journal of Intellectual Property Law & Practice 1347–1359 Abstract: This article supports India’s and South Africa’s proposal for an intellectual property (IP) waiver on COVID-19 tools at the World Trade Organization. Compulsory licencing is not a satisfactory solution to vaccine inequality because it is a drug-specific and country-specific process, with legal and administrative complexities for developing countries. An IP waiver, however, would allow developing and least developed countries to have better access to COVID-19 vaccines. Although several hurdles must first be overcome, including tech transfers, data disclosures, investments in production capabilities and an end to exports on raw materials, these are not insurmountable. In addition, because of the unprecedented amounts of public funding allocated throughout the vaccines’ development cycle, a waiver would not harm innovation in the short term or medium term by removing incentives to develop essential pharmaceutical products.
Franceschin, Alberto, ‘Intellectual Property and Transfer of Technology in Foreign Investment Law with Special Reference to Voluntary Licensing in the Aftermath of Covid-19’ (Masters Thesis, Political Science, Legal and International Studies, Università Degli Studi di Padova, 2024) Abstract: Intellectual Property Rights are widely acknowledged as fundamental means for protecting the ‘creations of mind’ and guarantying just revenues and incentives to their owners. Simultaneously, as technological progress is not equally disseminated around the globe, contributing to the unequal distribution of well-being, advocating for international transfer of technology is within the agenda of major multilateral organizations. At the heart of this dissertation lies this tension between appropriate protection of Intellectual Property Rights and broader diffusion of technological progress, which has been analyzed through an extensive use of primary resources retrieved from domestic and international organizations’ databases and complemented with various national pieces of legislations. The result is a currently review of the posture of state actors over this issue, completed with the most recent debate within the WTO over voluntary licensing agreement in the aftermath of Covid-19.
Frankel, Susy, ‘COVID-19, Vaccines and International Knowledge Governance on Trial’ (2022) 12 Queen Mary Journal of Intellectual Property (forthcoming) Abstract: 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 have 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, this was not the position in much of the developing world, where the problem now seems to be the distribution of vaccines. Distribution may have always been difficult but the failure for timely local supply has exacerbated the problem of vaccine inequality between the developed and developing world. The problem has several likely causes including intellectual property rules. That said, it is not necessarily the existence of patents (or other rules) but the insufficiency of checks and balances that are necessary to address global public health needs. This has 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 is not fit for purpose in a pandemic.
Frye, Brian L, ‘Literary Landlords in Plaguetime’ (SSRN Scholarly Paper No ID 3701236, 28 September 2020) Abstract: Copyright scholars disagree about whether we should conceptualize copyright as a form of property. This essay accepts the property metaphor and asks what it entails. It observes that if copyright is property, then copyright owners are landlords. It reflects on why copyright owners love the property metaphor, but hate the landlord metaphor. And it asks how conceptualizing copyright owners as landlords might affect our assessment of their moral claims.
Gao, Hua, ‘Chinese Legislation and Theoretical Basis for Patent Parallel Import: Consideration of Parallel Import of Pharmaceutical Patents During the Pandemic’ (2024) 6(1) Scientific and Social Research 71–84 Abstract: The current Chinese Patent Law permits parallel import, but its theoretical basis is disputed. Neither the principle of domestic exhaustion of rights nor the principle of international exhaustion of rights can be used as the theoretical basis to support parallel import. Chinese legislation can set aside the traditional dispute between the principle of exhaustion of rights and the principle of territoriality, support parallel import in principle, and make exceptions in which parallel import can be prohibited if the parallel importer violates the contract or authorization agreement or conducts unfair competition to damage the legitimate rights and interests of the patentee or the consumer. The primary objective of legislation on parallel imports of pharmaceutical patented products should be better protection of public health. Permitting parallel import of patented medicine is of utmost significance to decrease the price of patented drugs and expand the accessibility of drugs. However, we should also prevent the import of fake and inferior goods. China should be cautious about permitting the parallel import of ‘repackaged’ pharmaceutical patented products in legislation and law enforcement. Regarding administrative enforcement, the customs should set up special supervision authorities for patent import and export, and standardize the enforcement procedure for parallel import.
Gilbert, Penny et al, ‘2B Patent Law Session. Patents and the Pandemic’ (28th Annual Intellectual Property Law & Policy Conference, Fordham University School of Law, 8 April 2021) Abstract: Vaccination programs clearly offer a way out of the pandemic, or so we hope, but a return to any kind of normality is going to need vaccines to be made available not just in our own countries, but also worldwide as soon as possible. That brings us on to the topic that we’re here to discuss with the panel, the role of patents in responding to COVID-19. What has that been and has it ensured that we’re going to have access to vaccines? How are we going to cope with access to vaccines in poorer countries and facilitate additional manufacturing to make sure we have adequate supplies for everyone? Have patents provided the motivation for investment in research into this rapid development of coronavirus vaccines or do we think that they are actually getting in the way of a broader rollout?
Gobir, Habeeb, ‘Intellectual Property, SMEs, and Economy Recovery in Nigeria’ (SSRN Scholarly Paper ID 4016693, 25 January 2022) Abstract: Small and Medium Size Enterprise (SMEs), without any doubt, play an important role in the growth and development of a nation. As a matter of fact, ever since the outbreak of Covid-19, many countries around the world are now shifting their focus to the development of SMEs as the primary driver of economic recovery, and Nigeria should not be an exception. Nigeria, as a case study, is one country struggling to bounce back into normalcy due to the economic implications occasioned by the outbreak of COVID-19. In Nigeria, SMEs play an important role in the country’s economic development. Sadly, despite this, Nigeria continues to struggle to accelerate its development. This study will show the significance of SMEs to the Nigerian economy as well as their role in the recovery process. The paper went on to show how a strong IP regime benefits both SMEs and Nigeria, as well as how a lack of IP awareness among most SMEs contributes to the country’s economic downturn. It was concluded at the end of the paper that SMEs need to protect their IP rights before they can serve as a perfect drive for economic recovery in Nigeria.
Gurgula, Olga, ‘Drug Prices, Patents and Access to Life-Saving Medicines: Changes Are Urgently Needed in the COVID-19 Era’ (2021) European Intellectual Property Review (forthcoming) Abstract: When patented life-saving drugs are inaccessible to patients due to high prices it is evident that the system does not perform its intended function and urgently requires reforming. The paper discusses the evidence recently revealed by the US House Committee on Oversight and Reform that directly contradicts pharmaceutical companies’ traditional argument justifying strong patent protection as a vehicle for recouping their R&D investments. It further suggests that structural and comprehensive changes are necessary, including a rigorous investigation into pharmaceutical pricing and patenting practices, ensuring adequate access to the drugs developed with public funds, and assuming the responsibility for public health by governments.
Gurgula, Olga and John Hull, ‘Compulsory Licensing of Trade Secrets: Ensuring Access to COVID-19 Vaccines via Involuntary Technology Transfer’ (Queen Mary Law Research Paper No 363/2021, 23 June 2021) Abstract: This paper considers how vaccine technology to meet the challenges of the COVID-19 pandemic can be made available to increase the production of vaccines. Its primary focus is on trade secrets, which are one of the main intellectual property rights protecting the complex manufacturing processes of vaccine production. The compulsory licensing of trade secrets presents some unique obstacles and consideration is given to some practical solutions that might balance the interests of technology owners and the public interest in increased access to vaccines. In particular, this paper suggests that to make the currently discussed proposals on accelerating the production of COVID-19 vaccines, including compulsory licensing of patents and the IP waiver, work, an additional mechanism of compulsory licensing of trade secrets is required. It is believed that a proposal for a new mechanism of compulsory licensing of trade secrets coupled with a discussion on the content of such licences, challenges that would need to be addressed and the potential wording of such a licence, would provide useful guidance to governments on how to make their compulsory technology transfer mechanisms more effective.
Gurgula, Olga and Luke McDonagh, ‘Access Denied: The Role of Trade Secrets in Preventing Global Equitable Access to COVID-19 Tools’ (SSRN Scholarly Paper No 4484507, 19 June 2023) Abstract: The COVID-19 emergency has intensified a long-running debate over access to health technologies by illustrating the conflicts between intellectual property (IP) rules and global health objectives. While this debate has traditionally focused on patents, the pandemic brought to light concerns over other forms of IP such as trade secrets and other confidential information. During the COVID-19 pandemic, the UK government made extensive reference to trade secret provisions as a way of restricting transparency during public procurement procedures. Pharmaceutical companies relied on trade secret protection to prevent other companies accessing manufacturing methods of COVID-19 vaccines and other commercially valuable information. In non-pandemic times, the UK government withholding certain procurement information, and private companies refusing to reveal trade secrets, may in limited circumstances be justifiable to protect commercially sensitive information. However, in the context of a global emergency such actions must be questioned. This report provides a critical analysis of these issues, concluding that greater transparency is required in the public procurement process - especially in a time of emergency - to ensure a fair and equitable allocation of resources, and to guarantee accountability on the part of both the UK government and the pharmaceutical industry. We explain that the UK government prioritised trade secret protection over transparency during the public procurement of COVID-19 vaccines, and that pharmaceutical companies utilised trade secrecy strategies to prevent generic manufacturers from producing vaccines. We explore how this prevented good governance and denied equitable access to COVID-19 health products. We set out recommended legal and policy options to ensure that access to pandemic health tools is not denied again during emergency circumstances. Our recommendations cover transparency, technology transfer (including involuntary technology transfer in the form of compulsory licensing of trade secrets), fair distribution of IP ownership, competition and open innovation.
Harankaha, HaM, ‘Intellectual Property Rights and Global Pandemic: A Patent Law Perspective’ (Proceedings of the Annual Research Symposium 2021, Faculty of Law, University of Colombo, 23rd November 2021, 2021) 205 Abstract: COVID-19 Global Pandemic has rapidly made countries, governments and policy makers rethink and change their standards, policy decisions in order to adjust with the unpredictable phenomenon. Intellectual Property Rights (IPR) and intellectual property policies are not an exception to this. While IPR promotes research and development, technological development and transfer of technology, it also inspires individual rights, non-competition in the market place and monopoly rights that would hinder some human rights such as the right of health, healthcare and food. In response to the rapid expansion of the pandemic, there are moves from many developed countries who are the owners of many IPR, Patent Offices, research institutions and research universities to go for waivers of IPR and soften the procedure adopted for patent granting. The US Government’s announcement that it would support the temporary waivers of IP rights relating to COVID-19 medicinal products including vaccination, the US Patent and Trademarks Office’s (USPTO) decision to prioritize patent examination for COVID related inventions for a nominal fee, the move of some IPR owners to grant free licenses to manufacture vaccines and other COVID related products, and universities and research institutions coming forward to collaborate with industries in curbing the COVID-19 Pandemic are few among them. However, these moves are subjected to many criticisms from IPR perspectives. It is argued that IP protection should not liberalize but should introduce a massive drive of technology transfer and capacity expansion. This paper analyzes how this global situation and new trends in IPR would affect the Sri Lankan IP law and recommends that Sri Lanka should look forward to promoting technology transfer while softening its IPR laws for COVID related inventions.
Heled, Yaniv, Ana Santos Rutschman and Liza Vertinsky, ‘The Need for the Tort Law Privileges of Self-Defense and Necessity in Intellectual Property Law’ (SSRN Scholarly Paper ID 3642833, 3 July 2020) Abstract: The COVID-19 pandemic has laid bare inherent tensions between the protection of intellectual property (IP) and the health of individuals touched by life-threatening medical conditions. Examples from around the world have made front page news: hospitals desperate for ventilator parts while 3D-printing instructions for such parts remain unshared for fear of liability; potentially lifesaving medicines whose manufacture and distribution on sufficient scale is limited by the threat of patent infringement; proprietary clinical data essential for making life-or-death decisions withheld from doctors and patients; the list continues. The threat of liability for IP infringement also dampens the ability to innovate under conditions of emergency, further contrasting the protection of IP with the protection of human lives. A number of policy responses for the current pandemic have been advanced, including the application of government rights under the Defense Production Act to IP contexts, compulsory licensing, legislation that would allow for emergency overrides to IP protections, and efforts to encourage companies to make their IP freely available voluntarily through the Open COVID Pledge. But fears of disrupting IP protections have curtailed the use of these measures, leaving the tensions between protection and life-saving access largely unaddressed. In this Article we argue that the time is ripe for doctors, hospitals, independent compounders, medical products manufacturers, engineers and, ultimately, litigants and the courts to consider self-defense and necessity as an old-new tool for resolving IP disputes. Doing so would not only be ethically sound but would also help to resolve many of the public health critiques that have been plaguing IP law by attenuating ingrained misalignments between IP frameworks and the furtherance of public health goals. The Article demonstrates the need for the self-defense and necessity doctrines in IP law; explains how such claims may allow defendants to avoid liability in circumstances in which infringement is necessary to prevent adverse public health outcomes; and shows why the adoption of these doctrines is needed to increase preparedness ahead of future—indeed expected—outbreaks of infectious diseases.
Hilty, Reto et al, ‘Covid-19 and the Role of Intellectual Property: Position Statement of the Max Planck Institute for Innovation and Competition of 7 May 2021’ (Max Planck Institute for Innovation & Competition Research Paper No 21–13, 7 May 2021) Abstract: In this Statement, the authors take a position on the waiver of intellectual property (IP) protection currently being considered by the members of the World Trade Organisation. The waiver was initiated by India and South Africa as a measure to enable rapid access to affordable medical products that are necessary to combat Covid-19. The initiative gained momentum after the US decided to support it. The authors do not consider this path to be expedient. The Statement presents factual and legal arguments why a comprehensive waiver of IP protection is unlikely to be a necessary and suitable measure towards the pursued objective. Overall, it argues that IP rights may so far have played an enabling and facilitating rather than hindering role in overcoming Covid-19. The global community might not be better off if IP rights are waived, neither during nor after the pandemic. There are more efficient and direct ways to supply developing countries with vaccines quickly – if the industrialised countries are willing to do their share.
Hilty, Reto et al, ‘Position Statement of 5 July 2022 on the Decision of the WTO Ministerial Conference on the TRIPS Agreement Adopted on 17 June 2022’ (Max Planck Institute for Innovation & Competition Research Paper No 22–14, 5 July 2022) Abstract: On 17 June 2022, after nearly one and a half years of intense debate concerning the proposal to waive IP protection in view of the COVID-19 pandemic, the Ministerial Conference of the World Trade Organization adopted a decision on the TRIPS Agreement. It has not waived any intellectual property rights as such but instead mainly clarified the application of the existing TRIPS flexibilities, in particular, regarding compulsory licensing of patents. The Position Statement shows that the Ministerial Decision makes no substantive difference in the existing international legal framework, except for lifting the limitation on the exportation of vaccines manufactured in accordance with the Decision. To the extent that the Decision can make the application of TRIPS flexibilities more expedient, it is to be welcomed. At the same time, it is argued that such facilitating effect should not be limited to, or justified by, the exceptional circumstances of the COVID-19 pandemic. More critically, it should not be restricted to COVID-19 vaccines, of which there is currently no shortage – rather, the same level of TRIPS flexibilities should apply to all medicinal products needed to overcome the COVID-19 pandemic.
Haugen, Hans Morten, ‘Does TRIPS (Agreement on Trade‐Related Aspects of Intellectual Property Rights) Prevent COVID‐19 Vaccines as a Global Public Good?’ (2021) 24(3/4) Journal of World Intellectual Property 195–220 Abstract: The article analyses the global public goods approach to COVID‐19 technologies, embedded in 2020 affirmations by the World Health Assembly (WHA), the UN Human Rights Council and G20 on broad immunization against COVID‐19. After identifying the access to COVID‐19 tools (ACT) Accelerator members, the UN efforts are identified, focusing primarily on the UN human rights bodies, acknowledging how these and the WHA have mutually reinforced each others’ efforts. The article finds that the global public goods terminology appeared in UN resolutions in 2020, while wording that included vaccines—on an equal footing as medicines—appeared in 2016, and recognition of generic medicines appeared in 2019. The so‐called Trilateral Cooperation on IP and public health between two UN specialized agencies and the World Trade Organization (WTO) has increased awareness of the flexibilities within WTO’s TRIPS Agreement. These flexibilities are explained. With notable exceptions, like India, these flexibilities are not widely applied in domestic legislation. A different emphasis characterizes the millennium development goals era as compared to the sustainable development goals era, and this shift is explained by applying relevant theories. Among pro‐TRIPS developed countries there is an acknowledgment of obstacles created by the IP system, but their overall position has not changed.
Ho, Cynthia M, ‘IP Nationalism: Addressing the COVID Crisis and Beyond’ (SSRN Scholarly Paper ID 3910806, 23 August 2021) Abstract: This Article coins and explains the phenomena of IP nationalism. Just as some nations engage in vaccine nationalism by hoarding limited COVID vaccines, so, too, some nations are hoarding critical knowledge and technology by resisting modification of usual IP rules during the pandemic, such as a proposed waiver of international IP obligations. Countries that are home to IP-owning pharmaceutical companies often benefit from strong global IP rights, since that usually improves domestic GDP for IP-intensive products such as drugs. Even nations without strong IP exports may embrace IP nationalism because current international laws provide economic benefits to these countries in terms of increased trade for non-IP goods. As this Article explains, countries that embrace IP nationalism raise incomplete, or affirmatively false arguments asserting that barriers to accessing medicines are primarily caused by non-IP issues, which hides how IP and IP nationalism are nonetheless creating barriers to access.IP nationalism is harmful. Failure to modify traditional IP rights has contributed to inadequate supply of COVID vaccines, which will likely result in more variants that threaten global health and suppress global economic recovery due to disruption of global supply chains. Even outside a pandemic, where IP nationalism could economically benefit countries with IP-intensive exports, it still creates other harms. For example, IP nationalism results in strong global IP rights that often make necessary goods, such as life-saving medicines, unaffordable to many people worldwide. Furthermore, these rights primarily promote innovation that is most profitable, rather than what is most socially desirable. For example, companies are incentivized to pursue and market treatments of questionable utility, such as the newly approved Alzheimer’s drug that may not even be effective, simply because they generate substantial profits. In contrast, vaccines beyond COVID and antibiotics, though desperately needed by all, are generally not pursued due to low profitability.This Article argues that IP for essential treatments such as COVID vaccines should be considered ‘global public goods’ available to all, contrary to beliefs held by supporters of IP nationalism. This would be an admittedly radical, yet necessary change from current norms. First, this could encourage countries to embrace the proposed waiver of international IP rules for COVID treatments. Although waiving traditional IP rights will not immediately increase vaccine supply, it would permit available and interested companies to expand vaccine capacity and create competition that would likely increase supply and lower costs, allowing poorer countries greater access to the vaccine. In addition, recognition of IP covering pandemic treatments as global public goods would help avoid replicating the current vaccine apartheid in subsequent pandemics and begin to counteract well-documented racial and ethnic disparities regarding access to medicines.
Huang, Vicki T, ‘COVID-19 as a Trade Mark in Australia: Issues and Implications’ [2020] European Intellectual Property Review (forthcoming) Abstract: In the past, well-publicized adverse events have triggered surges in ‘tragedy’ trade mark applications for signs such as ‘9/11’ or ‘MH370’. Unsurprisingly (as at 31 March 2020) there were 57 trade mark applications for the word ‘COVID-19’ across trade mark registers across the globe. In Australia, these types of marks face a variety of legal hurdles that may prevent registration. These include the question of whether the mark is ‘distinctive’ and the bar against ‘scandalous’ marks. This article discusses how ‘COVID-19’ (and other tragedy related trade marks) challenges the boundaries of these rules; the likelihood of COVID-19 being registered; and whether Australian law should change to expressly proscribe against ‘tragedy’ trade marking.
Hudson, Emily, ‘Copyright Guidance for Using Films in Online Teaching During the COVID-19 Pandemic’ (SSRN Scholarly Paper ID 3667025, 4 August 2020) Abstract: This Guidance discusses copyright options for using feature films and other audiovisual content in online teaching. It responds to concerns amongst UK higher education institutions (HEIs) that moving education online as a result of the COVID-19 pandemic raises new copyright risks. At many HEIs, in-person lectures may not be possible in the coming academic year due to COVID-related social distancing requirements. Even if some face-to-face teaching is possible, many students will undertake some or all of their studies remotely. One particular concern has been ensuring that Film Studies departments can screen feature films to students online, this being an essential part of those programmes. But lecturers in other disciplines also use a variety of films in their teaching, making these copyright questions of broader relevance. HEIs are keen to know whether they may use audiovisual content in online teaching without a licence. The key take-home message from this Guidance is that there are a number of exceptions in the Copyright, Designs and Patents Act 1988 (CDPA) on which HEIs may be able to rely. It focuses in particular on the fair dealing exception for illustration for instruction in s. 32 of the CDPA, and quotation in s. 30(1ZA).
Hudson, Emily, ‘Updated Copyright Guidance for Using Films, Audiovisual Works and Images in Online Teaching: Beyond the Covid Pandemic’ (SSRN Scholarly Paper ID 4042770, 24 February 2022) Abstract: In August 2020, I released guidance in relation to the copyright options for using feature films and other audiovisual content in online teaching. That guidance sought to address questions from UK higher education institutions (HEIs) in relation to the copyright implications of the sector-wide shift to remote learning necessitated by the Covid pandemic. HEIs were keen to know whether they could use audiovisual content in online teaching without a licence. The key take-home message was that there are a number of exceptions in the Copyright, Designs and Patents Act 1988 (CDPA) on which HEIs may be able to rely, including section 32 (fair dealing for the sole purpose of illustration for instruction) and section 30(1ZA) (fair dealing for the purpose of quotation). This Updated Guidance updates my earlier guidance. It includes new content, in particular a legal checklist for using section 32 and new analysis on the use of stills, photographs and other images by reference to fair dealing. It also considers the degree to which the 2020 analysis of fair dealing was dependent on the conditions that characterised the first year of the pandemic. Its key message is that many of the arguments that film and audiovisual works may be used in online teaching by reference to copyright exceptions are not dependent on the Covid pandemic. Rather than seeing these arguments as reflecting the exceptional and ‘unprecedented’ nature of the pandemic, it can be argued that the pandemic merely accelerated the emergence of new copyright norms and interpretations in relation to educational copying exceptions.
Hudson, Emily and Paul Wragg, ‘Proposals for Copyright Law and Education During the COVID-19 Pandemic’ (SSRN Scholarly Paper No ID 3617720, 3 June 2020) Abstract: This article asks whether the catastrophic impact of the COVID-19 pandemic justifies new limitations or interventions in copyright law so that UK educational institutions can continue to serve the needs of their students. It describes the existing copyright landscape and suggests ways in which institutions can rely on exceptions in the CDPA, including fair dealing and the exemption for lending by educational establishments. It then considers the viability of other solutions. It argues that issues caused by the pandemic would not enliven a public interest defence to copyright infringement (to the extent this still exists in UK law) but may be relevant to remedies. It also argues that compulsory licensing, while permissible under international copyright law, would not be a desirable intervention, but that legislative expansion to the existing exceptions, in order to encourage voluntary collective licensing, has a number of attractions. It concludes by observing that the pandemic highlights issues with the prevailing model for academic publishing, and asks whether COVID may encourage universities to embrace in-house and open access publishing more swiftly and for an even greater body of material.
Jashari, Adnan and Stefani Stojchevska, ‘Intellectual Property Rights in Outer Space: How Can Pharmaceutical Companies Protect COVID-19 Vaccine and Immunotherapy Developments Aboard the ISS US National Laboratory?’ (2023) 26(2) The Journal of World Intellectual Property 227–258 Abstract: Believing that space pharmaceuticals might be the key to winning the battle against COVID-19, global pharmaceutical companies such as AstraZeneca and Sanofi Pasteur are currently collaborating with the International Space Station National Laboratory (ISS-NL) on research projects aiming to develop vaccine-and-immunotherapy products. The present legal regime for outer space, however, does not provide clear guidelines on safeguarding intellectual property rights (IPRs), due to the difficulties of reconciling the territorial nature of patent law and the nonterritorial nature of space law. Responding to such a legal gap, this research paper argues how pharmaceutical companies can protect such medical innovations by taking into consideration the international principles of space law addressing IPRs and extraterrestrial jurisdiction, as well as the legal regime of the ISS-NL. With the exception of the possibility of the barriers between the two areas of law not being insurmountable, the proposed COVID-19 TRIPS Waiver furthermore impacts space pharmaceuticals’ IPRs and commercialization, which leads to the identification of some advantageous forms of agreements, including the Joint Endeavor Agreement, the Space Act Agreement, as well as the Cooperative Research and Development Agreement, for pharmaceutical companies defined as agreement partners with the National Aeronautics and Space Administration.
Jepson, Daniel, ‘In Case of Emergency Exploit Rights?: A Summary of the Crown’s Power to Exercise Intellectual Property Rights in an Emergency’ (2020) 33(2) Australian Intellectual Property Law Bulletin 22–24 Abstract: Recent events, including the COVID-19 pandemic, have led to calls for governments to use privately owned intellectual property for the public interest. Contact tracing technology, testing kits, potential treatments and research analysis are just a few examples of privately generated inventions and works that may be of incredible public benefit in a pandemic. This article considers how and when governments (and others authorised by them) may obtain rights in an emergency, particularly those connected with patents, designs and copyright.
Kameel, Tariq, Ramzi Madi and Kawthar Kayed, ‘The Compulsory Licensing for Exploiting Patented COVID-19 Pharmaceutical Treatment: Legal Approaches of Some Arab Countries’ (2021) 40(2) Biotechnology Law Report (advance article, published 10 March 2020) Abstract: This article deals with exploitation of a pharmaceutical patent to treat the novel coronavirus. The laws of several Arab nations, which regulate industrial property rights in regard to the use of compulsory licensing for exploiting patented COVID-19 pharmaceutical treatments, are examined, compared, and contrasted. The cases in which such laws permit use of compulsory licensing are clarified, such as in the interest of national security and in emergencies. This article concludes that the COVID-19 pandemic has posed a serious threat to the public health of various countries which has justified the use of compulsory licensing to exploit new patents. A patent owner has the right to be granted appropriate compensation during exploitation, and the new compulsory license terminates once the purpose for which it has been given terminates.
Kavia, Aditi and Karan Singh Chouhan, ‘Patent Rights & Pandemics: A Case of Public Interest vis a vis Monopoly Rights’ (2020) 1(1) E- Journal on Academic Innovations and Research on Intellectual Property Assets 47–66 Abstract: Unprecedented global health crisis caused by COVID 19 calls for an immediate response from countries to fight the pandemic and provide affordable medical care to its people by invoking provisions under patent laws. We understand patent laws as monopoly rights given to the patent holder for the invention, which makes us contemplate whether public interest holds any place under the patent laws. The paper sheds some light on the never-ending debate between these two opposing views, i.e., public interest and patent rights which has been rekindled and resurfaced due to the pandemic. The paper addresses the problem of access to medicine and how patent laws can be conducive in providing affordable medicine and promoting public health. Furthermore, it also elucidates several legal options available under WTO and domestic legislation under the context of public health, and whether they are adequate to combat the effects of the present pandemic. Finally, we will discuss any other alternative model, apart from compulsory licensing, which needs to be looked into to deal with the current public health crisis.
Kleyn, Madelein and Enrique Longton, ‘Patent Waiver in the Time of COVID-19’ (2021) 56(3) les Nouvelles: Journal of the Licensing Executives Society 269–272 Abstract: In light of the Covid-191 pandemic that has plagued the world since its December 2019 discovery in China, there has been growing support for the reduction or outright suspension of Intellectual Property (IP) rights related to Covid-19 treatments and therapies. Those who favor this approach refer to it as ‘patent waiver.’ The IP rights most frequently mentioned in this regard are patent rights, although other intellectual property rights have not escaped similar scrutiny. The movement to waive patent rights has become more widespread over the last several months with the approval of safe and effective Covid-19 vaccines credited with reducing transmissions of the virus and lowering morbidity and mortality rates. These encouraging results are seen among those who have been fully vaccinated and those who live in places where vaccines are readily available.
Klinowski, Mateusz and Karolina Szafarowicz, ‘Digitisation and Sharing of Collections: Museum Practices and Copyright During the COVID-19 Pandemic’ (2023) 36(5) International Journal for the Semiotics of Law - Revue internationale de Sémiotique juridique 1991–2019 Abstract: This article concerns the conflict between copyright and museums’ digitisation and online sharing of collections. This issue has recently become particularly important in connection with the COVID-19 pandemic. The authors outline the concept of a virtual museum and present the most important copyright provisions in EU law that may create obstacles for cultural institutions in realising virtual counterparts. To perceive copyright as the main obstacle in the process of digitisation and online sharing of collections is not unusual. Hence, the article briefly presents legal framework of the European copyright applicable to such situations. The authors argue that although copyright offers a range of possibilities for museums interested in digitising their collections, at the same time it is responsible for a chilling effect, resulting in fear of potential infringement and liability. The authors conclude that the EU’s development of new legislation, coinciding with the need for digitisation and online sharing of cultural heritage caused by the pandemic, has favoured public interest at the expense of creators’ rights, but still lacks satisfactory legal tools for effectively allowing cultural institutions to digitise and share their collections.
Kouletakis, Jade, Ayoyemi Lawal-Arowolo and Nkem Itanyi, ‘Copyright Law Protection of Films in Nigeria (Nollywood) and South Africa (Sollywood): Pre and Post-Covid-19 Pandemic’ (2023) 26(3) The Journal of World Intellectual Property 436–457 Abstract: The Covid-19 pandemic inflicted socioeconomic harm on an unprecedented scale. Across the world and to varying degrees, cinemas were closed, festivals were cancelled or postponed, and film releases were moved to future dates or delayed indefinitely. In 2020 the entire global theatrical and home/mobile entertainment market totalled $80.8 billion, the lowest figure since 2016 and a decline of 18% from 2019. Theatrical entertainment accounted for only 15% of the total global entertainment revenue, compared to 43% in 2019. While some has been written about the effects of Covid-19 on both international and local film industries, this article seeks to provide an African perspective focusing on the realities in Nigeria and South Africa, respectively. This article examines the importance of filmmaking industries in Nigeria and South Africa as well as the difficulties faced during the Covid-19 pandemic. Copyright laws in both terrains are critically reviewed based on the capacity of these laws to protect the interests of film industries pre and post-Covid-19.
Kovac, Mitja and Lana Rakovec, ‘The COVID-19 Pandemic and Long-Term Incentives for Developing Vaccines: Patent Law under Stress’ (2022) 25(2) The Journal of World Intellectual Property 292–316 Abstract: Continents are facing an apocalyptic pandemic that is terribly dangerous for millions of their inhabitants. This paper seeks to address the role of intellectual property (IP) law in addressing the problem of the COVID-19 pandemic. We suggest that the current international IP law regime and the Trade-Related Aspects of Intellectual Property Rights Agreement are not insurmountable obstacles for access to a successful COVID-19 vaccine. The publicly advocated fundamental reform or even abolition of the present IP law regime under serious information asymmetries might be counterproductive and distortive. Via existing compulsory licensing, advance purchase agreements and the employment of patent-pools, research subsidies, reward mechanisms and reputational sanctions, governments can take the steps needed to effectively overcome any IP-associated barriers to access to crucial medicines/vaccines, particularly during the COVID-19 pandemic. Moreover, the current wave of medical research on COVID-19 suggests the previous vaccine R&D ‘failures’ were driven by the modest demand for such vaccines and were not due to an inadequate IP-incentive stream. The paper also suggests today’s EU competition law rules on the horizontal exchange of information could be seen as an impediment to innovation and thus be temporary suspended.
Kumar, Hemant, ‘Granting of Compulsory License to Indian Pharmaceutical Companies: A Moonshot to Cure India’s Covid Vaccine Woes’ (2021) 25 Supremo Amicus Journal (unpaginated) Abstract: Vaccine manufacturers such as Pfizer/BioNTech and Moderna have been in talks with Government of India but at the present juncture it seems that the talks have reached a stalemate on over the issue of liability of the vaccine manufacture in event of deaths caused by the said vaccine manufactured by same.38 Therefore, accordingly due to prevalent circumstances in regard to vaccinations it would be well served if the Government of India would act and permit the development and manufacturing of Covid vaccines under the aegis of compulsory license as envisioned in The Patents Act, 1970 and in international instruments to which India is a party to such as ‘TRIPS Agreement (The Agreement on Trade Related Aspects of Intellectual Property Right)’ by virtue of being a member of World Trade Organisations (WTO).
Kumar, Mrityunjay and Nalin Bharti, ‘Why Patent Waiver for Covid-19 Vaccines and Pharmaceuticals?’ (2023) 26(2) The Journal of World Intellectual Property 195–226 Abstract: Patent protection emerged as one of the most challenging barriers to the access to medicines, medical equipment, and vaccines as well for the treatment and containment of Covid-19 when it became a pandemic. The severe scarcity of vaccines and pharmaceutical products were weakening the fight against Covid-19, and endeavor to contain the recurrence of pandemic waves while mutation of the SARS-CoV-2 was also on the full swing. Therefore, India and South Africa jointly proposed for patent waiver at WTO in October 2020 to effectively deal with the short-supply of medicines, medical equipment, vaccines and high price concern related to these products. After 20 months of consultation and negotiations with major stakeholders, the WTO came up with decision on patent waiver in 12th Ministerial Conference (12th MC). The time taken to reach to the decision in the pandemic situation and the narrow scope of the decision is a serious concern for the entire world to deal effectively with Covid-19 and its variants. This paper attempts to analyse the patent waiver in the context of the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). It discusses patent barriers, alternative measures and needs for equitable access to vaccines and pharmaceuticals amidst the pandemic. Paper applies the qualitative methodology of research mainly content analysis method in the framework of contextualisation, decontextualisation, and recontextualisation. Results show that suspending certain provisions of the TRIPS required for the production of vaccines and medicines would prove a crucial tool for economies to return to its pre-Covid-19 era. Paper concludes that, patent waiver can be one of the most important tool to fight the Covid-19 (as WHO has not yet declared the end of pandemic) and will pave the way to deal with any such unknown future pandemic effectively.
Kumar, Sapna, ‘Patents, Pharma, and the Pandemic’ (SSRN Scholarly Paper ID 3636456, 26 June 2020) Abstract: Highly-developed countries have generally supported strong patent rights and opposed utilizing compulsory licensing to obtain patented products without patent holders’ permission. But the COVID-19 pandemic has caused governments to reassess their position. Aided with taxpayer money, pharmaceutical companies are developing new vaccines and treatments. Unfortunately, there is no guarantee that they will be able to produce a sufficient quantity of any newly developed drugs, and the cost may be prohibitively expensive to most. Several countries have consequently reconsidered their past opposition to compulsory licensing and have passed new legislation bolstering their ability to provide patented drugs to their citizens for the duration of the pandemic. The United States, however, remains staunchly opposed—driven by the belief that any crack in strong patent rights will harm innovation. This Article examines the growing compulsory licensing divide among highly-developed countries. It provides an overview of existing U.S. law and looks at how the U.S. government’s attitude towards the compulsory licensing of drugs has shifted over time. It then discusses how countries such as Germany and Canada have recently adapted their patent laws and taken a collaborative approach to safeguarding public health, while the Trump administration has pursued a path of ‘vaccine nationalism.’ Finally, the Article proposes federal and state solutions to ensure access to COVID-19-related pharmaceuticals.
Kumar, R Satish, ‘Compulsory License under the Patents Act’ (SSRN Scholarly Paper ID 3896012, 29 July 2021)Jurisdiction: India
Abstract: During the present COVID-19 pandemic the protection of intellectual property rights would have to be balanced with the public welfare. One such mechanism for balancing the rights of the intellectual property holder and the general public is compulsory licensing. Compulsory licensing allows production of affordable drugs and increases availability and supply. The present research paper seeks to discuss the broad principles governing compulsory licensing, the judicial view that has been taken on the same, and whether the same can be resorted in the present pandemic situation where hundreds of lives are being lost every minute, critical expensive drugs like Remdesivir, Tocilizumab, Favipiravir etc., which are expensive and in short supply, can be licensed to increase production and improve affordability.
Lasting, Hannah M, ‘Big Pharma, Big Problems: COVID-19 Heightens Patent-Antitrust Tension Caused by Reverse Payments’ (2021) 44(2) Seattle University Law Review 601–631 Abstract: In the wake of COVID-19, pharmaceutical companies rushed to produce vaccinations and continue to work on developing treatments, while the tension caused by reverse payments intensifies between patent and antitrust law. Lawmakers must address this tension, and the current pandemic should serve as a catalyst to prompt reform at the legislative level. By amending the Hatch-Waxman Act, lawmakers can ease the increasing strain between patent and antitrust policy concerns. In 2013, the U.S. Supreme Court attempted to resolve this tension in its landmark decision, F.T.C. v. Actavis, but the tension remains as lower courts struggle to produce a uniform standard when applying Actavis to reverse payment settlements arising as a result of the current Hatch-Waxman Act provisions. Much scholarship exists explaining and addressing the lingering issues surrounding reverse payment settlements. However, no better time exists to address this heightened problem in the pharmaceutical context than now--amidst the COVID-19 pandemic devastating the United States. Lawmakers must act now to shield consumers from big pharma barring public access to affordable medications through reverse payment settlements.
Lawson, Charles and Michelle Rourke, ‘The COVID-19 Pandemic and the TRIPS Waiver: Patents and Flexibility’ (2022) 29(3) Journal of Law and Medicine 663–676 Abstract: The World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provides for global minimum standard patents. These patents potentially limit access to products and processes for the surveillance, tracking, diagnosis and treatment of COVID-19. A possible solution currently under consideration is a TRIPS waiver of the implementation, application and enforcement for the prevention, containment or treatment of COVID-19. This article addresses the ways that TRIPS patents might be mediated including through TRIPS flexibilities. The article argues that there are sufficient means of derogating from patents (and potentially copyright, industrial designs and undisclosed information), although they alone will not resolve the access problems. The article concludes that the key patent problem is the transfer of know-how and that developing new ideas about addressing these patent know-how transfers is the presently unaddressed challenge.
Le, Thi Mai, ‘Potential Impact of Provisions of Intellectual Property Rights Related to the Pharmaceutical Sector in the Comprehensive and Progressive Agreement for Trans-Pacific Partnership on Access to Medicines, in the Context of the COVID-19 Pandemic’ (SSRN Scholarly Paper ID 3903976, 16 September 2020) Abstract: With the aim of strengthening the economic integration to liberalize trade and investment among members, 12 countries in the Pacific Rim including Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, the United States and Vietnam came together under a FTA called Trans-Pacific Partnership Agreement (TPP). After the withdrawal of the United States based on the consideration that the agreement would adversely affect the its economy and independence, the remaining 11 countries came up with a new FTA, now renamed as the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP). In terms of IPRs, among various provisions, CPTPP incorporated a few controversial articles intensively related to the pharmaceutical sector including patentability, patent term extension, test data exclusivity and patent linkage. These provisions promote a higher level of protection for IPRs compared to the TRIPs agreement; therefore, raise strong arguments regarding their potential consequences on public health. Although the first three provisions, namely patentability, patent term extension and test data exclusivity, were suspended in the transition from TPP to CPTPP, their possible impact on access to medicines has not withered yet based on the fact that the negotiation of these suspended articles can be reopened to welcome the United States back and attract new members to the game. The thesis will focus on analyzing the aforementioned IPRs introduced in CPTPP, both the suspended and remaining ones, in relation to access to medicines in member states, especially in developing countries. A comparison between these provisions and corresponding provisions under TRIPs, references to other TRIPs-Plus FTAs and arguments surrounding their justifications will be incorporated. The evaluation of potential impact of such IPRs on widespread access to affordable medicines will be elaborated through various examples and studies including those in countries which are not members of CPTPP but have already introduced such TRIPs-Plus provisions into their domestic laws. Especially, such provisions also raise strong concerns in the context of the COVID-19 pandemic when governments are putting their priorities on developing safe and effective vaccines and treatment medicines used against the disease. Therefore, the question of whether such provisions would create obstacles to member states in utilizing flexibilities set out under TRIPs such as compulsory licensing, and prevent them from timely and proper access to pharmaceutical products used for COVID-19 will also be discussed. At the end, this thesis comes up with several suggestions regarding possible actions for the countries to consider in order to minimize the potential impact of such provisions, while considering the scenario of a re-opening of negotiation and lift of the suspension of these provisions.
Lee, Peter, ‘COVID-19 Vaccines, Technical Disclosure, and Public-Private Quid Pro Quos’ (SSRN Scholarly Paper ID 4058717, 8 March 2022) Abstract: While COVID-19 vaccines have saved countless lives, their highly unequal distribution has generated significant concern. Biopharmaceutical firms hold patents on these vaccines, and critics have argued for weakening these patents to increase access to these essential resources. Biopharmaceutical patentees respond that weakening patents would not increase global vaccine production because third parties cannot effectively manufacture vaccines without proprietary tacit knowledge and trade secrets. This assertion, however, appears to conflict with the traditional quid pro quo of the patent system in which inventors receive exclusive rights in exchange for disclosing their inventions. This chapter argues that this paradox—biopharmaceutical patentees have disclosed their inventions, yet those disclosures do not enable technical artisans to effectively practice them—is highly problematic. It explores the importance of tacit knowledge—uncodified, experiential knowledge held by inventors—and trade secrets to practicing and commercializing patented technologies. Patent applicants often do not disclose invention-related tacit knowledge and trade secrets, and this chapter suggests modifying the patent quid pro quo to induce greater technical disclosure. It proposes resurrecting the best mode requirement of patentability and potentially extending disclosure obligation for a finite period of time during technological commercialization. It further argues that government agencies can leverage public research funds to promote greater technical disclosure by private innovators. Such measures can increase the disclosure of latent knowledge and codified trade secrets. However, transferring purely tacit knowledge, which is not amenable to codification, often requires direct interaction between technology generators and adopters. This chapter cautions against requiring such intensive tacit knowledge transfer as part of the patent quid pro quo. However, it suggests that additional public policy levers can be useful in motivating and facilitating such technical knowledge transfer.
Lee, Peter, ‘Patents and the Pandemic: Intellectual Property, Social Contracts, and Access to Vaccines’ (2022) 17 Washington Journal of Law, Technology & Arts (forthcoming) Abstract: This Article is based on the 2021 Shidler Lecture, which was delivered at the University of Washington School of Law on November 4, 2021. Through enormous public support and private initiative, biopharmaceutical firms have developed safe and effective COVID-19 vaccines in record time. These remarkable vaccines represent humanity’s best chance to end the devastating pandemic. But alongside the development and deployment of these vaccines have come difficult questions about ownership and access. Biopharmaceutical companies have patented many of the technologies underlying these vaccines, thus seeming to pit intellectual property rights against the interests of wide and rapid dissemination of these critical resources. While prevailing debates have been framed in the language of intellectual property, this Article suggests that contract principles can help break the impasse and lead to greater access to COVID-19 vaccines. This Article will explore the significant leverage that governments have in conditioning public research support on increased access to patented vaccines and related technical knowledge. It will also question whether biopharmaceutical firms have upheld their end of the patent bargain by adequately disclosing their technologies in exchange for exclusive rights. Finally, it will consider how changed circumstances may justify revisiting the bargain that developed and developing countries struck in strengthening global intellectual property standards. In a variety of ways, governments can leverage public funding, quid pro quos, and changed circumstances to increase access to patented vaccines, thus helping to improve health and welfare on a massive scale.
Levine, David S, ‘COVID-19 Trade Secrets and Information Access: An Overview’ (SSRN Scholarly Paper ID 3838892, 10 July 2020) Abstract: The unprecedented COVID-19 (COVID) virus has brought to the forefront many challenges associated with exclusive rights, information sharing, and innovation. How do we get effective diagnostics, treatments and vaccines quickly and safely to the public? More specifically, how do we ensure that sufficient quantities are produced, that health products are affordable, and that they are equitably distributed globally? Among many challenges on the road to this outcome is the difficult question of how to handle trade secrets, namely, information that is valuable because others do not know it.The most famous trade secret is the Coca-Cola formula, but trade secrecy spans a shockingly broad range of critical and life-saving information. Indeed, trade secrets are everywhere in the battle to defeat COVID, from clinical data to pharmaceutical manufacturing processes. For the public at large, COVIDtrade secrets raise two primary issues: (a) When do you have a COVIDtrade secret, and (2) Should access to that trade secret extend to competitors, civil society groups, and/or the public? Both are challenging questions, and the below presents a general overview of the framework for addressing each question.
Levine, David S and Joshua D Sarnoff, ‘Compelling Trade Secret Sharing’ (2023) 74(4) Hastings Law Journal 987–1056 Abstract: The unprecedented COVID-19 virus has brought to the forefront many challenges associated with exclusive rights in information, data, and know-how, all of which may constitute protected trade secrets. While patents have received more attention, trade secret information has limited the ability to perform research, develop, test, gain regulatory approval for, manufacture, and distribute globally and at sufficient scale and affordable prices the needed vaccines, therapeutics, diagnostics, medical devices, and personal protective equipment. Voluntary licensing efforts have proven inadequate to supply pandemic needs. Thus, compelling the sharing or licensing of trade secrets is needed not only to properly address COVID-19, but more importantly to address future pandemics and other serious global problems such as climate change. This Article explains the nature of trade secrets and their protection. It then describes the failures in COVID-19 responses resulting from trade secrets that were not voluntarily licensed. It explains why patent law disclosures have been inadequate to assure competitive global research, development, and production. Given the need for compelled trade secret sharing, this Article surveys the relevant international intellectual property law treaties addressing trade secrets. It demonstrates that, consistent with international law obligations, governments are free to compel trade secret sharing. Further, governments may not be obliged to award compensation for such sharing when regulating to address public health. Given this national freedom to act, this Article then provides numerous examples of existing United States, European, and other authorities that have been or could be used to compel the sharing or licensing of trade secrets. It also notes the potential to adopt more explicit legislation authorizing compelled or induced behaviors. This survey of authorities illustrates that compelling trade secret sharing or licensing should be unobjectionable whenever there is a need to protect lives, health, or the economy. Accordingly, this Article provides a first critical step toward rethinking the nature of international trade secret protections and seeks to develop the political will for governments to protect the global public from the harms that trade secret rights can generate.
Lo Bianco, Federico, ‘Comparative Patent Compulsory Licensing Under COVID-19’ (SSRN Scholarly Paper No ID 3580407, 19 April 2020) Abstract: It is fascinating to see how the law has always followed human needs and development. Historically, when a new issue came out the governments started legislating in order to ensure social stability and keep the trust of citizens on the politics, but sometimes the regulatory process may be undertaken in advance. Indeed, even if the compulsory licensing procedure has always been one of the flexibilities of the TRIPS agreement, ever since 1995, it has sporadically been used by some states while other nations have never applied this flexibility at all. Recently, due to the COVID-19 pandemic, the importance and the popularity of compulsory licenses have been growing all over the world.
Lukose, Prof Lisa and Alankrita Mathur, ‘Sustainable Development through the Prism of Indigenous Knowledge: A Revisit to Intellectual Property Rights Issues during COVID Pandemic’ (2022) 63(3) The Journal of Indian Law Institute 277–297 Abstract: Traditional notions of sustainable development have strong inter-generational considerations striving for sustainable utilization of resources. The sustainable development and intellectual property rights though traditionally have different areas of operation but the nexus between the two in contemporary world is extremely interesting to study. The existence of rich biodiversity on this earth is the greatest gift from God to mankind and the maintenance of the same for a better future is the collective responsibility of world community. The indigenous communities inhabiting the biodiversity rich areas, owing to their close association with nature plays remarkable role in conserving the environment and maintaining the ecological balances through indigenous knowledge. With the advent of biotechnology, biopiracy and commercial exploitation of such indigenous knowledge for economic gains have become rampant affecting adversely not only the very indigenous community but also certainly hampering the sustainable development goals. This paper shall be an attempt to (i) view sustainable development through the prism of indigenous knowledge and the related intellectual property rights concerns (ii) examine the IPR issues in the contemporary pandemic period and (iii) analyse the resilience of indigenous people in COVID-19 crisis and the lessons therefrom.
Madhusoodanan, Lavanya et al, ‘Patent Scenario of COVID-19 Vaccines: A Promising Analysis and Review of Innovation and Development’ (2024) 27(1) The Journal of World Intellectual Property 3–26 Abstract: Coronavirus disease 2019 (COVID-19), a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has had a devastating effect on world demographics and emerged as a significant global health emergency since the influenza pandemic of 1918. It emphasized the significance of international cooperation in battling SARS-CoV-2 efficiently ever since the discovery and publication of the virus’s genome in January 2020. The world took significant steps to combat the disease, ranging from increasing personal protective equipment production and emphasizing the importance of social distancing/masking to the Emergency Use Authorization of remdesivir/therapeutic antibodies. Despite significant advances in clinical research that have led to a better understanding of SARS-CoV-2 and COVID-19 management, limiting the virus’s and its variants’ spread, has become a growing concern as SARS-CoV-2 continues to cause chaos around the world, with many countries experiencing a second or third wave of outbreaks attributed primarily due to the emergence of mutant virus variants. Considering the potential threat of this global outbreak, scientist and medics have rushed to identify possible treatment regimens and effective therapeutic drugs and vaccinations. As a matter of fact, several COVID-19 vaccines candidate have been researched, created, tested, and reviewed at a breakneck pace. Finding patents, examining relevant patents for current research activities and assessing them plays a key part for the best possible research and development before establishing and executing a trading strategy, especially with recent technology advancements. Therefore, to support current research and development we have evaluated patents relevant to various COVID-19 vaccine technology platforms. The aim of the present research work is to map the existing work through an analysis of patent literature in the field of Coronaviruses, particularly COVID-19 vaccines which will subsequently help the organization launch campaigns, as well as academics and research-driven institutions with the aid of patent literature information for a range of initiatives to combat this circulating demon.
Marcowitz-Bitton, Miriam and Yotam Kaplan, ‘Recalibrating Patent Protection for COVID-19 Vaccines: A Path to Affordable Access and Equitable Distribution’ (SSRN Scholarly Paper ID 3855033, 27 May 2021) Abstract: A safe and effective COVID-19 vaccine is the holy grail of our generation, necessary to resurrect our societies, save millions of lives, and protect our economies from collapse. Patent protection is the primary legal mechanism for ensuring timely development of such a vaccine. The patent system is designed to create the necessary incentives for private parties to invest in developing the vaccine, knowing they will enjoy the fruits of their success. Indeed, patent protection is necessary to promote human knowledge generally as well as a quick, safe, and effective COVID-19 vaccine.Yet in reality, patent law may be obstructing the very goal it is intended to achieve. Patent law grants exclusive rights to inventors, enabling them to charge supracompetitive prices, delaying the distribution and dissemination of emerging technologies. In the context of the COVID-19 vaccine, patent protection means that vaccines will be financially out of reach for many. This produces a paradoxical result: rather than promote technological advancement for the public good, patent protection impedes it. Since universal immunity is necessary in the fight against the pandemic, delays in vaccine distribution can be catastrophic, costing millions of lives and carrying devastating economic consequences.This Article therefore proposes a novel, alternative patent regime, designed to overcome this paradox at the heart of patent law. We propose a mechanism that will eliminate the problem of over-protection of patent rights that exists under current patent law, while still providing sufficient incentive for inventors to invest in innovative efforts. Under our proposed regime, the developer of a new vaccine will be granted a patent protecting its invention, but this patent will expire once the patentee has recouped its investment, plus a handsome profit. This regime, which we term ‘recoupment patent,’ ensures that inventors are rewarded appropriately—but not excessively—for their innovative efforts. The result is a structure that encourages innovation while minimizing the time it takes for life-saving inventions to reach the public domain. We compare the proposed regime with other suggestions for reforming the patent system, including compulsory licensing, government incentives such as grants, subsidies, and prizes, and altruistic initiatives such as private-public partnerships, patent pools, and patent pledges, and we highlight the recoupment patent model’s advantages over these alternatives.
Masnun, Muh Ali, Eny Sulistyowati and Hananto Widodo, ‘Patent Vs Trade Secret: Considering the Legal Protection of Covid-19 Vaccine in Indonesia Related to the State Intervention’ (2020) 473 Advances in Social Science, Education and Humanities Research 352–356 Abstract: The purpose of this study is to analyze how the legal protection of Covid-19 vaccine through an intellectual property rights protection approach. The protection is to weigh between patents and trade secrets by linking state intervention with the basis that the Covid-19 pandemic has become a global problem so there must be state interference in this matter. Research used normative juridical supported by both primary and secondary legal materials. The results of the study that the legal protection of Covid-19 can use patents or trade secrets. Patents and trade secrets as an IPR regime the inherent exclusive rights granted by the state, however, are unlimited. One form of limitation of exclusive patent rights is the rules regarding compulsory licenses, while limiting exclusive rights to trade secrets by allowing the disclosure of trade secrets on the grounds of public health and safety. State intervention in protecting the public of patent or trade secret exclusivity is by applying compulsory licenses to patents or disclosing information on trade secrets.
Matheson AM, Sarah and Artemis Kirkinis, ‘Compulsory Licence and Crown Use Provisions in the Covid-19 Pandemic: The Australian Perspective’ (2021) 16(6) Journal of Intellectual Property Law & Practice 484–497 Abstract: In the global COVID-19 pandemic, there has been considerable speculation that global pressures facing governments, including the need to guarantee the supply of a vaccine or treatments (when available) and medical equipment, could lead to the compulsory licence or Crown use (otherwise known as government authorization) provisions being invoked. However, to date, collaborative approaches have prevailed; there have been some unconventional approaches to intellectual property rights, and considerable efforts to repurpose existing technology that shows any promise of application in the present context. Despite a pandemic being the very type of emergency that could trigger the use of these coercive powers, it may be that patented technology can be accessed without the need to invoke them. Instead, the mere fact of their existence may encourage an otherwise reluctant patentee to reach a timely arrangement for access to patented technology or products. In this way, compulsory licence and Crown use provisions serve an important role as safeguards to ensure the appropriate balance between a patentee’s reward for its investment, and the need for access to patented technology during a public health crisis.
Matthews, Duncan, ‘Reappraising the Relationship between Intellectual Property Rights and Human Rights: A COVID-19 Pandemic Response’ (Queen Mary Law Research Paper No 366/2021, 6 September 2021) Abstract: The Covid-19 pandemic, the greatest global health crisis of our times, has highlighted profound inequities in the manufacture and supply of diagnostics, treatments, and vaccines to health care systems worldwide. Crucially, it has revealed structural fault lines in the international intellectual property (IP) architecture. This has strained relations between those who assert that the protection and enforcement of intellectual property rights (IPRs) are essential components for future investment and innovation, and those who argue that IPRs relevant to healthcare technologies necessary to save lives during the pandemic should be temporarily set aside, with IP-protected health care products available unhindered by the existence of associated IPRs. Against the backdrop of the Covid-19 pandemic response, this paper adopts a human rights approach to reappraise the relationship between IPRs and access to health care technologies. It argues that, while tensions between IPRs as property rights, on the one hand, and the right to health as a human right on the other are not new, a human rights approach to IPRs is an important and valuable conceptual tool as we re-evaluate the IP response to the Covid-19 pandemic. It argues that a human rights approach can enable a fundamental rethinking of the relationship between IP, innovation and access, for the Covid-19 pandemic response and inform debates about future pandemic preparedness.
Mayana, Ranti Fauza, ‘Needs for a Comprehensive Copyright Legislation on Over-The-Top Platform in Breaking Covid-19 Cycle’ 10(1) NTUT Journal of Intellectual Property Law and Management 67–79 Abstract: New advances in the era of digital disruption have brought changes from the conventional era to the digital era during the Covid-19 pandemic. The changes have impacted on the economic industry and government as well as the emergence of new businesses from innovators to make strategies through digital platforms. This study aims to evaluate the protection of Copyright Law through the Over-The-Top platform from the perspective of Indonesian positive law and how the regulations and practices of using copyright objects on the Over-The-Top digital platform in breaking the cycle of Covid-19 pandemic. This study applies a normative juridical method, by providing explanations based on the provisions of the applicable law. Additionally, this study also utilizes a comparative juridical method by comparing several regulations. The results of this study indicate that, firstly, in Indonesia until recently, there has been no adequate regulation on the Over-The-Top Digital Platforms as well as changes in Digital Transformation based on Cyber law in Indonesia. Secondly, during the Covid-19, there have been many benefits from the digital platforms since the Government implemented the Work From Home policy. These platforms can be used to continue carrying out activities from home. Further, these platforms are also useful in breaking the Covid-19 cycle in Indonesia.
Mayana, Ranti F and Tisni Santika, ‘The Social Function of Intellectual Property and Government Intervention in Mitigating the Pandemic: A Perspective from Indonesia’ (2022) 25(3) The Journal of World Intellectual Property 694–713 Abstract: Indonesia declared Corona Virus Disease 2019 (COVID-19) a Public Health Emergency based on Presidential Decree No. 11 of 2020 considering the extensive victims and extraordinary impacts. This study analyzes how Indonesia addresses the social function of intellectual property and government intervention in mitigating the pandemic. This study shows that outside the patent waiver provisions, implementation is the key. Indonesian Government has set a strategic framework in accordance with the guidelines of the WHO by simultaneously takes two strategies of vaccine provision and procurement: First, purchasing vaccines from abroad and/or collaborating with national and/or international institutions, Second, the development of ‘Vaksin Merah Putih’ (Red and White Vaccine) independently in the country through a triple helgix synergy involving the government institutions/ministries, universities, and industries. The provision of COVID-19 Vaccines in Indonesia is free as a form of responsibility and presence of the state. Government is also continuously expanding its public communication network to eliminate vaccine hesitancy. Lastly, Indonesia has adopted the TRIPs Waiver provisions through the Indonesian Patent Law, Government Regulation Number 77 of 2020 concerning Procedures for Patent Implementation by the Government, Regulation of the Minister of Law and Human Rights No. 14 of 2021 concerning Amendments to the Regulation of the Minister of Law and Human Rights No. 30 of 2019 concerning Procedures for Granting a Compulsory Patent License. These regulations will later become the basis for the government, whether it will eventually implement a patent license through a compulsory license system or a government use the patent system not only for the COVID-19 vaccine but also other essential medicines in mitigating the pandemic.
McCarthy, Claudine, ‘Know How to Address Legal Issues Related to E-Learning during Pandemic’ (2021) 21(6) Campus Legal Advisor 1–5 Abstract: The shift from in-person to remote learning solutions has made it more important than ever to understand the role copyright laws play in online class presentations, Jeffrey D. Peterson, Esq., a Partner with the law firm of Michael Best & Friedrich LLP in Wisconsin, explained during a webinar hosted by the Employment Law Alliance.
McGivern, Lauren, ‘Trade-Related Aspects of Intellectual Property Rights Flexibilities and Public Health: Implementation of Compulsory Licensing Provisions into National Patent Legislation’ (2023) 101(4) The Milbank Quarterly 1280–1303 Abstract: Given the challenges associated with negotiating the COVID-19 Trade-Related Aspects of Intellectual Property Rights (TRIPS) Waiver, there are questions as to whether the World Trade Organization is able to effectively address pandemics and global crises under the current architecture. Although the framework set out by the TRIPS Agreement does not view intellectual property (IP) rights as a means to foster public health and development, IP rights should nonetheless be interpreted through a public health lens. Countries should implement compulsory licensing provisions into their patent legislation, which increase access to medicines and allow governments (especially in developing and least-developed countries) to better protect public health. Context The protection of intellectual property (IP) rights, given international legal effect through the World Trade Organization (WTO) Trade-Related Aspects of IP Rights (TRIPS) Agreement, has long been a contentious issue. In recent years, the long-standing debate on IP rights as a barrier to the access of affordable medicines has been heightened by the global vaccine inequity evidenced during the COVID-19 pandemic. The TRIPS Agreement contains a number of flexibilities that WTO members can exploit in order to accommodate their policy needs. Among these is the mechanism of compulsory licensing, whereby patent licenses may be granted without consent of the patent holder in certain circumstances. TRIPS Article 31bis created a special mechanism for compulsory licenses specifically for the export of pharmaceutical products to countries with insufficient manufacturing capacity. Methods We analyzed domestic patent legislation for 195 countries (193 UN members and two observers) and three customs territories. We analyzed patent legislation for provisions on compulsory licenses, including those defined in Article 31bis of the TRIPS Agreement. Findings We identified 11 countries with no patent legislation. Of the 187 countries with domestic or regional patent laws, 176 (94.1%) had provisions on compulsory licensing and 72 (38.5%) had provisions implementing TRIPS Article 31bis. Conclusions The results of this study have highlighted the gap in the implementation of TRIPS flexibilities in countries’ national patent legislation, especially in least-developed countries. Although it will not fully solve patent barriers to the access of medicines, implementation of compulsory licensing (and specifically those for the import and export of pharmaceutical products) will provide governments with another tool to safeguard their population’s public health. Further discussions are needed to determine whether the WTO can provide effective responses to future pandemics or global crises.
McMahon, Aisling and Edana Richardson, ‘Patents, Healthcare and Engaged Shareholders: A Pathway to Encourage Socially Responsible Patent Use?’ (2022) 42(2) Legal Studies 271–295 Abstract: This paper focuses on the drivers steering companies’ behaviour over uses of patented health technologies, taking Covid-19 as a case study. Global equitable access to health technologies is vital to bringing the pandemic under control. Reflecting this, global mechanisms for rightsholders to share intellectual property rights, data and know-how over such health technologies have been developed. Yet, to date, there is limited support from corporate rightsholders for such mechanisms. Instead, health technologies have been licensed largely based on bilateral deals, with vast global inequalities emerging. Given the traditional focus within company law on prioritising shareholders’ short-term financial value, we argue that it is unsurprising that many corporate rightsholders adopt a protectionist approach to patents, even in the face of health crises. However, we argue that the tide may now be starting to shift, catalysed by an emergence of engaged shareholders petitioning for socially responsible corporate behaviour, including for uses of intellectual property over health technologies in a manner that more clearly aligns with public interests. If harnessed and encouraged, such engaged shareholder behaviour could present an opportunity to reframe the conception of shareholder value towards one that considers a long-term sustainable approach and ultimately to shift corporate behaviour around uses of intellectual property over health technologies to take public interests into account.
Mehta, Khushi Samir, ‘The Unwavering Covid-19 Vaccines’ Intellectual Property Rights Debate’ (2022) 2(3) Jus Corpus Law Journal 212–227 Abstract: With timely, effective vaccinations being the only somewhat successful cure for the virus, a frenzy to make, distribute, and dose people should become the world’s priority, but it hasn’t been as straightforward as one might assume. India and South Africa (underdeveloped and developing) submitted a request to the World Trade Organization (WTO) on the patent rights of Covid19 vaccines on October 2, 2020. They have gotten unwavering backing from several other Member countries since then. They’ve suggested that several of the vaccine’s intellectual property rights be waived. Until the World Health Organization proclaims COVID-19 herd immunity, this exemption would allow any country to produce the vaccine with more design and manufacturing freedom (WHO). Until the pandemic is completely contained, this would apply not only to vaccinations but also to diagnostics, medicines, and other technology. However, this stance has not been accepted by all and has sparked a debate over the intellectual property rights of the Covid-19 vaccine with the developed countries and pharmaceuticals opposing this move suggested by the developing and underdeveloped nations. They contend that there is little evidence that IPRs are impeding the development and spread of COVID-19 vaccines and treatments. Waiving all IPRs associated with COVID-19 before such proof is established looks unnecessary and may be harmful. This paper attempts to explore and analyze both key stances and draw out possible solutions for this current dilemma which is keeping the world on its toes.
Mercurio, Bryan and Pratyush Nath Upreti, ‘From Necessity to Flexibility: A Reflection on the Negotiations for a TRIPS Waiver for COVID-19 Vaccines and Treatments’ (2022) World Trade Review (advance article, published online 17 August 2022) Abstract: This article critically examines the proposed waiver of intellectual property (IP) rights for COVID-19 vaccines under the World Trade Organization Agreement’s Trade-Related Aspects of Intellectual Property Rights (TRIPS), which was initiated in October 2020 when the pandemic raged and vaccines were unavailable. However, the landscape has now changed and the waiver may no longer be necessary. The Outcome Document, introduced in the TRIPS Council in May 2022, along with Ministerial Decision of June 2022 recognizes this by focusing on easing the requirements to use TRIPS-flexibilities to accomplish wider and cheaper access. In so doing, the Ministerial Decision reinforces the notion that TRIPS flexibilities can be a useful part of the policy toolkit, even in times of crisis. After providing an overview of the context and outlining justifications for the waiver proposal, the article analyses and identifies key implications and possible effects of the Ministerial Decision. The article concludes that while the Document may not be a perfect solution to the issue of access to vaccines, flexible application of TRIPS-flexibilities is a better resolution in the current environment, especially given the need for further innovation to combat COVID-19 and future pandemics.
Mitchell, Andrew D, Antony Scott Taubman and Theo Samlidis, ‘The Legal Character and Practical Implementation of a TRIPS Waiver for COVID-19 Vaccines’ (2023) Fordham Intellectual Property, Media & Entertainment Law Journal (forthcoming) Abstract: Almost two years after initial proposals for a COVID-19 waiver of TRIPS obligations, a Ministerial decision adopted at the 12th Ministerial Conference in June 2022 waived obligations under Article 31(f) and the System for pharmaceutical export under the TRIPS Annex, and clarified existing options under TRIPS for increasing access to COVID-19 vaccines. As support for a more expansive pandemic waiver continues and WTO waivers remain legitimate mechanisms under WTO law, further waivers may be contemplated as viable options to address obstacles identified in the current pandemic or future health crises. This article explores what additional options are or may be open to Members under a COVID-19 waiver in its current or proposed forms, and the practical considerations for implementing them. To guide practical choices in selecting appropriate and adapted responses to public health and other crises, this article also investigates more theoretical questions about the nature of a waiver, its legal character and effect, and its interaction with other international agreements.
Mohammed, Abdul Fasi, ‘An Overview on the Various Pricing Policies of Health-Related Products and Incentivizing the Innovation During the Health Emergency Situations’ (SSRN Scholarly Paper ID 3903246, 11 August 2021) Abstract: Patents are often seen as legal monopolies that impose exorbitant pricing, particularly for innovations in the pharmaceutical and medical device sectors where the inventions are usually protected through the patents. Many have argued that patent protection should not be extended to sectors where the public interest in obtaining those products or services is important, such as health-related products, which also includes the medications. This paper provides an overview of different policy choices that national governments might employ to both promote innovation in health-related goods and ensure low consumer prices for the basic medicines. Special consideration is given to the current COVID-19 health emergency and highlights the solutions through the published reviews to make the basic medications freely accessible to all countries.
Morten, Christopher and Charles Duan, ‘Who’s Afraid of Section 1498? A Case for Government Patent Use in Pandemics and Other National Crises’ (2020) 23 (Fall)Yale Journal of Law and Technology 1-96 Abstract: COVID-19 has created pressing and widespread needs for technologies such as vaccines and medical treatments, needs that may conflict—indeed, have already begun to conflict—with the exclusive rights conferred by United States patents. The U.S. government has a legal mechanism to overcome this conflict: government use of patented technologies at the cost of government-paid compensation under 28 U.S.C. § 1498. But while many have recognized the theoretical possibility of government patent use under that statute, there is today a conventional wisdom that § 1498 is too exceptional, unpredictable, and dramatic for practical use, to the point that it ought to be invoked sparingly or not at all, even in extraordinary circumstances such as a pandemic.Yet that conventional wisdom is a recent one, and it conflicts with both history and theory. This article considers the role of § 1498 specifically in the context of national crises and emergencies like COVID-19, a context so far not addressed substantially in the literature on the statute. We find that government patent use is not nearly as exceptional as it is commonly made out to be, and indeed has been not only used but expanded (through statutory amendment) over the last century. Review of the development and use of the statute during both world wars and the post–September 11 period reveals widespread acceptance of government patent use as a tool for addressing imminent national-scale problems, and it illuminates particular features of government patent use that become especially pertinent in times of crisis. In the United States, government patent use and national emergencies have a close and special relationship; each has shaped the other.Drawing from the lessons of history and analysis of the statute, we develop a novel framework for comparing § 1498 to other policy tools, including prizes, research grants, and patent buyouts. Under this framework, four features of § 1498 stand out: speed of invocation, flexibility in the scope of its use, post-crisis determination of compensation, and use of an impartial adjudicator. Whenever these four features are advantageous—which will be true in most national emergency situations, as we show—the U.S. government should strongly consider government patent use over patent buyouts and other policy tools. We show the advantages of these four features in a case study: government patent use to expand supply and access to the COVID-19 treatment remdesivir. Accordingly, and contrary to the conventional view of § 1498, we conclude that government patent should be an ordinary and important tool of government policy.
Munoz Tellez, Viviana, ‘The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines’ (SSRN Scholarly Paper ID 3640229, 10 April 2020) Abstract: The ongoing rapid spread of COVID-19 is challenging the capacity of governments and of the World Health Organization (WHO) to timely put in place a global coordinated response to the pandemic. Developing countries and Least Developed Countries (LDCs) in particular in Africa are especially vulnerable to the unfolding effects of the public health crisis. A priority area for global collaboration is to advance research and development (R&D) for vaccines and medicines that are made available, affordable and accessible worldwide.There is currently no vaccine and no proven safe and effective direct therapy for COVID-19. There is also the need to accelerate testing capacity and tools in developing countries and LDCs with increased access to low-cost diagnostics. The approach to the management of intellectual property rights by research institutions, pharmaceutical and biotech companies and R&D funders will decisively affect availability and access, as well as the transfer of technology and know-how. Governments must ensure that they have legislative and procedural frameworks in place to enable them to over-come any patent, data exclusivity and trade secret barriers to procure and produce COVID-19 diagnostics, vaccines, medicines and other therapeutics.
Murai, Maiko, ‘The Current Situation of Japanese Copyright Law Regarding Internet Transmission of Library Materials – The Amendment to the Copyright Act in 2021’ (2024) 73(10) GRUR International: Journal of European & International IP Law 917–927 Abstract: The COVID-19 pandemic prompted Japan to review Art. 31 of the Copyright Act in 2021, which pertains to limitations on copyright for library usage. As a result, access to library materials via the internet became legally permissible within certain limits. Specifically, the amendment allows (1) the National Diet Library to transmit rare or out-of-print materials to individuals on the internet; and (2) libraries and similar facilities to provide users with public transmission services (transmitting portions of copyrighted works to users for research or study purposes). This article introduces the revisions made to Art. 31 in the 2021 amendment, explains the current situation regarding internet transmission of library materials in Japan, and explores future issues. Transmission via the internet is not subject to physical or locational constraints. The provision of library materials via the internet will thus involve considering how to position and organize the relationship between the individual transmission service for rare or out-of-print library materials by the National Diet Library and public transmission services by individual libraries.
Muscolo, Gabriella and Amalia Luzzati, ‘Pharma & COVID-19: An Overview of EU and National Case Law’ [2021] e-Competitions - Antitrust Case Laws Bulletin Article No 99409 Abstract: While the waiver of certain provisions of the TRIPS agreement for the prevention, containment and treatment of COVID-19 by the General Council of Word Trade Organization is still under discussion, this contribution provides some preliminary food for thought on possible alternatives.
Mwangi, Jacquelene, ‘COVID-19 and the “Unlocking” of Innovation: Reflections on Law and Innovation in Sub-Saharan Africa’ (Afronomicslaw COVID-19 Symposium on International Economic Law in the Global South (May 2020), Symposium II: Intellectual Property, Technology and Agriculture) Abstract: Extract from Introduction: I will reflect on the logics that have obscured innovation namely, international intellectual property law and formal organization of innovation through ‘national innovation systems’. These two combine under the banner of legal modernization and economic growth, and have collectively undermined innovation that does not fit into their premises.
Myrick, Dorkina, Laura Barnabei and Enrico Bonadio, ‘COVID-19, Its Variants, and Patent Disclosures’ (2023) 4 European Intellectual Property Review (forthcoming) Abstract: The COVID-19 pandemic persists despite considerable international eradication efforts, with the global pandemic reigniting an old debate on the role of patent and other intellectual property rights for the development of essential medicines during exceptional health crises. Indeed, several patents have been granted to pharmaceutical companies such as AstraZeneca, Johnson & Johnson, Moderna, Pfizer, and Sinovac for SARS-Cov-2 vaccines and associated SARS-Cov-2 materials and components, including mRNA and nucleic acids, vaccine delivery vehicles, lipids, nanoparticles, and adjuvants. That said, commentators have highlighted the need to balance the interests of research-based pharmaceutical industries in seeking and exploiting patents in order to recoup their investments with the public interest in equitable vaccine access. And efforts to make effective COVID-19 vaccines available to people around the planet are even more crucial as new variants of the SARS-CoV-2 virus have emerged in rapid and continuous succession.Against this background, this article aims to highlight the complexity of the emergence of such vaccine-resistance COVID variants, along with means of global surveillance of such variants (Sections 2 and 3). Section 4 then expands upon how failure to fully disclose all aspects of the manufacturing process of a vaccine could impact negatively on vaccine efficacy, with Section 5 focusing on the interplay between patent disclosures and SARS-CoV-2 variants. Section 6 concludes.
Ncube, Caroline B, ‘Intellectual Property Norms in the Polycrisis—(Still) Omnipresent, Distracting, Irrelevant?’ (2024) 19(9) Journal of Intellectual Property Law & Practice 717–724 Abstract: Twenty years since Professor Cornish asked whether IP is ‘omnipresent, distracting, irrelevant?’, this article revisits that question following recent times of instability, which have compounded the polycrisis the world is facing, whilst the 2030 deadline to achieve the UN Sustainable Development Goals looms closer and closer. This contribution argues that IP plays a critical role as one of multiple regulatory systems seeking solutions in the highly dynamic and insecure contexts of the climate emergency, uneven global development and pandemics, requiring timely and comprehensive normative development. However, over the last two decades there has been a glacial pace towards setting appropriate IP norms and states, policymakers and legislatures have to move beyond merely settling for a ‘more of the same’ approach. The ongoing World Health Organization’s Pandemic Accord negotiations present an opportunity to confirm IP’s relevance to combatting the polycrisis by setting effective norms and a technology transfer mechanism. It is concluded that missing this opportunity would render debates about IP no more than a deadly distraction.
Ncube, Caroline, ‘The Musings of a Copyright Scholar Working in South Africa: Is Copyright Law Supportive of Emergency Remote Teaching?’ (Afronomicslaw COVID-19 Symposium on International Economic Law in the Global South (May 2020), Symposium II: Intellectual Property, Technology and Agriculture) Introduction: As we were reminded on twitter recently, The Statute of Anne, the world’s first copyright law, came into effect on April 10, 1710, three centuries and a decade ago. Its title reads in part, ‘An Act for the Encouragement of Learning…’. The veritable links between copyright and the right to education have been established by several scholars …The Statute of Anne is a forebear of South African copyright law which has its roots in English copyright law … Against this background, this post asks ‘is copyright still true to its original intent and is it supportive of emergency remote teaching in alignment with the right to education?’
Nithyananda, KV, ‘COVID-19 Vaccines Legal and Consumer Issues’ (2021) 56(15) Economic and Political Weekly 17–21 Abstract: The Epidemic Diseases Act, 1897 and National Disaster Management Act, 2005 grant the Government of India a great deal of autonomy and control in declaring an infectious disease as a pandemic and in suspending citizen’s rights. Three distinct but related legal issues regarding the government’s handling of intellectual property rights under the Trade Related Aspects of Intellectual Property Rights Agreement of the World Trade Organization, consumer rights, and product liability for the COVID-19 vaccines are discussed, as the raging pandemic has created uncertainties in the implementation of these laws.
Oke, Emmanuel Kolawole, ‘The Waiver of the TRIPS Agreement for COVID-19 at the WTO: A Rhetorical Analysis’ (2022) 12 Indian Journal of Intellectual Property Law (forthcoming) < > Abstract: This article presents a rhetorical analysis of the discussions and debates at the WTO’s TRIPS Council regarding the request submitted by India and South Africa for a waiver of certain obligations under the TRIPS Agreement in response to the COVID-19 pandemic. Considering the engagement in ‘rhetorical action’ by both sides of the COVID-19 waiver proposal debate, the article explores whether the discussions, debates, and negotiations at the TRIPS Council regarding the proposed waiver is likely to produce any useful solution. The article is structured into three main sections. Section 1 presents a brief overview of the role of the TRIPS Council in international intellectual property law. Section 2 examines both the waiver proposal by India and South Africa on the one hand and the counter-proposal by the EU on the other hand. Section 3 contains a rhetorical analysis of the discussions and debates surrounding the waiver proposal at the TRIPS Council.
Ola, Kunle, ‘Role of Traditional Knowledge in the COVID-19 Battle’ (2022) 25(2) The Journal of World Intellectual Property 279–291 Abstract: This article addresses the role of traditional medicine in the race to find a cure for the corona virus (COVID-19). It situates traditional medicine within the traditional knowledge and Intellectual Property discussion. The paper discusses the increased gravitation towards using traditional medicine but also identifies the existence of scepticism towards its use. The paper calls on the African and indigenous communities who make up a large portion of the traditional medicine community to play their role in the fight against COVID-19. The battle is real, the coronavirus ground is an intersecting one and the solution is out there, but we do not know for sure where the solution would come from and what quarters it will come from. It could be traditional medicine, medical science, or a curious combination of both. This paper advocates for collaboration, it advocates that we join hands to fight the virus. It advocates inclusion rather than exclusion.
O’Regan, Catherine, ‘Equal Access to Vaccines: Exposing the Limits of International Human Rights Law?’ in Shreya Atrey and Sandra Fredman (eds), Exponential Inequalities: Equality Law in Times of Crisis (Oxford University Press, 2023) 213 Abstract: The Covid-19 pandemic has caused millions of deaths since 2020. The virus’ capacity to produce variants that evade immunity has meant that the best way to prevent further deaths is through ensuring that as many people as possible worldwide are vaccinated. Production of vaccines is reaching the point where it could meet global demand, if vaccines were equitably distributed. So far, however, vaccination rates have been highest in the developed world, and people in developing countries, especially Africa, remain woefully under-vaccinated. This article considers whether international human rights law can contribute to ensuring equal access to vaccines. It concludes that although the provisions of the International Covenant on Economic, Social and Cultural Rights would support equal access to vaccines, there are various reasons why international human rights law may not be effective in securing equal access to vaccines. These include not only the state-centric approach of international human rights law and its weak enforcement mechanisms, but also the strong international law protection for patents under the World Trade Organization (WTO)’s Agreement on Trade-related Aspects of Intellectual Property Rights (TRIPs). Nevertheless, important steps have been taken by new institutions of global health governance, such as the Global Agency for Access to Vaccines (GAVI) and Coalition for Epidemic Preparedness Innovations (CEPI), to ensure equal access to vaccines but much work still needs to be done. The chapter concludes that the Covid-19 pandemic has illustrated how inequality between countries, as well as within them, can be exacerbated by a global health crisis.
Ouellette, Lisa Larrimore et al, ‘Innovation Institutions and COVID-19’ (SSRN Scholarly Paper No ID 3826687, 14 April 2021) Abstract: The COVID-19 crisis has starkly illustrated both the strengths and limitations of U.S. biomedical innovation institutions as deployed to fight a pandemic. These innovation institutions include not just intellectual property law, but also other legal systems that structure incentives for production and allocation of knowledge goods, including regulation by health agencies like the Food and Drug Administration, programs like Medicare and Medicaid that govern healthcare reimbursement, and government subsidies for research and development through agencies such as the National Institutes of Health. In this collection of essays from March 2020 through April 2021, originally published at Written Description, we explore the response of these legal institutions to a variety of COVID-19-related technologies including vaccines, diagnostics, pharmaceutical treatments, and medical devices. While each technology brings its own challenges, we find a number of common innovation inefficiencies present during the COVID-19 pandemic, such as a lack of robust interagency coordination, poor incentives to generate health information, and persistent difficulties in manufacturing health care technologies at scale. In addition, throughout our work we highlight inequities in the healthcare innovation ecosystem related to race, gender, wealth, and geography. Although U.S. innovation institutions have resulted in some remarkable successes—such as the record-breaking speed of vaccine development—the pandemic has also drawn attention to innovation policy failures. Policymakers should focus on addressing these problems now—before the next pandemic strikes.
Ouellette, Lisa Larrimore, ‘IP and Public Research in Health Emergencies: U.S. Law and Best Practices’ (SSRN Scholarly Paper No 4505930, 9 July 2023) Abstract: The urgent demands posed by the COVID-19 pandemic galvanized the scientific research community, with substantial support from government funding. The results of this research have often been protected by intellectual property (IP), including patents and trade secrecy, leading to substantial interest in the laws and policies that enable the public to benefit from publicly funded research. This discussion paper, prepared at the request of the World Intellectual Property Organization (WIPO) Patent and Technology Law Division, describes the U.S. approach to these issues and outlines best practices for future health emergencies. The U.S. government supports innovation through a pluralistic approach, mixing and matching the market exclusivity provided by IP with a host of other policy mechanisms. Most prominently, the government directly funds innovation ex ante through grants, R&D contracts, and national laboratories; supports additional ex ante R&D spending through tax incentives; and provides ex post innovation rewards ranging from government insurance like Medicare and Medicaid to procurement contracts like for the Department of Veterans Affairs and for COVID-19 vaccines and therapeutics. Under a broad definition that includes direct or indirect benefit from any of these forms of taxpayer support, every new medical product that reaches the U.S. public is at least partially ‘publicly funded,’ but most also depend on substantial private-sector investment. This paper examines these public funding policies, the legal framework for IP protections on publicly funded research, the implementation of these policies in contractual conditions attached to public R&D funding, and the application of these policies during the pandemic. COVID-19 presents both a global tragedy and an opportunity for structural changes. These reforms should not focus on whether an innovation benefited on any particular form of public funding, which has little bearing on key policy decisions such as who should have access to that innovation. Instead, two goals should guide reforms of IP and innovation systems: better aligning the rewards for new medical technologies with their social value, and providing widespread access to those innovations, both in the United States and around the globe.
Panicker, Krishnaveni A, ‘Exempting Covid Vaccines from IPR Laws: Its Impacts and How Far Can it be Effective’ (2021) 25 Supremo Amicus Journal (unpaginated) Abstract: The developing countries specifically and undoubtedly were in a very precarious situation throughout the pandemic, considering the availability of vaccines. To equalize the huge disparity in the vaccination rates between the advanced and developing countries, it is very necessary that IPR laws be compromised with, and situation be handled with equal access to the vaccine given to everyone. This paper emphasizes on the need to temporarily do away with IPR laws that ensures free flow and timely access of vaccines. Nevertheless, this can be a hindrance to research and can incentivize innovations in the field. Moreover, the suspension of IPR laws is necessarily coupled with compromise in the TRIPS agreement, whose legal implications are discussed herein. WTO, being the international body authorized for these negotiations related to waiving of IPR laws do not contain specified deadlines for the completion of these procedures and can go on for lengthy bouts of time. This paper also aims to throw light on the degree of effectiveness that can be instilled in the production of vaccines by waiving of IPR. Mere waiving of patent rights are not enough to kick-start production in developing countries because it is not humanly possible to replicate pharmaceuticals even if they are not protected by IPR. Therefore, it is not only necessary to remove the hurdles presented by patents removed but also to ensure that appropriate tech transfers are in place. The former without latter is meaningless and this paper discusses about the same in brief and also about the complications possessed by the waiving of IPR in brief. Therefore, entirely stressing on dissolving patent rights is not sufficient for ensuring equitable distribution of vaccines and equal production of vaccines.
Paradise, Jordan, ‘COVID-IP: Staring down the Bayh–Dole Act with 2020 Vision’ (2020) 7(1) Journal of Law and the Biosciences, Article lsaa073 Abstract: As the human and economic toll of the COVID-19 coronavirus steadily escalates, there is extreme uncertainty regarding the timeframe for prevention, detection, and treatment. 1 There is also concern about the eventual costs associated with approved products and the barriers to access created by the patent system. Industry, government, and academic collaborations are leading the charge in the discovery race, partnerships which have triggered calls for the activation of the federal governments so–called ``march–in rights’’ established in the Bayh–Dole Act. 2 The Bayh–Dole Act dramatically altered the patent protections available to federally funded institutions and initiated a 40-year debate over appropriate incentives for innovation and the scope of the government’s authority. The COVID-19 pandemic provides an opportunity to reflect on the purpose and impact of the historic legislation as well as contemplate the implications for our public health future. Patent rights for therapeutic compounds, methods of delivery, and medical diagnostics will significantly impact access to and cost of life-saving innovations. This article examines current calls for the U.S. government to utilize governmental march–in rights to quell concerns about patent monopolization and product pricing in the face of our current pandemic.
Pihlajarinne, Taina, Mahonen and Jukka Pratyush Nath Upreti (eds), Intellectual Property Rights in the Post Pandemic World (Edward Elgar, 2023) link to book page on publisher website
Book summary: This book addresses fundamental questions of intellectual property rights in the aftermath of the pandemic in a variety of contributions by an international authorship. It makes an up-to-date contribution to the current discussion on the role of intellectual property rights in the international context of sustainability, innovation and global justice.
Pila, Justine, ‘Reflections on a Post-Pandemic European Patent System’ [2020] European Intellectual Property Review (forthcoming) Abstract: Against the backdrop of COVID-19, this Opinion essay proposes three ways to improve the European patent system without the need for legislative reform. Each has particular implications for drug patenting, and reflects an interpretive conception of law and legal legitimacy as requiring the application of legislation in accordance with moral values, including those expressed in constitutional instruments. If adopted, the proposals would: restrict the patentability of second medical indications and anchor assessments of inventive step more firmly to patent policy; expand assessments of the moral and public policy implications of patenting inventions and extend the disclosure duties of applicants; and adapt the FRAND licensing system to cover essential medical technologies.
Poungjinda, Wachiraporn, Shubham Pathak and Ivan Bimbilovski, ‘Legal Protection against Patent and Intellectual Property Rights Violations Amidst COVID-19’ (2023) 7(Special Issue: COVID-19: Emerging Research) Emerging Science Journal 225–237 Abstract: The concept of legal principles for intellectual property (IP) protection is related to the adequate marketing of drug patents to protect patent rights. The objective of this research is to understand and analyze the factors affecting the market concerning international law, treaties, acts, and declarations, leading to encouraging creativity, production, increased investment, especially amidst the COVID-19 pandemic. The qualitative methodology provided for an in-depth understanding and analysis of primary and secondary research data gathered from key informant interviews and published literature. The collected data were analyzed with Strength, Weakness, Opportunity, and Threats (SWOT), a Delphi panel, and Correct, Adapt, Maintain, and Explore (CAME) analysis. The results found legal problems concerning the lack of rules to protect the rights and freedoms damaged by the monopoly on drug patents, complexities in the process of importing medicinal compounds, and how to access information with limited accessibility during COVID-19. Therefore, it is advisable to amend the law to curtail monopolies and to enact a law that prescribes rules for importing medicinal compounds to produce generic drugs in the country, including identifying the status of the patent holders. The research further paves the way for utilizing micro level research to be conducted in the development of intellectual property rights.
Priyan, Sherin and Gouri Gargate, ‘Patent Pools and Innovation-Based Approach in Global Healthcare Crisis’ (2023) 26(2) The Journal of World Intellectual Property 117–141 Abstract: During the COVID 2019 pandemic, the healthcare sector faced major jurisprudential questions about the intellectual property system. During this period, the world was in the midst of a healthcare crisis, wherein the debate between the reward for innovation versus accessibility to all at equitable rates have become intense. In a such challenging scenario, the scientific community were dedicated toward the research while the healthcare industry was indulging in arguments over the incentives on creation. In this paper, the authors, as IP researchers, argue that in a scenario where there is an intense dispute over innovation versus accessibility, probably patent pool can serve as a mechanism to handle the tussle. The authors have analyzed a few patent pool models that were chosen on the basis of the types of patents in the pool. Additionally, an attempt is made to scrutinize the laws governing patent pools in developed countries and developing countries. In doing so, the authors draw the benefits and limitations of the patent pools in healthcare. We follow a qualitative research methodology. The research is based on secondary data and has some limitations because of this.
Pryor, Gregor, ‘Music in the Metaverse’ (2022) 34(2) Intellectual Property & Technology Law Journal 15–19 Abstract: The article reports on the innovations by music industry players, particularly performing artists, in the delivery of live music performances due to challenges posed by the COVID-19 epidemic, including online streaming and the use of the metaverse. Also cited are the benefits of metaverse as a live music platform like the ability to interact with the audience in real time and the possibility of using an avatar or other visual representation of an artist.
Ramli, Ahmad M, Tasya S Ramli and Gabriela M Hutauruk, ‘Patent Waiver on COVID‐19 Vaccine: Indonesian Law Perspective’ (2022) 25(1) Journal of World Intellectual Property 174–185 Abstract: The second year of the COVID-19 pandemic has not shown any sign of decline. Considering that COVID-19 is a new virus variant, and vaccines are pharmaceutical and life science products that are full of inventions and innovations, the issue of vaccine patents is in the spotlight and attention of the world. Previously, Indonesia had taken the Government’s Patent Implementation mechanism for antiviral and antiretroviral drugs used for HIV and Hepatitis B in an effort to reduce the price of these drugs. In light of the global impact of the COVID-19 Pandemic that causes a large number of victims, the idea arose to apply a patent waiver to the COVID-19 vaccine. Second, to formulate what efforts the Government of Indonesia can take in responding to the patent waiver. Results of this study indicate that a patent waiver will actually have an impact on the exclusive rights attached to the inventor, but efforts to implement patents by the Government while respecting patent holders are considered appropriate in emergency conditions such as the COVID-19 pandemic situation, to increase the supply of vaccines globally and provide convenience for the public to access the COVID-19 vaccine. Second, in an effort to address the COVID-19 vaccine patent waiver, Indonesia can apply the Government’s Patent Implementation for the COVID-19 vaccine to reduce the price of the vaccine to fulfill public health rights in the midst of the pandemic, while still respecting the vaccine inventors.
Ramraj, Victor V and Aman Gebru, ‘COVID-19 Vaccines: Intellectual-Property Challenges and Transnational-Legal Opportunities’ (University of Victoria, UVic Graduate Student Law & Society Research Group Publications (video), 9 April 2021) Abstract: In October 2020, India and South Africa proposed the World Trade Organization (WTO) to temporarily suspend trade-related intellectual property rights to COVID-19 vaccines and technologies. The proposal aims to ensure that not only the wealthiest countries will be able to access and afford those vaccines and technologies. After the proposal was presented, analysts claim that a ‘vaccine apartheid’ has already been created. In response, in March 2021, Dr. Ngozi Okonjo-Iweala, Director-General of the WTO, invited countries and manufacturers to implement a framework that would provide developing countries with more opportunities to access COVID-19 technologies. On April 9, 2021, the UVic Graduate Student Law & Society Research Group hosted an academic discussion between Professor Victor V. Ramraj (University of Victoria-Faculty of Law) and Professor Aman Gebru (Duquesne University-School of Law). Both speakers 1) explained the proposal that India and South Africa presented to the WTO; 2) discussed other initiatives to facilitate access to COVID-19 vaccines and technologies like the COVAX initiative, which is co-led by the World Health Organization (WHO), CEPI, GAVI, and UNICEF; and 3) explored relevant legal, socio-economic, ethical, political, and international issues that could facilitate or restrict access to COVID-19 vaccines and technologies. Therefore, this event was one of the first (if not the first) thoughtful critical-legal discussions about the challenges and opportunities emerging from initiatives aiming to ensure global equitable access to COVID-19 vaccines and treatments, such as the initiative proposed by India and South Africa or COVAX.
Ranjan, Prabhash, ‘Compulsory Licences and ISDS in Covid-19 Times: Relevance of the New Indian Investment Treaty Practice’ (2021) 16(7) Journal of Intellectual Property Law & Practice 748–759 Abstract: Foreign investors are increasingly making use of investor-State dispute settlement (ISDS) to enforce their intellectual property rights. In this context, and taking into account the significance of compulsory licences (CLs) as a regulatory tool to fight the Covid-19 pandemic, this article studies India’s new investment treaty practice on the issuance of CLs. The article finds that India’s new investment treaty practice elucidates how India can issue CLs without worrying about investor-state dispute settlement claims.
Ridhani, Rohima Putri, ‘Cyber Law in Indonesia and Its Relation to Indonesian Copyrights Law’ (International Proceeding: Law and Development in the Era of Pandemic, Faculty of Law, Universitas Islam Indonesia, 28 November 2020, 2021) 111–117 Abstract: Ever Since the Covid-19 pandemic, many country policies have been implemented based on the World Health Organization (WHO). It is hoped the policy itself will help reduce the spread of Covid-19 while looking for a vaccine that can cure the disease. However, these policies have an impact on everyone’s activity patterns. The circumstances in which we have to reduce social contact require that we rely on technology such as the internet. The uncertainty of the internet’s position in its dimension makes us pay more attention to internet usage and try to be careful in using the internet. The existence of crimes that occur on the internet makes us have to protect the technology we use to access the internet both from outside. One aspect that is very vulnerable to the abuse of the internet is copyright. On the internet, we can easily quote or copy other people’s work and claim that it is our work. In this article, we will discuss where the internet’s real position is and what should be regulated on the internet? What is copyright, and how is it protected, and how does it relate to the laws governing the internet? This paper’s research method is a normative legal research method where the author will explain the theories of the experts and see the existing laws and regulations. With this writing, it is hoped that people can see the importance of copyright protection on the internet.
Rimmer, Matthew, ‘Australia’s COVID-19 Response: Intellectual Property and Public Health’ (SSRN Scholarly Paper No 4665395, 15 December 2023) Abstract: The purpose of the Commonwealth Government COVID-19 Response Inquiry (the Inquiry) is to identify lessons learned to improve Australia’s preparedness for future pandemics. There has been a growing literature on COVID-19 law and policy – looking at the responses of international institutions, national governments, and judicial systems to the public health crisis. This submission focuses upon the role of intellectual property in terms of Australia’s COVID-19 response. The Federal Government has responsibility for intellectual property law and policy – both under the intellectual property power and the external affairs power of the Australian Constitution. So this submission does concern the ‘role of the Commonwealth Government’ in terms of ‘key health response measures’ and ‘international policies to support Australians at home and abroad.’ This submission focuses on the intellectual property dimensions of Australia’s response to the COVID-19 crisis – which both has national and international dimensions. Part 1 of the submission considers Australia’s position in debates over international intellectual property and access to essential medicines. Part 2 addresses questions in respect of patent law and access to essential medicines in the COVID-19 public health emergency. Part 3 explores the diverse role of other forms of intellectual property during the COVID-19 crisis.
Rimmer, Matthew, ‘Australia’s Framework for Access to Essential Medicines: Patent Law, Public Health and Pandemics’ in Belinda Bennett and Ian Freckelton (eds), Australian Public Health Law: Contemporary Issues and Challenges (Federation Press, 2023) ch 10
Rimmer, Matthew, ‘The Internet Archive and the National Emergency Library: Copyright Law and COVID-19’ (2022) 11(5) Laws 79 Abstract: In the tradition of legal writing about landmark intellectual property cases, this paper provides an in-depth case study and analysis of an important copyright conflict during the COVID-19 crisis. The Internet Archive established the National Emergency Library to provide for access to knowledge for those who were unable to access their usual libraries, schools, and educational institutions. In response, four large publishers have brought a copyright lawsuit against the Internet Archive, alleging both direct copyright infringement, as well as secondary copyright infringement. The Authors Guild has supported this action. Fearful of litigation, the Internet Archive has decided to close the National Emergency Library earlier than it anticipated. The litigation raises a range of issues in respect of copyright infringement, the defence of fair use, library exceptions, digital lending, and intermediary liability. The conflict also raises questions about the operation of the first sale doctrine in the digital era. There are also divided views as to what, if any, remedies are appropriate in the case over the Internet Archive and the National Emergency Library. It is argued that there needs to better mechanisms under copyright law to enable access to knowledge in a public health crisis—such as the coronavirus outbreak. This case study makes a significant contribution to our understanding of the relationship between authors, publishers, and libraries in the digital age. It also provides an insight into copyright litigation—in particular, the role of amicus curiae submissions, and the nature and scope of copyright exceptions. This paper also raises larger considerations about the intersection of copyright law with larger concerns about access to knowledge, competition policy, and public health emergencies.
Rimmer, Matthew, ‘The Medical Right to Repair: Intellectual Property, the Maker Movement, and COVID-19’ (2023) 15 Sustainability, Article No. 14839 Abstract: This article considers the strengths and limitations of the use of 3D printing and additive manufacturing for the production of personal protective equipment (PPE) during the COVID-19 public health crisis. It explores the role of the Maker Movement in addressing the shortfall in medical equipment during the public health pandemic. Taking a comparative approach, this article evaluates the responses of both the commercial and amateur sides of the 3D printing community to the COVID-19 public health crisis. In the EU, the Fab Lab Network sought to overcome a breakdown in supply chains. In the US, Dale Dougherty of Make Magazine promoted Plan C, in which volunteers have worked together to produce PPE. In Australia, 3D printing has been used to augment supplies of PPE. In this context, a key issue across jurisdictions has been the tension between intellectual property rights and the right to repair—particularly when 3D printing has been applied to deal with shortages in PPE. Senator Ron Wyden put forward the Critical Medical Infrastructure Right-to-Repair Act of 2020 (US) to try to resolve these tensions. Open licensing has proven to be a helpful mechanism to enable open collaboration and sharing of 3D printing designs for the purposes of health care. Nonetheless, it is argued that there should be stronger recognition of the right to repair—particularly in the context of health-care and medical devices. The COVID-19 crisis has highlighted that there needs to be a broader array of intellectual property flexibilities to deal with public health emergencies—including in respect of the right to repair. As such, this article supports a broad vision of a TRIPS Waiver which includes the right to repair. The recognition of a right to repair will help promote the realization of the Sustainable Development Goals and a COVID-19 recovery. The topic of the medical right to repair has larger implications for sustainability and the Sustainable Development Goals (SDGs), particularly in respect of responsible production and consumption (SDG 12), as well as good health and well-being (SDG 3), innovation (SDG 9), and partnerships for the goals (SDG 17).
Rimmer, Matthew, ‘The People’s Vaccine: Intellectual Property, Access to Essential Medicines, and the Coronavirus COVID-19’ [2021] Journal of Intellectual Property Studies (forthcoming) Abstract: This paper explores intellectual property and access to essential medicines in the context of the coronavirus COVID-19 public health crisis. It considers policy solutions to counteract vaccine nationalism and profiteering by pharmaceutical companies and vaccine developers. This paper considers the campaign for the development of a People’s Vaccine led by the People’s Vaccine Alliance, UNAIDS, Oxfam and Public Citizen. The WHO has established the ACT Accelerator in order to boost research, development, and deployment of COVID-19 technologies. However, the operation of COVAX thus far has been falling short of its original ambitions. The Medicines Patent Pool has expanded its jurisdiction to include the sharing of intellectual property related to COVID-19. Meanwhile, Costa Rica has proposed a COVID-19 Technology Access Pool – an idea for a new institutional structure which has been taken up by the WHO. In the context of the coronavirus public health crisis, there has also been discussion of the use of compulsory licensing and crown use to counteract profiteering and anti-competitive behavior. There has been a push by Universities Allied for Essential Medicines (UAEM) and others for the public licensing of COVID-19 technologies developed with government funding. The Open COVID Pledge has been taken by a number of intellectual property owners. In response to the assertion of proprietary rights in respect of COVID-19 technologies, the open movement has championed the development of Open Science models of science. India and South Africa have put forward a waiver proposal in the TRIPS Council to enable countries to take action in respect of COVID-19 without fear of retribution under trade laws. While the United States has been willing to support a TRIPS Waiver for vaccines, there remain a number of opponents to a TRIPS Waiver – including the European Union, Germany, Japan, and Switzerland. This paper makes the case that international intellectual property law should accommodate a People’s Vaccine.
Rimmer, Matthew, ‘The Regional Comprehensive Economic Partnership: Intellectual Property and Trade in the Asia-Pacific’ (2024) 32(2) Asia Pacific Law Review 392–435 Abstract: This article considers the evolution of the Regional Comprehensive Economic Partnership (RCEP) – with a particular focus on intellectual property, trade, and sustainable development. This narrative concentrates on the position of Australia – while also discussing the interests of other participating nations. This article charts the aims and objectives of the intellectual property chapter of RCEP. It explores the copyright provisions of RCEP – considering the implications for access to knowledge, innovation, and competition. This article examines the treatment of trade mark law, Internet Domain Names, and geographical indications. It evaluates the regime for patent law and related rights such as data protection, trade secrets, and biologics – with a particular concern for access to medicines and the COVID-19 crisis. It also explores sui generis regimes of intellectual property – such as plant breeder’s rights, access to genetic resources, and Indigenous intellectual property. The conclusion considers the future of RCEP – especially given competing mega agreements such as the Trans-Pacific Partnership (TPP); the Belt Road Initiative; and the Indo-Pacific Economic Framework for Prosperity.
Rimmer, Matthew, ‘The UNDP Accelerator Lab Network: Intellectual Property, Innovation Policy, Sustainable Development, and the COVID-19 Recovery’ in Taina Pihlajarinne, Jukka Mahonen and Pratyush Upreti (eds), Rethinking the Role of Intellectual Property Rights in the Post Pandemic World: An Integrated Framework of Sustainability, Innovation and Global Justice (Edward Elgar, forthcoming, 2022) [pre-published chapter available on SSRN] Abstract: This Chapter considers the long-standing debate over intellectual property and sustainable development in the context of the coronavirus public health crisis. It provides a historical overview of the past phases of the debate in relation to intellectual property and sustainable development.This Chapter focuses upon the initiative of the UNDP Administrator Achim Steiner to establish a Technology Mechanism – the UNDP Accelerator Lab Network. This chapter charts the funding, governance, and structure of the UNDP Accelerator Lab Network – and its aspirations and ambitions. It considers the debate about the role of the technology mechanism in generating sustainable innovation. It examines whether this technology mechanism will help fast-track the United Nations Sustainable Development Goals (SDGs).This chapter also charts the impact of the coronavirus upon the fulfilment of the United Nations SDGs. It also explores the role of the UNDP Accelerator Lab Network during the coronavirus public health crisis - both in terms of its response to COVID-19, and its role in a future COVID-19 recovery. This chapter also considers what intellectual property reforms are necessary to boost the SDGs – particularly given the need for a COVID-19 recovery.
Roy, Gopal Krishna, ‘An Economic Case for Waiving Intellectual Property Rights on COVID Vaccines’ (SSRN Scholarly Paper ID 3851117, 21 May 2021) Abstract: India and South Africa approached World Trade Organization (WTO) to negotiate the temporary waiver of Intellectual Property (IP) rights on COVID-19 vaccines to remove the artificial barrier of patents and boost vaccine production. This commentary advocates for the waiver of IP rights on COVID-19 vaccines. We make a case for the debate on the validity of the COVID-19 vaccine to qualify for a patent. We briefly review the evidence on the association between vaccination and virus mutations. Evidence suggests that waiving patents is vital to increase vaccination worldwide and curb mutation and reduce the risk of more infectious new variants. We discuss the need for non-pharma sectors and the governments of developing countries with large informal sectors to lobby against the IP rights on COVID vaccine because of the economic cost borne by them due to new variants induced fatalities and lockdowns.
Sachs, Rachel et al, ‘Innovation Law and COVID-19: Promoting Incentives and Access for New Healthcare Technologies’ in I Glenn Cohen (ed), COVID-19 and the Law: Disruption, Impact and Legacy (Cambridge University Press, forthcoming, 2022) Abstract: As the devastating COVID-19 pandemic first swept the globe, it posed a crucial test of biomedical innovation institutions. Containing the virus required developing new technologies including diagnostic tests, pharmaceuticals, and vaccines; manufacturing these technologies at enormous scale; and rapidly distributing them globally. This, in turn, required mobilizing and coordinating scientists, industry, and government at levels not seen since World War II. Underlying the successes and failures of these efforts was the complex legal architecture of biomedical innovation and access.This chapter considers how this legal architecture both encouraged and impeded the development and allocation of new technologies in the fight against COVID-19—and provides lessons about how it might be better deployed for future pandemics. The chapter focuses on three key areas of innovation law: biopharmaceutical regulation, healthcare reimbursement, and government subsidies for research and development. The first part of this chapter discusses the need to coordinate government agencies in a public health emergency, especially as such coordination pertains to developing, validating, and distributing diagnostic tests. The second part counsels agencies to ensure that early access to therapies in a public health crisis does not obviate developers’ ability (or incentive) to generate robust information about such therapies’ safety and efficacy. The third relays lessons about the successes of incentives for COVID-19 vaccine development—and their failures for vaccine distribution. Addressing the flaws in U.S. biomedical innovation institutions that have been highlighted by COVID-19 will help avoid repeating these failures in the next pandemic.
Sahitya, Kadiyala Venkata and KI Pavan Kumar, ‘A Paradigm Shift in Indian and International Patent Regime- Critical Review on Ex- and Current Scenario (Covid-19 Impact)’ (2023) 28(4) Journal of Intellectual Property Rights 293–303 Abstract: The innovation markers are namely patents which give the creation the identity, novelty and utilization in industry or for commercial use in public. There were many patents filed under different judicatory laws of different countries which give the sole right and responsibility to own the invention till the expiry of patent by the owner (Patentee). The rules and regulations also enable the patentee to take necessary action against the misuse or prior use and also copying of invention. There are circumstances like national emergency like the Covid -19 pandemic which could create the urgency to make public access for the medicines under the clinical trial or the generic form before the expiry of the patent in order to increase the health care needs. The national emergency globally has awaken to recreate or amend few judiciary laws of different countries like waiver of patents, compulsory licenses and also paying a remuneration amount to the patentee. The countries like U.S, India, China, Japan have played a key role in managing the pandemic by encouraging generic medicine manufacturing and licensing. The COVID-19 crisis affects not only Patent Law. However, COVID-19 clearly presents an imminent threat to public health which, in most jurisdictions, is likely to justify the grant of compulsory licenses and more changes in the few penal codes and articles under specific provisions made by the government. There was also huge impact on the patent filings by different countries which enumerated the increase of 16 % by China and also a significant contribution by the countries like U.S, India, Europe, Japan, Italy, etc. The Data exclusivity was reported including the women investors share which is considerably high. The pandemic has shaped new reforms in digitalization aspects and kept open many avenues in the medical and technology sectors in the years to come.
Santos Rutschman, Ana, ‘Assessing Patent Pledges: A Case Study in the Vaccine and Biopharma Space’ (SSRN Scholarly Paper No 4893675, 31 May 2024) Abstract: At the height of the COVID-19 pandemic, the U.S. biopharma company Moderna pledged not to enforce its COVID-19 vaccine patents against competitors. While it has become fairly common for corporate actors to promise to engage in certain behaviors, companies in the biopharma space have been much more parsimonious in making promises directly concerning their intellectual property. A company promising to refrain from asserting its patents against direct commercial competitors at the height of market demand—brought about by the COVID-19 pandemic—is a new phenomenon in the biopharma world. Yet we know very little about the legal implications of such a promise. This essay presents a case study on the Moderna pledge. By complicating the enforceability analysis in this specific case, the essay also raises questions about how we should think about pledges of non-assertion more generally, particularly when they arise in the highly idiosyncratic context of biopharma research and development. The essay concludes with a brief reflection on implications of this vaccine case study for future analyses of the enforceability of patent pledges in contexts beyond biopharma innovation.
Santos Rutschman, Ana, ‘Intellectual Property as a Determinant of Health’ [2021] Vanderbilt Journal of Transnational Law (forthcoming) Abstract: Public health literature has long recognized the existence of determinants of health, a set of socio-economic conditions that affect health risks and health outcomes across the world. The World Health Organization defines these determinants as ‘forces and systems’ consisting of ‘factors combin[ing] together to affect the health of individuals and communities.’ Frameworks relying on determinants of health have been widely adopted by countries in the global South and North alike, as well as international institutional players, several of which are direct or indirect players in transnational intellectual property (IP) policymaking. Issues raised by the implementation of IP policies, however, are seldom treated as an integral part of analyses using these frameworks, even though IP bears direct effects on the dynamics of several determinants of health, such as access to health goods and health services. This article conceptualizes post-TRIPs IP as a contributing element to the literature on the socio-economic determinants of health. IP norms and policies have long been understood as playing a role in outcomes that closely align with determinants frameworks, but interventions inspired by institutions relying on determinants frameworks routinely fail to consider the role of international IP regimes. The article explores two consequences of this dissociation: first, it argues that TRIPs-implemented IP materially affects several determinants of health, both at the social and economic levels; and second, it argues that IP should be regarded on equal footing with other canonically recognized determinants of health. While taking steps towards the development of an IP framework that can be articulated with, and incorporated by, literature on the determinants of health, the article presents three short case studies on pharmaceutical and agricultural technologies—HIV prophylactic drugs (Truvada); drugs and vaccines needed for epidemic and pandemic preparedness (Ebola vaccines and COVID-19 treatments like remdesivir); and genetically modified rice crops.
Santos Rutschman, Ana, ‘Property and Intellectual Property in Vaccine Markets’ Texas A&M University Journal of Property Law (2021, forthcoming) Abstract: As biopharmaceutical forms of technology, vaccines constitute one of the most important tools for the promotion and maintenance of public health. Tolstoy famously wrote that ‘[h]appy families are all alike; every unhappy family is unhappy in its own way.’ Vaccine markets offer perhaps one of the most extreme embodiments of Tolstoy’s principle in the field of biopharmaceutical innovation. Vaccines are often described as one of the most unprofitable types of biopharmaceutical goods, under-incentivized from a research and development (R&D) perspective, and routinely failing to attract sufficient investment from traditional funders in biopharma. In this sense, and despite the scientifically well-established value of vaccines from a public health perspective, vaccine markets are often portrayed as a collection of unhappy families. Yet, at least throughout the developed world, there are plenty of examples of steadily profitable vaccine markets, as is the case of recently developed vaccines targeting the human papilloma virus (HPV). The Essay begins by mapping this dualism in vaccine R&D and commercialization, describing both ‘happy’ and ‘unhappy’ markets. It then connects the development of new vaccines with the default legal regime to promote innovation in the biopharmaceutical arena: the patent system. In exploring possible solutions for transactional problems arising in connection with the development of vaccine technology in the context of infectious disease outbreaks, the Essay asks whether the rights covering vaccine technologies are best understood as property rights or as something else. This inquiry is of course but a fragment of a much larger interrogation of the nature and mechanics of intellectual property systems: are intellectual property rights—and rights arising out of the grant of patents in particular—more like property or akin to something else? Arguing that under the current non-committal position of the Supreme Court there is room for understandings of patent rights that are not property-centric, the Essay concludes by exploring how less property-like protection—in the form of a liability regime for critical components of vaccine technology—can remove some of the most salient transactional obstacles to the development and commercialization of new vaccines targeting infectious disease pathogens like Ebola, Zika and COVID-19.
Santos Rutschman, Ana, ‘The COVID-19 Vaccine Race: Intellectual Property, Collaboration(s), Nationalism and Misinformation’ (2021) 64(1) Washington University Journal of Law & Policy 167–202 Abstract: The COVID-19 pandemic has brought a national and global vaccine race. This Article examines the race with respect to contemporary frameworks for biopharmaceutical research and development. Specifically, this Article focuses on the effect of patents, pre-production agreements, public-private partnerships, and vaccine misinformation. This Article analyzes lessons learned from the COVID-19 pandemic, advocates for promoting vaccine affordability and equity, and suggests modifications to existing preparedness frameworks to prepare for upcoming outbreaks of infectious disease.
Santos Rutschman, Ana, ‘The Intellectual Property of COVID-19’ (Saint Louis University Legal Studies Research Paper No 2020–28, 11 September 2020) Abstract: The response to COVID-19 is indissolubly tied to intellectual property. In an increasingly globalized world in which infectious disease pathogens travel faster and wider than before, the development of vaccines, treatments and other forms of medical technology has become an integral part of public health preparedness and response frameworks. The development of these technologies, and to a certain extent the allocation and distribution of resulting outputs, is informed by intellectual property regimes. These regimes influence the commitment of R&D resources, shape scientific collaborations and, in some cases, may condition the widespread availability of emerging technologies. As seen throughout this chapter, COVID-19 has exposed the shortcomings of ingrained reliance on intellectual property as a channel for the production and dissemination of medical technologies needed to address the problems posed by pandemics and epidemics. At the same time, COVID-19 has brought new life to countervailing efforts to explore legal and policy mechanisms to potentially offset some of the problems posed by the pervasiveness of, and shortcomings associated with, intellectual property dynamics. In tracing the dual ways in which intellectual property has affected preparedness for, and the response to, COVID-19, this chapter highlights three features of contemporary intellectual property regimes and examines their impact on innovation(s) needed to address public health crises. First, it explores the incentives function of patent law and policy, which places considerable emphasis on market-driven investment in R&D on medical technologies. In so doing, intellectual property becomes one of the driving forces of the commodification of goods—vaccines, drugs or ventilator parts, for example—which are best understood as public health goods. Second, the chapter illustrates how intellectual property has reinforced an ethos of siloed R&D, as illustrated by the COVID-19 vaccine race, which at the time of writing includes hundreds of separate vaccine development projects. These siloes further extend into the allocative domain: with the development of medical technologies now largely steeped in proprietary frameworks, several countries have resumed the practice of reserving significant amounts of emerging technologies for their domestic populations, thus curtailing the possibility of equitable transnational approaches to a global public health crisis. This approach is commonly known in the field of vaccines as ‘vaccine nationalism.’ Nationalism skews the distribution of medical technologies developed during a pandemic, reducing opportunities for transnational coordination and potentially limiting access to these technologies by populations in economically disadvantaged parts of the world.The chapter ends nonetheless on a positive note, as COVID-19 has also made it abundantly clear that the legal infrastructure needed to address many of these problems is already in place. Early in the pandemic, several countries signaled that they would rely on intellectual property mechanisms to ensure broad and equitable access to medical technologies developed during (and possibly after) the pandemic, such as vaccines and treatments for COVID-19. These mechanisms embody different types of commitments to share intellectual property, data and knowledge. At the allocative level, a significant number of countries joined an ad hoc vaccine distribution facility (COVAX) coordinated by Geneva-based international organizations. These efforts, albeit nascent and, in many cases, likely transient nature, constitute meaningful steps towards a better innovation ecosystem for medical technologies needed to prevent and respond to future pandemic.
Santos Rutschman, Ana, ‘The Mosaic of Coronavirus Vaccine Development: Systemic Failures in Vaccine Innovation’ Journal of International Affairs (21 March 2020) Abstract: Scientists are racing to develop vaccines against the novel coronavirus. While some vaccine candidates may enter the market in record time, the current vaccine innovation ecosystem exposes governance lacunas at both the international and domestic levels.
Sarnoff, Joshua D, ‘COVID-19 Highlights Need for Rights to Repair and Produce in Emergencies’ (SSRN Scholarly Paper ID 3636551, 19 May 2020) Abstract: The COVID-19 pandemic has highlighted the need for explicit rights to repair and to supply needed medical products during emergencies. Current law may deter such actions because of the risk of private intellectual property infringement and tort liability, and contracts may also prohibit making legitimate repairs. Legislation is needed to authorize in advance the right to repair and production rights for defined emergencies.
Sarnoff, Joshua D, ‘The Right to Repair in a Pandemic’ [2020] Northwest University Law Review, NULR of Note 1–3 Abstract: The COVID-19 pandemic has highlighted the need for explicit rights to repair needed medical products during emergencies. Current law may deter such actions because of the risk of private intellectual property infringement liability, and contracts may also prohibit making legitimate repairs. Congress should consider adopting limited exceptions to infringement to assure the ability to make repairs.
Schneider, Marius and Nora Ho Tu Nam, ‘Africa and Counterfeit Pharmaceuticals in the Times of COVID-19’ (2020) 15(6) Journal of Intellectual Property Law & Practice 417–418 Abstract: At a time where counterfeit and substandard medications and critical medical supplies, such as hand sanitizers and face masks, are flooding the world market due to the COVID-19 pandemic, the 2020 report from the Organisation for Economic Co-operation and Development and the European Union Intellectual Property Office on ‘Trade in Counterfeit Pharmaceutical Products’ finding that trade in falsified medicine reached USD 4.4 billion in 2016, threatening public health and safety, while enriching criminals and organized crime, is very timely.
Sharma, Sarita K, ‘A Study on Drug Counterfeiting in the Light Of Covid-19 Pandemic: Indian Scenario’ (2021) 25 Supremo Amicus Journal (unpaginated) Abstract: The world has been facing one of the most challenging times due to the Covid- 19 pandemic. The novel coronavirus comes with new variants and strains that are believed to be more contagious and dangerous. The world has witnessed millions of deaths and affected persons due to COVI-19 disease. There are no specific medicines and vaccines available for its cure, much less with firm conviction and certainty. The scientists and researchers have been painstakingly working round the clock to find a concrete preventive and curative solution for it. However, the pandemic has exploded the drug market and as a result, it has attracted many globally to take it as an emerging lucrative business opportunity. The arrival of new medicines and vaccines has increased their demands many folds, and so the temptations of the looters and fraudsters, who want fast cash. The consequence of the ongoing menace is the sharp hike in counter pharmaceutical products globally. However, in the present alarming state, where the racketeers are devising innovative techniques and methods to engulf the pharma market with counterfeit products, it is imperative to realize that drug counterfeit is a serious crime and not limited to IPR Crime. It is an economic or a whitecollar crime which affects the social order. Furthermore, using online portals as an interface for advertising and selling fake pharma products has brought the crime of drug counterfeiting into the ambit of cybercrime. Therefore, in this milieu, a robust mechanism is required to control and prevent the menacing pose by drug counterfeiting. This paper has attempted to study and explore the linkage or intersectional area between the economic or white-collar crime, corporate crime, IPR crime, and cybercrime from the viewpoint of the multidimensional effect and consequences caused by the commission of counterfeit drugs or medicines. An attempt has been made to explore that up to what extent the law provided in the criminal statute book of India is effective in preventing and controlling the crime efficiently.
Sharma, Sparsh, ‘The Debate around the Access to Vaccine and Licensing amidst Second Wave of COVID-19 in India’ (2021) 24(5–6) The Journal of World Intellectual Property 436–446 Abstract: The guardian of global health signified a ‘global response’ to contain COVID 19 utilising the platform of World Health Organization when the novel virus strain was spreading. The nature of ‘waves,’ that is, variable epidemiological patterns and peaks in trajectory, have been inconsistent and myriad in different regions and countries. Many researchers and scholars have deliberated on the possible ways forward to curb or mitigate the effects of the virus; and one such means is through universal vaccination. Hence, this article explores the positions to achieve that goal by looking at the licensing aspect and IP waiver debate and suggests a fine-tuning which balances all the interests, amidst the second wave in India.
Shoebridge, Grant and Jennifer Enmon, ‘COVID-19 Patent Rights in the Time of a Pandemic’ (2020) 33(2) Australian Intellectual Property Law Bulletin 35–38 Abstract: The COVID-19 pandemic and the urgent global need for effective treatments and/or a vaccine have implications for Australia’s new Crown use and compulsory licensing patent provisions as well as similar provisions from around the globe. With these provisions, a government and in some cases a third party can access and exploit a patented invention without authorisation of the patentee.
Sreenivasulu, NS, ‘COVID-19, Patents and Right to Health’ (2022) 3(5) CIFILE Journal of International Law 31–38 Abstract: The COVID-19 pandemic has created an unprecedented scene and situation across the globe in terms of the health of people at large. Hitherto unknown, unheard and unprecedented health emergency it has created which was never foreseen and anticipated by any wild stretch of the imagination by anyone. It has called for Resolution of the World Health Assembly, which recognizes that the COVID-19 pandemic has an impact on the poor and the most vulnerable, with repercussions on health and development gains, in particular in low-income countries. It further calls on cooperation between multilateral organizations and other stakeholders and the World Health Organization (WHO) to identify and provide options that respect the provisions of relevant international treaties, like the TRIPS Agreement and the flexibilities within TRIPS Agreement for ensuring Public Health. It is indeed required that, as proposed in the Doha declaration, flexibilities within the TRIPS agreement be used in protecting public health at large in the COVID pandemic times. Such flexibilities could include scaling up the development, manufacturing and distribution of medicines, including the vaccines, injunctions, capsules and tablets used in treating the COVID at present. It is also required that capacities be built for transparent, equitable and timely access to quality, safe, affordable and efficacious diagnostics, therapeutics, medicines, and vaccines for the treatment of COVID. It can be ensured only by using the flexibilities under international agreements like TRIPS while promoting the innovation in pharma for finding better solutions for COVID.
Stothers, Christopher and Alexandra Morgan, ‘IP and the Supply of COVID-19-Related Drugs’ (2020) 15(8) Journal of Intellectual Property Law & Practice 590–593 Abstract: Considers the implications for intellectual property law of the widespread collaboration between pharmaceutical companies in developing treatments for COVID-19. Examines the mechanisms developed in the UK, the US, Austria, Germany and the Netherlands for bypassing trading rights and patent rights.
Sun, Haochen and Madhavi Sunder (eds), Intellectual Property, COVID-19 and the Next Pandemic: Diagnosing Problems, Developing Cures (Cambridge University Press, 2024) Open Access e-book on Cambridge Core
Book summary: This volume assesses the role of intellectual property in pandemic times through lessons learned from COVID-19. Authored by an international roster of experts, chapters diagnose causes for the inequitable distribution of lifesaving COVID-19 vaccines and offer concrete suggestions for reform. From delinking vaccine development from monopoly rights in technology, to enhanced legal requirements under national and international law for sharing publicly funded technologies, to requiring funding from rich nations to former colonies to build local vaccine manufacturing capacity in low and middle-income countries (including those in Africa), this work highlights timely IP reforms that prepare us for the next pandemic.
Sunder, Madhavi and Haochen Sun, ‘Intellectual Property and “The Lost Year” of COVID-19 Deaths’ (SSRN Scholarly Paper No 4654683, 8 November 2023) Abstract: Protecting intellectual property (IP) is a question of life and death. COVID-19 vaccines, partially incentivized by IP, are estimated to have saved nearly 20 million lives worldwide during the first year of their availability in 2021. However, most of the benefits of this life-saving technology went to high- and upper-middle-income countries. Despite 10 billion vaccines being produced by the end of 2021, only 4 percent of people in low-income countries were fully vaccinated. Paradoxically, IP may also be partly responsible for hundreds of thousands of lives lost in 2021, due to an insufficient supply of vaccines and inequitable access during the critical first year of vaccine rollout, most notably in low-income countries that lacked the ability to buy or manufacture vaccines to save their populations. IP is implicated in the choked supply of COVID-19 vaccines in low-income countries, particularly during the crucial first year of the vaccines’ availability in 2021.This Article first diagnoses how the IP system bears some blame for a ‘lost year’ of COVID-19 deaths and devastation in 2021. While the promise of monopoly rights in breakthrough technology helps incentive life-saving innovation, holding life-saving knowledge hostage in corporate monopolies to maximize private profit has tragic consequences. This Article diagnoses a number of causes for the inequitable distribution of life-saving COVID-19 vaccines, from misguided reliance on IP rights and voluntary mechanisms to share knowledge and vaccines, to the rise of vaccine nationalism and vaccine diplomacy, to unequal global IP institutions that disenfranchise low-income countries and continue to reproduce colonial era dependency by poor countries on high-income nations’ for life-saving technologies. Ultimately, unequal access to life-saving vaccines during the COVID-19 pandemic wreaked untold havoc on human lives and the global economy. Glaring inequity in global access affected rich countries, as well, as variants emerged in poorly vaccinated parts of the world and spread worldwide, prolonging the health and economic effects of the pandemic.In response to the diagnosis, this Article develops cures to promote a timely and equitable supply of critical medicines in the next pandemic. As the WHO draft Pandemic Treaty recognizes, there is a critical ‘need to establish a future pandemic prevention, preparedness and response mechanism that is not based on a charity model.’ This Article suggests several reforms to prevent such inequity in the next pandemic, including delinking vaccine development that depends on public funding from monopoly rights in technology, enhanced legal requirements to share publicly funded technologies in pandemic times, and investment in technology transfer hubs and local vaccine manufacturing capacity in low- and middle-income countries. We further suggest reforming the IP system to create a robust global technology transfer mechanism and to stimulate faster sharing of patented medicines and vaccines.
Syam, Nirmalya and Muhammad Zaheer Abbas, ‘TRIPS Waiver Decision for Equitable Access to Medical Countermeasures in the Pandemic: COVID-19 Diagnostics and Therapeutics’ (SSRN Scholarly Paper No 4707065, 25 January 2024) Abstract: The Marrakesh Agreement Establishing the World Trade Organization (WTO) allows WTO Members to agree to temporarily waive obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement). However, the TRIPS Decision adopted by the 12th WTO Ministerial Conference in June 2022, after lengthy and protracted negotiations lasting for 20 months in the middle of a pandemic, allowed only a fragment of the waiver proposal submitted by India and South Africa. Moreover, since the adoption of the Decision there has been an impasse in the WTO about extending the Decision to COVID-19 diagnostics and therapeutics even though the WTO Members were mandated by the Decision to decide on this matter within six months of the Decision. This research paper analyses the current state of play and concludes that there is a need to immediately and unconditionally extend the Decision to COVID-19 diagnostics and therapeutics. Moreover, the paper suggests options for how the TRIPS flexibilities can be optimally utilized in a pandemic situation without developing countries being resigned to the vagaries of negotiations on a waiver which is supposed to be an urgent emergency solution. In this regard, the paper also suggests options that could be considered for reforming the process of decision-making on a waiver proposal to ensure that decisions on waivers are taken in a timely and expedited manner without being negotiated for an extensive period of time in the midst of an emergency.
Tahiri, Ryan, ‘Legal and Ethical Implications of U.S. and Canadian Vaccine Contracts: The Impact of Vaccine Nationalism on the Global Pandemic Response’ (2021) 53(1) University of Miami Inter-American Law Review 231–266 Abstract: This note explores the COVID-19 vaccine contracts between the U.S. and Canada and the impact of these types of agreements on the global pandemic response. These ‘pre-purchases,’ many of which were executed before the development of a vaccine, have afforded a select few nations the opportunity to stockpile vaccines, while other nations with fewer resources are unable to secure any doses. An effective method to counter the effects of the pandemic is the creation of a global vaccine network that provides equitable access to vaccine doses for nations in need. COVAX was launched to ensure that lower and middle-income nations have the opportunity to purchase vaccine doses at reduced costs for their respective populations. This initiative offers a realistic solution to shortening the timeline of the COVID-19 pandemic and bringing the global population closer to herd immunity.
Tang, Daren, ‘The Future of Intellectual Property and WIPO in a Time of Crisis and Opportunity’ (2022) 32(4) Australian Intellectual Property Journal 204–212 Abstract: The COVID-19 pandemic has emerged at a time when multilateralism is under unprecedented stresses and tensions. At the same time, the pandemic has transformed the ways in which we live and work – accelerating pre-existing trends towards digitalisation, and opening up further opportunities for the use of innovation and creativity to drive growth. In this address, the Director General of the World Intellectual Property Organization reflects on the ways in which WIPO and the global intellectual property ecosystem can respond to these developments and the challenges they bring.
Taubman, Antony Scott, ‘Solidarity as a Practical Craft: Cohesion and Cooperation in Leveraging Access to Medical Technologies within and Beyond the Trips Agreement’ (2022) 29(2) Asia-Pacific Sustainable Development Journal (forthcoming) Abstract: The COVID-19 pandemic has precipitated an unprecedented call for global solidarity that included a proposal to waive key obligations under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. The governance of intellectual property in a global health crisis entails consideration of the effective and coordinated agency of domestic governments to foster solidarity through practical action. This paper lays out the context for solidarity and considers its practical operation by focusing on the mechanism of interaction between the intellectual property system and access to medicines, historically and during the pandemic: authorization of the use of patented subject matter without right holders’ consent.
Tham, Benjamin and Mark Findlay, ‘COVID-19 Vaccine Research, Development, Regulation and Access’ (SMU Centre for AI & Data Governance, Research Paper, 30 June 2020) Abstract: Will the regulation of a vaccine for COVID-19 be left in the hands of health standards administrators and research conventions or will an alliance of political and economic imperatives, chorused by a loud philanthropic/humanitarian cadre push both the roll-out and access challenges? This brief review identifies current developments in the vaccine race and reflects on the way that political, commercial, hegemonic and humanitarian realities will influence law’s regulatory relevance particularly through intellectual property regimes. The conclusion, because of this speculative moment, is watch this space.The paper accepts the argument that substantive IP rights on their own are not to blame for adverse access outcomes, if they arise. But the need for compulsory licences and TRIPS exceptions reveals that a state cannot rely on the good intentions of successful manufacturers to promote social good when profits are potentially significant and market competition is constrained. The political and economic externalities pressuring more socially responsible commercial decision-making in the vaccine case are unique but even so law’s normative framework for justice and fairness is a counterbalance to private property exclusion when world health is at stake.
Thambisetty, Siva et al, 'The TRIPS Intellectual Property Waiver Proposal: Creating the Right Incentives in Patent Law and Politics to End the COVID-19 Pandemic' (LSE Legal Studies Working Paper, forthcoming, 24 May 2021) Abstract: The structure of global intellectual property law as incorporated in the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is implicated in the current lack of COVID-19 vaccines, medical equipment, medicines and diagnostics (hereafter, ‘health-technologies’), which are needed to combat the pandemic. Although equitable access to vaccines is in the moral, political and economic interests of the global public and requires global solidarity, the phenomenon of COVID-19 ‘vaccine nationalism’ has brought into sharp relief the misalignment of current legal and financial incentives to produce and distribute vaccines equitably. The crisis further demonstrates the failure of high-income countries (HICs) to realise the promise they made at the time of the TRIPS negotiations in 1994, that by agreeing to the terms of TRIPS, lower and middle-income countries (LMICs) would benefit from technology transfer and the building of productive capacity. As such, the current crisis is revealing not only of inadequacies of how to deal with global emergencies, but also of deficiencies within the international ‘patent bargain’ itself. This paper elucidates the legal issues surrounding the ‘TRIPS waiver’ proposal initially put forward by India and South Africa in October 2020, which, as of May 2021, is supported by more than 60 states, and which has received statements of support from the World Health Organisation (WHO). We analyse the different intellectual property rights relevant to the proposal – focusing primarily on patent rights and trade secrets – which are most relevant to the present COVID-19 vaccine context. We explain why the existing TRIPS flexibilities around compulsory licensing are incapable of addressing the present pandemic context adequately, both in terms of procedure and legal substance.The extent of the current health crisis posed by COVID-19 is as undeniable as the current global response is untenable. Given the ongoing absence of sufficient engagement by the pharmaceutical industry with proposed global mechanisms to share intellectual property rights, data and know-how to address the pandemic, we argue that mandatory mechanisms are needed. The TRIPS waiver is an essential legal instrument in this context for enabling a radical increase in manufacturing capacity, and hence supply, of COVID-19 vaccines, creating a pathway to achieve global equitable access. We make two arguments to this effect: first, the TRIPS waiver is a necessary and proportionate legal measure for clearing intellectual property (IP) barriers in a direct, consistent and efficient fashion, enabling the freedom to operate for more companies to produce COVID-19 vaccines and other health technologies without the fear of infringing another party’s IP rights and the attendant threat of litigation; and second, the TRIPS waiver acts as an important political, moral and economic lever towards encouraging solutions aimed at global equitable access to vaccines, which is in the wider interest of the global public.
Thampapillai, Dilan and Sam Wall, ‘Does International Law Need a Conscience? Evaluating the India–South Africa Proposal to Suspend TRIPS Obligations and the COVID-19 Vaccines’ (2021) 39(1) The Australian Year Book of International Law Online 141–152 Abstract: There is undoubtedly a consensus within the international community that ‘vaccine nationalism’ is an undesirable state of affairs. However, states are self-interested actors and in the absence of constraints imposed by international economic law this pursuit of rational self-interest is likely to result in an outcome that is unjust on a global scale. The recent proposal by India and South Africa to suspend TRIPS obligations for the duration of the COVID-19 pandemic has been rejected within the WTO. This proposal constitutes a recognition of the inadequacies surrounding the TRIPS compulsory licensing scheme. Yet, the immersion of intellectual property law within international investment law together with the proliferation of free trade agreements containing TRIPS-plus obligations would likely have made such a proposal unworkable. We argue that the fundamental problem is that the TRIPS Agreement lacks a defined concept of conscience that governs both its operation and interpretation. Such a principle exists in the common law within the field of private law. The principle, in its various doctrinal iterations, navigates the tensions between different parties while serving an underlying purpose of justice within the common law. It has much to offer international intellectual property law.
Tur-Sinai, Ofer and Leah Chan Grinvald, ‘Repairing Medical Equipment in Times of Pandemic’ (2021) 52(2) Seton Hall Law Review 461–505 Abstract: The COVID-19 pandemic that has gripped the world since early 2020 has underscored the need for an effective right to repair medical equipment. As healthcare systems have been pushed to the limit, keeping critical medical equipment (such as ventilators) in working order has become a matter of life and death. Unfortunately, the ability of hospitals and other healthcare providers to service and fix their medical equipment is often hindered by the tight control that original equipment manufacturers keep over repair of their products. On top of direct contractual restrictions on repair, one of the major difficulties encountered by hospital-based and third-party service providers is the lack of access to service manuals, service keys, schematics, replacement parts, and repair tools. The ability to block access to these critical items is abetted, in large part, by intellectual property laws. In August 2020, a new federal legislation was introduced to address this problem--the Critical Medical Infrastructure Right-to-Repair Act of 2020 (the ‘Act’). The Act was designed to facilitate repair of critical medical infrastructure during the current COVID-19 pandemic, and to do so, it addressed various relevant intellectual property issues. Although it failed to pass in 2020, the Act was the first attempt to enact federal repair legislation. Given this, this Article provides a critical analysis of the Act and examines the extent to which it could have served its prescribed goal. In addition, in the event the Act is reintroduced (or similar legislation is introduced) in the coming years, we provide constructive suggestions to improve it. We also investigate the role that courts could play, alongside such legislation, by using policy levers that already exist in intellectual property law to provide relief to hospital-based and independent service technicians and to mandate manufacturers to cooperate with them in certain circumstances.
Van Erp, Sjef, ‘Who “Owns” the Data in a Coronavirus Tracing (and/or Tracking) App?’ in Ewoud et al Hondius (ed), Coronavirus and the Law in Europe (Intersentia, 2020) Abstract: To combat the spread of the COVID-19 virus, e-health has taken a sudden leap forward. Already use cases were studied to see if by means of advanced IT tools, particularly e-health applications (apps), patients could be monitored from their homes so they did not need to visit a hospital for frequent checks. The corona pandemic gave rise to the rapid development of tracing (and/or tracking) e-health apps, which allow quickly finding the source of an infection as well as others who might have been infected because they were in the close vicinity of someone who became ill. The development and widespread use of these apps makes it even more urgent than it already was to answer questions regarding to whom the data gathered through such apps belong and what belonging means. Can the owner of the mobile device be considered the ‘owner’ of the data, what does ‘ownership’ then mean, do other stakeholders (such as health care providers, public health authorities) also have a claim to ‘ownership’?
Vane, Marie-Denise, ‘Fighting for IP Equity: A Zoom on the Forthcoming WHO Pandemic Agreement’ (2024) 9(3) LSE Law Review 372–412 Abstract: Faced with the impact of COVID-19, WHO Member States agreed to draft and negotiate an agreement on pandemic prevention, preparedness and response. A proposal for negotiating text of this WHO Pandemic Agreement was prepared by the Intergovernmental Negotiating Body’s Bureau and shared with its Drafting Group in October 2023 for its consideration. This process should lead to the adoption of a legally binding accord. This article considers the usefulness of this international instrument for pandemic prevention, preparedness and response in relation to intellectual property (IP) to ultimately recognise such usefulness but to argue that the negotiating text could be more ambitious. It focuses on the Agreement potential to mitigate the impact of IP regulations that favour developed countries and their pharmaceutical industries. The article first highlights how the international IP system, through the Agreement on Trade-Related Aspects of Intellectual Property Rights, disempowered developing countries in their battle against COVID-19. It then focuses on provisions relating to IP law found in the negotiating text to explore and question its potential to contribute to IP equity for developing countries for future pandemics. Finally, the article proposes recommendations to strengthen the impact of a WHO Pandemic Agreement in the fight for IP equity.
Varella, Marcelo Dias and Katia Adriana Cardoso de Oliveira, ‘The Flexibilization of Intellectual Property Rights in Cases of Health Crises: A Case Study of Brazil in the Face of the AIDS and COVID Sanitary Crises’ (2024) 27(3) Journal of World Intellectual Property 563–575 Abstract: Intellectual property (IP) law is traditionally considered rigid, with little room for maneuvering in crisis cases. In this article, through three case studies, we discuss how health crises have affected IP rights, especially in Brazil, and the relationship of Brazilian decision‐making with internationally accepted legal frameworks. In the first case, on the AIDS crisis, we discuss the initiatives of compulsory licenses in Brazil and the debate on the Doha Declaration on public health, in which the international community recognized the national margin of appreciation of TRIPs in specific cases, making the Brazilian government’s action viable. In the second case, on COVID, we discuss some proposals for waiver of IP rights that, although not effectively implemented, were important to pressure economic players to find solutions to transfer technology and expand the production of newly discovered vaccines, with the transfer of technology and expansion of Brazilian vaccine factories. In the third case, also on COVID, we discuss how the health crisis induced the Brazilian Judiciary, Executive, and Legislative branches to change different points of the IP law that had been under discussion for many years and reduced the extent of these rights, to increase access to medicines, but limited by international minimum standards. We conclude that IP law is essential for developing new drugs to deal with health crises. At the same time, these crises are essential for constructing Law that prevents abuses by dominant economic actors.
Vu-Dinh, Kim, ‘Help Was Not on the Way: Intellectual Property Liability Relief in a Pandemic Era’ (2022) 11(1) Arkansas Journal of Social Change and Public Service 30–61 Abstract: This Article argues for certain exceptions to intellectual property liability—particularly regarding patents and copyrights—during times of crisis, especially for those who are volunteers contributing to response efforts. The authors first consider the massive risk of liability associated with the good faith efforts of nonprofits and individuals who are micro-manufacturing personal protective equipment (PPE) and other medical devices during a public health crisis. The Article discusses potential relief options such as compulsory licensing, march-in rights, and Defense Protection Act rights by proxy, and also draws on analogy to tort and real property doctrines including Good Samaritan laws, the doctrine of public necessity as a defense to trespass, and postponement of evictions during COVID-19 in real property to the extent that each may be helpful in fashioning an analogous statutory emergency declaration as to certain forms of intellectual property liability.
Vučković, Romana Matanovac, Ivana Kanceljak and Marko Jurić, ‘Cultural Heritage Institutions During and after the Pandemic: The Copyright Perspective’ (2021) 5(EU 2021 – The Future of the EU in and After the Pandemic) EU and Comparative Law Issues and Challenges Series (ECLIC) 379–397 Abstract: The COVID-19 pandemic has imploded the traditional ways in which creative, cultural and artistic content are presented and consumed. Museums, libraries, archives, and other cultural institutions have been closed in lockdowns all around the European Union, and their content presented and consumed online. This paper will analyse how copyright rules affect cultural heritage institutions (publicly accessible libraries or museums, archives or film or audio heritage institutions) in the digital age. Four recent legal documents at the European level refer to the digitalisation of their collections and the digitised content’s exposure to the public in the Digital Single Market. These are Directive 2001/29/EC, Directive 2012/28/EU, Directive (EU) 2019/790 and Directive (EU) 2019/1024. This paper willfirst analyse how exclusive rights are regulated for authors, other creators, publishers, and producers in the digital age. Those rights need to be respected and exercised effectively by their owners. On the other hand, there is also a public interest, in that digitisation and access to digitised content should be free in cultural heritage institutions. To resolve the tension inherent in this relationship is not easy. The recent rapid change in consumption of creative, cultural and artistic content in the Single Digital Market (due to the pandemic caused by the COVID-19 virus) has triggered the need for swifter digitisation of cultural heritage institutions’ collections. The European legal framework offers some solutions to this need, which will be presented here. It does not resolve the situation generally, but refers to particular issues, such as orphan works, out-of-commerce works, text and data mining and the re-use of public sector information. In general, copyright protection prevails. Nevertheless, the tendencies towards free access grow stronger every day. This paper will analyse how these four directives interact with each other in the effort to resolve the tension between copyright, digitisation and free access to digitised content in cultural heritage institutions. At the end, two ideas for a new balance are presented.
Wachowicz, Marcos, ‘Open Access to Scientific Innovation as a Means to Combat COVID-19’ (2020) 69(8) GRUR International: Journal of European and International IP Law 783–784 Extract: A new policy of global scale is needed and it should prioritize licensing and open support, technology transfer, and new partnerships for technical access. As to the market, there is need for a commitment not to increase drug prices during the pandemic…. The challenge is not whether intellectual property exists, but how it will be exercised. In this area there is a great opportunity to practice intellectual property management, focusing on public interest, particularly during a pandemic. Thus, in the case of COVID-19, thinking about open licensing aims to eliminate a barrier to the production capacity of the input needed to face the pandemic.
Walker, John and Dr Dallas L Wilkinson, ‘Protection, Enforcement and Licensing of Trade Secrets in View of the COVID-19 Pandemic’ (2021) 56(3) les Nouvelles - Journal of the Licensing Executives Society 245–249 [pre-print on SSRN] Abstract: On June 24, 2020, the LESI Chemicals Engineering Environment Materials Committee (CEEM) held a webinar on the important topic of trade secret management and more broadly, IP management. The webinar drew together expert panelists from a wide range of industries and regions within the CEEM sector. This article further explores the issues discussed at that webinar.
Wijesinghe, Sanath, Chaminya Adikari and Ruwanthika Ariyaratna, ‘The Proposal for Waiver of WTO’s TRIPS Agreement to Prevent, Contain and Treat COVID-19: Investigating the Benefits and Challenges for Low- and Middle-Income Countries’ (2022) 17(2) Journal of Intellectual Property Law & Practice 179–192 Abstract: This article examines the benefits of the TRIPS waiver for low- and middle-income countries with particular reference to the challenges that these countries may face in the manufacturing and purchasing stages of COVID-19 vaccines. We assess arguments for and against the TRIPS waiver and suggest actionable solutions that could be provided by global policy actors to enable low- and middle-income countries to overcome such challenges. Actions for global solidarity and redistribution of resources appear to be instrumental factors in ensuring that low- and middle-income countries make the best use of the TRIPS waiver for equitable access to COVID-19 vaccines.
Wu, Xiaoping and Bassam Khazin, ‘Patent-Related Actions Taken in WTO Members in Response to the COVID-19 Pandemic’ (World Trade Organization, Economic Research and Statistics Division, Staff Working Paper ERSD-2020-12, 1 October 2020) Abstract: This working paper provides an overview of the patent landscape of medical treatments and technologies related to COVID-19, and of the patent status of two investigational medical treatments: remdesivir and lopinavir/ritonavir. It then presents various patent-related actions taken by legislators, policymakers, industry sectors, and civil society organizations in WTO Members since the outbreak. Furthermore, it elaborates on patent-related policy options provided by the TRIPS Agreement, and WTO Members’ national implementation and utilization of these options in their response to the COVID-19 pandemic.
Xu, Shuwen, ‘To Waive or Not to Waive: The Debate and Analysis of TRIPS Waiver’ (2023) 18(2) Asian Journal of WTO & International Health Law and Policy 423–450 Abstract: The COVID-19 pandemic has reignited the decades-long debate over intellectual property rights (hereinafter ‘IPRs’) and global inequitable access to medical products. After heated debates over South Africa and India’s IPRs waiver proposal, on June 17, 2022, the World Trade Organization (WTO) members finally agreed to waive patent rights on COVID-19 vaccines with limited conditions and delayed the discussion on waiver extension to COVID-19 diagnostics and therapeutics. In this battle against COVID-19, it is true that the global community has made progress in successfully developing effective medical products, but then the inequity in access to those products between developed and developing countries causes it to be further behind than it was when it made progress. The virus never distinguishes between rich and poor countries, and access to vaccines, diagnostics and therapeutics shouldn’t either. This article argues that waiving IPRs on COVID-19 medical products could improve global access to them. It compares both sides of the debate and emphasizes that a broader coverage of types of IPRs and pharmaceutical products is necessary to achieve global equitable access to COVID-19 vaccines and pharmaceutical products. In addition to lowering IPR barriers through the Waiver, increasing manufacturing capacity and re-distributing the global stockpile are also important solutions to making pharmaceutical products available to those in need.
Xue, Qiwei Claire and Lisa Larrimore Ouellette, ‘Innovation Policy and the Market for Vaccines’ (2020) 7(1) Journal of Law and the Biosciences Article lsaa026 Abstract: Vaccines play a crucial role in improving global public health, with the ability to stem the spread of infectious diseases and the potential to eradicate them completely. Compared with pharmaceuticals that treat disease, however, preventative vaccines have received less attention from both biomedical researchers and innovation scholars. This neglect has substantial human and financial costs, as vividly illustrated by the COVID-19 pandemic. In this article, we argue that the large number of ``missing’’ vaccines is likely due to more than lack of scientific opportunities. Two key aspects of vaccines help account for their anemic development pipeline: (1) they are preventatives rather than treatments; and (2) they are generally durable goods with long-term effects rather than products purchased repeatedly. We explain how both aspects make vaccines less profitable than repeat-purchase treatments, even given comparable IP protection. We conclude by arguing that innovation policy should address these market distortions by experimenting with larger government-set rewards for vaccine production and use. Most modestly, policymakers should increase direct funding—including no grants and public-private partnerships—and insurance-based market subsidies for vaccine development. We also make the case for a large cash prize for any new vaccine made available at low or zero cost.
Yanisky-Ravid, Shlomit and Regina Jin, ‘Summoning a New Artificial Intelligence Patent Model: In the Age of Pandemic’ (SSRN Scholarly Paper ID 3619069, 4 June 2020) Abstract: To combat the fast-moving spread of the pandemic we need an equally speedy and powerful tool. On the forefront against COVID-19, for example, AI technology has become a digital armament in the development of new drugs, vaccines, diagnostic methods, and forecasting programs. Patenting these new, nonobvious, and efficient technological solutions is a critical step in fostering the research and development, the huge investments as well as the commercial processes. This article considers the challenges of the current patent law as they apply to AI inventions in general and especially in the age of a global pandemic. The article proposes a novel solution to the hurdles of patenting AI technology by establishing a new patent track model for AI inventions (including the inventions that are made by AI systems and creative AI systems themselves). Unlike other publications promoting either complete abandonment of AI related patents, or advocating to maintain current patent laws, or recommending minor adjustment to patent laws, this article suggests a novel model of separate patent venue solely targeting AI inventions. The argument of this article is based on four pillars: the difficulty of having a patent-eligible subject matter, the hurdle of the ‘blackbox’ conundrum, the confusion of who is ‘a person of ordinary skills in the art’ (“POSITA"), and the criticality of establishing a new AI patent track model, a crucial step, especially during a global epidemic.The first pillar of the argument is the difficulty of having a patent-eligible subject matter in AI inventions. We therefore propose the new AI patent track model that would extend the scope of patent protection to cover creative AI systems, including both the algorithms and trained models, and AI-made inventions in order to, inter alia, incentivize investments of the ‘Multi-Players’.The second pillar of the argument of the argument is the hurdle posed by the ‘blackbox’ conundrum of AI systems that undermines the explainability and transparency of the inventions. In analogy to already existing rules applied to microorganism patents that are hard to describe, we advise a depository rule for AI working models to sufficiently describe the otherwise inexplicable inventions.The third pillar arises from the confusion of who is a person of ordinary skills in regard to the nonobviousness assessment of AI inventions. We submit an alternative standard of ‘a skilled person using an ordinary AI tool in the art’ under the new track model to enable the evaluation of the patentability of complex AI inventions.The fourth pillar of the argument is the criticality of establishing a new AI patent track model on the grounds that the current patent law regime has posed substantial hurdles and uncertainties for patenting AI inventions with regard to almost all patentability requirements. We analyzed each of the requirements to demonstrate that most, if not all, aspects of patent law are not suitable in the AI era; only a revolutionary new patent model specific for AI inventions could solve all the concerns while maintaining the patent incentive for innovations.Our model also suggests an expedited examination with the aid of AI tools and a shortened patent lifetime in light of the fast AI development and technology elimination speed. The article concludes with the hope to harness AI technology for the wellbeing of humanity, in general and especially during tough times in the current COVID-19 era and in general.
Yu, Peter K, ‘Can the Right to Science Reduce the Tensions Between Intellectual Property and Human Rights?’ (Texas A&M University School of Law Legal Studies Research Paper No 22–56, 10 November 2022) Abstract: The right to science—or, more formally, the right to enjoy the benefits of scientific progress and its applications—is one of the most underexplored rights in the Universal Declaration of Human Rights (UDHR) and the International Covenant on Economic, Social and Cultural Rights (ICESCR). Referred to as being ‘[t]ucked away at the tail end’ of the UDHR and the ‘most obscure of all the international human rights treaty provisions,’ this right did not become the subject of an authoritative interpretation by the U.N. Committee on Economic, Social and Cultural Rights (CESCR) until April 2020, amid the COVID-19 pandemic. Taking note of the release of General Comment No. 25 and the considerable frustrations over the tensions and conflicts between intellectual property and human rights during the COVID-19 pandemic, this chapter closely examines the right to science as incorporated in Article 27(1) of the UDHR and Article 15(1)(b) of the ICESCR. The new interpretive comment is of notable importance because it ‘open[s] … a door to a more complex, nuanced debate and, perhaps, a renewed importance for the right to science, and an evolving role in the protection of other human rights.’ This chapter further explores whether, and how, the right to science can help reduce the tensions and conflicts between intellectual property and human rights. This chapter begins by briefly recounting the drafting history of both Article 27(1) of the UDHR and Article 15(1)(b) of the ICESCR. The chapter then discusses three major problems brought about by strong protection and enforcement of intellectual property rights, as identified by the CESCR. It further outlines ten different areas in which the textual language in General Comment No. 25 can provide a much-needed boost to promote a human-centered approach to health innovations. The chapter concludes by cautioning that some of this language could nonetheless be used to reinforce the tensions and conflicts between intellectual property and human rights, or even support proposals for strengthening intellectual property protection.
Yu, Peter K, ‘Deferring Intellectual Property Rights in Pandemic Times’ (2023) 74(2) Hastings Law Journal 489–550 Abstract: This Article examines an unprecedented proposal that India and South Africa submitted to the World Trade Organization (WTO) in October 2020, which called for a waiver of more than thirty provisions in the Agreement on Trade-Related Aspects of Intellectual Property Rights to help combat COVID-19. It begins by recounting the proposal’s strengths and weaknesses. The Article then identifies the challenges surrounding the negotiation and implementation of the proposed waiver. It shows why these two sets of challenges were neither separate nor sequential, but deeply entangled at the time of the international negotiations. To respond to these challenges and the negotiation impasse at the WTO, this Article advances an alternative proposal that calls for the deferral of select intellectual property rights in pandemic times. Aiming to ‘split the difference’ between the proponents and opponents of the waiver, the proposal draws support from precedents involving temporal adjustments to intellectual property rights at both the international and domestic levels. The Article concludes by exploring the proposal’s scope, strengths, and limitations.
Zaman, Khorsed, ‘The Waiver of Certain Intellectual Property Rights Provisions of the TRIPS for the Prevention, Containment and Treatment of COVID-19: A Review of the Proposal under WTO Jurisprudence’ (2022) 13(2) European Journal of Risk Regulation 295–310 Abstract: This article is a critical legal analysis of the proposed TRIPS waiver under World Trade Organization (WTO) law. It reviews the existing TRIPS flexibilities and the ‘August 2003 TRIPS waiver’, highlighting the obstacles to achieving the goals of these legal instruments. It demonstrates that numerous critical TRIPS flexibilities, notably TRIPS Article 31bis, are ineffective, prompting some countries to submit a new waiver proposal to the WTO. It highlights several WTO rules that are also quite ambiguous. This paper argues that a WTO clarification might be an alternative to the new TRIPS waiver proposal if it is ultimately rejected due to a lack of consensus among WTO members. Finally, this article emphasises the importance of adopting a balanced approach that may simplify complicated TRIPS rules, decrease the risk of trade-based retaliation and improve collaboration in knowledge transfer and scaling up the manufacture of and access to lifesaving vaccines, pharmaceuticals and healthcare equipment.
Zupruk, Brian, ‘The Debate on Protecting Intellectual Property Rights for COVID-19 Vaccines & Therapeutics’ (SSRN Scholarly Paper No 4261152, 1 May 2022) Abstract: COVID-19 is proving a durable obstacle to global public health and to the world’s economies. And while the battle against COVID has largely been waged in laboratories and clean rooms of pharmaceutical giants seated in the world’s largest economies, the populations most in need do not have anywhere near proportional access to the fruits of those laboratory victories. The cutting-edge vaccines and therapeutics that are permanently changing the public health landscape are carefully guarded intellectual property in which major states, multilateral organizations, and the global pharmaceutical industry all have interest and stakes. Since Fall 2020, an outspoken movement has emerged that seeks a waiver of international intellectual property rights for COVID-19 vaccines and therapeutics through the World Trade Organization’s TRIPS Council, the governing body for transnational IP issues. Because TRIPS typically operates through unanimity, the waiver movement—launched by India and South Africa but now championed by the United States—faces a substantial hurdle: strenuous opposition from trade groups and some E.U. member states (most critically Germany.)This Note examines the IP landscape for COVID-19 intellectual property vis-à-vis the TRIPS Agreement; surveys the major policy and legal arguments on both sides of the TRIPS waiver debate; and looks at major precedent for one non-TRIPS solution to the IP waiver debate: public-private partnerships. The Note concludes that while it is possible to reach a workable solution through TRIPS, the WTO process has proven a poor fit for pandemic crises because of the baked-in consensus requirement and the generally ponderous pace of diplomacy. Instead, the Note posits that in the short-term, events on the ground may have overtaken the diplomatic process; and long-term, the goal should not be free-flowing pharmaceutical IP but investment in distributed vaccine production capacity and new supply chain development across the Global South.
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