Compulsory Licensing Research Articles

TRIPS to Where? A Narrative Review of the Empirical Literature on Intellectual Property Licensing Models to Promote Global Diffusion of Essential Medicines.

Governed through the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) since 1995, the current medical R&D system requires significant trade-offs between innovation and high monopoly prices for patented drugs that restrict patient access to medicines. Since its implementation, few amendments have been made to the original TRIPS agreement to allow low- and middle-income countries (LMICs) to facilitate access by generic manufacturers through flexible provisions, such as compulsory licensing and parallel import. Although a useful policy tool in theory, the routine use of TRIPS flexibilities in LMICs in the procurement of new essential medicines (EMs) is regarded as a ‘last resort’ due to strong political response in high-income countries (HICs) and new trade agreements’ restrictions. In this context, access-oriented biomedical Public-Private Partnerships (PPPs) have emerged. More recently, leading multilateral health organizations have recommended different types of intellectual property (IP) interventions, voluntary biomedical patent pools, as strategies to reduce prices and increase the diffusion of novel EMs in LMICs. Nevertheless, the recent Ebola and COVID-19 outbreaks highlight growing concerns regarding the use of TRIPS flexibilities and the limited success of voluntary mechanisms in promoting access to medicines in the Global South amidst health crises. This review aims at describing the state-of-the-art empirical research on IP-related options and voluntary mechanisms applied by emerging PPPs to guarantee timely and affordable access to EM in LMICs and reflect on both models as access paradigms. Some suggestions are put forward for future research paths on the basis of these analyses and in response to contemporary debates on waiving key IP rights on COVID-19 therapies, diagnostics, and vaccines.

PATENT WAIVER OF COVID-19 VACCINE: REALIZING A BALANCE OF RIGHTS THROUGH PATENT VALUATION

This article describes a new idea about patent valuation in patent waivers that developing countries have proposed for some time. Vaccines are a necessity for every country during the current COVID-19 pandemic. Valuation is required in the commercialization of patents, including COVID-19 vaccine patents, compulsory licenses, and waivers can be an option for countries to obtain a COVID-19 vaccine. This article uses a qualitative research method with a normative juridical approach by describing it normatively. This research results in the balance of rights for inventors or pharmaceutical companies that have patents and the world countries that need vaccines. This balance and justice can be realized by the valuation of economic and moral rights. The valuation still exists even though the patent waiver is applied. The adequate economic valuation for vaccines is the cost-based approach because the inventor or pharmaceutical company must be reimbursed for the production costs incurred. On the other hand, a reward can apply the valuation of moral rights for inventors and pharmaceutical companies that produce vaccines. The inventors or pharmaceutical companies can increase their good name. Mandatory waivers and compulsory licenses can be carried out by countries’ economic conditions and policies while still paying attention to the rights of inventors and pharmaceutical companies. In this way, world health will be achieved, and innovation can continue to be carried out.

The Future of Music Copyright Collectives in the Digital Streaming Age

The Future of Music Copyright Collectives in the Digital Streaming Age

Prawo cywilne PRL — wybrane zagadnienia prawa autorskiego

The author, presenting in a limited way the results of research on the law of the Polish People’s Republic, discusses two institutions regulated in the 1952 Act on copyright — the compulsory license under art. 16 and 17 and the implementation of the Council of Ministers’s powers (resulting from art. 33 § 1) to determine the principles and rates of remuneration for authors and contract templates. In accordance with art. 33 § 2, in relation to the provisions of the contracts covered by them, they were absolutely binding. The first of them limited the protection of subjective “ownership” rights to works, enabling their specific, although limited by their function, “expropriation”, while the second resulted in a significant and real restriction of the freedom of contracts regarding the use and disposal of copyright to works. This analysis leads to the conclusion that adapting the law shaped in a different system and political realities — in this case, its specific “totalization” — does not require large-scale changes in the existing regulation. It is only enough to modify the institutions of fundamental importance for the implementation of the principles of a specific political order. At the same time, in the reality of the totalitarian state of the Polish People’s Republic, the acts issued on the basis of art. 33 of the Copyright Act of 1952 were the most important to fulfil the purpose of these principles.

Does International Law Need a Conscience? Evaluating the India–South Africa Proposal to Suspend TRIPS Obligations and the COVID-19 Vaccines

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.

Compulsory licensing of trade secrets: ensuring access to COVID-19 vaccines via involuntary technology transfer

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.

Patents, access to health and COVID-19 – the role of compulsory and government-use licensing in Ireland

As the race for effective vaccines and treatments for COVID-19 continues, attention must turn to how such health-technologies will be accessed globally once developed. Patents play a significant role in this context because they give the patent-holder the right to stop others using patented inventions. Patents are available on diagnostics, medicines and vaccines and could form significant access obstacles for COVID-19. Moreover, whilst many patent-holders may be willing to license health-technologies reasonably, others may not. Therefore, it is imperative that national governments ensure effective avenues exist to intervene with patent-holder discretion via compulsory licensing. This article focuses on the legal framework applicable in Ireland for such compulsory licensing interventions, interrogating the effectiveness of the current framework in alleviating access issues posed by patents for COVID-19. It demonstrates how the current framework could be reformed to make it more effective in tempering patent-holder control, where needed, whilst remaining in compliance with Ireland’s international obligations.

Proposals for copyright law and education during the COVID-19 pandemic

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 Copyright, Designs and Patents Act 1988 (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.

Ukrainian experience in implementation of the flexible provisions of the TRIPS Agreement in the context of European integration and the pandemic

Keywords: intellectual property, human rights, patients' rights, pharmaceutical nationalism,protectionism, vaccines, generics, COVID-19
 The article concerns the analysis of global trends in theparadigm of intellectual property rights on the objects used in the diagnosis, preventionand treatment of COVID-19. The experience of the implementation of pharmaceuticalnationalism policies provided by the EU, Canada and Israel are presented in the article.The authors provide the legal backgrounds of the need for Ukraine to be a co-sponsor ofthe IP waivers proposals, which are submitted to the TRIPS Council by some membersof the WTO. The authors stress the need for Ukraine to use the historic opportunity forthe development of the national pharmaceutical industry, which would contribute tothe interests of the domestic patient, and make proposals for the necessary changes tonational legislation.The authors also stressed the position of the governments of Germany and France.Thus, in Germany there is the Law on Governmental Use of Patented Inventions duringa Pandemic. The law provides, inter alia, for amendments to the Patent Law, accordingto which the Federal Ministry of Health has the right to authorize the use of relevantpatents to ensure the production and supply of pharmaceuticals or medical devices.In 2020, France adopted the Emergency Law № 2020-290 to combat theCOVID-19 epidemic, which introduced Article 3131 15 of the French Public HealthCode. This rule authorizes the Prime Minister to issue orders to recover or seize allgoods and services necessary to combat the disaster, to temporarily control the price ofproducts and, if necessary, to take any measures to ensure that patients are providedwith appropriate drugs to deal with the disaster, related to health. It is useful forUkraine to use the experience of Canada in terms of facilitating negotiations with majorvaccine manufacturers to establish national drug production and in terms of developinglegislation in the field of compulsory licensing.It is obviously, voluntary licences from patent owners, which provide for the fulltransfer of technology, and not just patent disclosure, are the most effective tool for thenational production of biosimilars. However, international experience shows that pharmaceuticalcompanies are holding back the issuance of compulsory licences. Therefore,our government's biosecurity portfolio should include an effective tool for compulsory licensingor emergency use of biosimilars and generic drugs by the Government.

SCOPE OF PROTECTION AND DEPENDENCE BETWEEN PATENT RIGHTS

Based on European doctrine and the Author's previous work, the present work intends to illuminate the judicatively complex question of what are the requirements or assumptions whose verification make a invention patented (and therefore a technical solution provided with inventive activity and novelty in relation to the state of the art) “mysteriously” dependent on another previously patented invention, allowing the holder of the latter (dominant patent) to prevent the commercial exploitation of the first (dependent patent) - a situation that is susceptible of being released by entering into a voluntary license agreement or by granting a compulsory license. Basically, taking into account the Portuguese Industrial Property Code, European doctrine and jurisprudence and the European Patent Convention, we seek to demonstrate that the solution to these issues lies in the delimitation of the concrete (technological) scope of patent protection previously registered.

Waive the IP Rights and Save Lives

In October of 2020, when India and South Africa proposed a waiver from certain provisions of the TRIPS agreement, it was meant to increase local manufacturing capacity in these countries although the waiver, in enabling vaccination of populations across the globe, would be critical to normalize global trade. The waiver was proposed as a tool to kick-start prevention, containment and treatment of COVID-19. While there is an imminent need to meet a growing supply-demand gap for all medical products, COVID-19 related products are urgently required in poorer nations to contain the pandemic. The paper hopes to capture the benefits of the waiver and compares it with the existing flexibilities, being compulsory licensing.

GOOD FAITH IN TRIPS COMPULSORY LICENSING OF PHARMACEUTICAL PATENTS: LESSONS FROM PREVIOUS PANDEMIC CASES

The COVID-19 pandemic impacts the world of patents as countries prepare their legal framework to ease the process of compulsory licensing. Some like India and South Africa even went further by proposing a suspension for patents needed to combat COVID-19 which is still under discussion. It is a real possibility that a patented drug that is effective against COVID-19 would potentially see compulsory licensing in many countries its patent holder is doing business. This article discusses why compulsory licensing is an essential issue by examining its legitimacy, previous cases of compulsory licensing, and the conduct of states in cases of compulsory licensing issuance, particularly in examples of Thailand, Brazil, and India. The article will examine ways of remedy against compulsory licensing, including a theoretical possibility for constitutional review of treaties. The remedies discussed shall include international and domestic remedies, both litigation and alternative measures. The research shall use qualitative research methods with the use of primary and secondary legal sources. The result of this article found that a combination of soft law power of the Doha Declaration and the invocation of subsequent compulsory licensing cases be the support pillars of compulsory licensing practice. However, the practice of compulsory licensing both by the patent holder and the state actors is still not performed entirely in good faith according to the Vienna Convention of the Law of Treaties (VCLT) 1969 and the TRIPS Agreement. Hence, such patent holders need to be familiar with both international and domestic remedies, especially the possibility for constitutional review of treaties remedies.

Health regulation and technological development: innovative strategies for accessing medicines in the SUS.

Regulatory science involves articulating knowledge that can establish the scientific bases for the definition of adequate and efficient regulatory mechanisms and practices. The interfaces between systemic and sectoral health and technological development policies were studied based on documentary analysis, especially from the National Pharmaceutical Policy (PNAF), with impacts on health regulation and stimulating the production of medicines of interest to the Unified Health System (SUS). The initiatives for the nationalized production of ARV "Efavirenz", which was the subject of a compulsory license in 2007, and the establishment of Partnerships for Productive Development (PDP), contributed to defining innovative regulatory frameworks and practices, emphasizing the Regulatory Technical Committees (CTR) for monitoring the internalization of technologies and health registration of the resulting products. The permeation capacity of the principles and strategic axes of the PNAF was identified in the sectoral policies that were analyzed. As of 2014, no macro or sectoral policies on expanding access to medicines in the SUS with impacts on regulations were identified.

Conditions for Granting Compulsory License for Dependent Invention Use

The paper deals with the institution of compulsory licensing for dependent inventions. Currently, its most important application is in the pharmaceutical industry. In order to launch generic drugs that are dependent inventions pharmaceutical companies have to enter into licensing agreements with the developers of original drugs. The law enforcement practice that began in 2018 in the Russian Federation showed that paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation, which establishes the conditions for granting a compulsory license for the use of a dependent invention, needs to be harmonized and supplemented in order to protect and regulate the balance of private and public interests. To solve this problem, the author analyses the wording of the corresponding legal norm found in international agreements, in particular in the TRIPS Agreement, and in the national legislation of different countries as well as the effectiveness of its application. Based on the results of the study, possible clarifications are given to the conditions for granting a compulsory license for the use of a dependent invention under paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation.

Access to Pharmaceutical Patents in the COVID-19 Emergency: A Case for Government Use in Nigeria

AbstractThe 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.

Compulsory Licensing in the Case of a Dependent Patent: The Interplay between Intellectual Property Law and Civil Law

Compulsory Licensing in the Case of a Dependent Patent: The Interplay between Intellectual Property Law and Civil Law

Intellectual property rights trump the right to health: Canada’s Access to Medicines Regime and TRIPs flexibilities in the context of Bolivia’s quest for vaccines

ABSTRACT The failure of the Canadian pharmaceutical company Biolyse Pharma to obtain authorization under Canada’s Access to Medicines Regime (CAMR) to produce 15 million badly needed doses of a generic copy of a vaccine needed by a developing country is the occasion for a reflection on the right to health and the compatibility of this right with the dominant system of intellectual property rights (IPR) under the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), the Doha Declaration and subsequent decisions. Global health justice and intellectual property rights are difficult to reconcile because patent-supported pricing limits equitable access to medicines and, in addition, produces distortions in the allocation of resources in health research. A ‘delinkage’ of production and development costs is therefore called for. In spite of this, governments of countries with an important pharmaceutical sector are often hesitant to agree to sharing of information and technologies. The ‘flexibilities’ (mainly ‘waivers’ and ‘compulsory licenses’) provided for under the TRIPS system are not applied in a serious and consistent way in order to allow developing countries to deal with health crises, as is illustrated by extreme variation in rates of vaccination between the developed and the less developed world.

Waiving COVID-19 Vaccine Patents: A Bad Idea and a Dangerous Precedent

The Biden Administration believes that suspending COVID-19 vaccine patents will expedite the swift development of high quality “cheap” versions of existing vaccines and hasten the pandemic’s end. This view is dangerously wrong. Vaccinating the world is essential, but temporarily waiving patent rights for COVID-19 vaccines (also known as “compulsory licensing”) will actually slow their availability to the developing world.
 
 While providing no gain, compulsory licensing promises lots of pain. Waiving patent protection discourages cutting-edge research investments, which in turn produce breakthrough treatments not just for COVID-19, but for other diseases, like cancer. Weakening these protections would be anti-patient and counterproductive.
 
 The reality is that, in order to save the world, we must all work together as partners. The remarkable speed with which we developed diagnostics, therapeutics, and vaccines to combat COVID-19 points to the need for more collaboration, not less. Patents are a foundational principle upon which that success rests.
 
 While the policy of temporarily waiving patents seems fair and humanitarian, the devil is in the details. Such a policy will not result in a single citizen of the developing world getting vaccinated one minute sooner. In fact, the unintended consequences are the reverse. More confusion, lower quality, less transnational cooperation. A triple play of disastrous global proportions.

The Legislative Approach and System Improvement of China's Compulsory Licensing for Drug Patents.

Compulsory licensing for drug patents is of great significance to ensure the accessibility of drugs. Although the development of China’s compulsory licensing system for drug patents has been gradually improved, there are still problems. For example, the scope of the object is not realistic, the setting of the initiating subject is unreasonable, the reasons for issuance are not clear, the duration and scope of the license are not refined, and the provisions on the exploitation fee are missing. Consequently, in order to improve China’s compulsory licensing system for drug patents, it is necessary to expand reasonably the scope of the object, remove the restrictions on the initiating subject, adjust the initiating rights of different subjects, determine the duration and scope of the license and the applicability of the hearing on a case-by-case basis, and determine a reasonable exploitation fee by taking into account the national income, patent cost, market share and other factors, in consideration of the flexibly international norms and the actual situation in China.

Application of Parallel Importation and Voluntary License in the Covid-19 Vaccines Patent as a Strategy for Handling the Health Emergency Situations in Indonesia

This article examines how the application of Parallel Importation and Voluntary License in the Application of the Covid-19 Vaccine Patent as a Strategy for Handling Health Emergency Situations in Indonesia. The problem of the Covid-19 vaccine happens in many countries around the world, including Indonesia whos trying to find a vaccine that can neutralize the Covid-19 Virus. As a consequence of the tremendous demand for vaccines, the world pharmaceutical industry is encouraged to provide Covid-19 vaccines for the needs of 7.8 billion. This article uses normative legal research with a statute, conceptual, and comparative law approach. The results showed that mechanisms such as parallel importation and voluntary licenses could be reached to procure the Covid-19 vaccine. If parallel importation and voluntary licenses are not successful, then the Government shall take a win-lose approach, such as Compulsory Licensing and Use of Patents by the Government, or initiate an anti-monopoly lawsuit.