Author: Papers

Long Live the Common Law of Copyright!: Georgia v. Public.Resource.Org., Inc. and the Debate over Judicial Role in Copyright

Posted by | Aug 31, 2020 |

[Shyamkrishna Balganesh] Abstract: In Georgia v. Public.Resource.Org, Inc., the Supreme Court resurrected a nineteenth century copyright doctrine — the government edicts doctrine — and applied it to statutory annotations prepared by a legislative agency. While the substance of the decision has serious implications for due process and the rule of law, the Court’s treatment of the doctrine recognized an invigorated role for courts in the development of copyright law through the use of principled reasoning.

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United States: An Obsolete Trade Practice Undermines Access to the Most Expensive Drugs at More Affordable Prices

Posted by | Aug 31, 2020 | , , ,

[Maria Fabiana Jorge] Access to affordable drugs is a top policy priority for the United States with real bipartisan support but it increasingly seems to be an unreachable goal, in part, due to conflicting government policies. While the Administration’s Blueprint to Lower Drug Prices and Reduce Out-of-Pocket Costs highlighted the importance of competition to ensure lower drug prices, U.S. trade policy in general, and the Special 301 Annual Review in particular, do exactly the opposite: broaden and lengthen the monopolies granted to pharmaceutical companies thus delaying or deterring the launch of generic and biosimilar drugs and with that, the chances of lowering drug prices.

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The Right to Process Data for Machine Learning Purposes in the EU

Posted by | Aug 28, 2020 | , ,

[Mauritz Kop] Abstract: Europe is now at a crucial juncture in deciding how to deploy data driven technologies in ways that encourage democracy, prosperity and the well-being of European citizens. Normative preferences about how related technology laws ought to be designed should define sustainable exponential innovation policy. These preferences are dynamic and contextual. The upcoming European Data Act provides a major window of opportunity to change the story. In this respect, it is key that the European Commission takes firm action, removes overbearing policy and regulatory obstacles, strenuously harmonizes relevant legislation and provides concrete incentives and mechanisms for access, sharing and re-use of data. The article argues that to ensure an efficiently functioning European data-driven economy, a new and as yet unused term must be introduced to the field of AI & law: the right to process data for machine learning purposes.

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The TRIPS Agreement Article 73 Security Exceptions and the COVID-19 Pandemic

Posted by | Aug 25, 2020 | , ,

[Frederick Abbott] Abstract: The COVID-19 pandemic has caused Governments to contemplate measures to override patents and other intellectual property rights (IPRs) in order to facilitate production and distribution of vaccines, treatments, diagnostics and medical devices. This paper discusses whether the COVID-19 pandemic may be considered an “emergency in international relations” and how WTO Member States may invoke Article 73 (“Security Exceptions”) of the TRIPS Agreement as the legal basis for overriding IPRs otherwise required to be made available or enforced. It concludes that the pandemic constitutes an emergency in international relations within the meaning of Article 73(b)(iii) and that this provision allows Governments to take actions necessary to protect their essential security interests.

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From Struggle to Surge: China’s TRIPS Experience and Its Lessons for Access to Medicines

Posted by | Aug 21, 2020 | ,

[Peter Yu] Abstract: The WTO TRIPS Agreement has imposed unprecedented burdens on countries in the developing world. Although many developing and least developed countries continue to struggle with the Agreement’s high intellectual property protection and enforcement standards, large or populous emerging economies, such as Brazil, China, India, South Africa, Thailand, have managed to adapt the Agreement with some success. As economic and technological conditions improved, these emerging economies began to secure even greater benefits from the TRIPS-based intellectual property system, thereby initiating a self-reinforcing virtuous cycle. Out of all emerging economies, no country provides a better illustration for a complete transformation of its intellectual property system and pharmaceutical landscape than China.

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The COVID-19 Vaccine Race: Intellectual Property, Collaboration(s), Nationalism and Misinformation

Posted by | Jul 27, 2020 | ,

[Ana Santos Rutschman] Abstract: Vaccines have long played a crucial role in the prevention, mitigation and eradication of infectious diseases. More than any other recent outbreak, the COVID-19 pandemic has brought the phenomenon of the vaccine race to the forefront of personal, national and global preoccupations. This symposium contribution examines the early features and takeaways of the COVID-19 vaccine race in four parts.

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How Far Can Regulations Go? A South African Public Law Perspective on the Potential Response through Regulations to Legitimate and Genuine Issues in the Copyright Amendment Bill, B-13B of 2017

Posted by | Jul 27, 2020 | , ,

[Jonathan Klaaren] Abstract: This working paper addresses several issues in South African law relevant to determining whether and to what extent regulations may address genuine problems in the Copyright Amendment Bill [CAB]. Regulations are of course not yet drafted for this Bill and the Bill remains a Bill and is not yet an Act. Indeed, as discussed further below, the Bill is currently under consideration in the Presidency as part of a section 79 process. This working paper addresses several issues in South African law relevant to determining whether and to what extent regulations may address genuine problems in the Copyright Amendment Bill [CAB]. Regulations are of course not yet drafted for this Bill and the Bill remains a Bill and is not yet an Act. Indeed, as discussed further below, the Bill is currently under consideration in Parliament as part of a section 79 process. In addition to its focus on the CAB, this paper identifies a set of emerging South African public law issues associated with similarly situated legislation.

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Regulating Technology Through Copyright Law: A Comparative Perspective

Posted by | Jul 17, 2020 | , ,

[Pamela Samuelson] The EU’s recently adopted DSM Directive marks a break after 30-some years of general convergence in the way EU and US copyright laws have regulated digital technologies. Given the differences in underlying rationales for IP rights and in the legal cultures of the EU and US, the two might pursue divergent paths going forward, particularly in respect of ISP liability and press publisher rules.

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Special Section 301: US Interference with the Design and Implementation of National Patent Laws

Posted by | Jul 10, 2020 | ,

[Carlos Correa] … This paper examines the patent-related claims made by the USTR in relation to the developing countries on the USTR Priority Watch List. It argues that the regulations and practices identified by the USTR show a legitimate use of the flexibilities provided for by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), and that the ignorance of the public interests of the countries concerned (for instance, with regard to access to affordable medicines) has contributed to the discredit (and ineffectiveness) of the Special Section 301.

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Kenya’s Intellectual Property Bill, 2020, and Its Shortcomings in Adopting all Lawful TRIPS Public Health Flexibilities

Posted by | Jul 2, 2020 | , ,

[Brook Baker] Abstract: Given the importance of access to medicines to human rights and well-being in Kenya, it is appropriate to analyze whether Kenya has currently incorporated the allowed public health flexibilities to the greatest extent possible in its draft Intellectual Property Bill, 2020. This analysis will focus on the patent, utility model, and enforcement measures only as they are the ones directly relevant to access to medicines and other health technologies. The analysis starts with the premise that Kenya wishes to avoid granting unwarranted patents on unworthy inventions, especially with respect to medicines and other health technologies.

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Equitable Access to COVID-19 Related Health Technologies: A Global Priority

Posted by | Jun 19, 2020 | , ,

[Zeleke Temesgen Boru] Abstract: … Even though the race to develop these technologies can be hailed as a pivotal undertaking, the development of health technologies alone may not expedite equitable access to the outcome of such development. Particularly, the lack of access to health technologies may befall if the conventional model of health technology pricing, which is derived from monopoly rights created by IP protection, is set. However, legal as well as policy tools can be used to overcome such hurdles and ensure global access to health technologies. In this sense, this paper discusses plausible legal and policy options that can help to accelerate access to health technologies targeting COVID-19.

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Copyright Exceptions Across Borders: Implementing the Marrakesh Treaty

Posted by | Jun 15, 2020 | , ,

[Laurence R. Helfer, Molly K. Land, and Ruth L. Okediji] Abstract: This article reviews state ratification and implementation of the Marrakesh Treaty since its conclusion in 2013. We find that most states have adhered closely to the Treaty’s text, thus creating a de facto global template of exceptions and limitations that has increasingly enabled individuals with print disabilities, libraries and schools to create accessible format copies and share them across borders. The article argues that the Marrakesh Treaty’s core innovation—mandatory exceptions to copyright to promote public welfare—together with consultations with a diverse range of stakeholders, may offer a model for harmonising human rights and IP in other contexts.

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The Case for Compulsory Licensing During COVID-19

Posted by | Jun 11, 2020 | , ,

[Hillary Wong] Over the past few months, the COVID-19 pandemic has devastated industrialized countries in Asia, Europe, and North America. The outbreak will inevitably escalate in developing countries as well. While there is yet to be a proven cure or treatment for COVID-19, commonly referred to as the coronavirus, researchers are racing to test new and existing drugs in search of an effective panacea. As governments of developing countries ramp up efforts to fight the virus, they must take measures not only to contain the virus but also to ensure that COVID-19 treatments will be accessible and affordable following discovery.

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Proposals for Copyright Law and Education During the COVID-19 Pandemic

Posted by | Jun 9, 2020 | , ,

[Emily Hudson and Paul Wragg] 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.

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Non-Violation and Situation Complaints under the TRIPS Agreement: Implications for Developing Countries

Posted by | May 26, 2020 | ,

[Nirmalya Syam] While the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) provided for the applicability of non-violation and situation complaints to the settlement of disputes in the area of intellectual property (IP), when the World Trade Organization (WTO) agreements were adopted in 1994, a moratorium was put in place until WTO Members could agree on the scope and modalities for the application of such complaints. However, for more than two decades, discussions in the TRIPS Council on the subject have remained inconclusive. The biannual WTO Ministerial Conference has granted extensions of the moratorium with regularity. This paper reviews the debate on the applicability of non-violation and situation complaints under the TRIPS Agreement, including the arguments consistently held by two WTO Members that if the moratorium is not extended by consensus, non-violation and situation complaints would become automatically applicable.

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Availability of research articles for the public during pandemic – a case study

Posted by | May 12, 2020 | ,

[Augustine Joshua Devasahayam] Abstract: The coronavirus 2019 (COVID-19) disease has affected millions of lives, forcing most of us to stay at home and work. However, there is an immediate need to conduct research on potential drugs against COVID-19. In this article, the extent to which major publishers have provided access for the public to read research articles relevant to potential drug candidates for the COVID-19 disease are presented.

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South Centre Research Paper 108: Public Health and Plain Packaging of Tobacco: An Intellectual Property Perspective

Posted by | May 3, 2020 |

[Thamara Romero] Abstract In 2018, a World Trade Organization (WTO) Panel ruled that plain packaging of tobacco products was consistent with Australia’s obligations under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and was in the interest of public health. Plain packaging restricts the use of logos, colours and brand images to reduce the demand for and consumption of tobacco products by diminishing their advertising appeal. This paper discusses the intellectual property aspects triggered by the implementation of plain packaging, examines the best practices for its implementation and provides analysis of Australia’s case from the public health perspective. It also highlights the main arguments used in the dispute against Australia and provides practical guidance for WTO Members on implementing measures to protect public health.

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South Centre Policy Brief 76: Evolution of Data Exclusivity for Pharmaceuticals in Free Trade Agreements

Posted by | May 2, 2020 | ,

[Wael Armouti] Abstact: Free trade agreements (FTAs) introduce higher intellectual property (IP) protection than those established in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS-plus provisions) that deprive the parties from benefits of the use of flexibilities found in the TRIPS Agreement to protect public health. One such TRIPS-plus requirement is that of data exclusivity. It establishes that the government should provide an exclusivity period for the test data developed by the originator company, on the grounds of an incentive rationale and considerations of fairness. The negative impact of the data exclusivity approach in developing countries means that the entry of cheap generic products is delayed, even under a compulsory license, which will affect access to affordable medicines. Countries that have already signed the FTAs can mitigate its effects on public health by limiting the scope of and providing exceptions to data exclusivity in national legislation.

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South Centre Research Paper no. 107: Guide for the Granting of Compulsory Licenses and Government Use of Pharmaceutical Patents

Posted by | Apr 23, 2020 | ,

[Carlos M. Correa] Like other rights, patent rights are not absolute. There are situations in which their exercise can be limited to protect public interests. Such situations may arise, for instance, when access to needed pharmaceutical products must be ensured. Compulsory licenses and government use for non-commercial purposes are tools, provided for under most laws worldwide, that can specifically be used to address public health needs. This document is intended to provide legal guidance for the effective use of such tools, consistently with the international law.

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Rethinking R&D for Pharmaceutical Products After the Novel Coronavirus COVID-19 Shock

Posted by | Apr 21, 2020 | ,

[Germán Velásquez] The unprecedented global health crisis caused by the coronavirus –COVID-19– pandemic, during the first quarter of 2020, brings back with particular urgency the discussion about the research and development (R&D) model for pharmaceuticals and other health technologies. The COVID-19 crisis shows that there is an urgent need to re-design the global public health governance for health R&D. The adoption of a binding instrument –as allowed by Article 19 of the WHO Constitution– on this matter was proposed many years ago. This brief argues that it is time to revive and materialize this initiative.

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