Papers

Papers

  • Joined: March 4, 2014
  • Articles: 358

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

[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.

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

[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.

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

[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.

From Flexible Balancing Tool to Quasi-Constitutional Straitjacket – How the EU Cultivates the Constraining Function of the Three-Step Test

[Martin Senftleben] Abstract: In the international intellectual property (IP) arena, the so-called “three-step test” regulates the room for the adoption of limitations and exceptions (L&Es) to exclusive rights across different fields of IP. Given the openness of the individual test criteria, it is tempting for proponents of strong IP protection to strive for the fixation of the meaning of the three-step test at the constraining end of the spectrum of possible interpretations. As the three-step test lies at the core of legislative initiatives to balance exclusive rights and user freedoms, the cultivation of the test’s constraining function and the suppression of the test’s enabling function has the potential to transform the three-step test into a bulwark against limitations of IP protection.

The COVID-19 Pandemic: R&D and Intellectual Property Management for Access to Diagnostics, Medicines and Vaccines

[Viviana Muñoz Tellez] 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.

Eighteen Years After Doha: An Analysis of the Use of Public Health TRIPS Flexibilities in Africa

[Yousuf A Vawda and Bonginkosi Shozi] Abstract: As we observe the 18th anniversary of the Doha Declaration on the TRIPS Agreement (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health, it is appropriate to take stock of intellectual property developments and endeavour to present a comprehensive account of the situation in the African continent in respect of the implementation of TRIPS flexibilities, specifically those regarding access to medicines. This research paper provides an overview of the extent to which selected African countries have adopted legal and policy frameworks with regard to TRIPS flexibilities, examines the actual use of these flexibilities in enabling access to medicines in those countries, and suggests some recommendations for optimising the use of the flexibilities in pursuing public health imperatives.

The Intellectual Property of Vaccines: Takeaways from Recent Infectious Disease Outbreaks

[Ana Santos Rutschman] Abstract: This Essay examines the ways in which intellectual property regimes influence incentives for the development of new vaccines for infectious diseases. Charting the tension between market forces and public health imperatives, the Essay considers an emerging solution to the long-standing problem of insufficient incentives for vaccine research and development: the rise of public-private partnerships in the health space.

The Conflicts between Copyright and the Norms of Online Re-Creations: An Empirical Analysis

[Khanuengnit Khaosaeng] Abstract: As a fundamental principle, by granting exclusive rights, copyright provides economic incentives to encourage authors and artists to express their ideas, and in that process, create a new work. As a general rule, when using a protected work, a person needs permission from the copyright holder of such work. However, this article finds that: economic interests provided by copyright are not the primary incentives for authors to create a work; and due to some obstacles, people cannot conform to the copyright rule that permission to use a copyright work is required. These conclusions are supported by an original empirical study on the social norms concerning the practice of online re-creations.

Reconstructing Rights: Project Synthesis and Recommendations

[P. Bernt Hugenholtz and Martin Kretschmer] Abstract: ... This introductory chapter gives an overview of a collaborative research project (‘Reconstructing Rights’) that normatively examined the core economic rights protected under EU copyright law, with the aim of realigning these rights with economic and technological realities. Five ‘borderline’ cases are being examined to explore the implications of different theoretical models: (1) Digital Resale; (2) Private Copying; (3) Hyperlinking and Embedding; (4) Cable Retransmission; (5) Text and Data Mining.

The Case for Disclosure of Original Biologics Manufacturing Information

[Yaniv Heled] Abstract: Ten years after the enactment of the Biologics Price Competition and Innovation Act (BPCIA), competition in biologics markets remains scant and far from sufficient for lowering prices of biologics to the level of 80-90% price drops seen in generic drug markets. This reality is not a result of one or two cardinal reasons, but many. If lowering the price of biologics is the goal and competition is the means by which we seek to achieve that goal, then there does not seem to be a quick fix to address all of the many impediments to competition that plague biologics markets. Yet, certain changes to how the Food and Drug Administration (FDA) evaluates and approves biologics may go a long way toward the creation of meaningful competition in biologics markets. One such change would be making original biologics' manufacturing information available to follow-on manufacturers.

The Machine As Author

[Daniel Gervais] Abstract: The use of Artificial Intelligence (AI) machines using deep learning neural networks to create material that facially looks like it should be protected by copyright is growing exponentially. From articles in national news media to music, film, poetry and painting, AI machines create material that has economic value and that competes with productions of human authors. The Article reviews both normative and doctrinal arguments for and against the protection by copyright of literary and artistic productions made by AI machines.

Second Medical Use Patents – Legal Treatment and Public Health Issues

[Clara Ducimetière] Abstract: This paper attempts to give an overview of the debate surrounding the patentability of new therapeutic uses for known active ingredients, both in developed and developing countries. After close scrutiny of international patentability standards, this paper concludes that second medical uses do not qualify per se for patent protection and have only been protected in several jurisdictions by means of a legal fiction.