Author: Papers

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

Posted by | Apr 21, 2020 | ,

[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.

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

Posted by | Apr 13, 2020 |

[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.

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Urgent Legal Lessons From a Very Fast Problem – Covid 19

Posted by | Apr 10, 2020 |

[Eric E. Johnson and Theodore C. Bailey] Abstract: The course of a pandemic is dictated not just by biology, but also by law. And crucially, unlike biology, law can be readily adapted in response to a pandemic. Unfortunately, the current law does not take account of the compressed timeframe and rapidly changing social needs that distinguish pandemic times from normal times. We thus suggest three urgent, early lessons for law in the pandemic context: First, free information flows save lives, an observation which has ramifications for freedom of speech and press, copyright law, and patent law. Identifying particular hazards that patent law poses to the free flow of scientific research findings, we suggest a government-funded reward system as an adjunct to the patent system to incentivize pandemic-relevant research and its rapid publication.

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

Posted by | Apr 1, 2020 | , ,

[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.

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

Posted by | Mar 10, 2020 | ,

[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.

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

Posted by | Mar 6, 2020 | ,

[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.

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Reconstructing Rights: Project Synthesis and Recommendations

Posted by | Feb 17, 2020 | ,

[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.

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The Case for Disclosure of Original Biologics Manufacturing Information

Posted by | Feb 13, 2020 |

[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.

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The Machine As Author

Posted by | Jan 6, 2020 |

[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.

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Second Medical Use Patents – Legal Treatment and Public Health Issues

Posted by | Jan 6, 2020 | ,

[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.

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What is Left of User Rights? – Algorithmic Copyright Enforcement and Free Speech in the Light of the Article 17 Regime

Posted by | Jan 4, 2020 | , ,

[Sebastian Felix Schwemer and Jens Schovsbo] Abstract: Article 17 of the Directive on copyright and related rights in the Digital Single Market (the DSM Directive) has strengthened the protection of copyright holders. Moving forward, online content-sharing providers will be responsible for copyright infringement unless the use of works on their platforms is authorized or if they have made ‘best efforts’ to obtain an authorization and prevent the availability of unlicensed works. At the same time, the Directive has made it clear that users of protected works shall be able to rely on the existing limitations and exceptions regarding quotation, criticism and review and caricature, parody or pastiche. The Directive even casts these limitations and exceptions as user rights.

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Who Holds the Right to Exclude for Machine Work Products?

Posted by | Dec 27, 2019 |

[Garry Gabison] Abstract: This article investigates whether the inventions and works created by Artificial Intelligence should be patent-able and copyright-able and if so, who should be assigned these rights. This article uses US case law and incentive economics to answer these questions. This article discusses who of the machine, its creators, owners, or operators should be assigned the rights to exclude others if policymakers want to promote the progress of science and useful arts. All four candidates raise legal problems.

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Patents of Introduction and the Spanish Innovation System

Posted by | Dec 16, 2019 |

[Patricio Sáiz] Abstract: In this paper we will reflect on the design of the Spanish Innovation System, especially in one of its institutional aspects (the patent system), in order to understand the real role and function of a curious legal process the “patent of introduction”, which in practice promoted and permitted anyone to protect foreign third-person technologies in order to implement them locally, providing they were not already established. Although this legal practice represents a very clear declaration of intentions concerning the innovation policy and despite its existence in other patent systems in lagging countries, economic and technology historians have paid little or no attention to the subject.

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Medicines and Intellectual Property: 10 Years of the WHO Global Strategy

Posted by | Dec 16, 2019 | ,

[Germán Velásquez] Abstract: The negotiations of the Intergovernmental Working Group on Public Health, Innovation and Intellectual Property (IGWG) (2006-2008), undertaken by the Member States of the World Health Organization (WHO), were the result of a deadlock in the 2006 World Health Assembly where the Member States were unable to reach an agreement on what to do with the 60 recommendations in the report on Public Health, Innovation and Intellectual Property submitted to the Assembly in the same year by a group of experts designated by the Director-General of the WHO.

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The Obscure Consumer in the Chinese Intellectual Property Law

Posted by | Dec 9, 2019 | ,

[Jyh-An Lee and Yangzi Li] Abstract: Conventional wisdom suggests that an ideal intellectual property (IP) regime should consider various interests, such as incentives for creators and inventors, social access to creative works, market competition, and economic development. Nevertheless, the interest of consumers has long been neglected in IP policy-making. This article systematically reviews recent Chinese court decisions on IP and explores their implicit consumer policy implications. The article reveals that the Chinese courts have occasionally embedded consumer policy considerations when applying the Copyright Law, Patent Law, Trademark Law, and the Anti-Unfair Competition Law. Moreover, this article illustrates how policy goals underlying the IP regime and consumer protection law are consistent or supplementary with each other in the implementation of different categories of IP laws.

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Analyzing the Impact of Trade and Investment Agreements on Pharmaceutical Policy: Provisions, Pathways and Potential Impacts

Posted by | Dec 2, 2019 |

[Deborah Gleeson, Joel Lexchin, Ronald Labonté, Belinda Townsend, Marc-André Gagnon, Jillian Kohler, Lisa Forman, and Kenneth C. Shadlen] Abstract: Trade and investment agreements negotiated after the World Trade Organization’s Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which other provisions in trade agreements can affect pharmaceutical policy and, in turn, access to medicines have been little studied. There is a need for an analytical framework covering the full range of provisions, pathways, and potential impacts, on which to base future health and human rights impact assessment and research.

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The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States?

Posted by | Nov 25, 2019 |

[Simone A. Rose and Tracea Rice] Abstract: The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars.

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Report and Webinar: Rethinking Trade Treaties & Access to Medicines

Posted by | Nov 12, 2019 | , ,

The Boston University Global Development Policy Center is hosting a webinar on Wednesday, November 13 from 9-11AM to launch the latest GDP Center report Rethinking Trade Treaties and Access to Medicines: Toward a Policy-Oriented Research Agenda hosted by the Trade & Medicines Working Group. The report synthesizes the state of knowledge on trade and investment treaties on access to medicines and advances a policy oriented research agenda intended to help policy-makers, civil society, and others make more informed decisions as they debate contemporary trade and investment treaties.

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Worldwide Inequality in Access to Full Text Scientific Articles: The Example of Ophthalmology

Posted by | Nov 4, 2019 |

[C. Boudry et al.] Abstract: … The problem of access to medical information, particularly in low-income countries, has been under discussion for many years. Although a number of developments have occurred in the last decade (e.g., the open access (OA) movement and the website Sci-Hub), everyone agrees that these difficulties still persist very widely, mainly due to the fact that paywalls still limit access to approximately 75% of scholarly documents. In this study, we compare the accessibility of recent full text articles in the field of ophthalmology in 27 established institutions located worldwide.

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How Will Recent Trade Agreements that Extend Market Protections for Brand-Name Prescription Pharmaceuticals Impact Expenditures and Generic Access in Canada?

Posted by | Oct 30, 2019 | , ,

[R.F. Beall, L. Hardcastle, F. Clement and A. Hollis] Abstract: Canada recently entered into two multinational trade agreements (i.e., the Canada, United States, and Mexico Trade Agreement; and the Comprehensive Economic and Trade Agreement with the European Union). The resulting federal policy changes will prolong periods of market protection afforded to eligible brand-name prescription drugs by extending competition-blocking patent and data exclusivity terms. While previous studies have analysed these two policy changes in isolation, it remains unknown what the total combined impact will be in a typical year.

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