Papers

Papers

  • Joined: March 4, 2014
  • Articles: 391

The Incentive Argument in Pharmaceutical Patent Law

[Aaron Poynton] Abstract: This working paper critically examines the pharmaceutical industry and the incentive argument in patent law. It begins by framing an overview of the industry and patent law, focusing on U.S. and U.K. law, and multilateral agreements, and efforts by international organizations, such as the World Trade Organization (WTO). Next, the paper considers patent incentive arguments on both sides of the issue to provide a well-researched and more balanced perspective. It then views the longstanding debate through the lenses of contemporary issues related to Covid-19 vaccines and the recent patent waivers considered by many countries. Lastly, this paper provides concluding opinions supporting the argument that intellectual property protection is core to innovation in the pharmaceutical industry, but patent waivers may be a necessary tool in certain situations. It concludes by recommending fixing the TRIPS compulsory licensing provision flaws and carefully finding a TRIPS waiver solution that could strike the desired balance between protecting intellectual property (IP) and providing for the common good.

The Right to Research in Africa: Making African Copyright Whole

[Desmond Oriakhogba] Abstract: The imbalance existing within the African copyright ecosystem in relation to access to information for research and education became more prominent during the COVID-19 pandemic. As teaching, learning and research inevitably occur on digital platforms, learners and researchers continue to grapple with the challenges of accessing materials owing largely to the protection of these resources under copyright law. Similarly, African libraries and knowledge curators found themselves ill-equip to perform their role of enabling access to information. To create the balance, therefore, there is a dire need for the recalibration of the African copyright system from the perspective of human rights law.

Zen and the Art of Repair Manuals: Enabling a Participatory Right to Repair Through an Autonomous Concept of EU Copyright Law

[Anthony D. Rosborough] Abstract: Repair manuals are an essential resource for repairing today’s modern and computerised devices. Though these manuals may contain purely utilitarian and uncopyrightable facts, they often receive copyright protection in their entirety as literary works. This protection can impede community-based efforts toward fostering a culture of participatory repair throughout the EU, including repair cafés and tool libraries. Participatory repair activities provide numerous environmental, social, and economic benefits. This article explores whether directive 2001/29/EC’s exception for “uses in connection with the repair or demonstration of equipment” at Article 5(3)(l) (the “Repair Exception”) may offer an avenue for enabling such non-profit activities

The Divisional Game: Using Procedural Rights to Impede Generic/Biosimilar Market Entry

[Katarina Foss-Solbrekk] Abstract: Despite being used frequently by practitioners in a wide array of technical fields, divisional patent applications (“divisionals”) seldom attract scholarly attention. The lack of scholarly attention is an error, particularly in the pharmaceutical field. Recent case law in the UK reveals that after generic/biosimilar manufacturers successfully revoke patents standing in the way of market entry, divisionals claiming protection for similar subject-matter as the patent that has just been revoked can crop up, hindering generic/biosimilar medicines from entering the market. Moreover, right before or after proceedings start, rightsholders de-designate countries to avoid a negative judgment that may affect a court elsewhere, meaning generic/biosimilar manufacturers initiated legal proceedings for nothing. Such practices demonstrate that divisionals deserve our attention. This article thus fills the scholarly gap by showing how divisionals are (mis)used in practice, before arguing that patent reform is necessary to prevent this from occurring.

Study on EU Copyright and Related Rights and Access To and Reuse of Data

[Martin Senftleben] Executive Summary: To safeguard freedom of expression and information, and the freedom of sciences, of researchers,[1] it is important to improve the legal framework for scientific research in copyright, related rights and sui generis database law. In particular, it is important to remove imbalances that pose obstacles to data access and reuse. Article 5(3)(a) of the Information Society Directive could serve as a reference point for this legislative step.

Rules of Engagement: Copyright and Automated Gatekeepers’ Influence on Creative Expression

[Michael Carroll] Abstract: This Essay turns questions about artificial intelligence and copyright law around. Rather than focus on algorithms as potential authors, this Essay argues for more attention to the role of algorithms as gatekeepers on social media and how creators adapt their creative choices to meet the demands of these automated tastemakers. Using TikTok’s “For You” algorithm and its role in breaking Lil Nas X’s hit song “Old Town Road” as a case study, this Essay poses the question whether algorithmic gatekeeping is simply a difference in degree or a difference in kind from an artist’s perspective. While tentative, this Essay concludes that this change is a difference in kind because of the rule-bound nature of software, the absence of transparency and accountability for algorithmic decision making, and the flawed data models that inform this form of cultural gatekeeping.

Conceptualizing a ‘Right to Research’ and Its Implications for Copyright Law: An International and European Perspective

[Christophe Geiger and Bernd Justin Jütte] Copyright, at international, European and national levels, does not provide a legal framework that prioritizes enabling and incentivizing research using protected works and information to the extent necessary and desirable in a digital, data-driven society in order to build a sustainable ecosystem for innovation and creativity. While small progress has been made, for example with the recent introduction of specific exceptions for research purposes and for text and data mining in certain national legislations as well as in the European Union law, a horizontal approach towards a more research-friendly copyright ecosystem has so far failed to evolve. By revisiting international and European human and fundamental rights instruments as well as the aims and objectives of the European Union, it is possible to distill research as a constitutional and ethical imperative. Conceptualizing a fundamental ‘Right to Research’ and integrating it into a constitutional dialogue provides a convincing argument to rethink copyright towards a research-oriented normative system.

A Pandemic Treaty for Equitable Global Access to Medical Countermeasures: Seven Recommendations for Sharing Intellectual Property, Know-How and Technology 

[Katrina Perehudoff, Ellen 't Hoen, Kaitlin Mara, Thirukumaran Balasubramaniam, Frederick Abbott, Brook Baker, Pascale Boulet, Mohga Kamal-Yanni, Manuel Martin, Viviana Munoz Tellez, Yannis Natsis, Vicente Ortún-Rubio, Sandeep Rathod, Maties Torrent, Yousuf Vawda, Luis Villarroel, James Love] ... We recommend that a pandemic treaty ensures sufficient financing for biomedical research and development (R&D), creates conditions for licensing government-funded R&D, mandates technology transfer, shares intellectual property, data and knowledge needed for the production and supply of products, and streamlines regulatory standards and procedures to market medical countermeasures. We also recommend that a pandemic treaty ensures greater transparency and inclusive governance of these systems. The aim of these components in a pandemic treaty should be to craft a better collective response to global health threats, consistent with existing international law, political commitments and sound public health practice.

How Well Did Copyright Laws Serve Libraries During COVID-19?

[International Federation of Library Associations] The report involved a survey of 114 libraries worldwide and 28 interviews during February and March 2022. Respondents were from 29 countries. 83% of responding library professionals said they had copyright-related challenges providing materials during pandemic-related facility closures. These intersected with ongoing challenges predating the pandemic, including budget pressures, external financial crises, difficult negotiations with publishers, and demand for eBooks that outpaces publisher offerings.

Compliance of National TDM Rules with International Copyright Law – An Overrated Nonissue?

[Martin Senftleben] Abstract: ... lawmakers in countries seeking to devise an appropriate TDM regime may wonder whether the adoption of a restrictive approach is necessary in the light of international copyright law. In particular, they may feel obliged to ensure compliance with the three-step test laid down in Article 9(2) of the Berne Convention, Article 13 of the TRIPS Agreement and Article 10 of the WIPO Copyright Treaty. An imbalanced, restrictive interpretation of the three-step test, however, can lead to an overly cautious approach that stifles TDM and makes broad inroads into the right to research – instead of establishing a proper balance between copyright protection and the right to research that supports TDM activities. Against this background, the analysis raises the question whether international copyright law covers TDM activities at all.

Progress as Impact: A Contemporary View of the Copyright and Patent Clause

[Alina Ng] Abstract: The Constitution grants Congress the power to promote the progress of science and the useful arts through the intellectual property clause. ... This article argues that intellectual property laws need to have a more contemporary understanding of progress, one that reflects the reality and practicality of how progress actually unfolds and shows how construing progress as making an impact on social and economic welfare through entrepreneurial activities may be a more contemporarily appropriate understanding we should strive for.

Ensuring the Visibility and Accessibility of European Creative Content on the World Market: The Need for Copyright Data Improvement in the Light of New Technologies and the Opportunity Arising from Article 17 of the CDSM Directive

[Martin Senftleben, Thomas Margoni, Daniel Antal, Bodó Balázs, Stef van Gompel, Christian Handke, Martin Kretschmer, Joost Poort, João Quintais, Sebastian Schwemer] Abstract: In the European Strategy for Data (COM(2020) 66 final), the European Commission highlighted the EU’s ambition “to acquire a leading role in the data economy.” At the same time, the Commission conceded that the EU would have to “increase its pools of quality data available for use and re-use.” In the creative industries, this need for enhanced data quality and interoperability is particularly strong (section 1). Without data improvement, unprecedented opportunities for monetising the wide variety of creative content in EU Member States and making this content available for new technologies, such as artificial intelligence (“AI”) systems, will most probably be lost (section 2).