Category Academic Resources

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in the way of market entry, divisionals claiming protection for similar subject-matter as the patent that has just been revoked can crop up, hindering generic/biosimilar medicines from entering the market.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.

International Copyright Flexibilities for Prevention, Treatment and Containment of COVID-19

[Sean Flynn, Erica Nkrumah and Luca Schirru] Abstract: Most policymaking attention with respect to intellectual property barriers to COVID-19 prevention, treatment and containment has been focused on patents. This focus is reflected in the World Trade Organisation (WTO) Ministerial Decision on the TRIPS Agreement, adopted on 17 June 2022, which provides a limited waiver of TRIPS rules on compulsory licences for production of COVID-19 vaccines. The original WTO proposal for a TRIPS waiver, however, explicitly applied to all forms of intellectual property, including copyright. This article outlines the numerous ways in which copyright can create barriers to addressing COVID-19. It also provides a description of international copyright treaty provisions that permit uses of copyright materials in response to the barriers identified, despite the exclusion of copyright from the final TRIPS waiver.

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.

IP Reveries: Class 3: Parsing the P -‘Property’ of IPR

[Lokesh Vyas and Swaraj Paul Barooah] The IP Reveries series is an experimental ‘fun’ series set in an imaginary classroom where we are using a dialogue format to raise questions and discussions around IP that traditionally don’t find a place to get voiced either due to long standing assumptions, or due to being seen as ‘too trivial’ to discuss in more formal settings. The series is authored by Lokesh Vyas and myself in equal measure. For an introduction to this new IP Reveries series, please check the introduction post here. Classes I and II brief – In the first two classes, we tickled the term ‘IPR’ and assessed what is actually so ‘intellectual’ in “Intellectual Property Rights”. Today, we will look at the ‘P’ (i.e. property) part of IPR and check if it can get us something else.

Movement Forward on ABS for the Convention on Biological Diversity: Bounded Openness Over Natural Information

[Joseph Henry Vogel, Manuel Ruiz Muller, Klaus Angerer, and Christopher May] “Access to genetic resources” and “fair and equitable sharing of benefits arising [from their] utilization” is the third objective of the 1992 United Nations Convention on Biological Diversity (CBD). The expression is included in the full title of the 2010 Nagoya Protocol (NP). Neither agreement defined “material” in the phrase “genetic material” which resulted in misinterpretation that the object of access for R&D is tangible. Unfairness ensues.

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.

IP Reveries: Class 2 – Interrogating the I – ‘Intelligence’ in IPR

[Lokesh Vyas and Swaraj Paul Barooah] I What’s in a name! In the last class, we essayed to examine the term IPR and saw how wide this umbrella opens. Given that the term “I.P.R.” is often the beginning of misunderstandings about the subject, the next few classes will seek to unravel the subconscious framework that these comprising words may have for the actual subject. The idea behind focusing on this theme is that while these considerations are almost never explicitly discussed in judgments or academic theory, to say that they haven’t played a strong role in the rhetorical narrative and understanding of “IPR” in the public consciousness would be a hasty conclusion. Indeed, this term was specifically ‘chosen’ to replace the term ‘monopoly’ or ‘privilege’ which had an unpleasant ring. (see text accompanying footnote 13 here). This class will start by digging into the term ‘Intellectual’ (‘I’) and seeing what it entails.

Trading Intellectual Property Rights in Europe: From IP Nationalism to International IP

[Aurora Plomer] Abstract: ...This article’s original contribution to the existing scholarship is twofold. It shows that European States viewed patents as legal shields against foreign industrial piracy spurred by international trade fairs aimed at showcasing national industrial power and the capture of new markets. Secondly, it documents the legal malleability and indeterminacy of patent rights and the role of courts in providing further definition of these rights largely to the benefit of intellectual property (IP) holders in the nineteenth century.

IP Reveries – An Introduction & Class 1 – IPR: A Tantalising Term or Troubling Terminology?

[Lokesh Vyas and Swaraj Paul Barooah] Intellectual Property Rights – a fascinating ‘subject’ that inadvertently touches upon so many aspects of our day to day life, whether we’re conscious of it or not. A few decades ago, even most lawyers wouldn’t have been able to clearly explain what a patent is. Fast forward to today, and while there’s still plenty of misunderstanding – patents, copyrights, trademarks, inventions, innovations, 4th industrial revolution, etc have all become buzzwords! Simultaneously, the ever growing division between “pro-IP” and “anti-IP” people have polarised views to such a large extent that it has become increasingly difficult to question another’s position, without being forced into a camp – a theme Shamnad touched upon frequently. Is there space for a genuine discussion around the whats, whys, whens and hows underlying the IP system? For asking questions such as – why does “pro-IP” often get translated to ‘easy grant of patents’ instead of ‘a better IP system’? Is IP a rule or an exception, in a free-market society? What implications do the colonial origins of the IP regime have in a post-colonial world, if any? What type of incentives do people look for, and what trade-offs can we make to give those incentives? What role does IP play in the larger ‘knowledge economy’? And for that matter – where does one even ask these questions? Legal academia desires formal strait-jacketed, peer-reviewed answers, not open-questions, with variable perspective-based answers (especially if they in turn give rise to further questions!). And classrooms often do not have time or mind-space to allow for wandering discussions, when they have a time-bound syllabus to teach. 

The COVID-19 TRIPS Waiver and the WTO Ministerial Decision

[Peter Yu] Abstract: .. This chapter traces the TRIPS waiver debate from the submission of the original proposal by India and South Africa in October 2020 to the final adoption of the Ministerial Decision on the TRIPS Agreement in June 2022. The chapter further evaluates the strengths and weaknesses of this newly adopted decision, comparing it with the earlier TRIPS waiver proposal. It concludes by offering suggestions for future actions that WTO members on both sides of the waiver debate could take to help combat the COVID-19 pandemic.