Papers

Papers

  • Joined: March 4, 2014
  • Articles: 332

Inequitable by Design: The Law and Politics of Global COVID-19 Vaccine Access – And a Way Out

[Ximena Benavides] Abstract: ...This Article analyzes the power dynamics of vaccine manufacturing and distribution of U.S. pharmaceutical companies in the context of global COVID 19 vaccination. Drawing on the health-justice and law-and-political-economy scholarship of the last decade, this Article demonstrates how a “patent culture” shaped by intellectual property law fundamentally neglects health-equity principles as it politicizes healthcare access. These contemporary frameworks suggest that the global COVID-19 vaccine-access problem is the result of avoidable policy choices of big manufacturers and affluent governments. Despite a long history of inequities in access to healthcare, policy choices—as predicted by Hart’s inverse equity theory—have favored a purposely inequitable-by-design vaccination program driven by the wealth and power of those allowed to control vaccine production and supply globally.

Bulgaria Falls Into All the Traps Set by Article 5 of the CDSM Directive

[Ana Lazarova] Abstract: With Article 5 of the CDSM Directive, the EU legislator aspired to remedy the inherited legal fragmentation in the area of copyright exceptions and limitations, by introducing a mandatory exception for the purpose of ‘illustration for teaching’ in the digital environment. Bulgaria already had an educational exception as per the InfoSoc Directive, which was rather broad, technology neutral and unrestricted in terms of its beneficiaries. Now, the ‘digital’ exception under Article 5 is being transposed in parallel with the pre-existing one, both provisions largely overlapping in scope and with no clear collision norms available. This is yet another national implementation showing that the new exception, initially envisaged as a mandatory minimum of user rights protection, would likely exacerbate, instead of remedy the fragmented legal landscape in the EU. It would appear that the regime under Article 5 may come to do a disservice to free use for educational purposes.

A Study of Patent Thickets

[Bronwyn H. Hall, Christian Helmers, Georg von Graevenitz and Chiara Rosazza Bondibene] Executive Summary: This report analyses whether entry of UK enterprises into patenting in a technology area is affected by patent thickets in the technology area. The aim is to contribute to our understanding of the role of patent thickets as a barrier to entry into new technologies for UK enterprises, in particular small and medium sized enterprises (SMEs). The report consists of several parts: 1) a review of the literature on patent thickets, including the limited empirical evidence regarding effects of patent thickets on R&D investments and competition; 2) discussion of the factors contributing to thicket formation and growth; 3) an empirical evaluation of the extent to which patent thickets appear to be barriers to entry in some technology areas.

Biological Patent Thickets and Delayed Access to Biosimilars, An American Problem

[Rachel Moodie and Bernard Chao] Abstract: Drug prices in the United States are higher than in other countries. Generic drugs offer one path to lower these prices. The Biologics Price Competition and Innovation Act ('BPCIA') was passed in 2010 to promote the entry of biosimilars, generic versions of a new class of biologic drugs. These drugs have proven to be effective at treating a variety of illnesses including various autoimmune diseases and cancers. But to date, few biosimilars have entered the U.S. market. Patent thickets covering biologic drugs may be one cause. Our study seeks to test this hypothesis by comparing patent assertions against the same biosimilar drugs in the United States, United Kingdom and Canada.

Copyright and Digital Teaching Exceptions in the EU: Legislative Developments and Implementation Models of Art. 5 CDSM Directive

[Giulia Priora, Bernd Justin Jütte & Péter Mezei] Abstract: Article 5 of the 2019 EU Directive on Copyright in the Digital Single Market (CDSM) attempted to modernize the regime of copyright exceptions and limitations related to teaching activities. Its aim is to enhance the flexibility behind permitted uses to the benefit of educational institutions regarding their digital and cross-border teaching. The pressing need for such a legislative reform was confirmed by the outbreak of the COVID-19 pandemic, which dramatically moved teaching environments to online platforms.

Reverse Payment: A Comparative Study

[Garry Gabison and Zaakir Tameez] Abstract: This Article compares reverse payment settlements, also known as pay-for-delay deals, in the United States and Europe. These deals occur where a branded drug manufacturer sues, settles with, and pays a generic manufacturer to delay the entry of its generic. Unlike the United States, which has a decentralized drug purchasing system, European healthcare systems such as those in France and the United Kingdom wield monopsony buying power over drugs. We investigate whether regulator and monopsony power can neutralize these anticompetitive agreements.

Fahrenheit 2020: Torching the Internet’s Library of Alexandria at the Height of a Global Pandemic

[Stephen Beemsterboer] Abstract: For more than a decade, the Internet Archive has been collecting and digitizing books as part of its “Open Library” project. The unofficial e-books are made available to the public under a legally untested concept called “controlled digital lending” (CDL), premised on the notion that libraries should be able to lend their books online in much the same way that they do in person. Under the theory, a library may grant restricted digital access to one patron at a time per physically held copy of a book. Once a patron’s access to the book ends, another’s may begin. The process is meant to digitally replicate a physical library loan, and it works just like borrowing an official e-book through a local library.

Forfeiting IP

[Deepa Varadarajan] Abstract: Can intellectual property (IP) rights be lost? Much attention has been paid to how IP rights are acquired and whether threshold requirements are too laxed or onerous. But surprisingly little attention has been paid to the question of IP forfeiture. That is, once IP rights are acquired, what—if anything—do owners have to do to keep those rights or risk losing them forever. The answer, it turns out, varies widely across the IP landscape and has important consequences for follow-on innovation, competition, and the public domain.

Extraterritoriality: Intellectual Property

[Timothy R. Holbrook] Abstract: Intellectual property rights, particularly patents, copyrights, and trademarks, have been the subject of international treaties for quite some time. Those treaties all treat intellectual property rights as national in nature, with attendant territorial limits. ... For extraterritoriality, that means that the use of one nation’s intellectual property to leverage control over the acts and markets of another have significant implications for sovereignty. These concerns could be vindicated through a robust use of conflicts of law in extraterritorial jurisprudence. The role of conflicts has been, at best, unclear in U.S. law. This chapter suggests, however, that when the conflict is one over the validity within the foreign country, conflict concerns should be at their apex. In other words, why should one jurisdiction allow an IP right holder to leverage a right into a country that would find that right invalid? This dynamic goes beyond merely holding someone liable for acts in a foreign country; it directly undermines the political choices of that sovereign in a far more significant way.

Intellectual Property and the African Continental Free Trade Area: Lessons and Recommendations for the IP Protocol

[Caroline B. Ncube] Abstract: This paper aims to explore the contours of the future intellectual property (IP) protocol of the African Continental Free Trade Area (AfCFTA) Agreement... This paper frames the IP protocol within the architecture of the AfCFTA Agreement, meaning that it will follow the structure of other protocols and will be guided by the Agreement’s foundational principles and objectives. With the place, shape and form of the protocol so established, the paper considers the substantive aspects that ought to be addressed. It also considers provisions on technical assistance, capacity building and cooperation.

Access To Medicines and Pharmaceutical Patents: Fulfilling The Promise of TRIPS Article 31bis

[Ezinne Miriam Igbokwe and Andrea Tosato] Abstract: ... The most contentious [TRIPS] issue has long been the impact of the TRIPS patents regime on access to medicines. Our Article contributes to this debate by illuminating an oft-overlooked facet of TRIPS: Article 31bis. Enacted following the Doha Declaration of 2001, this provision was designed to enable Members with inadequate manufacturing capabilities to import patented pharmaceuticals produced by generics manufacturers under an export compulsory license (ECL) issued by another Member. Initially welcomed with enthusiasm, ECLs have enjoyed minimal success. We propose an explanation for the current fallow state of Article 31bis and suggest approaches to fulfill its promise.

The Implementation of Art. 17 DSM-Directive in Germany: A Primer with Some Comparative Remarks

[Matthias Leistner] Abstract: The implementation of the DSM-Directive in the European Member States is underway.... In regard to Art. 17, two basic models have emerged. Many Member States, in particular France, closely follow the wording of the Directive with only rather minor differences concerning the legislative technique and certain details, such as the definition of the OCSSPs. By contrast in Germany, the legislator, on the basis of an historic and contextual interpretation as well as interpretation in conformity with fundamental rights, has enacted a different system. Art. 17 is implemented in a balanced way providing for ex ante safeguards during the blocking and stay down procedure for certain contents which are not manifestly infringing (minor contents, user generated contents) and therefore regarded as presumably authorized by law. This effectively amounts to a collectively remunerated notice and delayed takedown system for such presumably legal contents.