Author: Papers

How to license Article 17? Exploring the Implementation Options for the New EU Rules on Content-Sharing Platforms

Posted by | Oct 3, 2019 | ,

[Martin Husovec and João Quintais] Abstract: How can the EU Member States license Article 17 of the new Directive on copyright and related rights in the Digital Single Market? This is the central question that this paper addresses. To answer it, we first analyse the nature of the right included in Article 17. We argue that the nature of the right has a number of serious consequences for its licensing.

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Pharmaceutical ‘Pay-for-Delay’ Reexamined: A Dwindling Practice or a Persistent Problem?

Posted by | Oct 1, 2019 |

[Laura Karas, Gerard F. Anderson and Robin Feldman] Abstract: The Supreme Court ruled in FTC v. Actavis that a delay in generic entry may be anticompetitive when part of a patent settlement that includes a large and otherwise unjustified value transfer to the generic company, termed a reverse payment patent settlement, or “pay-for-delay.” Following Actavis, drug companies have limited the size of reverse payments and have fashioned settlement terms that include more discreet categories of compensation to generic companies. In light of the fact that such settlements retain the potential for anticompetitive effects, the apparent size of the reverse payment may no longer be a useful gauge of the legality of pay-for-delay deals.

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Copyright as an Obstacle or an Enabler? A European Perspective on Text and Data Mining and Its Role in the Development of AI Creativity

Posted by | Sep 26, 2019 | ,

[Eleonora Rosati] Abstract: Text and data mining (TDM) may be performed in a variety of fields and for different purposes. Among other things, TDM techniques may be used to ‘train’ Artificial Intelligence (AI), also for the purpose of AI-driven creativity. In this context, copyright restrictions might be in place, even if copies made of pre-existing content are only used internally and are instrument to the creation of something ‘new’. Recently, in the context of the Directive 2019/790 on copyright in the Digital Single Market, the EU legislature introduced two new mandatory exceptions for TDM.

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Monitoring and Filtering: European Reform or Global Trend?

Posted by | Sep 23, 2019 | , ,

[Giancarlo Frosio and Sunimal Mendis] Abstract: …Article 17 of the newly enacted EU Directive on the Digital Single Market has come under fire for the heightened level of liability it imposes on online services providers (OSPs) for copyright infringing content stored or transmitted by them. Based on an analysis of case-law from multiple jurisdictions and an overview of industry practice, this chapter seeks to locate the new European reform within a much wider global trend that aims to impose proactive monitoring and filtering obligations on OSPs.

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Digitisation, Copyright and the GLAM Sector: Constructing a Fit-For-Purpose Safe Harbour Regime

Posted by | Sep 13, 2019 | ,

[Samuel Coad] Abstract: Copyright law does not currently align with the legitimate activities of galleries, libraries, archives and museums (GLAMs). The GLAM sector plays a central role in collecting and promoting access to cultural works. Increasingly, GLAM institutions are employing innovative digital technologies to expand access to culture and foster greater levels of cultural participation. Despite the utility underlying digitisation, copyright limits the use of digital technologies within the GLAM sphere.

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Access to Information of Disabled People on the Web: A Dispute between Accessibility and Digital Rights Management

Posted by | Sep 13, 2019 | ,

[Wariya Lamlert and Oranuch Sawetrattanasatian] Abstract: … the regulations which are beneficial to the accessibility of disabled people are overruled by DRM. More specifically, the challenges posed by DRM include: (1) Negligence of disabled people’s rights, (2) Conflict of accessibility, and (3) Ignorance of copyright-related exceptions. This study is a cross disciplinary study probing the issue of disabled people in both legal studies, through relevant legislation, and information studies, through the topic of information access on the Web.

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Medicine For All: The Case for a Public Option in the Pharmaceutical Industry

Posted by | Sep 11, 2019 |

[Dana Brown] Executive Summary: … Public ownership in pharmaceutical R&D would ensure that more intellectual property related to drug development would be held by public institutions and utilized in the public interest. Right now, a small number of newer medications are responsible for the majority of pharmaceutical spending by public programs like Medicare and Medicaid. Ensuring that new drug development is done in the public interest assures that not only do we get the medications that we need for the most pressing public health concerns (rather than the most profitable health issues), but also that those medications come at an accessible price.

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University Patenting: Is Private Law Serving Public Values?

Posted by | Sep 10, 2019 | ,

[Lisa Larrimore Ouellette and Rebecca Weires] Abstract: … What return does the public receive for the tax dollars spent on R&D, primarily at universities? Does privatizing this research through patent law in fact serve public values? From this social welfare perspective, could the Bayh–Dole framework be improved? In this symposium contribution, we seek to tackle these questions, including by identifying the key empirical questions that must be resolved to answer them. In short, we conclude the benefits of university patenting may justify the costs where licensees need exclusivity to undertake the costs of commercialization. For the substantial portion of university patenting that is not necessary for commercialization, evidence of other plausible benefits is not yet sufficient to justify the costs. Much of the data needed to investigate these plausible benefits — and related costs — rests in the hands of universities and federal grant agencies.

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Intellectual Property under the Scrutiny of Investor-State Tribunals: Legitimacy and New Challenges

Posted by | Sep 6, 2019 | ,

[Clara Ducimetière] In 2009, C.S. Gibson was suggesting that: “With this early coverage of intellectual property in BITs, it is perhaps surprising that there has yet to be a publicly reported decision concerning an IPR-centered investment dispute. Given the trajectory of the modern economy, however, in which foreign investments reflect an increasing concentration of intellectual capital invested in knowledge goods protected by IPRs, this could soon change”. A couple of years later, the first investment cases dealing with IP issues were made public.

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Bargaining Failure and Freedom to Operate: Re-Evaluating the Effect of Patents on Cumulative Innovation

Posted by | Sep 5, 2019 |

[Fabian Gaessler, Dietmar Harhoff and Stefan Sorg] Abstract: We investigate the causal effect of patent rights on cumulative innovation, using large-scale data that approximate the patent universe in its technological and economic variety. We introduce a novel instrumental variable for patent invalidation that exploits personnel scarcity in post-grant opposition at the European Patent Office. We find that patent invalidation leads to a highly significant and sizable increase of follow-on inventions

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Legal Challenges For Online Digital Libraries

Posted by | Aug 28, 2019 | , ,

[Argyri Panezi] Abstract: Libraries have traditionally played a central role in collecting and organizing material and giving wide access to culture and knowledge. Does the existing copyright framework provide enough space for online digital libraries to claim an equivalent central role in the online space? This article explores the legal challenges for online digital libraries’ collection building.

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When Markets Fail: Patents and Infectious Disease Products

Posted by | Aug 23, 2019 |

[Jonathan J. Darrow, Michael S. Sinha and Aaron S. Kesselheim] Abstract: New antibiotics and vaccines aimed at treating or preventing infectious diseases can be highly valuable public health innovations, particularly when these products address unmet medical needs. Although patents are considered the primary means of incentivizing new product development, reduced private investment in this area has led policymakers to create new and sometimes costly supplemental incentive schemes for antibiotics. But the legislative initiatives launched over the past 15 years to overcome the shortcomings of the patent system have had limited success, in part because they do not adequately address the reasons underlying the disconnect between patents and the antimicrobial market.

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Patent Pooling to Increase Access to Essential Medicines

Posted by | Aug 19, 2019 | ,

[Esteban Burrone et. al.] In 2016, the Lancet Commission on Essential Medicines Policies, the World Health Organization (WHO) and other stakeholders called for the patent pool to expand its mandate to a broader range of patented essential medicines.[5,6] Here, we outline the findings of a released feasibility study on expanding the patent pool’s mandate,[7] laying out the public health case for adapting its model to disease areas beyond the initial three focus diseases. In May 2018, the patent pool acted on the results of the feasibility study and expanded its mandate to include other patented essential medicines.

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Are Foreigners Treated Equally Under TRIPS?

Posted by | Aug 15, 2019 |

[Gaétan de Rassenfosse, Paul H. Jensen, T’Mir Julius, Alfons Palangkaraya, and Elizabeth Webster] Abstract: The TRIPS Agreement, administered by the World Trade Organisation, ensures the smooth functioning of the international patent system. It promises among others that local and foreign firms are treated in the same, non-discriminatory manner. We test for whether national treatment has been upheld in the five largest patent offices and document the existence of a systematic bias against foreign firms in patent examination decisions. We find that filing international patent applications under the Patent Cooperation Treaty can reduce some of the bias.

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The Same Problem, Different Outcome: Online Copyright Infringement and Intermediaries’ Liability Under the US and the EU Law

Posted by | Aug 10, 2019 | ,

[Lia Shikhiashvili] Abstract: … Recently, the European Union has adopted a new Copyright Directive, which, in article 17 (ex-article 13) indirectly introduces filtering and monitoring obligations to online platforms that allow users to upload content. It creates the “de facto strict liability regime” for internet intermediaries to root out copyright-infringing content. In contrast with this approach, in the United States internet intermediaries still benefit from the legislative immunities that exclude them from copyright-infringement liability uploaded by their users. This article compares the new European Union directive with the United States approach and shows that these differences might create uncertainties in the digital marketplace. This article also reviews potential consequences of the article 17 and demonstrates the need of harmonized secondary liability regime to Internet Service Providers at European level, without sacrificing safe harbor provisions. The article proposes the adoption of “fair use doctrine” and “fair remuneration” provisions as an effective and alternative tool to protect the rights of all players in the digital scene and simultaneously tackle the so-called “value gap” problem.

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Global Drug Diffusion and Innovation with a Patent Pool: The Case of HIV Drug Cocktails

Posted by | Aug 8, 2019 |

[Lucy Xiaolu Wang] Abstract: …I study the impact of the first joint licensing platform for drug bundling (the Medicines Patent Pool) on global drug diffusion and innovation. The pool allows generic firms worldwide to sublicense drug bundles cheaply and conveniently for sales in a set of developing countries. I construct a novel dataset from licensing contracts, public procurement, clinical trials, and drug approvals. Using difference-in-differences methods, I find robust evidence that the pool leads to a substantial increase in generic supply of drugs purchased. In addition, the branded-drug makers and other entities, such as public institutions, respond to the pool with higher R&D inputs as measured by clinical trials. The R&D input increase is accompanied by increases in generic drug product approvals. Finally, I estimate a structural model to quantify welfare gains and simulate counterfactuals. The total benefit far to consumers and firms exceeds the associated costs.

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Mainstreaming or Dilution? Intellectual Property and Development in WIPO

Posted by | Jul 15, 2019 | ,

[Nirmalya Syam] In 2007 Member States of the World Intellectual Property Organization (WIPO) unanimously adopted a set of 45 recommendations which constitute the WIPO Development Agenda. Developing countries sought to give new direction to WIPO through the Development Agenda, away from the pursuit of facilitating and strengthening protection, acquisition and enforcement of intellectual property (IP) rights as an end in itself towards an approach that would be sensitive to the impact of IP on development, both in terms of opportunities as well as costs.

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Patents, Trade and Medicines: Past, Present and Future

Posted by | Jul 1, 2019 | , ,

[Kenneth Shadlen, Bhaven Sampat and Amy Kapczynski] Abstract … We draw attention to the conceptual and methodological challenges of assessing the effects of patent provisions in trade agreements on prices and access to drugs, with particular emphasis on the importance of timing. Depending on when countries began allowing drugs to be patented, TRIPS-Plus provisions have different effects; and when pharmaceutical patenting has been in place for more countries for more time, the effects of TRIPS-Plus provisions will change again.

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Copyright, and Photographs or Videos of Public Art, in South Africa: An Imperfect Picture

Posted by | Jun 24, 2019 | ,

[Bram Van Wiele] Abstract: The rise of digital photography and videography has made the creation, sharing and commercialisation of high-quality photographs and videos more accessible, in terms of both cost and skills required. This thematic report examines the impact on copyright infringement of the increase in photographs and videos containing public art. It then analyses the applicability, for such photographs and videos, of the general exceptions for protection of artistic works in South Africa’s Copyright Act 98 of 1978.

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Product Patents and Access to Innovative Medicines in a Post TRIPS Era

Posted by | Jun 13, 2019 | ,

[Jayashree Watal and Rong DAI] This paper examines access to new and innovative pharmaceuticals in a post-TRIPS era. The WTO’s TRIPS Agreement (TRIPS) makes it obligatory for WTO members – except least-developed country members (LDCs) – to provide pharmaceutical product patents with a 20-year protection term. Developing country members, other than LDCs, were meant to be compliant with this provision of TRIPS by 2005. Access to medicines generally includes two distinct components, viz. availability and affordability. This study investigates these two sub-components of access to medicines and poses two questions in this context: (1) How does the introduction of product patents in pharmaceuticals affect the likelihood of pharmaceutical firms making available new and innovative medicines in those markets? (2) For launched new and innovative medicines, how much do firms adjust their prices to local income levels in order to make these products affordable?

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