Papers

Papers

  • Joined: March 4, 2014
  • Articles: 358

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

[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.

Who Holds the Right to Exclude for Machine Work Products?

[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.

Patents of Introduction and the Spanish Innovation System

[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.

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

[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.

The Obscure Consumer in the Chinese Intellectual Property Law

[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.

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

[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.

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

[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.

Report and Webinar: Rethinking Trade Treaties & Access to Medicines

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.

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

[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.

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

[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.

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

[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.

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

[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.