[Olga Gurgula] Abstract: Pharmaceutical companies have been increasingly exploiting the patent system to delay or even block generic competition. Some of these practices, such as ‘pay-for-delay’ agreements, have attracted the attention of competition authorities. However, other practices remain outside of competition authorities’ investigative activities in most jurisdictions.
[Charles Duan] Abstract: ... In this Article, I review the universe of administrative challenges on drug patents that have proceeded through appeal to the Federal Circuit. I find that a large fraction of patents challenged this way are deemed unpatentable at both the agency and appellate levels, and that administrative cancellation of drug patents correlates closely with subsequent generic drug competition and reduced drug prices. The data suggests that these effects are not due to bias against patents, but rather because of the expertise of administrative adjudicators and the remarkably low quality of the drug patents challenged. Indeed, I find that nuanced aspects of these administrative proceedings, particularly at the appellate level, in fact are biased in the opposite direction — against patent challengers. These findings suggest that inter partes review and other administrative challenge proceedings likely serve an important purpose for lowering the costs of medicines, and those proceedings could potentially be improved.
Professor Sara Bannerman shared insights on the historical context of copyright and the need to consider research as a human right during our Right to Research event series last semester. As an expert in copyright history, Bannerman stressed the importance of knowing about the past to understand the present and future of copyright and intellectual property.
[Sean Flynn] The 43rd Meeting of the WIPO Standing Committee on Copyright and Related Rights made substantial progress on issues of concern to a newly formed Access to Knowledge Coalition https://www.a2k-coalition.org/ These include the adoption of a work programme on limitations and exceptions, progress on the limitations and exceptions provision in the draft broadcast treaty, and the reviving of a second meeting of the SCCR. These advances were promoted in part by changes in representation from Brazil, Chile, Colombia and Argentina and the continuing expertise and leadership within the African Group.
[Kyle Courtney and Juliya Ziskina] Abstract: Libraries have continuously evolved their ability to provide access to collections in innovative ways. Many of these advancements in access, however, were not achieved without overcoming serious resistance and obstruction from the rightsholder and publishing industry. The struggle to maintain the library’s access-based mission and serve the public interest began as early as the late 1800s and continues through today. We call these tactics the "publishers' playbook."
[Sean Flynn] Where allowed by copyright law, digital uses for education, research and cultural heritage are contributing to social and economic development. This document describes some recent developmental uses of copyright limitations and exceptions that are relevant to the issues being discussed at the 43rd meeting of the WIPO Standing Committee on Copyright and Related Rights. The examples were collected by members of the Access to Knowledge Coalition.
[Sean Flynn] I submit the following comments on limitations and exceptions issues in agenda items for the 43rd Meeting of the World Intellectual Property Organization Standing Committee on Copyright and Related Rights... The current draft of the Broadcast Treaty continues to raise important public interest concerns. Although the mandate of the Committee is to work on a “signal based” approach, the treaty continues to use a rights-based structure and language modeled on the Rome Convention rather than the more appropriate Brussels Convention. The use of a rights-based model causes particular problems of layering rights on top of each other because broadcast signals normally carry copyrighted content. Although there is now on opt-out in Article 10 - permitting alternative effective regulatory means - the dominance of the rights based perspective in the drafting will encourage adoption of its model.
[Chebet Koros, Joshua Kitili, Cynthia Nzuki and Natasha Karanja] ...The Strathmore University Centre for Intellectual Property and Information Technology Law carried out a study to determine the relationship between Kenya’s technology and copyright legal framework that affect the use of TDM research. It had four specific targets: to determine if Kenya’s technology policy promotes technology, learning, and research; to understand the prospects and plans for enabling a legal environment for research and development of technology; to assess the role of copyright law in enabling TDM research, and finally to provide recommendations for national, regional, and international copyright policies that enable TDM research. This policy brief is a summary of that study with specific policy recommendations resulting from the study.
[Deuksin Kwon, Ha Young Lee, Joon Hyung Cho, and So Young Sohn] Abstract: In open patent pools (OPPs), members share their patents to each other. What gains do they expect by sharing patents? In this study, we analyze the effects of an OPP strategy on technological performance in terms of creating shared value (CSV). A panel regression was performed to compare the technological performance of firms in the open invention network (OIN), which is a Linux industry OPP, to those of non-OIN firms using their patent data. Our results demonstrate that the leading groups in the OIN achieved innovation by having more patent applications, forward citations, and collaborative activities than non-participants. Furthermore, OIN firms play a more significant role in promoting knowledge spillovers than non-participants. We demonstrate the positive effects of an OPP strategy on innovation by empirically measuring the technological performance of CSV strategies. Our findings provide insights for institutions that consider implementing an OPP strategy for innovation, including other types of open innovation.
The 43rd meeting of the World Intellectual Property Organization Standing Committee on Copyright and Related Rights will consider a Second Revised Draft Text for the WIPO Broadcasting Organizations Treaty (“Second Revised Draft”). A question that is likely to be posed is whether the text contains sufficient consensus to move toward a diplomatic conference. Considerable questions have been raised about the need for and scope of rights in an anti-piracy treaty that would ultimately cover content of signals that are already protected by other copyright and related rights treaties, for example by KEI and Professor Bern Hugenholtz. This note focuses on the limitations and exceptions provisions of the Second Revised Draft. For comments embedded in a redlined version of the Draft showing changes from the version presented in SCCR 42, see PIJIP’s redlined version of the Second Revised Draft.
In this, third video of PIJIP’S video series on the Right to Research in International Copyright Law, Dr. Sanya Samtani of the University of Pretoria discusses how access to knowledge in general and the right to research may be considered human rights in the context of international human rights instruments and the obligations of nation-states. Furthermore, she asserts that the state has a duty to respect research rights by making sure there are no unjustifiable limits on access, protecting research rights from third-party violations.
[Mike Palmedo] I have a new paper in the Journal of Globalization and Development. "Evaluating the Impact of Data Exclusivity on the Price of Pharmaceutical Imports" finds large increases in the price of imported medicines when the U.S.'s trading partners implement data exclusivity to meet FTA obligations. The full impact of data exclusivity laws took many years to become apparent though observation of aggregated prices, because the laws themselves only applied to medicines new medicines.