TRIPS & the Life Sciences”- Webinar 4: Data Exclusivities and TRIPS Art. 39.3
Webinar 18 January 2018
Sign-up & questions: Jakob.firstname.lastname@example.org
This webinar will address the on-going discussions on the need and/or obligation to provide data protection from the perspective of the life sciences. Professor Peter Yu from University of Texas will present and Mr. Eric M. Solovy, partner in Sidley Austin LLP will be discussant. The webinar is organised by research fellow Jakob Wested and professor Timo Minssen, Center for Information and Innovation Law, University of Copenhagen in collaboration with the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA). Professor Minssen will moderate the webinar.
Introduction to the theme
The value of data has become increasingly important in the innovation discourse. In many fields access to data form the basis for innovative efforts through e.g. big data analysis and real world evidence. In the life science industry, data has the additional role as the key unlocking the market for life science products, due to the regulatory requirement to demonstrate the safety and efficacy of products. Significant competitive effect thus relates to the adoption of regimes governing the access, use and protection of data. It has been argued that the provision of regulatory data exclusivity is a suitable and necessary tool to create an incentive to undertake e.g. the costly development of complex biological products and get them approved for marketing. However, others have argued, that elaborate data protection schemes have significant detrimental effects on static and dynamic competition in the life science industry. Furthermore, adoption of open science governance principles and regulations of transparency introduces additional aspects of public health and interest to the discussion of the accessibility and uses of regulatory data. Finally, increased data protection could affect the mechanisms in place to ensure access to medicine such as compulsory licensing regimes. The issues of data protection thus touch upon numerous complex issues such as market dynamics, the configuration of the patent system, technological development, knowledge governance and public interest as well as the interpretation of the TRIPS agreement.
Art. 39 in the TRIPS agreement require that member states provide effective protection from unfair competition. This requirement includes the protection of undisclosed information and art 39.3 refer specifically to the protection of data that is submitted to authorities for the purpose of obtaining a marketing approval for pharmaceutical products. The TRIPS agreement provides a regime of de minimis protection for intellectual property. Thus, in the isolated context of art 39.3 the current debate on data protection presents itself as a question of what this minimum level of protection for data required by TRIPS consists of. In the wording of art 39.3, it is stated that the subject of protection is data the origination of which involves a considerable effort, while the purpose of protection is to safeguard against unfair commercial use. But what dos these terms “considerable effort”, “unfair” and “Commercial” mean and how may they be construed in a TRIPS consistent manner? An on-going debate has been whether the obligation enshrined in 39.3 entailed a requirement for MS to provide a regime of data exclusivity or whether other measures could suffice that would address the unfair competition perspective, e.g. the grant of market exclusivity. The adaptation of data protection schemes has become reinvigorated due to national and plurilateral initiatives such as the Biologics Price Competition and Innovation Act (BPCIA) in US, the plurilateral Trans Pacific Partnership (TPP) and the Regional Comprehensive Economic Partnership (RCEP) where the adoption of data exclusivity regimes are central components.
About the Webinar series “Reinterpreting TRIPS in the life sciences”
In 2017 - 2018 the Centre for Information and Innovation Law (CIIL) at University of Copenhagen and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) will organize four webinars focusing on issues emerging from the interpretation of TRIPS in relation to the life sciences. The webinars aim to bring together scholars, industry and practitioners in constructive discussion on the pressing legal issues arising at this intersection.
About the Presenters
Peter Yu is Professor of Law and Co-Director of the Center for Law and Intellectual Property at Texas A&M University School of Law. Before joining Texas A&M University, he held the Kern Family Chair in Intellectual Property Law and was the founding director of the Intellectual Property Law Center at Drake University Law School. He served as Wenlan Scholar Chair Professor at Zhongnan University of Economics and Law in Wuhan, China and a visiting professor of law at Hanken School of Economics, the University of Haifa, the University of Helsinki, the University of Hong Kong, the University of Strasbourg and Washington and Lee University. He also founded the nationally renowned Intellectual Property & Communications Law Program at Michigan State University, at which he held faculty appointments in law, communication arts and sciences, and Asian studies. Born and raised in Hong Kong, Professor Yu is a leading expert in international intellectual property and communications law. He also writes and lectures extensively on international trade, international and comparative law, and the transition of the legal systems in China and Hong Kong. A prolific scholar and an award-winning teacher, he is the author or editor of six books and more than 100 law review articles and book chapters. He serves as the general editor of The WIPO Journal published by the World Intellectual Property Organization (WIPO) and chairs the Committee on International Intellectual Property of the American Branch of the International Law Association.
Eric M. Solovy is partner in Sidley Austin LLP in Washington DC and counsels companies, trade associations and governments on international trade and intellectual property matters, and litigates disputes over such matters. In 2014, he was named by Law360 Rising Stars as one of the top five international trade lawyers in the United States under the age of 40, and is consistently recognized in Who’s Who Legal: Trade and Customs. Eric focuses on litigation before the World Trade Organization (WTO), having been at the center of some of the most complex and contentious disputes in its history. In the intellectual property area, Eric represents clients in litigation before the U.S. Court of Appeals for the Federal Circuit in complex patent disputes, including in the fields of pharmaceuticals, biotechnology, software, and hardware. In addition, Eric combines his experience in both international trade and intellectual property law, and frequently counsels, writes, and lectures on the international trade law and policy aspects of intellectual property protection, including with respect to intellectual property protection in the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement) and various Free Trade Agreements.
Materials & Readings
Yu, Peter K., Data Exclusivities in the Age of Big Data, Biologics, and Plurilaterals (March 3, 2018). Texas A&M Law Review Arguendo, Vol. 5, 2018. Available at SSRN: https://ssrn.com/abstract=3133810
G. Lee Skillington, Eric M. Solovy, The protection of test and other data required by Article 39.3 of the TRIPS Agreement, Northwestern Journal of International Law & business, vol. 24, 1, 2003-2004.
Kim, Daria, Enabling Access to Clinical Trial Data: When is Unfair Use Fair? (March 26, 2015). Chicago-Kent Journal of Intellectual Property 14:2 (2015).
Lybecker, Kristina M. Essay: When Patents Aren't Enough: Why Biologics Necessitate Date Exclusivity Protection. William Mitchell Law Review 40.4 (2014): 1427-1442.