IP and Regulatory Rights in the Age of Personalized Medicine
March 15 @ 14:00 – 16:00 CET
To celebrate the launch of Evergreening Patent Exclusivity in Pharmaceutical Products (Hart, 2021) by Frantzeska Papadopoulou, on Tuesday 15 March 2022, the Institute for Intellectual Property and Market Law (IFIM) at Stockholm University will host an online conference to discuss the current state and future of patent law and regulatory rights in the very exciting new field of personalized medicine.
Personalized medicine, referred to also as precision medicine, is a medical model separating patients into different groups—with medical decisions, practices, interventions and/or products being tailored to the individual patient (or to the specific group) based on their predicted response or risk of disease. While personalized medicine seems to be an essential of modern healthcare, it is also rather unclear how innovations that are developed for its purposes align with patentability requirements and, in general, the way the patent system operates. Furthermore: how does the legal system of marketing authorization and other regulatory rights apply to personalized medicines? What needs to be done in order to provide a frictionless adaptation of the legal framework to new forms of healthcare?
These are some of the questions that will be discussed by a panel of prominent academics and practitioners working with these challenges in their respective roles.
The Speakers (in alphabetical order)
Duncan Matthews is the former Director of the Queen Mary Intellectual Property Research Institute and a member of the Centre for Commercial Law Studies. He has acted as an advisor to the European Patent Office (EPO), the European Commission, the European Parliament, the UK Intellectual Property Office (IPO), the World Intellectual Property Organization (WIPO) and the World Health Organization (WHO). He is the author of over 60 publications on intellectual property law and is co-editor of the Research Handbook on Intellectual Property and the Life Sciences. He teaches European, U.S and international patent law to postgraduate law students and he is an expert on the patent provisions of the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights. His research interests include: the relationship between competition law and patent law, the role of patents in the governance of CRISPR gene editing technologies, IP responses to Covid-19, intellectual property law in China, and the development of the Unified Patent Court of the European Union.
Frantzeska Papadopoulou is Professor of Intellectual Property Rights at the Law Faculty, Stockholm University. She is the Editor-in-Chief of the Stockholm Intellectual Property Law Review and a Member of the Advisory Board of the National Library of Sweden. She is the author of several books and articles, including Evergreening Patent Exclusivity in Pharmaceutical Products (2021) and The Protection of Traditional Knowledge in Genetic Resources (2017).
Ulf Petrusson is Professor of Law and Director of the Institute for Innovation and Social Change at Law Department, School of Business, Economics and Law, University of Gothenburg. He is also an Affiliated Professor at Chalmers University of Technology and one of those responsible for Chalmers School of Entrepreneurship. He was one of the Founders and the Director of the Center for Intellectual Property at Chalmers University of Technology and University of Gothenburg between 1999 and 2020.
Roberto Romandini is a Legal Member of the Board of Appeals of the EPO. Before that, he worked for several years as a lawyer in Milan and as Senior Research Fellow at the Max Planck Institute for Innovation and Competition in Munich. Since 2013, he has been teaching a seminar in patent law at the Munich Intellectual Property Law Center in Munich.
Hanna Tilus is a partner at Cirio law firm, where she specialises in the Life Sciences industry focusing on intellectual property, regulatory, marketing law and personal data protection (GDPR). She has gained extensive experience advising a wide range of companies within the life sciences industry, including pharma, MedTech, healthcare and food companies. Furthermore, Hanna has in-house experience of the life sciences industry, having worked at the global life sciences company Bayer with responsibility for legal affairs, corporate compliance and data protection primarily in Sweden but also in relation to global issues, including working out of the pharma HQ in Berlin.
Laura Valtere is an R&D specialist for the INDIGO Project at the University of Luxembourg. The project focuses on the transformative impact of innovative information technologies on rule-making and decision-making procedures. Furthermore, in her PhD thesis Personalised Medicine, Incentives from Exclusivities provided by IP and Regulatory Law (close to completion), she investigates the adequacy of the current system of incentives for pharmaceutical research (patents, SPCs, data and market exclusivities) for promoting the development of personalized medicine.
Li Westerlund is the Vice President of Global IP for the Bavarian Nordic Group and has the operational responsibility to develop, define, implement and enforce the intellectual property strategies of the company. Dr. Westerlund has 25 years of experience predominantly in the sector of intellectual property-patent law, including from both US and Swedish law firms prior to joining Bavarian Nordic in 2004. Her experience includes Junior Judge in Swedish courts and legal intern at the Court of Appeals for the Federal Circuit (CAFC) for the former Chief Judge Paul R. Michel and extensively published Professor of Law.
Håkan Yildirim is a European patent attorney by profession and works as the Head of Intellectual Property at Xbrane Biopharma AB, a Swedish pharmaceutical development company in the field of biosimilars. He obtained his PhD degree in medical sciences from Karolinska Institutet in 2005. There, he conducted cross-disciplinary research on vaccines by using various techniques, including from analytical chemistry, organic chemistry, biochemistry and molecular biology. The turn of his career path towards working as a patent professional took place in 2007, when he was enrolled as patent examiner at the Swedish Patent and Registration Office.
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