Timo Minssen - Böcker

This book provides an analytical overview of the function and application of competition law and intellectual property (IP) law in the pharmaceutical and biotechnology sectors. It offers a general introduction to the foundations and principles of competition law and its interface with intellectual property law, as well as a brief scientific preface, and an overview of the competitive environment and innovation system in which the pharmaceutical industry operates. It presents and discusses practices and conduct that have been identified as allegedly anticompetitive, analysing them from the perspectives of both competition and intellectual property law. The book discusses the issues raised by the 2009 EU (European Union) Pharmaceutical Sector Inquiry in depth, with reference to the case law that has developed since the Inquiry was published. In particular, the book scrutinises the cases and investigations in the European Union and United States regarding 'pay-for-delay' and other settlement agreements, the misuse of the patent systems, the misuse of the courts, and the alleged misuse of the regulatory system by pharmaceutical companies. It considers co-marketing, co-promotion, and co-branding from an antitrust perspective. There is discussion of different patent strategies and whether they violate competition law or patent law. The book also covers the introduction of the unitary patent in Europe, the Unified Patent Court, and their implications for the utilization of competition law.The book describes and explains developments relating to competition law and intellectual property law in the relevant sectors, putting them into context from both a theoretical and practical perspective. It addresses important competition law issues that arise where IP rights are acquired and utilised in Europe. It also contains useful guidance on how to deal with competition issues that arise within the intellectual property framework, and discusses when competition law is applicable and when exemption under intellectual property law may be applied. This comprehensive and detailed analysis is invaluable to practitioners, researchers, and students alike.

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

Regulators have been more permissive for medical devices compared to their drug and biologic counterparts. While innovative products can thereby reach consumers more quickly, this approach raises serious public health and safety concerns. Additionally, the nature of medical devices is rapidly changing, as software has become as important as hardware. Regulation must keep pace with the current developments and controversies of this technology. This volume provides a multidisciplinary evaluation of the ethical, legal, and regulatory concerns surrounding medical devices in the US and EU. For medical providers, policymakers, and other stakeholders, the book offers a framework for the opportunities and challenges on the horizon for medical device regulation. Readers will gain a nuanced overview of the latest developments in patient privacy and safety, innovation, and new regulatory laws. This book is also available as Open Access on Cambridge Core.

Large-scale, interoperable biobanks are an increasingly important asset in today's life science research and, as a result, multiple types of biobanks are being established around the globe with very different financial, organizational and legal set-ups. With interdisciplinary chapters written by lawyers, sociologists, doctors and biobank practitioners, Global Genes, Local Concerns identifies and discusses the most pressing issues in contemporary biobanking.This timely book addresses pressing questions such as: how do national biobanks best contribute to translational research?; What are the opportunities and challenges that current regulations present for translational use of biobanks?; How does inter-biobank coordination and collaboration occur on various levels?; and how could academic and industrial exploitation, ownership and IPR issues be addressed and facilitated? Identifying that biobanks foundational and operational set-ups should be legally and ethically sound, while at the same time reflecting the hopes and concerns of all the involved stakeholders, this book contributes to the continued development of international biobanking by highlighting and analysing the complexities in this important area of research.Academics in the fields of law and ethics, health law and biomedical law, as well as biobank managers and policymakers will find this insightful book a stimulating and engaging read.Contributors include: T. Bossow, T.A. Caulfield, B.J. Clark, Å. Hellstadius, J.R. Herrmann, K. Høyer, M. Jordan, J. Kaye, N.C.H. Kongsholm, K. Liddell, J. Liddicoat, M.J. Madison, T. Minssen, B. Murdoch, W. Nicholson Price II, E. Ortega-Paino, M. Prictor, M.B. Rasmussen, K. Sargsyan, J. Schovsbo, A.M. Tupasela, E. van Zimmeren, F. Vogl, H. Yu, P.K. Yu

This book addresses the growing importance of trade secrets in today's society and business and the related increase in litigation, media and scholarly attention. Written by a team of international experts, it uses the new EU Trade Secrets Directive as a prism through which to discuss the complex legal issues involved.Featuring both EU and wider international perspectives, chapters examine the Directive's aim of harmonizing legislation on the protection of trade secrets across the EU, and discuss how this has been implemented by member states. Contributors also explore the effects of the new regime on contentious issues and crucial sectors such as medicine, big data and AI, as well as considering its relationship with US law in particular. Scholars and students of patent law, innovation, and EU law and governance, particularly those with an interest in the topic of information freedom, will find this book of great significance in their research. Practitioners working in trade secrets and intellectual property more broadly will also find this book's comprehensive analysis of the Directive and its practical implications invaluable. Contributors include: T. Aplin, R. Arnold, N. Bruun, R. Cooper Dreyfuss, B. Díaz Alaminos, B. Domeij, N. Lee, T. Minssen, A. Nordberg, A. Ohly, N. Rajam, T. Riis, S.K. Sandeen, J. Schovsbo, J.S. Sherkow, H. Udsen, B. van der Donk, M. van Eechoud

This edited collection examines the ethical, legal, social and policy implications of genome editing technologies. Moreover, it offers a broad spectrum of timely legal analysis related to bringing genome editing to the market and making it available to patients, including addressing genome editing technology regulation through procedures for regulatory approval, patent law and competition law.In twelve chapters, this volume offers persuasive arguments for justifying transformative regulatory interventions regarding human genome editing, as well as the various legal venues for introducing necessary or desirable changes needed to create an environment for realizing the potential of genome editing technology for the benefit of patients and society.

Data sharing – broadly defined as the exchange of health-related data among multiple controllers and processors – has gained increased relevance in the health sciences over recent years as the need and demand for collaboration has increased. This includes data obtained through healthcare provisions, clinical trials, observational studies, public health surveillance programs, and other data collection methods. The practice of data sharing presents several notable challenges, however. Compliance with a complex and dynamic regulatory framework is essential, with the General Data Protection Regulation being a prominent example in a European context. Recent regulatory developments related to clinical trial transparency, trade secrecy, data access, AI training data, and health data spaces further contribute to the difficulties. Simultaneously, government initiatives often encourage scientists to embrace principles of “open data” and “open innovation.”The variety of regulations in this domain has the potential to impede widespread data sharing and hinder innovation. This edited volume, therefore, compiles comparative case studies authored by leading scholars from diverse disciplines and jurisdictions. The book aims to outline the legal complexities of data sharing. By examining real-world scenarios from diverse disciplines and a global perspective, it explores the normative, policy, and ethical dilemmas that surround data sharing in the health sciences today.Chapter Patient Perspectives on Data Sharing, Chapter Supplementary Measures and Appropriate Safeguards for International Transfers of Health Data after Schrems II are available open access under a Creative Commons Attribution 4.0 International License via link.springer.com.