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Author: Georgia A. Roussou Publisher: Edward Elgar Publishing ISBN: 1035309963 Category : Law Languages : en Pages : 267
Book Description
This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
Author: Georgia A. Roussou Publisher: Edward Elgar Publishing ISBN: 1035309963 Category : Law Languages : en Pages : 267
Book Description
This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
Author: Frantzeska Papadopoulou Publisher: Bloomsbury Publishing ISBN: 150995029X Category : Law Languages : en Pages : 298
Book Description
This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.
Author: Callesen Klinge, Ulla Publisher: Edward Elgar Publishing ISBN: 1803927380 Category : Law Languages : en Pages : 287
Book Description
Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.
Author: Institute of Medicine Publisher: National Academies Press ISBN: 030904491X Category : Medical Languages : en Pages : 225
Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.
Author: Helena Legido-Quigley Publisher: World Health Organization ISBN: 9289071931 Category : Medical Languages : en Pages : 242
Book Description
People have always travelled within Europe for work and leisure, although never before with the current intensity. Now, however, they are travelling for many other reasons, including the quest for key services such as health care. Whatever the reason for travelling, one question they ask is "If I fall ill, will the health care I receive be of a high standard?" This book examines, for the first time, the systems that have been put in place in all of the European Union's 27 Member States. The picture it paints is mixed. Some have well developed systems, setting standards based on the best available evidence, monitoring the care provided, and taking action where it falls short. Others need to overcome significant obstacles.
Author: Mckee Publisher: McGraw-Hill Education (UK) ISBN: 0335226442 Category : Medical Languages : en Pages : 312
Book Description
While there may be consensus on the broader issues of the core objectives of the health care system, expectations differ between EU countries, and European national policy-makers. This book seeks firstly to assess the impact of the enlargement process and then to analyse the challenges that lie ahead in the field of health and health policy.
Author: Christophe Geiger Publisher: Edward Elgar Publishing ISBN: 178811308X Category : Law Languages : en Pages : 559
Book Description
'This book fills a gap in IP law. There are many publications on substantive and procedural law in IP litigation. But it was impossible to find a book that addresses the role of the judiciary in IP like this one does. It provides unique insights into the matter from a variety of angles. It brings together editors and authors from the bench, the bar and academia coming from all over Europe, the US and Japan. This book is a must-have for everyone who has an interest in international IP litigation.' - Klaus Grabinski, Justice, Federal Court of Justice (Bundesgerichtshof), Germany 'This volume makes an important contribution to our understanding of the contours of intellectual property protection through a critical examination of the global trend to adjudicate IP disputes in specialized courts. The editors have assembled an extraordinary group of scholars, practitioners and judges to compare their experiences with various adjudicatory structures.' - Rochelle Dreyfuss, New York University, School of Law, US Intellectual Property and the Judiciaryexamines the role of judges in the development, interpretation, and application of intellectual property (IP) law and norms. In this regard, the authors engage in a comparative analysis of various national, European and international court systems while also exploring the competing and complementary roles of legislators and executive actors. Each chapter seeks to capture the comparative institutional advantages of government bodies within existing legal frameworks as well as offering a thorough examination of both the common law and civil law traditions in the context of judicial treatment of IP. The result is a series of proposals relating to the architecture of judiciaries and the functional role of judges with the goal of optimally positioning jurists to address complex issues and advance IP doctrine and policy. Featuring high-level authors from both academia and practice, the book will be of great interest to academic researchers and practicing lawyers who have a focus on IP. It will be of particular value to those who are engaged in the rapidly changing enforcement environment of intellectual property rights. Contributors include: V. Cassiers, M. Ekvad, S. Frankel, C. Geiger, D. Gervais, S. Granata, J. Griffiths, E. Izyumenko, T. Kandeva, S. Lugienbuehl, B. Lynn, S. Martin, C. Mulder, M.O. Müller, C. Nard, K. O'Malley, C.S. Petersen, A. Plomer, J. Schovsbo, X. Seuba, A. Strowel, T. Takenaka, A. von Mühlendahl, G. Würtenberger, P. Yu
Author: Winfried Tilmann Publisher: Oxford University Press ISBN: 0191071935 Category : Law Languages : en Pages : 1832
Book Description
The creation of the Unified Patent Court (UPC) is the most prominent change in the European legal landscape for the last four decades. This book explains how the new system works in practice and how to make the best use of its provisions. It offers readers an in-depth and comprehensive commentary on the legal mechanisms of the upcoming ratified European Patent Law, and advice on potential problems that users of the forthcoming regulations may face. The book first describes the creation of the Unified European Patent Law and how its four new legislative texts interact. The new legislative texts are then explained and commented on in detail, rule by rule, with diverse approaches and perspectives from a practitioner team comprising patent litigators, European patent attorneys, law professors and patent judges. The Commentary takes into account the practical needs of users of the new system on both the prosecution and enforcement sides, addressing substantive and procedural problems. This book is the most authoritative text on the Unitary Patent and Unified Patents Court, and an invaluable tool for practitioners in this rapidly developing area of law.
Author: William J. Brock Publisher: John Wiley & Sons ISBN: 1118370392 Category : Science Languages : en Pages : 568
Book Description
A single-source reference with a broad and holistic overview of nonclinical studies, this book offers critical training material and describes regulations of nonclinical testing through guidelines, models, case studies, practical examples, and worldwide perspectives. The book: Provides a complete overview of nonclinical study organization, conduct, and reporting and describes the roles and responsibilities of a Study Director to manage an effective study Covers regulatory and scientific concepts, including international testing and Good Laboratory Practice (GLP), compliance with guidelines, and animal models Features a concluding chapter that compiles case studies / lessons learned from those that have served as a Study Director for many years Addresses the entire spectrum of nonclinical testing, making it applicable to those in the government, laboratories and those actively involved in in all sectors of industry
Author: Georgia A. Roussou
Author: Georgia A. Roussou
Author: Marco Stief
Author: Frantzeska Papadopoulou
Author: Callesen Klinge, Ulla
Author: Institute of Medicine
Author: Helena Legido-Quigley
Author: Mckee
Author: Christophe Geiger
Author: Winfried Tilmann
Author: William J. Brock