Elgar Monographs in Intellectual Property Law – serie

This book comprehensively elaborates on the EU framework for regulatory protection in life science industries. Żaneta Zemła-Pacud discusses the rules governing regulatory exclusivities and rewards for both innovative life science products and the regulatory data underlying them. The analysis focuses primarily on pharmaceuticals, such as reference medicinal products, orphan drugs and paediatric medicines, but it also encompasses goods from the agrochemical and food sectors, such as plant protection products, novel food, genetically modified food and feed.The book illustrates how regulatory exclusivities and rewards are granted, what protection they confer, and how they can be enforced. Recognising their practical importance, it further presents how regulatory protection is integrated into IP strategies and what challenges this may pose. Against this background, the author presents and comments on coming changes to the system and provides an up-to-date analysis of the legislation driving EU reform of pharmaceutical regulation. To complete the picture of regulatory protection in the EU, the book situates the system within the framework of other protective regimes, including the protection of regulatory data against disclosure. Finally, referring to European civil law tradition, the author carefully analyses the framework’s normative legal bases and proposes categorising regulatory protection as a sui generis instrument of protection for Intellectual Property.This book is an insightful and stimulating contribution to the literature on intellectual property and pharmaceutical law. It is an essential read for scholars in those fields and policymakers involved in the legal reform of the pharmaceutical sector. Practising lawyers, judges, and national regulators will greatly benefit from timely insights into the field.

Exploring the potential for alignment as well as conflicts between IP and climate change, Intellectual Property, Climate Change and Technology encourages a coherent and integrated approach to decision making.This groundbreaking book identifies and challenges the lack of intersection between intellectual property law and climate change law at national level. It argues that intellectual property confers private rights on the results of innovation and creativity, while climate change law and policy exists more in the public sphere without engagement with intellectual property, with no space for the conflict between this private power and public goal to be investigated in litigation. This thought-provoking book will be of great interest to scholars working in the fields of IP, climate change law, human rights, and planning and sustainable development, challenging the assumption that some problems are dealt with only through consideration of certain areas of the law. Proposing new processes for policy and law making in order to remove barriers between these fields, Intellectual Property, Climate Change and Technology will also be a valuable resource for members of parliament and policy makers.

As the Internet continues to alter our online world, the structure of copyright in its current form becomes inadequate and unfit for purpose. In this bold and persuasive work, Daniel Gervais argues that the international copyright system is in need of a root and branch rethink. This ambitious and far-reaching book sets out to diagnose in some detail the problems faced by copyright, before eloquently mapping out a path for comprehensive and structured reform.This book’s main objectives are to identify structural and other deficiencies within the current system, and to outline a structured approach to copyright reform. Part I of the book is thus diagnostic in nature, Part II offers detailed and concrete pathways to improve the current system, whilst in the Epilogue, a clear path to revise the Berne Convention is proposed.Contributing a reasoned and novel voice to a debate that is all too often driven by ignorance and partisan self-interest, this book will be required reading for all copyright scholars and practitioners with an interest in the future direction of the field.

This book contends that the concept of fairness should be embraced and developed as a middle ground between strictly utilitarian and fundamental rights-based approaches to intellectual property (IP) law.Annette Kur, Nari Lee and Anna Tischner provide elegant arguments as to why this should be the case, and offer insights into how fairness as a legal notion can fulfil the role of mediator between the property aspects of IP law, market regulation and general welfare. They explore the terms and concepts of fairness in EU legislation, analyse the overarching network of goals and values set by EU law, and address the predominant theories that inform the notion of fairness and the use of empirical methods as a tool for its concretization. Ultimately, the book presents a conceptual framework of fairness to form a toolkit for legislative and judicial decision making and applies this to emerging challenges in IP law, such as AI regulation.Showcasing multifaceted perspectives, relevant doctrines and positive norms, this book is a valuable resource for scholars and researchers of European law and intellectual property law. It is also beneficial to judges, IP practitioners, policymakers, and IP offices.