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.

Appearing at a time when the ancient problem of the individual versus the state once again occupies the minds of thinking Europeans, this important new book thoroughly evaluates the judicial system of the European Union, fully describing the nature of the judicial protection available to individuals, undertakings, and member States. With attention to the rapid and continuing development of the Community legal order, Schermers and Waelbroeck provide a much-needed perspective on the reasoning of the European Court of Justice in significant decisions, especially recent cases, and shed revealing light on how the rule of law may develop in future. An introductory chapter offers a masterful description of how Treaty provisions, Community acts, international law, and national legal orders interact in the procedures and decisions of the Court of Justice. Further chapters provide analysis and insight into such matters as the following: the crucial role of national courts as guarantors of the rights of individuals in Community law the validity of acts taken by Community institutions and member States, and protection against them the delivery of non-judicial opinion and other tasks of the Court of Justice the composition, function, and rules of procedure of the Court the organisation of the Court of First Instance and the appeal procedure against its decisions. Judicial Protection in the European Union is organised to facilitate its prodigious reference value. All important cases are examined, and abundant footnotes clearly indicate relevant precedents in each case. This is a fundamental source for students of European law, as well as a basic reference for practitioners and a valuable analysis of the strengths and weaknesses of the European system of judicial protection.

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.

With its focus on drugs so recently introduced that they have yet to be found in any other textbooks or general references, the information and insight found here makes this a genuinely unique handbook and reference. Following the successful approach of the previous volumes in the series, inventors and primary developers of successful drugs from both industry and academia tell the story of the drug's discovery and describe the sometimes twisted route from the first drug candidate molecule to the final marketed drug. The 11 case studies selected describe recent drugs ranging across many therapeutic fields and provide a representative cross-section of present-day drug developments. Backed by plenty of data and chemical information, the insight and experience of today's top drug creators makes this one of the most useful training manuals that a junior medicinal chemist may hope to find. The International Union of Pure and Applied Chemistry has endorsed and sponsored this project because of its high educational merit.

Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.

A comprehensive picture of IP activity around the world based on statistics from national and regional IP offices, WIPO and the World Bank. Covers filing, registration and renewals data for patents, utility models, trademarks, industrial designs, microorganisms and plant variety protection. Also includes an analysis of participation by women inventors in international patenting.