Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”

While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area, they are national IP rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact in the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an easily accessible overview of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains separate national chapters for eleven key jurisdictions ? i.e., Germany, the United Kingdom, France, the Netherlands, Belgium, Italy, Spain, Portugal, Sweden, Iceland, and Switzerland, as well as a concluding chapter summarizing the fundamentals of SPC law and practice in sixteen further European countries. The contributors to this book, all experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on a range of specific topics of practical and strategic relevance, including: • What is or is not an ‘active ingredient' amenable to SPC protection? • What is required for an active ingredient to be ‘protected' by a basic patent? • What relevance has the ‘core inventive advance' of the basic patent? • Can SPCs be obtained for ‘loose' combinations of separately formulated active ingredients? • Which basic patent should be chosen for an SPC filing? • Which types of marketing authorizations can be relied upon? • Under which conditions can SPCs be obtained for a new specific salt, ester or other derivative of a previously approved active ingredient, for a new specific enantiomer of a previously approved racemate, and for new therapeutic applications of previously approved active ingredients? • Can affiliated companies obtain several SPCs for the same product? • Does the revocation of an SPC enable the filing of a new SPC for the same product? • What are the limits to the filing of ‘unfriendly' SPCs based on third-party marketing authorizations? • What relevance does the product definition of an SPC have for its scope of protection? • What is the scope of protection of an SPC in relation to derivatives of an active ingredient? • How is the SPC term calculated, and how can an erroneous term be corrected? • How can SPCs and paediatric extensions be invalidated, and which grounds of invalidity can be invoked? • What pitfalls must be avoided in terms of unfair competition law? This book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing strategies. Its practice-oriented, country-by-country format makes it easy to compare the national practices and the respective national case law of the different European countries.

The author has succeeded in her chief aim in writing this book to introduce a compact and accessible account of EU intellectual property law. . . this book is a useful background and excellent starting point for understanding EU intellectual property law. Jamil Ammar, European Intellectual Property Review This book s innovative contribution is to view EU IP law as a subject in its own right, not just an extra to accounts of national law. The very up-to-date coverage strikes an excellent balance between detail and overview, while Dr Seville also discusses thoughtfully the wider international frameworks, policy issues and debates in which development of EU IP law is enmeshed. Dr Seville fully deserves the gratitude of IP lawyers and students for this outstandingly helpful study. Hector Macqueen, Edinburgh Law School, UK The book is as timely as it is well-written and thorough. The contributions of the EU to most aspects of intellectual property law are increasingly dominant. This treatment places them apart from the national laws of member states, thus emphasising the common core that now they provide. Many will want to study this presentation. William R. Cornish, University of Cambridge, UK Intellectual property (IP) is a crucial contributor to economic growth and competitiveness within the EU. This book offers a compact and accessible account of EU intellectual property law and policy, covering copyright, patents, designs, trademarks and the enforcement of rights. The author also addresses aspects of the free movement of goods and services, competition law, customs measures and anti-counterfeiting efforts. Setting EU intellectual property law in its wider international context, this work reveals the framework within which the national IP laws of member states operate. The book seeks to highlight the most important policy issues and arguments of relevance to the EU, both within the Union, and in its relations with the rest of the world. With its detailed references, cross-referencing and suggestions for further readings, EU Intellectual Property Law and Policy is essential reading for postgraduate students and academic lawyers in IP and EU law. Practitioners seeking a broad account of the area will also appreciate this important contribution.

This new edition is a comprehensive and practical guide to European patent law – a 'ius commune'. The book highlights the areas of consistency and difference between the most influential European patent law jurisdictions: the European Patent Office, England and Wales, France, Germany, and the Netherlands. The book also draws insights from further afield, with contributions from other, very active, patent jurisdictions, including Italy, Sweden, Denmark, and Switzerland. Uniquely, the book addresses European patent law by subject matter area, assessing the key national and EPO approaches together rather than nation by nation. Each chapter outlines the common ground between the national approaches and provides a guide for the possible application of European patent law in national courts and the UPC in the future. In addition to featuring content on new countries, the second edition includes new chapters dedicated to the substantive aspects of FRAND, declarations, and evidence. There is also an expanded commentary on construction, including common terms used in patent claims. A must-read for anyone working in the field of European patent law.