Oswin Ridderbusch – författare

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 (EEA), they are national intellectual property 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 on the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an in-depth review 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 detailed national chapters for all European states that provide SPCs − i.e., the twenty-seven EU Member States (Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden), the EEA/EFTA states Norway and Iceland, as well as the United Kingdom, Switzerland/Liechtenstein, Serbia, Bosnia and Herzegovina, Albania, and North Macedonia. The contributors to this book, all seasoned experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on the most pertinent SPC-related topics of practical and strategic relevance.

The considerably expanded second edition of this handbook offers a comprehensive analysis of European SPC law and practice, covering all European states with SPC systems in detailed national chapters. As such, this book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing and litigation strategies. Its practice-oriented approach, in combination with a country-by-country format where all chapters follow the same structure, makes it easy to compare the national practices and the respective national case law of the different European countries.

‘The present work fills a gap and provides, for the first time, an overview of the SPC practice in the EU Member States, which despite the intended harmonization by the respective EU legislation is still decidedly inconsistent in some areas. Altogether, this successful work, with its streamlined structure and clear language that is immediately comprehensible even to non-native speakers, functions not “only” as a source of information for European attorneys, authorities and courts. It also conveys – perhaps not at all intended by the authors – the unique diversity of this European legal regime, which for many exerts a special fascination. The present Practitioner’s Guide can be recommended without reservation and should not be missing in any specialist library.’

– Jürgen Schell, Judge at the German Federal Patent Court, on the first edition of this book.

Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have become firmly established in the ranks of blockbuster drugs, currently accounting for about half of the top 10 best-selling medicines. At the same time, a body of case law dealing specifically with the patentability of antibody-related inventions and the enforcement of antibody patents has emerged in major jurisdictions. The, at times, significant divergences between different jurisdictions have been compounded by recent decisions in the United States, which have severely curtailed the possibilities to obtain broad antibody patents. It is therefore essential to understand how antibody inventions are assessed in different jurisdictions in order to secure an optimal patent protection and to successfully enforce such patents.

This book provides practitioners with a comprehensive resource elucidating all aspects of the patenting of antibodies from initial drafting and prosecution to enforcement, using a country-by-country format. The updated and expanded Second Edition covers more than 30 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, Belgium, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, the Netherlands, Poland, Spain, Sweden, Switzerland, the United Kingdom, the United States of America, Canada, Mexico, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Argentina, Brazil, Chile, China, India, Israel, Japan, Singapore, South Korea, Taiwan, Australia, and New Zealand. The 49 contributors to this book, all distinguished experts in this field, provide clear and practice-oriented advice on a range of topics including:

 •     Which types of antibody inventions are patent-eligible?

•     Which types of functional and structural features are accepted for claiming antibodies?

•     What needs to be considered when defining antibodies in terms of their antigen, target affinity, binding specificity, epitope, competitive binding and other characteristics in relation to reference antibodies, as well as their effects on the target?

•     Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits?

•     Which breadth of claims is accepted for antibody inventions, and what experimental support is required?

•     Which specific medical applications of antibodies can be claimed?

•     How is inventive step assessed in the specific case of antibody inventions?

•     What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence?

All chapters follow the same structure, which makes this book easily accessible and allows a direct comparison between different jurisdictions. Practitioners will find the much-needed tools and guidance to secure the best possible patent protection for antibody inventions in more than 30 of the most important jurisdictions worldwide.

This book is the fifth volume in the AIPPI Law Series which has been established together with the International Association for the Protection of Intellectual Property (AIPPI), a non-affiliated, non-profit organization dedicated to improving and promoting the protection of intellectual property at both national and international levels.