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Antibody Patenting: A Practitioner's Guide to Drafting, Prosecution and Enforcement, 2nd Edition

Antibody Patenting: A Practitioner's Guide to Drafting, Prosecution and Enforcement, 2nd Edition

作者： Jürgen Meier; Oswin Ridderbusch
出版商： Kluwer Law International
ISBN: 9789403536262
出版时间 August 2023
规格： Hardback
适应领域： International ? 免责申明：
Countri(es) stated herein are used as reference only

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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.
About the Editors

About the Contributors

Foreword
Renata Righetti Pelosi, President of AIPPI

Acknowledgments

Introduction
Jürgen Meier & Oswin Ridderbusch

Chapter 1
European Patent Office
Jürgen Meier & Hans-Rainer Jaenichen

Chapter 2
France
Cyra Nargolwalla & Isabelle Labarre

Chapter 3
Germany
Oswin Ridderbusch

Chapter 4
Italy
Olga Capasso

Chapter 5
The Netherlands
Martin Klok

Chapter 6
Poland
Marta Kawczynska

Chapter 7
Spain
Juan Arias

Chapter 8
Switzerland
Philipp Marchand

Chapter 9
United Kingdom
Daniel Lim & Claire Baldock

Chapter 10
Israel
David Gilat & Mirit Lotan

Chapter 11
United States of America
Michele M. Wales & John C. Todaro

Chapter 12
Argentina
Martín Bensadon & Cristian D. Bittel

Chapter 13
Andean Community: Bolivia, Colombia, Ecuador, and Peru
Andres Rincon & Sergio Arboleda

Chapter 14
Brazil
Maria Carmen de Souza Brito & Pedro Henrique Borges de Figueiredo

Chapter 15
Canada
Graeme Boocock & Charles Boulakia

Chapter 16
Chile
Rodrigo Marré Grez & Allison Ortega del Valle

Chapter 17
Mexico
Hector E. Chagoya-Cortes & Israel Jiménez

Chapter 18
China
Gesheng Huang

Chapter 19
India
Mamta Rani Jha

Chapter 20
Japan
Takashi Fujita & Osamu Yamamoto

Chapter 21
Singapore
Khoo Kian Hoe

Chapter 22
South Korea
Min Son

Chapter 23
Australia
Michael Christie

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