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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

  • Author:
  • Publisher: Kluwer Law International
  • ISBN: 9789403536262
  • Published In: August 2023
  • Format: Hardback
  • Jurisdiction: International ? Disclaimer:
    Countri(es) stated herein are used as reference only

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  • Description 
  • Contents 
  • Details

    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

    Table of Cases

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