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

Antibodies have revolutionized medicine and biotechnology, and have become indispensable tools in therapy, diagnostics, analytics, and research. Therapeutic antibodies, for example, have come to dominate the ranks of blockbuster drugs, currently accounting for 10 out of the top 15 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, most notably Amgen v. Sanofi, 872 F.3d 1367 (Fed. Cir. 2017), 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. It covers 23 of the most important IP jurisdictions worldwide – i.e., the European Patent Office, France, Germany, Italy, the Netherlands, Poland, Spain, Switzerland, the United Kingdom, Israel, the United States of America, Argentina, the Andean Community (Bolivia, Colombia, Ecuador, and Peru), Brazil, Canada, Chile, Mexico, China, India, Japan, Singapore, South Korea, and Australia. The 35 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 23 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.

Dr. Jürgen Meier is a European and German Patent Attorney, and a partner at Vossius & Partner, Munich. He has extensive experience representing clients before both national German courts, including the Federal Supreme Court, and the EPO. He primarily focuses on the fields of biotechnology, (bio-)pharmaceuticals, and employees inventions. In the antibody field, he handles cases relating, inter alia, to next generation antibodies, bi- and multispecific binders, antibody modification/purification technologies, and therapeutic antibodies, like Herceptin®, Stelara®, Actemra®, Avastin®, Mabthera®, anti-A , anti-PD-1 or anti-PD-L1. Jürgen currently serves as the Chairman of the AIPPI Sub-Committee for Biotechnology and Plant Varieties and has been an active member of this committee for many years. He also actively participates in the AIPPI Study Questions and Surveys. In addition to his frequent publications in the IP field, he is present at conferences and IP associations like AIPPI, JIPA or AIPLA. He is co-author of the sixth edition of From Clones to Claims on the EPO s jurisdiction in the field of biotechnology in comparison to the US and Japanese practice as well as the annually revised AIPPI Law Series book Patent Protection for Second Medical Uses . Jürgen regularly lectures at academic institutions, including the CEIPI/Strasbourg, the LMU and TU Munich, University Würzburg and the Medical University Vienna. Oswin Ridderbusch is a German and European patent attorney and a partner at the IP law firm Vossius & Partner. He graduated in biochemistry from the University of Tübingen, focusing on medicinal chemistry and protein biochemistry, and conducted research at the Max Planck Institute for Developmental Biology. His practice includes the drafting and prosecution of patent applications, mainly in the fields of antibodies and biologics, small molecular pharmaceuticals, formulations, drug delivery technologies, functional foods and diagnostics, as well as contentious postgrant proceedings including opposition, revocation and infringement actions, and the filing of supplementary protection certificates (SPCs). He further provides counsel in the strategic management of patent portfolios and prepares freedom-to-operate and due diligence opinions. Oswin is an editor and author of the handbook European SPCs Unravelled: A Practitioner s Guide to Supplementary Protection Certificates in Europe . He has been a member of the Executive Committee of AIPPI since 2017, and engages in AIPPI s Standing Committee on the Unitary Patent and the Unified Patent Court.