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

<p style="text-align:justify;mso-layout-grid-align:none;text-autospace:none" class="MsoNormal"><span style="mso-fareast-language:EN-US">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.</span>

<p style="text-align:justify;mso-layout-grid-align:none;text-autospace:none" class="MsoNormal"><span style="mso-fareast-language:EN-US">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:</span>

<p style="text-align:justify;mso-layout-grid-align:none;text-autospace:none" class="MsoNormal"><span style="mso-fareast-language:EN-US"> </span><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">Which types of antibody inventions are patent-eligible?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">Which types of functional and structural features are accepted for claiming antibodies?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">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?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">Which pitfalls must be avoided when defining amino acid sequences, chemical modifications or glycosylation patterns, and when relying on cell line deposits?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">Which breadth of claims is accepted for antibody inventions, and what experimental support is required?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">Which specific medical applications of antibodies can be claimed?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpMiddle"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">How is inventive step assessed in the specific case of antibody inventions?</span>

<p style="margin-left:14.2pt;mso-add-space:auto;text-align:justify;text-indent:-14.2pt;mso-list:l0 level1 lfo1;mso-layout-grid-align:none;text-autospace:none" class="MsoListParagraphCxSpLast"><span style="mso-list:Ignore">•</span><span style="font:7.0pt "Times New Roman"">     </span><span style="mso-fareast-language:EN-US">What has to be considered when enforcing antibody patents, including in relation to biosimilars as well as the doctrine of equivalence?</span>

<p style="text-align:justify;mso-layout-grid-align:none;text-autospace:none" class="MsoNormal"><span style="mso-fareast-language:EN-US">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.</span>

<p style="text-align:justify;mso-layout-grid-align:none;text-autospace:none" class="MsoNormal"><span style="mso-fareast-language:EN-US">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.</span>

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Dr. Jürgen Meier is a European and German Patent Attorney, a registered UPC representative, 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 in prosecution, oppositions, appeals and in litigation. He primarily focuses on the fields of biotechnology, including microbiology and fermentation technologies, immunology, neurosciences, (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-Aβ, anti-cytokines, and immunomodulating antibodies such as anti-PD-1, anti-PD-L1, anti-TIGIT and anti-LAG3. Jürgen currently serves as the Chairman of the AIPPI Committee for Biotechnology and has been an active member of this committee and the sister Pharma 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 regularly invited as a speaker to conferences and IP associations like AIPPI, JIPA or AIPLA. He is a co-author of the last two editions of From Clones to Claims: A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents and also contributes as an author to the forthcoming seventh edition. Jürgen also authored the EPO chapter in the first and second edition of the AIPPI Law Series book Patent Protection for Second Medical Uses. He regularly lectures at academic institutions, including the CEIPI/Strasbourg, the Ludwig-Maximilians-University Munich and the Technical University of Munich, University Würzburg and the Medical Universities Vienna and Linz. Oswin Ridderbusch is a German and European patent attorney, a registered UPC representative, 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 post-grant proceedings including opposition, revocation and infringement actions. Oswin specializes in the prosecution and litigation 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 second edition of the handbook European SPCs Unravelled: A Practitioner’s Guide to Supplementary Protection Certificates in Europe and an author of the forthcoming seventh edition of From Clones to Claims: A Handbook on Patenting Biotech and Biopharmaceutical Inventions in the European Patent Office and on Enforcing such Patents. He is regularly invited as a speaker to international conferences. He is also an active member of AIPPI and engages in AIPPI’s Standing Committee on the Unitary Patent and the Unified Patent Court.