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Author: Jürgen Meier
Publisher: Kluwer Law International B.V.
ISBN: 9403510803
Category : Law
Languages : en
Pages : 488
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Book Description
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.
Author: Jürgen Meier
Publisher: Kluwer Law International B.V.
ISBN: 9403510803
Category : Law
Languages : en
Pages : 488
Get Book
Book Description
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.
Author: Jürgen Meier
Publisher: Kluwer Law International B.V.
ISBN: 9403542063
Category : Law
Languages : en
Pages : 707
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Book Description
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.
Author: Phillipe Ducor
Publisher: Kluwer Law International B.V.
ISBN: 9041106987
Category : Law
Languages : en
Pages : 200
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Book Description
The avenue consisting in lowering the non obviousness standard, chosen by the Federal Circuit in In re Deuel, is rejected in a detailed critic of the case. Several current examples of sui generis intellectual property rights are then described. A "no action" scenario is also examined, emphasizing that the rapid changes occurring in biotechnology might ultimately make the current problem obsolete. Finally, broader issues such as the growing secrecy in basic science are acknowledged, and linked to the disappearance of a clear distinction between basic and applied research.
Author: Stefan Dübel
Publisher: John Wiley & Sons
ISBN: 3527329374
Category : Science
Languages : en
Pages : 2538
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Book Description
Still the most comprehensive reference source on the development, production and therapeutic application of antibodies, this second edition is thoroughly updated and now has 30% more content. Volume 1 covers selection and engineering strategies for new antibodies, while the second volume presents novel therapeutic concepts and antibodies in clinical study, as well as their potential. Volumes 3 and 4 feature detailed and specific information about each antibody approved for therapeutic purposes, including clinical data. This unique handbook concludes with a compendium of marketed monoclonal antibodies and an extensive index. Beyond providing current knowledge, the authors discuss emerging technologies, future developments, and intellectual property issues, such that this handbook meets the needs of academic researchers, decision makers in industry and healthcare professionals in the clinic.
Author: Ulrich Storz
Publisher: Springer
ISBN: 9783642295256
Category : Science
Languages : en
Pages : 0
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Book Description
SpringerBriefs in Biotech Patents present timely reports of intellectual properties (IP) issues and patent aspects in the field of biotechnology. This new volume in the series focuses on the particular IP issues of therapeutics, vaccines and molecular diagnostics. The first chapter concentrates on basics principles for protecting antibody compounds. Additional ways to create follow-up protection for antibody therapeutics are also discussed. The second chapter gives an overview of the patent landscape in molecular diagnostics, and discusses issues of patentability with respect to the different technologies and compounds used therein. The third chapter gives a broad overview of areas of law that are particularly relevant to the patenting of peptide vaccines and therapeutic peptides as products and in compositions. The scope of patentable subject matter is discussed, as it has been the focus of much wrangling and debate in the courts.
Author: William R Strohl
Publisher: Elsevier
ISBN: 1908818093
Category : Medical
Languages : en
Pages : 697
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Book Description
The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity
Author: Hans R Jaenichen
Publisher:
ISBN: 9783452298232
Category :
Languages : en
Pages : 800
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Book Description
Author: Clinton B. Mathias
Publisher: Springer Nature
ISBN: 3030199223
Category : Medical
Languages : en
Pages : 399
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Book Description
Medicine has entered a golden age in which therapeutic agents are becoming widely available due to advances in basic science and technology. As such, many drugs have been developed that target inflammatory processes and/or the immune system. This book is intended for health professionals examining the modulation of inflammation by immunotherapeutic drugs. The immune system fills the primordial role of host defense and resistance to infections with pathogenic microorganisms. Several hematopoietic-derived cells constituting the innate and adaptive immune systems cooperate to provide barriers for microbial colonization and/or promote pathogen destruction within the host. Conversely, many immune cells are also involved in the pathogenesis and propagation of chronic inflammatory diseases. The beginning of this book details various components of the immune system including the cell types, lymphoid tissues, soluble cytokines and surface molecules that are essential for host defense. Breakdowns in immune tolerance, or dysregulated immune responses to antigens derived from self tissues or innocuous sources, can lead to the development of autoimmunity or chronic inflammatory diseases. Pathophysiologic roles for the immune system are detailed in corresponding chapters on autoimmunity, epithelial surfaces (lungs, skin, intestine), and transplantation, with special emphasis placed on immunotherapeutic drug targets. The last section of the book focuses on treatments that stimulate our immune system to specifically target and fight infectious diseases and cancer. In each chapter, the medications used to treat various diseases/conditions in terms of their mechanism of action and other pharmacologic properties are detailed. Chapters begin with a table showing drug names and classifications. The importance of basic science and clinical trials cannot be understated in the context of drug development. As such, the discovery of certain medications that had a lasting impact in medicine and pharmacy are highlighted in chapter subsections named “Bench to Bedside.” Several clinical applications of immunotherapeutic drugs are described within end-of -chapter case studies including practice questions. The Pharmacology of Immunotherapeutic Drugs is a reference for immunologists and clinicians (medical doctors, pharmacists, nurses) examining the modulation of inflammatory processes by a variety of medications targeting the cells and mediators of our immune system.
Author: Jorge A. Goldstein
Publisher:
ISBN: 9781731924261
Category :
Languages : en
Pages : 0
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Book Description
Author: Eléonore Gaspar
Publisher: Kluwer Law International B.V.
ISBN: 9403528354
Category : Law
Languages : en
Pages : 567
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Book Description
This book addresses the issue of trademark use that may be required for the protection and/or maintenance of trademark rights. Since the first edition of this book in 2018, there have been significant modifications in some countries, particularly, following the implementation of EU Directive 2015/2436 in the EU countries. Laws around the world do not attach the same consequence to the lack of use of a trademark, and courts do not always assess in the same way whether a trademark is genuinely used. This is a fundamental issue for trademark owners since, depending on the jurisdiction, lack of genuine use can lead to the refusal of trademark registration, the revocation of trademark rights, or prevent the owner of a non-used trademark from initiating an action based on its trademark. This detailed analysis provides clarity, insight, and guidance on the legal issues and practical implications of genuine use of trademarks in twenty-six jurisdictions worldwide. This book was developed within the framework of 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. This topic was the subject of an AIPPI study, and its subsequent Resolution – The Requirements of Genuine Use of Trademarks for Maintaining Protection (2011, Hyderabad) – which aims to harmonize this issue of genuine use of trademarks. The authors of the chapters for each jurisdiction were carefully selected based on their extensive experience and in-depth knowledge of trademark protection in their respective jurisdictions. Each chapter considers issues and topics such as the following: types of use that qualify as genuine use of a trademark, including requirements as to whether uses are consistent with the function of the trademark or made in the course of trade; requirements as to the volume, duration, and frequency of use; impact of the trademark’s designation of goods and services; issues relating to the sign used, particularly, if it is used in a different form from the registered trademark (this includes consideration of alteration of the distinctive character, or the potential impact of a plurality of registered trademarks for different signs, or the question of use in black and white or in colour); proof to be provided to evidence genuine use as a trademark, including issues of timing and territory; situations in which the issue of genuine use can be of importance; valid reasons for non-use; consequences of lack of use depending on the context, including possible revocation of trademark rights; and case law examples. As a comparative law study and a collection of contributions from around the world on a key issue of trademark law, this book is of tremendous practical interest. Trademark owners, parties involved in or contemplating enforcement proceedings, and interested legal practitioners will benefit greatly from its thorough comparative analysis and guidance. It is also exceptionally valuable as a comprehensive resource for academics and researchers interested in the international harmonization of trademark law.
