Antibody Patent Evolution
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Antibody Patent Evolution
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Author : Theodore Teng
language : en
Publisher:
Release Date : 2022
Antibody Patent Evolution written by Theodore Teng and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022 with categories.
Therapeutic antibodies in clinical medicine are become an important focus for the biotechnology industry. In 2021, four of the top six selling prescription drugs were monoclonal antibodies, leading to a reported revenue of over $67 billion dollars. Accordingly, it is no surprise that the patentability rules for antibody patents have become increasingly important to drug companies, health care providers, and consumers alike. In this paper we outline the evolution of antibody patents from broad genus type claims to narrow species type claims. In this paper we explain how the US Patent and Trademark Office (USPTO) has made this shift to catch up with the scientific changes in antibody technology. Additionally, we suggest how the USPTO could use the written description requirement and the reverse Doctrine of Equivalents to correctly limit the scope of antibody patents while still incentivizing the generation of new antibody therapies.
Antibody Patenting
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Author : Jürgen Meier
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2023-08-22
Antibody Patenting written by Jürgen Meier and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-22 with Law categories.
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.
Therapeutic Antibody Engineering
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Author : William R Strohl
language : en
Publisher: Elsevier
Release Date : 2012-10-16
Therapeutic Antibody Engineering written by William R Strohl and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-10-16 with Medical categories.
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
Biotechnology And The Patent System
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Author : Claude E. Barfield
language : en
Publisher: A E I Press
Release Date : 2007
Biotechnology And The Patent System written by Claude E. Barfield and has been published by A E I Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2007 with Law categories.
American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.
Process Scale Purification Of Antibodies
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Author : Uwe Gottschalk
language : en
Publisher: John Wiley & Sons
Release Date : 2017-03-07
Process Scale Purification Of Antibodies written by Uwe Gottschalk and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-03-07 with Medical categories.
Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
A Patent System For The 21st Century
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Author : National Research Council
language : en
Publisher: National Academies Press
Release Date : 2004-10-01
A Patent System For The 21st Century written by National Research Council and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2004-10-01 with Science categories.
The U.S. patent system is in an accelerating race with human ingenuity and investments in innovation. In many respects the system has responded with admirable flexibility, but the strain of continual technological change and the greater importance ascribed to patents in a knowledge economy are exposing weaknesses including questionable patent quality, rising transaction costs, impediments to the dissemination of information through patents, and international inconsistencies. A panel including a mix of legal expertise, economists, technologists, and university and corporate officials recommends significant changes in the way the patent system operates. A Patent System for the 21st Century urges creation of a mechanism for post-grant challenges to newly issued patents, reinvigoration of the non-obviousness standard to quality for a patent, strengthening of the U.S. Patent and Trademark Office, simplified and less costly litigation, harmonization of the U.S., European, and Japanese examination process, and protection of some research from patent infringement liability.
Patenting The Recombinant Products Of Biotechnology And Other Molecules
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Author : Phillipe Ducor
language : en
Publisher: Kluwer Law International B.V.
Release Date : 1998-06-19
Patenting The Recombinant Products Of Biotechnology And Other Molecules written by Phillipe Ducor and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 1998-06-19 with Law categories.
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.
Intellectual Property Rights And The Life Science Industries
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Author : Graham Dutfield
language : en
Publisher: World Scientific
Release Date : 2009
Intellectual Property Rights And The Life Science Industries written by Graham Dutfield and has been published by World Scientific this book supported file pdf, txt, epub, kindle and other format this book has been release on 2009 with Law categories.
This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.
Guide To Eu Pharmaceutical Regulatory Law
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Author : Sally Shorthose
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2017-02-17
Guide To Eu Pharmaceutical Regulatory Law written by Sally Shorthose and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-02-17 with Law categories.
In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Patent Fundamentals For Scientists And Engineers
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Author : Thomas T. Gordon
language : en
Publisher: CRC Press
Release Date : 2000-03-15
Patent Fundamentals For Scientists And Engineers written by Thomas T. Gordon and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2000-03-15 with Technology & Engineering categories.
International in scope, Patent Fundamentals for Scientists and Engineers, Second Edition provides a clear explanation of the patent system and patent principles. Designed for non-lawyers, this book includes information on the patenting process, obtaining patent protection, and how to recognize patentable inventions and avoid legal problems of infringement. New in the Second Edition: Techniques for searching the Internet Internet addresses for patent information and references A new chapter providing the forms required to file a patent Expanded coverage of international patents The nontechnical style of this book makes it easy to read and understand. By providing a basic working knowledge of patents, Patent Fundamentals for Scientists and Engineers, Second Edition enables non-specialists to make well-informed decisions affecting new and patentable products. It is an ideal book for anyone without prior legal knowledge who needs to understand the patent system, including scientists, engineers, inventors, researchers, business managers, entrepreneurs, and patent liaison workers.