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Author: Salim Mamajiwalla
Publisher:
ISBN: 9781621820833
Category : Medical
Languages : en
Pages : 0
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Book Description
Patents are an important way of protecting inventions in the pharmaceutical and biotechnology industries. However, intellectual property law reforms have not kept pace with the rapid advances in genomics, synthetic biology, and stem cell research. Meanwhile, universities are increasingly spinning off companies that use these technologies, requiring the academic scientists involved to gain an understanding of intellectual property law and the patent system as it applies to biomedical innovations. This collection from Cold Spring Harbor Perspectives in Medicine aims to provide a clear, current, and comprehensive understanding of biomedical intellectual property and the laws that protect it. The contributors describe patent laws and practices in the United States, Canada, Australia, and the European Union. They explain the roles of regulatory agencies in intellectual property, various opinions on the patentability of biological materials (e.g., DNA and stem cells), and the implications of recent court decisions (e.g., the Myriad case). Practical issues related to licensing agreements and patent applications are also discussed. The authors offer guidance on the criteria for patent eligibility (e.g., utility, nonobviousness, and novelty), issues related to timing and possession, and rules for determining inventorship. Other topics include trade secrets, research exemptions, and the protection of traditional knowledge related to biological resources. This volume will serve as an essential reference for all scientists, physicians, and technology transfer professionals seeking to navigate the complex rules, regulations, and procedures concerning intellectual property in biotech and pharma.
Author: Salim Mamajiwalla
Publisher:
ISBN: 9781621820833
Category : Medical
Languages : en
Pages : 0
Get Book Here
Book Description
Patents are an important way of protecting inventions in the pharmaceutical and biotechnology industries. However, intellectual property law reforms have not kept pace with the rapid advances in genomics, synthetic biology, and stem cell research. Meanwhile, universities are increasingly spinning off companies that use these technologies, requiring the academic scientists involved to gain an understanding of intellectual property law and the patent system as it applies to biomedical innovations. This collection from Cold Spring Harbor Perspectives in Medicine aims to provide a clear, current, and comprehensive understanding of biomedical intellectual property and the laws that protect it. The contributors describe patent laws and practices in the United States, Canada, Australia, and the European Union. They explain the roles of regulatory agencies in intellectual property, various opinions on the patentability of biological materials (e.g., DNA and stem cells), and the implications of recent court decisions (e.g., the Myriad case). Practical issues related to licensing agreements and patent applications are also discussed. The authors offer guidance on the criteria for patent eligibility (e.g., utility, nonobviousness, and novelty), issues related to timing and possession, and rules for determining inventorship. Other topics include trade secrets, research exemptions, and the protection of traditional knowledge related to biological resources. This volume will serve as an essential reference for all scientists, physicians, and technology transfer professionals seeking to navigate the complex rules, regulations, and procedures concerning intellectual property in biotech and pharma.
Author: Sigrid Sterckx
Publisher: Cambridge University Press
ISBN: 1107006945
Category : Business & Economics
Languages : en
Pages : 375
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Book Description
This book provides the first comprehensive study of what cannot be patented and what should not be patentable in Europe.
Author: Jürgen Meier
Publisher: Kluwer Law International B.V.
ISBN: 9403510803
Category : Law
Languages : en
Pages : 516
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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: Andrea Stazi
Publisher: Edward Elgar Publishing
ISBN: 1784715905
Category : Business & Economics
Languages : en
Pages : 335
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Book Description
In todayês technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inve
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309089107
Category : Science
Languages : en
Pages : 186
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Book Description
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.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309167183
Category : Political Science
Languages : en
Pages : 352
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Book Description
This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.
Author: Maureen O'Sullivan
Publisher: Routledge
ISBN: 0429595034
Category : Law
Languages : en
Pages : 149
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Book Description
This book critiques the decision-making process in Article 53(a) of the European Patent Convention. To date, such decisions have been taken at high levels of expertise without much public involvement. The book eschews traditional solutions, such as those found within legislative, judicial and patent office realms and instead develops a radical blueprint for how these decisions can be put to the public. By examining wide-scale models of participatory democracy and deliberation, this book fills a significant gap in the literature. It will be invaluable for patent lawyers, academics, practitioners and intellectual property and patent officials.
Author: Claude E. Barfield
Publisher: A E I Press
ISBN: 9780844742564
Category : Law
Languages : en
Pages : 116
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Book Description
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.
Author: OECD
Publisher: OECD Publishing
ISBN: 9264056440
Category :
Languages : en
Pages : 162
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Book Description
This manual provides guiding principles for the use of patent data in the context of S&T measurement, and recommendations for the compilation and interpretation of patent indicators in this context.
Author: National Research Council
Publisher: National Academies Press
ISBN: 0309100674
Category : Science
Languages : en
Pages : 189
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Book Description
The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
