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Author: Brian Fitzgerald
Publisher: Sydney University Press
ISBN: 1743326564
Category : Law
Languages : en
Pages : 546
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Book Description
This book provides an overview of key legal issues facing e-Research: data exchange and data management, collaborative endeavour, the role and operation of privacy law, and commercialisation.
Author: Brian Fitzgerald
Publisher: Sydney University Press
ISBN: 1743326564
Category : Law
Languages : en
Pages : 546
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Book Description
This book provides an overview of key legal issues facing e-Research: data exchange and data management, collaborative endeavour, the role and operation of privacy law, and commercialisation.
Author: Geertrui van Overwalle
Publisher: Cambridge University Press
ISBN: 0521896738
Category : Law
Languages : en
Pages : 517
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Book Description
The cost of patent licenses needed to design a new genetic test or treatment may ultimately prevent research projects getting started, as individual components are protected by different patent owners. This book examines legal measures which might be used to solve the problem of fragmentation of patents in genetics.
Author: Kristina Hug
Publisher: Springer Science & Business Media
ISBN: 1607619598
Category : Science
Languages : en
Pages : 463
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Book Description
For many years, the ethical discussion surrounding human embryonic stem cell research has focused on the moral status of the embryo. This text takes a wider moral berth and focuses on numerous ethical, legal and social aspects involved in translating the results of stem cell research into diagnostic and therapeutic applications. Translational Stem Cell Research is broken into ten sections. It opens with an overview of the latest in stem cell research, focusing on specific diseases and the treatment of burn victims. Part II discusses the issues involved in the many steps from bench to bedside, ranging from first research in vitro to clinical trials. Part III covers scientific, regulatory and ethical challenges to basic research, and Part IV details issues regarding stem cell banks. Part V explores ethical, economic and strategic issues involved in collaboration between universities and industry, and Part VI addresses legal problems raised by patents on human stem-cell based inventions plus the extent to which there can be technological solutions to a moral dilemma. Part VII presents imaginative ways of communicating research to the general public and how to create conditions for a constructive dialogue. Part VIII probes psychosocial and cultural factors affecting judgment and decisions about translational stem cell research, and Part IX explores problems and procedures raised by an examination of the evaluation of stem cell research projects in research ethics committees. The book closes with a look into the future of translational stem cell research and stem cell-based therapeutic applications.
Author: Keith E. Maskus
Publisher: Emerald Group Publishing
ISBN: 0444527648
Category : Law
Languages : en
Pages : 559
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Book Description
Offers comprehensive and analytical literature surveys of the central questions regarding the linkages between intellectual property protection, international trade and investment, and economic growth. This book covers such questions as policy coordination in IPR, dispute resolution, and markets for technology and technology transfer.
Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 0309316324
Category : Medical
Languages : en
Pages : 236
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Book Description
Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
Author: Geoffrey A. Manne
Publisher: Cambridge University Press
ISBN: 1139498533
Category : Business & Economics
Languages : en
Pages : 559
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Book Description
Any legal regime must attempt to assess the trade-offs associated with rules that will affect incentives to innovate, allocative efficiency, competition, and freedom of economic actors to commercialize the fruits of their innovative labors. The essays in this book approach this critical set of problems from an economic perspective.
Author: Rochelle C. Dreyfuss
Publisher: Edward Elgar Publishing
ISBN: 0857933078
Category : Business & Economics
Languages : en
Pages : 639
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Book Description
This timely Handbook marks a major shift in innovation studies, moving the focus of attention from the standard intellectual property regimes of copyright, patent, and trademark, to an exploration of trade secrecy and the laws governing know-how, tacit knowledge, and confidential relationships. The editors introduce the long tradition of trade secrecy protection and its emerging importance as a focus of scholarly inquiry. The book then presents theoretical, doctrinal, and comparative considerations of the foundations of trade secrecy, before moving on to study the impact of trade secrecy regimes on innovation and on other social values. Coverage includes topics such as sharing norms, expressive interests, culture, politics, competition, health, and the environment. This important Handbook offers the first modern exploration of trade secrecy law and will strongly appeal to intellectual property academics, and to students and lawyers practicing in the intellectual property area. Professors in competition law, constitutional law and environmental law will also find much to interest them in this book, as will innovation theorists.
Author: Matthew Rimmer
Publisher: Edward Elgar Publishing
ISBN: 1848440189
Category : Law
Languages : en
Pages : 393
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Book Description
Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.
Author: University of California, Davis. School of Law
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 920
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Book Description
Author: Giulia Schneider
Publisher: Springer Nature
ISBN: 3030954277
Category : Law
Languages : en
Pages : 388
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Book Description
This book explores the emerging economic reality of health data pools from the perspective of European Union policy and law. The contractual sharing of health data for research purposes is giving rise to a free movement of research data, which is strongly encouraged at European policy level within the Digital Single Market Strategy. However, it has also a strong impact on data subjects' fundamental right to data protection and smaller businesses and research entities ability to carry out research and compete in innovation markets. Accordingly the work questions under which conditions health data sharing is lawful under European data protection and competition law. For these purposes, the work addresses the following sub-questions: i) which is the emerging innovation paradigm in digital health research?; ii) how are health data pools addressed at European policy level?; iii) do European data protection and competition law promote health data-driven innovation objectives, and how?; iv) which are the limits posed by the two frameworks to the free pooling of health data? The underlying assumption of the work is that both branches of European Union law are key regulatory tools for the creation of a common European health data space as envisaged in the Commissions 2020 European strategy for data. It thus demonstrates that both European data protection law, as defined under the General Data Protection Regulation, and European competition law and policy set research enabling regimes regarding health data, provided specific normative conditions are met. From a further perspective, both regulatory frameworks place external limits to the freedom to share (or not share) research valuable data.
