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Titlebook: Intellectual Property Rights in Pharmaceutical Test Data; Origins, Globalisati Adam Buick Book 2023 The Editor(s) (if applicable) and The A

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書目名稱Intellectual Property Rights in Pharmaceutical Test Data
副標(biāo)題Origins, Globalisati
編輯Adam Buick
視頻videohttp://file.papertrans.cn/470/469217/469217.mp4
概述Provides detailed analysis of data exclusivity laws in over 50 international agreements and 25 national jurisdictions.Presents original empirical findings on the impact of data exclusivity on the appr
圖書封面Titlebook: Intellectual Property Rights in Pharmaceutical Test Data; Origins, Globalisati Adam Buick Book 2023 The Editor(s) (if applicable) and The A
描述.This book considers the intellectual property protection of clinical test data that has been submitted to governments, in particular through test data exclusivity rights. It focuses on how these intellectual property rights first emerged in the early 1980s, how they have globalised over the past four decades, and what impact they have had upon access to medicine. ?.This book makes a number of significant and original contributions to the literature around the protection of submitted test data. First, the book draws upon the theory of regulatory globalisation to provide an explanation of how intellectual property rights in submitted pharmaceutical test data have become nearly ubiquitous in the legal systems of most major economies. Second, through a comprehensive analysis and synthesis of provisions on the protection of submitted test data in free trade agreements, as well as a comparison of a range of national approaches to the protection of submitted test data, it reveals the broader global regulatory pattern that has given rise to these intellectual property rights. Third, by analysing data on drug approvals in the US, it provides an empirical insight into the impact of test dat
出版日期Book 2023
關(guān)鍵詞Test data exclusivity; Access to medicine; Globalisation of intellectual property; data exclusivity; TRI
版次1
doihttps://doi.org/10.1007/978-3-031-29436-5
isbn_softcover978-3-031-29438-9
isbn_ebook978-3-031-29436-5
copyrightThe Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl
The information of publication is updating

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Conclusion,This final chapter first summarises the major findings of this book before moving to discuss some of the implications of those findings. Finally, it offers a few concluding remarks on the book as a whole.
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An Overview of the Protection of Submitted Test Data, this book. Firstly, the role of pharmaceutical test data in the process of drug development is described. Secondly, this chapter provides an overview of the issues surrounding the protection of submitted pharmaceutical test data, and in particular the issues surrounding test data exclusivity. Both
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The Globalisation of Test Data Exclusivity,lusivity requirements in trade agreements and other instruments have evolved over time and between parties. The chapter firstly examines the role that trade agreements negotiated by the US, EFTA/Switzerland and EU have played in the globalisation of test data exclusivity. Then, the chapter moves to
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