Intellectual Property Rights in Pharmaceutical Test Data : Origins, Globalisation and Impact
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 fou...
Gespeichert in:
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| Format: | Livre numérique |
| Sprache: | Anglais |
| Veröffentlicht: |
Cham :
Springer International Publishing
2023.
Cham : Springer Nature |
| Online Zugang: | Accès sur la plateforme Springer Accès sur la plateforme ISTEX Accès Université d'Orléans |
| Anmerkung: |
Springer e-books droit et criminologie (Licence nationale) |
| Autres localisations: | Voir dans le Sudoc |
| Edition sous un autre format: | • Intellectual property rights in pharmaceutical test data, origins, globalisation and impact, Adam Buick, 2023, Cham, Switzerland, Springer Nature Switzerland AG, 1 vol. 227 p., 3-031-29435-1 • Intellectual Property Rights in Pharmaceutical Test Data, Texte imprimé, 9783031294372 • Intellectual Property Rights in Pharmaceutical Test Data, Texte imprimé, 9783031294389 |
| Zusammenfassung: | 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 data exclusivity in national pharmaceutical markets. Fourth, the book covers a number of developments regarding test data exclusivity that have occurred as a result of responses to the COVID-19 pandemic, both at the national level as well as at the World Trade Organisation (WTO). This book will appeal to academics researching the intersection of intellectual property and the life sciences, civil society activists working to promote access to medicines, and students (particularly those at the post-graduate level) studying the relationship between intellectual property and medicine. |
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| Beschreibung: | Springer e-books droit et criminologie (Licence nationale) |
| ISBN: | 9783031294365 |
| Zugangseinschränkungen: | Accès en ligne pour les établissements français bénéficiaires des licences nationales Accès soumis à abonnement pour tout autre établissement Conditions particulières de réutilisation pour les bénéficiaires des licences nationales. https://www.licencesnationales.fr/wp-content/uploads/2024/02/2023-10_Collex_Springer_CCTP.pdf |