Evergreening patent exclusivity in pharmaceutical products: supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs
"This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal po...
Gespeichert in:
| 1. Verfasser: | |
|---|---|
| Format: | Buch |
| Sprache: | English |
| Veröffentlicht: |
Oxford ; New York
Hart
2021
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| Schlagworte: | |
| Zusammenfassung: | "This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture"-- |
| Beschreibung: | xxix, 277 Seiten 25 cm |
| ISBN: | 9781509950287 1509950281 9781509950324 150995032X |
Internformat
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| 505 | 8 | |a Regulating the EU pharmaceutical sector : a multilayered challenge -- Setting the stage for regulatory rights : the regulatory agencies and the marketing authorisation procedure -- Data exclusivity -- The supplementary protection certificate -- The paediatric extension -- Orphan drugs -- Advanced therapy medicinal products -- How effective is the effectiveness test in the field of regulatory rights? | |
| 520 | 3 | |a "This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture"-- | |
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| 653 | 0 | |a Patent extensions / European Union countries | |
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| 653 | 0 | |a Patent extensions | |
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Datensatz im Suchindex
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| author | Papadopoulou, Frantzeska |
| author_GND | (DE-588)1163969338 |
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| author_sort | Papadopoulou, Frantzeska |
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| bvnumber | BV047942006 |
| contents | Regulating the EU pharmaceutical sector : a multilayered challenge -- Setting the stage for regulatory rights : the regulatory agencies and the marketing authorisation procedure -- Data exclusivity -- The supplementary protection certificate -- The paediatric extension -- Orphan drugs -- Advanced therapy medicinal products -- How effective is the effectiveness test in the field of regulatory rights? |
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| id | DE-604.BV047942006 |
| illustrated | Not Illustrated |
| index_date | 2024-07-03T19:35:34Z |
| indexdate | 2024-07-10T09:25:50Z |
| institution | BVB |
| isbn | 9781509950287 1509950281 9781509950324 150995032X |
| language | English |
| oai_aleph_id | oai:aleph.bib-bvb.de:BVB01-033323467 |
| oclc_num | 1398661283 |
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| owner_facet | DE-M382 DE-19 DE-BY-UBM |
| physical | xxix, 277 Seiten 25 cm |
| publishDate | 2021 |
| publishDateSearch | 2021 |
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| publisher | Hart |
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| spelling | Papadopoulou, Frantzeska Verfasser (DE-588)1163969338 aut Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs Frantzesksa Papadopoulou Oxford ; New York Hart 2021 xxix, 277 Seiten 25 cm txt rdacontent n rdamedia nc rdacarrier Regulating the EU pharmaceutical sector : a multilayered challenge -- Setting the stage for regulatory rights : the regulatory agencies and the marketing authorisation procedure -- Data exclusivity -- The supplementary protection certificate -- The paediatric extension -- Orphan drugs -- Advanced therapy medicinal products -- How effective is the effectiveness test in the field of regulatory rights? "This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture"-- Drugs / European Union countries / Patents Patent extensions / European Union countries Patent medicines / Law and legislation / European Union countries Patent laws and legislation / European Union countries Drugs Patent extensions Patent laws and legislation Patent medicines / Law and legislation European Union countries Patents Online version Papadopoulou, Frantzeska Evergreening patent exclusivity in pharmaceutical products Oxford ; New York : Hart, 2021 978-1-50995-030-0 |
| spellingShingle | Papadopoulou, Frantzeska Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs Regulating the EU pharmaceutical sector : a multilayered challenge -- Setting the stage for regulatory rights : the regulatory agencies and the marketing authorisation procedure -- Data exclusivity -- The supplementary protection certificate -- The paediatric extension -- Orphan drugs -- Advanced therapy medicinal products -- How effective is the effectiveness test in the field of regulatory rights? |
| title | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs |
| title_auth | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs |
| title_exact_search | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs |
| title_exact_search_txtP | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs |
| title_full | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs Frantzesksa Papadopoulou |
| title_fullStr | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs Frantzesksa Papadopoulou |
| title_full_unstemmed | Evergreening patent exclusivity in pharmaceutical products supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs Frantzesksa Papadopoulou |
| title_short | Evergreening patent exclusivity in pharmaceutical products |
| title_sort | evergreening patent exclusivity in pharmaceutical products supplementary protection certificates orphan drugs paediatric extensions and atmps |
| title_sub | supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs |
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