Coverart for item
The Resource Evergreening patent exclusivity in pharmaceutical products : supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs, Frantzesksa Papadopoulou, (electronic resource)

Evergreening patent exclusivity in pharmaceutical products : supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs, Frantzesksa Papadopoulou, (electronic resource)

Label
Evergreening patent exclusivity in pharmaceutical products : supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs
Title
Evergreening patent exclusivity in pharmaceutical products
Title remainder
supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs
Statement of responsibility
Frantzesksa Papadopoulou
Creator
Subject
Language
eng
Summary
"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"--
Assigning source
Provided by publisher
http://library.link/vocab/creatorName
Papadopoulou, Frantzeska
Dewey number
346.2404
Index
index present
Literary form
non fiction
Nature of contents
  • dictionaries
  • bibliography
Series statement
Bloomsbury eBooks.
http://library.link/vocab/subjectName
  • Drugs
  • Patent extensions
  • Patent medicines
  • Patent laws and legislation
Label
Evergreening patent exclusivity in pharmaceutical products : supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs, Frantzesksa Papadopoulou, (electronic resource)
Link
https://eui.idm.oclc.org/login?url=https://doi.org/10.5040/9781509950317?locatt=label:secondary_bloomsburyCollections
Instantiates
Publication
Distribution
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type MARC source
rdacontent
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?
Control code
9781509950317
Dimensions
unknown
Edition
First edition.
Extent
1 online resource.
Form of item
online
Isbn
9781509950317
Media category
computer
Media MARC source
rdamedia
Other control number
10.5040/9781509950317
Specific material designation
remote
System control number
(OCoLC)1257446956
Label
Evergreening patent exclusivity in pharmaceutical products : supplementary protection certificates, orphan drugs, paediatric extensions and ATMPs, Frantzesksa Papadopoulou, (electronic resource)
Link
https://eui.idm.oclc.org/login?url=https://doi.org/10.5040/9781509950317?locatt=label:secondary_bloomsburyCollections
Publication
Distribution
Bibliography note
Includes bibliographical references and index
Carrier category
online resource
Carrier MARC source
rdacarrier
Color
multicolored
Content category
text
Content type MARC source
rdacontent
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?
Control code
9781509950317
Dimensions
unknown
Edition
First edition.
Extent
1 online resource.
Form of item
online
Isbn
9781509950317
Media category
computer
Media MARC source
rdamedia
Other control number
10.5040/9781509950317
Specific material designation
remote
System control number
(OCoLC)1257446956

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