Supplementary Protection Certificates For Medicinal Products
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Supplementary Protection Certificates For Medicinal Products
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Author : Georgia A. Roussou
language : en
Publisher: Edward Elgar Publishing
Release Date : 2023-01-20
Supplementary Protection Certificates For Medicinal Products written by Georgia A. Roussou and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-01-20 with Law categories.
This book explores whether the judicial developments related to the Supplementary Protection Certificate (SPC) regulation correspond to the objectives of the European legislator. Examining the role of SPCs for medicinal products in the European patent system, it highlights both the jurisprudence of the Court of Justice of the European Union and the respective judgements of the member states’ national courts.
Supplementary Protection Certificates Spc
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Author : Marco Stief
language : en
Publisher:
Release Date : 2015-07
Supplementary Protection Certificates Spc written by Marco Stief and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-07 with categories.
Application And Importance Of Supplementary Protection Certificates For Medicinal Products In The European Union
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Author : Katarzyna Zbierska
language : en
Publisher:
Release Date : 2012
Application And Importance Of Supplementary Protection Certificates For Medicinal Products In The European Union written by Katarzyna Zbierska and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012 with categories.
Supplementary Protection Certificates Spc
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Author : Marco Stief
language : en
Publisher:
Release Date : 2021
Supplementary Protection Certificates Spc written by Marco Stief and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with categories.
Supplementary Protection Certificates Supplementary protection certificates (SPC) extend the effects of patents for medicinal products by a maximum of five and a half years, i.e. the certificate becomes effective at a time when the respective pharmaceutical is widely known on the market and thus generates the maximum revenue. This explains the enormous economic value of SPCs. They protect some of the most valuable products in the pharmaceutical industry. The legal basis for the SPC for medicinal products is a European Regulation. The obtaining provisions of that Regulation, the scope of protection etc. are highly disputed and have been the subject of numerous decisions of the CJEU. This handbook provides valuable insights into the world of SPCs and the most significant case law and legal sources at EU and national level of Germany, the UK, France, Italy, the Netherlands and Switzerland. The second completely revised edition specifically addresses recent developments of SPCs including manufacturing waivers and the implications of “Brexit”
European Spcs Unravelled
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Author : Alexa von Uexküll
language : en
Publisher: Kluwer Law International B.V.
Release Date : 2018-11-08
European Spcs Unravelled written by Alexa von Uexküll and has been published by Kluwer Law International B.V. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-11-08 with Law categories.
While supplementary protection certificates (SPCs) are governed by the same substantive rules in all Member States of the European Union and the European Economic Area, they are national IP rights. The formal requirements and procedural practices of the national patent offices granting SPCs still differ significantly, and these divergences can have a substantial impact in the prosecution of SPCs across Europe. This one-of-a-kind handbook provides an easily accessible overview of SPC law in Europe, covering all substantive and procedural aspects of prosecution, enforcement and invalidation, as well as SPC-related aspects of unfair competition law. Following an overarching European chapter, which addresses general considerations and the relevant European Union law, including the jurisprudence of the Court of Justice (CJEU) and the EFTA Court, this book contains separate national chapters for eleven key jurisdictions ? i.e., Germany, the United Kingdom, France, the Netherlands, Belgium, Italy, Spain, Portugal, Sweden, Iceland, and Switzerland, as well as a concluding chapter summarizing the fundamentals of SPC law and practice in sixteen further European countries. The contributors to this book, all experts in the field of SPCs in their respective jurisdictions, provide clear and hands-on guidance on a range of specific topics of practical and strategic relevance, including: • What is or is not an ‘active ingredient' amenable to SPC protection? • What is required for an active ingredient to be ‘protected' by a basic patent? • What relevance has the ‘core inventive advance' of the basic patent? • Can SPCs be obtained for ‘loose' combinations of separately formulated active ingredients? • Which basic patent should be chosen for an SPC filing? • Which types of marketing authorizations can be relied upon? • Under which conditions can SPCs be obtained for a new specific salt, ester or other derivative of a previously approved active ingredient, for a new specific enantiomer of a previously approved racemate, and for new therapeutic applications of previously approved active ingredients? • Can affiliated companies obtain several SPCs for the same product? • Does the revocation of an SPC enable the filing of a new SPC for the same product? • What are the limits to the filing of ‘unfriendly' SPCs based on third-party marketing authorizations? • What relevance does the product definition of an SPC have for its scope of protection? • What is the scope of protection of an SPC in relation to derivatives of an active ingredient? • How is the SPC term calculated, and how can an erroneous term be corrected? • How can SPCs and paediatric extensions be invalidated, and which grounds of invalidity can be invoked? • What pitfalls must be avoided in terms of unfair competition law? This book provides invaluable assistance to IP practitioners in devising successful pan-European SPC filing strategies. Its practice-oriented, country-by-country format makes it easy to compare the national practices and the respective national case law of the different European countries.
Supplementary Protection Certificates For Medicinal Products And Plant Protection Products
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Author : Great Britain. Patent Office
language : en
Publisher:
Release Date : 1997
Supplementary Protection Certificates For Medicinal Products And Plant Protection Products written by Great Britain. Patent Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1997 with categories.
Supplementary Protection Certificates For Medicinal Products
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Author : Great Britain. Patent Office
language : en
Publisher:
Release Date : 1992
Supplementary Protection Certificates For Medicinal Products written by Great Britain. Patent Office and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1992 with categories.
Supplementary Protection Certificates Spc
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Author : Marco Stief
language : en
Publisher:
Release Date : 2021-12-31
Supplementary Protection Certificates Spc written by Marco Stief and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-31 with categories.
Pharmaceutical Patents Under The Spc Regulation
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Author : Callesen Klinge, Ulla
language : en
Publisher: Edward Elgar Publishing
Release Date : 2022-10-07
Pharmaceutical Patents Under The Spc Regulation written by Callesen Klinge, Ulla and has been published by Edward Elgar Publishing this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-10-07 with Law categories.
Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.
Supplementary Protection Certificates Patent Extensions
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Author : Duncan Curley
language : en
Publisher: Elsevier
Release Date : 2025-01-15
Supplementary Protection Certificates Patent Extensions written by Duncan Curley and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-01-15 with Business & Economics categories.
Supplementary Protection Certificates (SPC) (Patents Extensions) for pharmaceutical and veterinary products were introduced in Europe in 1993. In 1996, a similar regime was introduced for agrochemical (crop protection) products. SPCs extend the period of protection given by a patent for a maximum of five years after the patent has expired. SPCs are of enormous commercial significance to the pharmaceutical and biotechnology industries, since they provide additional monopoly protection at a time when many products are reaching peak sales. Supplementary Protection Certificates (Patent Extensions): Law and Practice provides a practical, unifying and comprehensive guide to the law as it now stands. Provides a comprehensive, practical guide to the EU Regulations Drawing on the case law from the EU Member States and the European Court of Justice, contains an examination of the kinds of products that may be protected by SPCs and the limitations of the European SPC regime Details the new system for the grant of six-month pediatric extensions to SPCs for medicinal products