Supplementary Protection Certificates for Medicinal Products PDF Download
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Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
ISBN: 1035309963
Category : Law
Languages : en
Pages : 267
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Book Description
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.
Author: Georgia A. Roussou
Publisher: Edward Elgar Publishing
ISBN: 1035309963
Category : Law
Languages : en
Pages : 267
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Book Description
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.
Author: Marco Stief
Publisher:
ISBN: 9783848702992
Category :
Languages : en
Pages : 350
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Book Description
Author: Marco Stief
Publisher:
ISBN: 9783406779275
Category :
Languages : en
Pages :
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Book Description
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”
Author: Frantzeska Papadopoulou
Publisher: Bloomsbury Publishing
ISBN: 150995029X
Category : Law
Languages : en
Pages : 298
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Book Description
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.
Author: Ghidini, Gustavo
Publisher: Edward Elgar Publishing
ISBN: 1803922257
Category : Law
Languages : en
Pages : 353
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Book Description
Reforming Intellectual Property brings together 19 of the world’s leading scholars in the field to offer their unique insight into the future of intellectual property. Providing a diverse array of perspectives on the most pressing reforms needed in the current IP regime, whether in terms of legislation at national and international levels, or interpretation of existing law, this exceptional book highlights the key issues in this area and sets out an agenda for future research and policy.
Author: Mark Anderson
Publisher: Bloomsbury Publishing
ISBN: 1526509083
Category : Law
Languages : en
Pages : 1123
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Book Description
Covers the laws surrounding commercial transactions that involve the development, use of commercialisation of technology and associate intellectual property rights. Types of transactions that fall within this category are research and development contracts and intellectual property licences and these form the main focus of the book. Written by experts and describing the many different areas of law that affect technology agreements such as IP, contract law, competition law and tax, this is the leading guide to this complex area of law. The new Fourth Edition has been brought completely up to date including: - Coverage of EU Horizon 2020 replacing Framework 7 funding scheme - General Data Protection Regulation (GDPR) - Updates in line with the Charities Act 2011 - New section on different types of standard agreements available (Lambert, NIHR, EU consortium agreements) - New material dealing with variety of relevant patent legislation: Unitary Patent and Unified Patents Court, the Intellectual Property Act 2014, Legislative Reform (Patents) Order 2014, Patents (Supplementary Protection Certificates) Regulations) 2014 - New material on the EU Trade Secrets Directive - Coverage of Regulations No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC - Addition of research exception (new section 22A) from freedom of information from 1 October 2014 (Freedom of Information Act 2014) - Coverage of Technology Transfer Regulation, 316/2014 and related guidelines
Author: J.H. Bowman
Publisher: Routledge
ISBN: 1351954555
Category : Language Arts & Disciplines
Languages : en
Pages : 685
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Book Description
This important reference volume covers developments in almost every aspect of British library and information work during the ten-year period 1991-2000. Some forty contributors, all of whom are experts in their subject, provide a robust overview of their specialities along with extensive further references which act as a starting point for further research. The book provides a comprehensive record of what took place in library and information management during a decade of considerable change and challenges. It is an essential reference resource for librarians and information professionals.
Author: Thomas Riis
Publisher: Kluwer Law International B.V.
ISBN: 9403501820
Category : Law
Languages : en
Pages : 400
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Book Description
Derived from the renowned multi-volume International Encyclopaedia of Laws, this monograph provides a survey and analysis of the rules concerning Intellectual Property Law in Denmark. It covers every type of intellectual property right in depth – copyright and neighbouring rights, patents, utility models, trademarks, trade names, industrial designs, plant variety protection, chip protection, trade secrets, and confidential information. Particular attention is paid throughout to recent developments and trends. The analysis approaches each right in terms of its sources in law and in legislation, and proceeds to such legal issues as subject matter of protection, conditions of protection, ownership, transfer of rights, licences, scope of exclusive rights, limitations, exemptions, duration of protection, infringement, available remedies, and overlapping with other intellectual property rights. The book provides a clear overview of intellectual property legislation and policy, and at the same time offers practical guidance on which sound preliminary decisions may be based. Lawyers representing parties with interests in Intellectual Property Law in Denmark will welcome this very useful guide, and academics and researchers will appreciate its value in the study of comparative intellectual property law.
Author: Constantin Stefanou
Publisher: Routledge
ISBN: 1351160265
Category : Law
Languages : en
Pages : 257
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Book Description
This informative book provides an in-depth study of Cyprus' efforts to join the European Union. It examines the various steps taken towards harmonization in various contexts, the suitability of the country for EU accession, and the political problems surrounding the Cypriot EU accession. Constantin Stefanou also broadens the scope to consider the wider issues surrounding EU accession negotiations for applicant countries, especially with reference to the new and untested EU guidelines. The volume will be of great value to those interested in Europe and the European Union in general, and European Law and the development of Cyprus in particular.
Author: Richard Hacon
Publisher: Kluwer Law International B.V.
ISBN: 9041145192
Category : Law
Languages : en
Pages : 711
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Book Description
In our technological society patent law plays a central role as an incentive for the development and marketing of new technologies in many fields of business. The number of patent applications continues to grow considerably every year. International and European conventions and other instruments have been implemented in order to simplify the application for and enforcement of patents and which also govern the scope of protection afforded by a patent in Europe. Others are being planned. This second edition of Concise European Patent Law aims to offer the reader a rapid understanding of all the provisions of patent law in force in Europe that have been enacted at the European and international levels. This volume takes the form of an article-by-article commentary on the European Patent Convention and the relevant European Community legislation and international treaties. It is intended to provide the reader with a short and straightforward explanation of the principles of law to be drawn from each provision, with references to the most important case law. Editors and authors are prominent specialists (both academics and practitioners) in the field of international and European patent law. Concise European Patent Law, second edition is one of a series of volumes of commentary on European Intellectual property legislation edited by Thomas Dreier, Charles Gielen and Richard Hacon, based on the respected German and Dutch series ‘Kurzkommentar and Tekst en Commentaar.’
