Supplementary Protection Certificates (SPC) PDF Download

Author: Marco Stief
Publisher:
ISBN: 9783848702992
Category :
Languages : en
Pages : 350

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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: 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: Catherine Seville
Publisher: Edward Elgar Publishing
ISBN: 1848447469
Category : Law
Languages : en
Pages : 483

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Book Description
The author has succeeded in her chief aim in writing this book to introduce a compact and accessible account of EU intellectual property law. . . this book is a useful background and excellent starting point for understanding EU intellectual property law. Jamil Ammar, European Intellectual Property Review This book s innovative contribution is to view EU IP law as a subject in its own right, not just an extra to accounts of national law. The very up-to-date coverage strikes an excellent balance between detail and overview, while Dr Seville also discusses thoughtfully the wider international frameworks, policy issues and debates in which development of EU IP law is enmeshed. Dr Seville fully deserves the gratitude of IP lawyers and students for this outstandingly helpful study. Hector Macqueen, Edinburgh Law School, UK The book is as timely as it is well-written and thorough. The contributions of the EU to most aspects of intellectual property law are increasingly dominant. This treatment places them apart from the national laws of member states, thus emphasising the common core that now they provide. Many will want to study this presentation. William R. Cornish, University of Cambridge, UK Intellectual property (IP) is a crucial contributor to economic growth and competitiveness within the EU. This book offers a compact and accessible account of EU intellectual property law and policy, covering copyright, patents, designs, trademarks and the enforcement of rights. The author also addresses aspects of the free movement of goods and services, competition law, customs measures and anti-counterfeiting efforts. Setting EU intellectual property law in its wider international context, this work reveals the framework within which the national IP laws of member states operate. The book seeks to highlight the most important policy issues and arguments of relevance to the EU, both within the Union, and in its relations with the rest of the world. With its detailed references, cross-referencing and suggestions for further readings, EU Intellectual Property Law and Policy is essential reading for postgraduate students and academic lawyers in IP and EU law. Practitioners seeking a broad account of the area will also appreciate this important contribution.

Author: Lionel Bently
Publisher: Oxford University Press, USA
ISBN: 0199645558
Category : Law
Languages : en
Pages : 1441

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Book Description
'Intellectual Property Law' is the definitive textbook on this subject. It clearly sets out the law in relation to copyright, patents, trade marks, passing off and confidentiality, whilst enlivening the text with illustrations and diagrams.

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: Paul Torremans
Publisher: Oxford University Press
ISBN: 0198734778
Category : Law
Languages : en
Pages : 787

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Book Description
Holyoak and Torremans Intellectual Property Law provides a complete introduction and overview of UK intellectual property law. It examines how the law has developed through key statutory provisions and leading cases, and highlights the increasing influence of the EU and other international jurisdictions in shaping the law in its global context.

Author: Johanna Gibson
Publisher: Routledge
ISBN: 1317114930
Category : Law
Languages : en
Pages : 216

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Book Description
Intellectual Property, Medicine and Health examines critical issues and debates including access to knowledge and medicinal products, human rights and development, innovations in life technologies and the possibility for ethical frameworks for intellectual property law and its application in public health. The central question of trust and the beneficial interests of society in the use of products of intellectual property, particularly in the fulfillment of the right to access medicinal products, emerge as key to achieving meaningful access to knowledge in health and medicine and the realization of relevant and equitable use of the benefits of scientific research in all societies.

Author: Rafal Sikorski
Publisher: Kluwer Law International B.V.
ISBN: 9403524146
Category : Law
Languages : en
Pages : 474

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Book Description
Patents as an Incentive for Innovation Edited by Rafal Sikorski & Zaneta Zemla-Pacud Patents are a reward for human inventiveness. A well-functioning patent system must provide incentives for innovation, safeguard dynamic competition and protect the public interest – a balancing act fraught with difficulty in the ‘connected’ global world. This ground-breaking book is the first to deeply analyse how patent law today performs its function of stimulating innovation in the crucial sectors of healthcare, agriculture, artificial intelligence and communications technology. Patent specialists, practitioners and scholars from various jurisdictions thoroughly describe how patent rights can be deployed to incentivize investments in researching and developing socially critical innovations without sacrificing the public’s interest in sharing the benefits that are produced. Among the emerging issues of patent rights investigated are the following: protectability and morality of according private rights over material derived from the human body; licensing on fair, reasonable and non-discriminatory (FRAND) terms; the supplementary protection certificate (SPC) manufacturing waiver; patent eligibility of artificial intelligence-related inventions; excessive enforcement of patents by patent assertion entities; enforcement of second medical use innovations; the so-called farmer’s privilege, the farm-save seed exemption, and breeders’ rights; international trade regulations and their influence on patent systems; human enhancement technologies and the consequences of patenting them; specifics of patent protection for biologic medicines; challenges posed by artificial intelligence for the disclosure requirement in patent law; and standard essential patent licensing, particularly in the context of the 5G standard. Perspectives taken into consideration by the authors include protectability criteria, length and scope of the granted protection, mechanisms for dealing with the friction between generalized application and specialized concerns, and rights enforcement. These aspects are analysed on the domestic, international and global levels. The COVID-19 pandemic has highlighted the urgent need to strike the right balance between innovation and access in healthcare and other technologies, a need rooted in patent law. Because the problems discussed – and solutions offered – in this collection of expert essays are of tremendous practical and cultural significance, the book will be of immeasurable value to practitioners, policymakers and researchers in patent law and other fields of intellectual property law.

Author: Institute of Medicine
Publisher: National Academies Press
ISBN: 030904491X
Category : Medical
Languages : en
Pages : 225

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Book Description
Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.