Supplementary Protection Certificates (SPC) PDF Download

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

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Book Description

Author: The late Catherine Seville
Publisher: Edward Elgar Publishing
ISBN: 1781003483
Category : Law
Languages : en
Pages : 588

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Book Description
This fully updated book offers a compact and accessible account of EU intellectual property (IP) law and policy. The digital age brings many opportunities, but also presents continuing challenges to IP law as the EU’s programme of harmonisation unfolds. As well as addressing the main IP rights (copyright, patents, designs, trade marks and related rights), the book also considers IP’s relationship with the EU’s rules on free movement of goods and competition, as well as examining the enforcement of IP rights. Taking account of numerous changes, this timely second edition covers the substantive provisions and procedures which apply throughout the EU, making extensive reference to the case law. The author considers how the exploitation of IP is increasingly global; harmonisation, in contrast, is only partial, even at the EU level. In response, the book sets EU IP law in its wider international context. It also seeks to highlight policy issues and arguments of relevance to the EU, in its relations both within the Union and with the rest of the world. Designed as a compact and approachable account of these difficult and technical areas, and with advice on further reading and research, this unique book is useful both as a work of reference and for more general study. It is essential reading for postgraduate students, academic researchers and legal practitioners alike.

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: Faraat Ali
Publisher: CRC Press
ISBN: 1040044824
Category : Medical
Languages : en
Pages : 373

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Book Description
Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively. Features: Discusses how recent developments of medicinal and food products have opened up innovative solutions for many of the current challenges societies face presently. Explores the manifold variations between the regulatory bodies in different countries that have not previously been collected to this extent. Presents details on the substantial progress in analytical methodologies for labelling applications and the creation of appropriate test criteria for pharmaceuticals and their safety analysis. Reviews how more worldwide collaboration and cooperation in the regulatory area is still required.

Author: Margherita Colangelo
Publisher: Bloomsbury Publishing
ISBN: 150996553X
Category : Law
Languages : en
Pages : 257

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Book Description
This book explores the fundamental and inextricable relationship between regulation, intellectual property, competition law, and public health in pharmaceutical markets, examining their interconnections and the delicate balance between the various interests and policy goals at stake. Although pharmaceutical markets are heavily regulated and subject to close antitrust scrutiny, there is a constant requirement for existing rules and policies to tackle a number of persistent, complex issues. The variety of anti-competitive practices occurring in this sector, the worrying rise in drug prices, and major, far-reaching concerns over the accessibility of medicines are sources of frequent controversy in academic and policy debates. Understanding the unique features and dynamics of the pharmaceutical industry requires a tailored and multifaceted approach. The study is enhanced by the adoption of a comparative perspective, tracing convergence and divergence between EU and US systems through the analysis of relevant applicable rules, significant cases, and policy choices. Pursuant to this rigorous approach, the book provides an original and thought-provoking critique of the challenges of regulating pharmaceutical markets.

Author: Justine Pila
Publisher:
ISBN: 0198831285
Category : Law
Languages : en
Pages : 712

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Book Description
European Intellectual Property Law offers a full account of the main areas of substantive European intellectual property law - including the law of copyright and related rights, patents and plant variety rights, trademarks, design rights, and rights in data and information.

Author: Trevor Cook
Publisher: Bloomsbury Publishing
ISBN: 1526508699
Category : Law
Languages : en
Pages : 944

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Book Description
A User's Guide to Patents, Fifth Edition provides guidance on the areas of European and UK patent law and procedure that are most important in day-to-day practice. This new edition sets out how patents can be obtained, exploited and enforced and addresses wider public policy aspects of patents and their economic significance, as well as past and likely future trends that affect legal practitioners. It is essential reading for IP practitioners, solicitors and barristers, patent attorneys, in-house lawyers, management executives and inventors. Unique selling points: Explains how patents can be exploited and enforced by reference to the most recent UK and EPO case law Identifies and discusses the different patent law issues that can arise in specific industrial sectors Full tabulation of all English patent validity and infringement decisions given after full trial since 1997 Addresses wider public policy aspects of patents and their economic significance, as well as past and likely future trends in the field, both in Europe and internationally The following relevant developments are included: The new UK law as to infringement by equivalents following Actavis v Lilly (UKSC 2017) The degree to which new types of plant, produced by using certain modern biotechnological techniques, can be patented in the light of the exclusion for 'products obtained by essentially biological processes' and the ongoing controversy as to this between the EPO, the EPO Boards of Appeal and the EU The developing case law in the UK and the EPO on plausibility in the context of insufficiency and obviousness The Unjustified Threats Act 2017 and other procedural developments, such as those involving Arrow type declarations of obviousness Developments in standards related patent litigation, as in Unwired Planet v Huawei (Patents Court 2017, CA 2018)

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: Winfried Tilmann
Publisher: Oxford University Press
ISBN: 0191071935
Category : Law
Languages : en
Pages : 1832

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Book Description
The creation of the Unified Patent Court (UPC) is the most prominent change in the European legal landscape for the last four decades. This book explains how the new system works in practice and how to make the best use of its provisions. It offers readers an in-depth and comprehensive commentary on the legal mechanisms of the upcoming ratified European Patent Law, and advice on potential problems that users of the forthcoming regulations may face. The book first describes the creation of the Unified European Patent Law and how its four new legislative texts interact. The new legislative texts are then explained and commented on in detail, rule by rule, with diverse approaches and perspectives from a practitioner team comprising patent litigators, European patent attorneys, law professors and patent judges. The Commentary takes into account the practical needs of users of the new system on both the prosecution and enforcement sides, addressing substantive and procedural problems. This book is the most authoritative text on the Unitary Patent and Unified Patents Court, and an invaluable tool for practitioners in this rapidly developing area of law.

Author: Dennis Campbell
Publisher: Lulu.com
ISBN: 1329608658
Category : Law
Languages : en
Pages : 252

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Book Description
The annual Journal of the International Institute for Law and Medicine examines legal issues relating to health care, medicinal products, intellectual property rights in pharmaceuticals, and liability in North America, Latin America, Europe, Africa, and Asia.