Supplementary Protection Certificates (SPC) PDF Download

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

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Book Description

Author: Josef Drexl
Publisher: Edward Elgar Publishing
ISBN: 0857932462
Category : Law
Languages : en
Pages : 347

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Book Description
Public health, safety and access to reasonably priced medicine are common policy goals of pharmaceutical regulations. As both the context for innovation and competitive structure change, industry actors dynamically challenge the balance between the incentive for protection and the achievement of those policy goals. Considering the arguments from the perspectives of innovation, competition law and patent law, this book explores the difficult question of balancing protection with access, highlighting the difficulties in harmonization and coordination. The contributors to this book, including academics, judges and practitioners from Europe, the US and Japan, explore to what extent patent strategies and life-cycle management practices take advantage of patent laws and health-care regulation and disrupt the necessary balance between incentives for innovation and access to affordable medicine and health care. Addressing fundamental questions in the field of pharmaceutical innovation, this book will appeal to scholars and practitioners in intellectual property, competition law and life sciences regulation, as well as pharmaceutical companies and regulators.

Author: Theona Elizee
Publisher: Ethics International Press
ISBN: 1804419125
Category : Medical
Languages : en
Pages : 241

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Book Description
This book critically assesses the development of pharmaceutical patent Term Extensions, and their impact; in particular, the practical impact on generic market entry. It focusses on European Supplementary Protection Certificates (SPCs), and the extent and effect on access to cheaper medication in terms of cost and availability. Policy making for pharmaceuticals requires considerations on availability and price. For developing countries, it appears impossible to form policy without promoting generic medicines, which are proven as an effective health care remedy to access and availability. A 20-year maximum patent term is generally recognised by originators to be insufficient. The European Union’s response saw the initiation of SPCs, officially administered since the 1980’s, and despite numerous complaints on their efficacy and fitness for purpose, SPCs provide significant barriers to entry for generic medications. Conclusions are drawn based on legislative review and re-analysis/interpretation of published data which considers the means of optimising existing legal structures, and presents practical solutions for addressing access and public health obligations under International Law. This is especially relevant for countries with little or no manufacturing capabilities.

Author: The Law The Law Library
Publisher: Createspace Independent Publishing Platform
ISBN: 9781720613220
Category :
Languages : en
Pages : 110

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Book Description
Patents Act 1990 (Australia) (2018 Edition) The Law Library presents the complete text of the Patents Act 1990 (Australia) (2018 Edition). Updated as of May 15, 2018 This book contains: - The complete text of the Patents Act 1990 (Australia) (2018 Edition) - A table of contents with the page number of each section

Author:
Publisher: DIANE Publishing
ISBN: 1428951938
Category :
Languages : en
Pages : 129

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Book Description

Author: Bryan Mercurio
Publisher: Routledge
ISBN: 1317389786
Category : Law
Languages : en
Pages : 271

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Book Description
This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges

Author: Andreas Hübel
Publisher: Springer Science & Business Media
ISBN: 3642248462
Category : Science
Languages : en
Pages : 53

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Book Description
Patents protecting biotechnological invention are becoming ever more important. Because biotechnology has many differences with respect to other technologies, lessons learned in other fields of technology cannot simply be transferred to adopt a suitable strategy for dealing with biotechnology inventions. In this volume, general aspects of biopatent law will be discussed. This involves questions of patentability, including ethical issues and issues of technicality, as well as questions of patent exhaustion in cases were reproducible subject matter, like cells or seeds, is protected. Moreover, active and passive patent strategies are addressed. Further, insight will be given into patent lifetime management and additional protective measures, like supplementary protection certificates and data exclusivity. Here, strategies are discussed how market exclusivity can be extended as long as possible, which is particularly important for biopharmaceutical drugs, which create high R&D costs.

Author: American Bar Association. House of Delegates
Publisher: American Bar Association
ISBN: 9781590318737
Category : Law
Languages : en
Pages : 216

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Book Description
The Model Rules of Professional Conduct provides an up-to-date resource for information on legal ethics. Federal, state and local courts in all jurisdictions look to the Rules for guidance in solving lawyer malpractice cases, disciplinary actions, disqualification issues, sanctions questions and much more. In this volume, black-letter Rules of Professional Conduct are followed by numbered Comments that explain each Rule's purpose and provide suggestions for its practical application. The Rules will help you identify proper conduct in a variety of given situations, review those instances where discretionary action is possible, and define the nature of the relationship between you and your clients, colleagues and the courts.

Author: United States. Congress. Senate. Committee on the Judiciary. Subcommittee on Patents, Copyrights, and Trademarks
Publisher:
ISBN:
Category : Law
Languages : en
Pages : 496

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Book Description

Author: World Intellectual Property Organization
Publisher: WIPO
ISBN: 9280526510
Category : Law
Languages : en
Pages : 44

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Book Description
This Guide aims to assist users in searching for technology information using patent documents, a rich source of technical, legal and business information presented in a generally standardized format and often not reproduced anywhere else. Though the Guide focuses on patent information, many of the search techniques described here can also be applied in searching other non-patent sources of technology information.