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Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Competition Law and IP Rights in Pharmaceuticals and Biotechnology
Author: Björn Lundqvist
Publisher: Oxford University Press, USA
Total Pages: 576
Release: 2031-05-30
Genre: Law
ISBN: 9780198724827

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A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.


Competition Law and Patents

Competition Law and Patents
Author: Irina Haracoglou
Publisher: Edward Elgar Publishing
Total Pages: 272
Release: 2008-01-01
Genre: Law
ISBN: 1848440111

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This is an incredibly interesting book on an increasingly pertinent topic. . . the book is succinctly written and provides a comprehensive overview of EU law. . . providing a really useful analysis of the European cases concerned with the imposition of a duty to deal in relation to intellectual property. . . This book is a thoroughly enjoyable read, and perhaps because of its brevity the author retains her focus on the central issues being examined. I found it to be engaging and thought provoking. Jane Nielsen, Competition and Consumer Law Journal The book caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself. Journal of Intellectual Property Rights Using the example of research tools in biopharmaceutical research and innovation, this book examines the complexities of the relationship between two fundamental areas of law and policy intellectual property rights and competition law. It addresses a question that is certain to become paramount in other industries also: how to strike the balance between initial and follow-on innovation so as to ensure that access to essential research tools (or other fundamental elements to follow-on innovation) is not impeded. The book concludes by suggesting how competition law could be used to complement the patent balance. Competition Law and Patents caters for various groups ranging from those with a general interest in competition law, patent law and/or biopharmaceuticals, to students who want to understand how competition and intellectual property work in practice (or to understand the interface between the two policies), and from practitioners and policymakers to people within the biopharmaceutical industry itself.


Intellectual Property and Competition Law

Intellectual Property and Competition Law
Author: Gustavo Ghidini
Publisher: Edward Elgar Publishing
Total Pages: 177
Release: 2006-01-01
Genre: Law
ISBN: 1845429931

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The book ends with a comprehensive selection of the relevant bibliography. This part is all the more valuable to the reader as Ghidini does not simply list the relevant literature but puts it in it general context and comments on it. Ghidini s book is a fascinating trip through the system of IP laws. Beatriz Conde Gallego, Intellectual Property and Competition Law Intellectual Property and Competition Law by Gustavo Ghidini provides a persuasively presented descriptive analysis of a distinctively European perspective on intellectual property law and its relationship to competition law. Professor Ghidini expertly presents the evolution of intellectual property laws and its contemporary manifestations with respect to the expansion copyright law in technological fields and the inevitability conflict with patent law, the attempt at creating monopolies (such as in biotechnology), and so much more. A seminal work of impressive and articulate scholarship, Intellectual Property and Competition Law should be considered mandatory reading for students and researchers in the field of intellectual property rights and a very strongly recommended addition to academic library International Economics and Judicial Studies reference collections. The Economics Shelf, Midwest Book Review . . . the provocative nature of this book is one of its great strengths, as are its cohesiveness and erudition. Mel Marquis, European Competition Law Review We in the United States have much to learn not only from Gustavo Ghidini s careful analysis of modern trends in the European IP regime but also from his thoughtful development of the thesis that free competition should be understood as the overarching principle guiding both IP protection and what we call antitrust law. Rudolph J.R. Peritz, New York Law School, author of Competition Policy in America and American Antitrust Institute, US This rich and challenging book offers a critical appraisal of the relationship between intellectual property law and competition law, from a particularly European perspective. Gustavo Ghidini highlights the deficiencies in studying each of these areas of law independently and argues for a more holistic approach, insisting that it is more useful, and indeed essential, to consider them as interdependent. He does this first by examining how competition and intellectual property (IP) converge, diverge, and inform one another. Secondly, he assesses how IP law can be interpreted through the guiding principles of competition law antitrust and unfair competition and within the overarching principle of free competition. The book traces the evolution of modern IP law, which it claims is marked heavily both by over-protectionist trends such as the extension of copyright law to technological fields, where it trespasses on the territory of patent law and by attempts to monopolize the achievements of basic research, such as in the example of biotechnology. Through an examination of such emerging issues as access to standards of information and patenting of genetic materials, the author makes a clear case for a reading of IP law that promotes dynamic processes of innovation by competition , and competition by innovation , with related benefits to consumer welfare such as wider choices, greater access to culture and information, and lower prices. Advanced students and researchers in all areas of intellectual property will find this book a stimulating alternative to traditional interpretations of the subject.


Patent Strategies and Competition Law in the Pharmaceutical Sector

Patent Strategies and Competition Law in the Pharmaceutical Sector
Author: Duncan Matthews
Publisher:
Total Pages: 13
Release: 2016
Genre:
ISBN:

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Competition policy is an under-utilised tool. Policy coherence between the IP system and competition must be strengthened in order to promote innovation and access to health technologies. Article 8(2) of the TRIPS Agreement provides flexibilities for governments to adopt competition law measures to prevent abuse of intellectual property rights, including IP rights related to the life sciences, namely the pharmaceutical industry and the biotechnology sector. Post-TRIPS, some countries have implemented competition laws but in practice are not using these effectively. This is particularly striking in the pharmaceutical sector, where abuses of intellectual property rights, such as reverse payment agreements and strategic patenting, risk allowing pharmaceutical companies to extend their market monopoly by blocking the entry of both generic and innovative medicines and, as a result, stifling competition and harming consumers. Nevertheless, these practices lack adequate attention by competition authorities. Such anti-competitive practices create particular challenges for the developing world as they can lead to significant barriers to innovation and access. Used effectively, competition policy can be in the best interests of society. It is conducive to freedom of choice and lower prices while, potentially, also serving as an important driver for innovation and access.


Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law
Author: Josef Drexl
Publisher: Edward Elgar Publishing
Total Pages: 347
Release: 2013-01-01
Genre: Law
ISBN: 0857932462

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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.


Patent Pools, Competition Law and Biotechnology

Patent Pools, Competition Law and Biotechnology
Author: Devdatta Malshe
Publisher: Routledge
Total Pages: 102
Release: 2018-05-15
Genre: Law
ISBN: 0429016166

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Exploring the relationship between competition law and technology pools, this book provides general-purpose details of the biotechnology patent pool scheme while discussing historical developments, approaches of the US Department of Justice, Federal Trade Commission, and the European Union Competition Commission via EU regulations. In addition to these regulatory approaches and evolution in concept and theory of technology pools, this book illustrates relationship issues including tying arrangements and essential facility consideration vis-à-vis technology pools. It analyzes the modalities of forming such pools in the area of biotechnology, specifically illustrating that the formation of technology pools is possible and can be safely undertaken, and proposes a viable solution and structure. Patent pools in the biotechnology industry will pave the way towards open collaborative research, reducing patent thickets. Formation of such pools will increase access to various technology and patents otherwise out of bounds, resulting in a reduction of licensing costs and a spur in the development of new solutions. Most importantly, such pools will reduce the frequency of patent toll gates, making the entire spectrum of research interesting from the perspective of researchers as well as investors. This book will be an aid to researchers studying intellectual property, patents, and biotechnology, as well as to interest groups including funding agencies, venture funds, angel investors, and proponents of the open-source movement.


Intellectual Property Rights and the Life Science Industries

Intellectual Property Rights and the Life Science Industries
Author: Graham Dutfield
Publisher: Routledge
Total Pages: 301
Release: 2017-03-02
Genre: Law
ISBN: 1351927132

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This book analyses the history of the international patent regime and the life science industries, both of which can be traced back to the late 19th century. The development of patent law is inextricably linked to expanding capacities to elucidate, manipulate and commercially exploit the molecular properties of micro-organisms, plants, animals and other organic raw materials. The story of the life science industries begins with the European synthetic dyestuff firms and culminates in present-day conglomerates like Aventis, Novartis and Pharmacia. Throughout the last century, chemical, pharmaceutical, seed and biotechnology firms were actively involved in reforming patent law and plant variety rights. The major beneficiaries have been the largest firms whose market dominance and influence over peoples' lives - aided by friendly intellectual property laws - has never been greater. This sparkling and stimulating book reveals the key repercussions caused by the expansion of life science industries for issues of international equity, public health, food security and biological diversity.


Research Handbook on Intellectual Property and the Life Sciences

Research Handbook on Intellectual Property and the Life Sciences
Author: Duncan Matthews
Publisher: Edward Elgar Publishing
Total Pages: 529
Release: 2017-06-30
Genre: Law
ISBN: 1783479450

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Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.


Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law

Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law
Author: Amalia Athanasiadou
Publisher: Kluwer Law International B.V.
Total Pages: 520
Release: 2018-08-14
Genre: Law
ISBN: 9403501146

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Reverse payment settlements or “pay-for-delay agreements” between originators and generic drug manufacturers create heated debates regarding the balance between competition and intellectual property law. These settlements touch upon sensitive issues such as timely generic entry and access to affordable pharmaceuticals and also the need to preserve innovation incentives for originators and to strengthen the pipeline of life-saving pharmaceuticals. This book is one of the first to critically and comparatively analyse how such patent settlements and various other strategies employed by the pharmaceutical industry are scrutinised by both United States (US) and European courts and enforcement authorities, and to discuss the applicable legal tests and the main criteria used for their assessment. The book’s ultimate objective is to provide guidance to the pharmaceutical industry regarding the types of patent settlements, strategies and conduct which may be problematic from US antitrust and European Union (EU) competition law perspectives and to assist practitioners in structuring settlements which are both efficient and compliant. To this end, an exhaustive legal analysis of some of the most controversial issues regarding pharmaceutical patent settlements is provided, including: – the lengthy split among US Circuit Courts on the issue of pay-for-delay settlements, its resolution by the US Supreme Court in FTC v. Actavisand subsequent jurisprudence; – the decision of Lundbeck v. Commissionby the European General Court and the Servier decision of the European Commission; – the Roche/Novartisdecision of the European Court of Justice and the most important decisions by National Competition Authorities on pharma patent settlements in the EU; – an overview of other types of strategies such as product-hopping and product reformulations, no-authorised generic commitments, problematic side-deals, mechanisms affecting generic substitution; – the rejection of the “scope of the patent” test in both the US and the EU and the balancing of patent law and antitrust law considerations in the prevailing applicable tests; – the benefits of settlements and the main criteria for assessing their legitimacy under US antitrust and EU competition law. The analysis provides concrete examples of both illegitimate and legitimate settlements and strategies, emphasising on conduct that falls within a grey zone and on the circumstances and criteria under which such conduct could be deemed problematic from an antitrust perspective. This book will serve as a valuable guide for pharmaceutical companies wishing to minimise the risk of engaging in conduct that could potentially infringe US antitrust and EU competition law. It further aims to save courts and enforcement agencies and also practitioners and academics considerable time and resources by providing an exhaustive analysis of the relevant caselaw, with the ultimate goal to increase legal certainty on the most controversial aspects of patent settlements in the pharmaceutical industry.


Intellectual Property Rights and the Life Science Industries

Intellectual Property Rights and the Life Science Industries
Author: Graham Dutfield
Publisher: World Scientific
Total Pages: 429
Release: 2009
Genre: Law
ISBN: 9812832289

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This book is a highly readable and entertaining account of the co-evolution of the patent system and the life science industries since the mid-19th century. The pharmaceutical industries have their origins in advances in synthetic chemistry and in natural products research. Both approaches to drug discovery and business have shaped patent law, as have the lobbying activities of the firms involved and their supporters in the legal profession. In turn, patent law has impacted on the life science industries. Compared to the first edition, which told this story for the first time, the present edition focuses more on specific businesses, products and technologies, including Bayer, Pfizer, GlaxoSmithKline, aspirin, penicillin, monoclonal antibodies and polymerase chain reaction. Another difference is that this second edition also looks into the future, addressing new areas such as systems biology, stem cell research, and synthetic biology, which promises to enable scientists to OC inventOCO life forms from scratch.