Download or read book Patent Strategies and Competition Law in the Pharmaceutical Sector written by Duncan Matthews and published by . This book was released on 2016 with total page 13 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law written by Amalia Athanasiadou and published by Kluwer Law International B.V.. This book was released on 2018-08-14 with total page 520 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Competition Law and IP Rights in Pharmaceuticals and Biotechnology written by Björn Lundqvist and published by Oxford University Press, USA. This book was released on 2031-05-30 with total page 576 pages. Available in PDF, EPUB and Kindle. Book excerpt: A comprehensive analysis of European competition law and intellectual property law issues affecting the pharmaceutical and biotechnology sectors, offering both theoretical and practical perspectives.
Download or read book Pharmaceutical Innovation Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Strategic Patenting and Evergreening in Pharmaceutical Sector Competition Law as a Panacea written by Monika Mulchandani and published by . This book was released on 2020-10-06 with total page 58 pages. Available in PDF, EPUB and Kindle. Book excerpt: What is the efficacy of Competition Law in regard to scrutinizing strategic patenting practices and evergreening in the pharmaceutical sector under the arrangements of Patent law? The book is a comprehensive study of the pharmaceutical sector in relation to consumer protection whilst considering the excessive price affliction on the availability of affordable health services. It focuses on anti-competitive agreements like cartels, parallel pricing, predatory pricing by pharmaceutical companies including other aspects under competition law, and patients being fettered by patents under intellectual property laws. Drugs being an essential commodity have been part of unfair-trade practices and its implication is leading to extensive price discrimination on a global level. It is a comparative analysis of the implementation of laws in different jurisdictions for the availability of drugs at fair prices, which will include the legal hurdles in the promotion and adoption of low-cost generic drugs by various jurisdictions. The line where fair profits end and the extortion in the name of innovation and exclusivity rights start is a bleak one. This book is aimed at finding that balance that encourages innovation in the pharmaceutical sector as well as makes these innovative drugs affordable and available for common man's use with the efficacy of Competition Law in place. The primary objective of this book is to highlight the capitalist approach of pharmaceutical companies in defeating the larger public interest and the discrepancies of law leading to ethical misconduct.
Download or read book Competition and Patent Law in the Pharmaceutical Sector written by Giovanni Pitruzzella and published by Kluwer Law International. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?
Download or read book Blocking Patents in European Competition Law written by Angelika S. Murer and published by Kluwer Law International B.V.. This book was released on 2021-12-03 with total page 386 pages. Available in PDF, EPUB and Kindle. Book excerpt: In practice and jurisprudence in European competition law, it is especially difficult to define the boundaries of patent abuse as an offence. In this thoroughly researched book, the author answers the question of when and how an application for a blocking patent can amount to an abuse of a dominant position under Article 102 TFEU. Drawing on legal literature and European Union (EU) case law, the presentation analyses a constellation of blocking patenting strategies and proposes potential remedies where abuse is involved. With detailed descriptions of the characteristics of potentially abusive and non-abusive behaviour regarding applications for blocking patents, the book provides the following and more: a comprehensive analysis of the case law of the EU courts on the abuse of a dominant position in cases which involve intellectual property rights; insights on how patenting strategies affect competition with a particular focus on the application of blocking patents; an overview of the developments in doctrine and practice which led to the current understanding of the seemingly conflictual goals of competition and intellectual property law; and insights on the difficulties of defining relevant markets and establishing whether an undertaking holds a dominant position. The book illustrates the mechanisms of blocking patenting strategies with examples from the pharmaceutical industry because blocking strategies have particular relevance in applying for patents in that context. A test scheme for analysing the application of a blocking patent under Article 102 TFEU is included. Additionally, the book provides an outlook on the topic of patents and shortages of supply in light of the COVID pandemic. Practitioners and policymakers requiring an understanding of the conceptual framework of the abuse concept within EU competition law and how it relates to patent strategies will welcome this invaluable book. They will not only be able to set the conduct of applying for blocking patents into the Article 102 TFEU context but also have decisive tools to approach questions on the intersection of patent law and competition law in the EU.
Download or read book Studies on Competition and Antitrust Issues in the Pharmaceutical Industry written by Ann-Kathrin Lehnhausen and published by Springer. This book was released on 2016-11-14 with total page 95 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication examines how drug originator manufacturers manage to shield their products from competition. It characterizes the pharmaceutical industry in detail and analyzes actions that violate antitrust laws in the USA and/or the European Union. The publication examines, for example, pay-for-delay strategies, market foreclosure, resale price maintenance, but also mergers and acquisitions, while taking into account market specificities such as the unique research and development process. The study explains why drug prices sometimes remain at elevated levels even after the drug’s patent protection has expired. Knowing the characteristics of such anticompetitive strategies helps customers such as health insurance companies to develop effective counter-strategies.
Download or read book Competition Law and Patents written by Irina Haracoglou and published by Edward Elgar Publishing. This book was released on 2008-01-01 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Competition Law and Policy in the Japanese Pharmaceutical Sector written by Akira Negishi and published by Springer Nature. This book was released on 2022-02-08 with total page 252 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the first book published that focuses on competition law and policy in the Japanese pharmaceutical sector. It consists of chapters written and edited by academics who research the industry from various perspectives, including economics, competition law, pharmaceutical regulations, and intellectual property law. Competition policies involving pharmaceutical products attract attention from academics and policymakers worldwide. The pharmaceutical industry is regulated by drug laws that vary from country to country and are affected by differing practices and industrial structures. The book begins by examining drug regulations and trade practices in the industry that are peculiar to Japan and its healthcare system. It then presents the Japanese Antimonopoly Act and cases involving it, and discussions of current competition law issues in the Japanese pharmaceutical industry. The book also discusses innovation and intellectual property and economic analyses of pharmaceutical regulations and drug discovery. The chapters include comparative studies on Japanese regulations vs. those in the European Union and the United States. Japan is one of the biggest pharmaceutical markets in the world. With this in mind, the book provides “one-stop shopping” for anyone interested in pharmaceutical regulations in the country. Covering the basics but extending to in-depth explorations of complex problems, this book appeals not only to students and academics, pharmaceutical companies and regulators, but also to those dealing with real-world policy issues that encompass competition policy, intellectual property, and pharmaceutical regulation. Chapter 11 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com
Download or read book EU Law of Competition and Trade in the Pharmaceutical Sector written by Pablo Figueroa and published by Edward Elgar Publishing. This book was released on 2019 with total page 758 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a systematic analysis of the law and practice of EU competition and trade in the pharmaceutical sector. Authored by leading private practitioners, economists, scholars and high-level officials at competition regulators, this work provides valuable insider knowledge on the application of law and policies to the pharmaceutical industry. The work contains extensive commentary on the legislation and the latest case law and administrative precedents in this sector, at both EU and national level, including certain significant jurisdictions (e.g., the US, China). Coverage of various key developments includes the recent pay-for-delay antitrust investigations, the perennial issues around parallel trade, and an examination of mergers among pharmaceutical companies and medical devices manufacturers. In addition to the legal analysis, it offers vital economic and business perspectives to ensure that the reader has the full range of tools with which to prepare for cases and conduct transactions within the pharmaceutical industry.
Download or read book Strategic Accumulation of Patents in the Pharmaceutical Industry and Patent Thickets in Complex Technologies Two Different Concepts Sharing Similar Features written by Olga Gurgula and published by . This book was released on 2018 with total page 20 pages. Available in PDF, EPUB and Kindle. Book excerpt: This paper discusses the problem of strategic accumulation of patents in the pharmaceutical industry. In the academic legal discussion this strategy is often confused with the notion of patent thickets. It will be argued, however, that these two strategies, although sharing similar features, are, nevertheless, distant issues and therefore require different analysis. The paper will first discuss the notion of patent thickets in complex technologies, including their definition, factors that contribute to their growth, examples of patent thickets and how the problem of patent thickets in complex technologies is currently being resolved. The subsequent part will analyse the specific strategy of pharmaceutical companies identified by the European Commission as 'patent thickets' in its Pharmaceutical Sector Inquiry. It is argued that this strategy of pharmaceutical companies is not, in fact, 'patent thickets' according to the classical, traditional meaning of the term, and should, therefore, be detached from the notion of patent thickets. This definition is misleading, and because of the incorrect qualification of this practice by the Commission and the academic community, it has not received adequate analysis under competition law. Therefore, the aim of this paper is to identify what patent thickets are and to dissociate strategic accumulation of patents in the pharmaceutical industry from the concept of patent thickets. It is hoped that the conclusions made in this paper will help to attract attention of the competition authorities to the problem of strategic accumulation of patents for the benefit of the consumer welfare.
Download or read book Regulation Innovation and Competition in Pharmaceutical Markets written by Margherita Colangelo and published by Bloomsbury Publishing. This book was released on 2023-04-20 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book The Interplay Between Competition Law and Intellectual Property written by Gabriella Muscolo and published by Kluwer Law International B.V.. This book was released on 2019-01-17 with total page 566 pages. Available in PDF, EPUB and Kindle. Book excerpt: Although competition law and intellectual property are often interwoven, until this book there has been little guidance on how they work together in practice. As the intersection between the two fields continues to grow worldwide, both in case law and in regulation, the book's markets-based approach, focusing on sectors such as pharmaceuticals, IT, telecoms, energy and agriculture in eleven of the world's most active jurisdictions, provides a much-needed in-depth understanding of how this interplay reveals itself among the different legal systems. Written by a range of authors including judges, regulators, academics, economists and practitioners in both fields, the book provides an international comparative perspective as well as detailed analysis of specific cases, policies and proposals for change. Among the issues and topics covered are the following: – free movement of goods and the protection of intellectual property rights; – standard essential patents & injunction in patent cases; – intellectual property rights between technological development and consumer protection; – geo-blocking; – online platforms and antitrust; – excessive prices. In this context, special attention is paid throughout to the increasing dialogue among Competition Authorities and between Judges and Competition Authorities around the world. As matchless remedy for the lack of uniformity heretofore, the book's investigation of the nexus between competition law and intellectual property in different sectors and in various countries takes a giant step towards a more-balanced approach and more-levelled regulation and practices. It will be warmly appreciated by policy makers, decision makers, regulators, practitioners and academics in both competition law and intellectual property fields
Download or read book Strategic Patenting in the Pharmaceutical Industry written by Olga Gurgula and published by . This book was released on 2019 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Intellectual Property Related Generic Defense Strategies in the European Pharmaceutical Market written by Marc P. Philipp and published by Nomos Verlagsgesellschaft. This book was released on 2011 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Introduction -- Governance framework of Europe's pharmaceutical sector -- Competitive dynamics in Europe's pharmaceutical market -- Potential future limitations for generic defense -- Implications of business model transformations -- Conclusion & managerial recommendation.
Download or read book Competition in the Pharmaceutical Marketplace written by United States. Congress. Senate. Committee on the Judiciary and published by . This book was released on 2002 with total page 56 pages. Available in PDF, EPUB and Kindle. Book excerpt:
