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Patent Settlements In The Pharmaceutical Industry Under Us Antitrust And Eu Competition Law
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Book Synopsis Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law by : Amalia Athanasiadou
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 349 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.
Book Synopsis Competition and Patent Law in the Pharmaceutical Sector by : Giovanni Pitruzzella
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?
Book Synopsis The Antitrust Enterprise by : Herbert HOVENKAMP
Download or read book The Antitrust Enterprise written by Herbert HOVENKAMP and published by Harvard University Press. This book was released on 2009-06-30 with total page 392 pages. Available in PDF, EPUB and Kindle. Book excerpt: After thirty years, the debate over antitrust's ideology has quieted. Most now agree that the protection of consumer welfare should be the only goal of antitrust laws. Execution, however, is another matter. The rules of antitrust remain unfocused, insufficiently precise, and excessively complex. The problem of poorly designed rules is severe, because in the short run rules weigh much more heavily than principles. At bottom, antitrust is a defensible enterprise only if it can make the microeconomy work better, after accounting for the considerable costs of operating the system. The Antitrust Enterprise is the first authoritative and compact exposition of antitrust law since Robert Bork's classic The Antitrust Paradox was published more than thirty years ago. It confronts not only the problems of poorly designed, overly complex, and inconsistent antitrust rules but also the current disarray of antitrust's rule of reason, offering a coherent and workable set of solutions. The result is an antitrust policy that is faithful to the consumer welfare principle but that is also more readily manageable by the federal courts and other antitrust tribunals.
Book Synopsis Patent Remedies and Complex Products by : C. Bradford Biddle
Download or read book Patent Remedies and Complex Products written by C. Bradford Biddle and published by Cambridge University Press. This book was released on 2019-06-27 with total page 379 pages. Available in PDF, EPUB and Kindle. Book excerpt: Through a collaboration among twenty legal scholars from North America, Europe and Asia, this book presents an international consensus on the use of patent remedies for complex products such as smartphones, computer networks, and the Internet of Things. This title is also available as Open Access on Cambridge Core.
Book Synopsis Intellectual Property and Competition Law by : Steven Anderman
Download or read book Intellectual Property and Competition Law written by Steven Anderman and published by OUP Oxford. This book was released on 2011-02-10 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Examining the relationship between intellectual property and competition law with a particular focus on European law, this book highlights areas emerging new frontiers.
Download or read book Drug Wars written by Robin Feldman and published by Cambridge University Press. This book was released on 2017-06-09 with total page 165 pages. Available in PDF, EPUB and Kindle. Book excerpt: While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.
Book Synopsis Generic drug entry prior to patent expiration an FTC study by :
Download or read book Generic drug entry prior to patent expiration an FTC study written by and published by DIANE Publishing. This book was released on 2002 with total page 129 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis Multi-dimensional Approaches Towards New Technology by : Ashish Bharadwaj
Download or read book Multi-dimensional Approaches Towards New Technology written by Ashish Bharadwaj and published by Springer. This book was released on 2018-07-23 with total page 350 pages. Available in PDF, EPUB and Kindle. Book excerpt: This open access edited book captures the complexities and conflicts arising at the interface of intellectual property rights (IPR) and competition law. To do so, it discusses four specific themes: (a) policies governing functioning of standard setting organizations (SSOs), transparency and incentivising future innovation; (b) issue of royalties for standard essential patents (SEPs) and related disputes; (c) due process principles, procedural fairness and best practices in competition law; and (d) coherence of patent policies and consonance with competition law to support innovation in new technologies. Many countries have formulated policies and re-oriented their economies to foster technological innovation as it is seen as a major source of economic growth. At the same time, there have been tensions between patent laws and competition laws, despite the fact that both are intended to enhance consumer welfare. In this regard, licensing of SEPs has been debated extensively, although in most instances, innovators and implementers successfully negotiate licensing of SEPs. However, there have been instances where disagreements on royalty base and royalty rates, terms of licensing, bundling of patents in licenses, pooling of licenses have arisen, and this has resulted in a surge of litigation in various jurisdictions and also drawn the attention of competition/anti-trust regulators. Further, a lingering lack of consensus among scholars, industry experts and regulators regarding solutions and techniques that are apposite in these matters across jurisdictions has added to the confusion. This book looks at the processes adopted by the competition/anti-trust regulators to apply the principles of due process and procedural fairness in investigating abuse of dominance cases against innovators.
Book Synopsis The Patent-Competition Interface in Developing Countries by : Thomas K. Cheng
Download or read book The Patent-Competition Interface in Developing Countries written by Thomas K. Cheng and published by Oxford University Press. This book was released on 2021-12-16 with total page 545 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book proposes an approach to the patent-competition interface for developing countries. It puts forward a theoretical framework after canvassing relevant policy considerations and examines the many reasons why patent protection is not essential for generating innovation incentives in developing countries. These include the tendency of the patent system to overcompensate innovators, the availability of other appropriation mechanisms for innovators to monetize their innovations, and the lack of appropriate technological capacity in many developing countries to take advantage of the incentives generated by the patent system. It also argues that developing countries with a small population need not pay heed to the impact of their patent system on the incentives of foreign innovators. It then proposes a classification of developing countries into production countries, technology adaptation countries, and proto-innovation countries and argues that dynamic efficiency considerations take on different meanings for developing countries depending on their technological capacities. For the vast majority of developing countries bereft of meaningful innovation capacity, foreign technology transfer is the main vehicle for technological progress. The chief dynamic policy consideration for these countries is hence incentives for technology transfer instead of innovation incentives. There are three main means of voluntary technology transfer: importation of technological goods, foreign direct investment, and technology licensing. Competition law regulation of patent exploitation practices interacts with these three means of technology transfer in different ways and an appropriate approach to the patent-competition interface for these countries needs to take these into account. Distilling all these considerations, the book proposes a development stage-specific approach to the patent-competition interface for developing countries. The approach is then applied to a number of patent exploitation practices, including unilateral refusal to deal, patent tying, excessive pricing for pharmaceuticals, reverse payment settlements, and restrictive licensing practices.
Book Synopsis Directory of EU Case Law on State Aids by : René Barents
Download or read book Directory of EU Case Law on State Aids written by René Barents and published by Kluwer Law International B.V.. This book was released on 2019-10-07 with total page 1308 pages. Available in PDF, EPUB and Kindle. Book excerpt: This new edition of an immensely useful book follows the same proven format as its predecessors, updates its analysis of case law with hundreds of new decisions by the courts of the European Union (EU), and thus remains the quickest source of reference for practitioners working with EU State aid matters. Following a highly organized sequence of subject headings, it presents extracts from all judgments and orders of both the Court of Justice and the General Court of the EU on the Treaty on the functioning of the European Union (TFEU) rules on State aids. All the relevant case law of both courts until the end of 2018 is covered. There is a new chapter on legal protection and additional material on the concept of State aid, advantages for undertakings, selectivity, forms of State aid, procedures and unlawful aids. With this book practitioners will quickly find relevant paragraphs and full citations regarding all issues raised by Articles 107–109 TFEU, including the following and much more: territorial scope of State aids; Article 107(1) EC and WTO Agreements; conditions for categorizing a national measure as State aid; free movement of goods; undertakings; private versus public investment; justification of selective measures; interstate trade and competition; tax measures; restructuring aids; procedural aspects; and locus standi of trade associations. In many areas, the extracts relate to points of the judgments which are not or only partially covered in official summaries. For accessibility of this case law, this updated edition of the preeminent analysis of EU State aid case law has no peers. Practitioners in this key area of EU competition law will find this book indispensable.
Book Synopsis New Developments in Competition Law and Economics by : Klaus Mathis
Download or read book New Developments in Competition Law and Economics written by Klaus Mathis and published by Springer. This book was released on 2019-03-18 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book further develops both the traditional and the behavioural approach to competition law, and applies these approaches to a variety of timely issues. It discusses several fundamental questions regarding competition law and economics, and explores the applications of competition law and economics. In turn, the book analyses the interplay of intellectual property rights and patents in various aspects of competition law, and investigates the impacts that developments in information technology, such as big data analytics, have on competition law. The book also discusses the impact of energy law reforms on energy markets from a competition law perspective. Competition law is a classic field of economic analysis. This is largely due to the fact that competition law uses terms such as market, price, and competition and must therefore rely on economic know-how and analyses. In the United States, economic analysis has greatly influenced not just the scholarship on antitrust law, but also judicial decisions and agency enforcement. Antitrust law and economics are based on the traditional paradigm of neoclassical economics, which relies on the assumption that the market players, i.e. consumers and producers, are rational. This approach to competition law was later received in Europe under the banner of a “more economic approach”. For the past two decades, behavioural law and economics, which seeks to generate better insights into legal phenomena by providing more realistic psychological foundations for economic models, and to offer a multitude of applications in legislation and legal adjudication, has challenged the traditional economic approach to law in general and, more recently, to competition law specifically.
Book Synopsis The Interplay Between Competition Law and Intellectual Property by : Gabriella Muscolo
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 633 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
Book Synopsis Regulation, Innovation and Competition in Pharmaceutical Markets by : Margherita Colangelo
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.
Book Synopsis The New EU Competition Law by : Pablo Ibáñez Colomo
Download or read book The New EU Competition Law written by Pablo Ibáñez Colomo and published by Bloomsbury Publishing. This book was released on 2023-12-14 with total page 335 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides the first comprehensive account of the New EU Competition Law: an emerging understanding of the discipline that breaks from the consensus of the early 2000s and that ventures into uncharted territories. Competition law has undergone fundamental transformations in the past decade, from the rise and fall of the 'effects-based approach' to the challenge of Big Tech and the growing interaction with intellectual property. Making sense of these changes and fully grasping their implications can be difficult. The book discusses the shift from traditional enforcement in the industrial era to the sort of intervention that a knowledge-based economy demands. It presents the changes that the field is undergoing (policy priorities, relationship with regulation and intangible assets, move away from efficiency and consumer welfare) and illustrates them by reference to the most significant developments. The analysis includes an up-to-date evaluation of the Digital Markets Act and addresses the application of EU competition law to key areas, including energy, pharma, telecommunications and online platforms. Conceived as a 'modular' book, practitioners and advanced students will find it useful as a map to navigate the underlying trends and as an in-depth dissection of the key case law and administrative practice of the past decade.
Book Synopsis The Shaping of EU Competition Law by : Pablo Ibáñez Colomo
Download or read book The Shaping of EU Competition Law written by Pablo Ibáñez Colomo and published by Cambridge University Press. This book was released on 2018-07-12 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: Based on a unique and comprehensive database, The Shaping of EU Competition Law combines qualitative and quantitative approaches to shed light on the evolution of EU competition law. It brings a new perspective to some of the most topical issues in the field including due process and the intensity of judicial review. The author's main purpose is to examine how the institutional structure influences the substance of EU competition law provisions. He seeks to identify patterns in the behaviour of the European Commission and the EU Courts and how they interact with each other. In particular, his analysis considers how the European Commission reacts to the case law and whether, and in what instances, the EU courts defer to the analysis of the administrative authority. The analysis is supported by the database and an unprecedented array of statistics and figures free to view online.
Book Synopsis Merger Control in the EU and Turkey by : Fevzi Toksoy
Download or read book Merger Control in the EU and Turkey written by Fevzi Toksoy and published by Kluwer Law International B.V.. This book was released on 2022-05-11 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: As a country on the way to integration with the European Union (EU), Turkey has been following EU principles in establishing and improving its merger control regime, as well as overall competition law, keeping pace with changes in relevant EU legislation and case law. This book presents, for the first time, a description and analysis of the relationship between the EU and Turkish merger control law and practice. The second edition of the book considers the legislative changes that occurred in 2020-2021, including the reform of the Turkish Competition Law which introduced the significant impediment to effective competition (SIEC) test into the Turkish concentration control. The authors—all three, both practicing lawyers and academicians in Turkey—focus on comparing substantive, procedural and jurisdictional issues and draw parallels on their regulation in the two jurisdictions. These matters include the following: determining whether a transaction shall be regarded as a notifiable merger, hence be subject to control; financial thresholds used for allocating jurisdictions; extraterritoriality of merger control; relationship between the SIEC test and the dominance test; determination of the relevant market; techniques used for assessment of horizontal and non-horizontal mergers; notification requirements; procedural duties of competition authorities in relation to remedies; third-party rights; gun-jumping fines and other sanctions for failure to comply with merger control requirements; and peculiarities of assessment of mergers in the Big Data world. Each chapter provides an overview of the respective issues in the EU and Turkey, projecting a clear understanding of the main similarities and differences in the two regimes. A notable feature is an in-depth analysis of applicable case law concerning each issue, with most of the Turkish decisions available in English for the first time. The book’s comparative approach will prove to be of great value. With its clear answers to questions about what transactions are subject to merger control, what criteria are used in assessing those transactions, and the main issues that a foreign company should be aware of while merging with another foreign company with effect in Turkey and/or EU, the book will be of immeasurable value for lawyers and their business clients dealing with multijurisdictional merger cases. Interested academics and policymakers will also find much here to attract their attention.
Book Synopsis EU Law of Competition and Trade in the Pharmaceutical Sector by : Pablo Figueroa
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 733 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.
