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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 EU Competition Law and Pharmaceuticals by : Wolf Sauter
Download or read book EU Competition Law and Pharmaceuticals written by Wolf Sauter and published by Edward Elgar Publishing. This book was released on 2022-11-15 with total page 325 pages. Available in PDF, EPUB and Kindle. Book excerpt: This timely book discusses the application of the EU competition rules to pharmaceuticals, covering the prohibitions on anticompetitive agreements and abuse of dominance, and merger control. It carefully considers the balance between competition and innovation, as well as between competition and regulation, and concludes that competition and regulation are not alternatives, but complementary, and that novel ways of taking into account risk and real innovation through competition assessments have been developed.
Book Synopsis Blocking Patents in European Competition Law by : Angelika S. Murer
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.
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 Private Enforcement of European Competition and State Aid Law by : Ferdinand Wollenschläger
Download or read book Private Enforcement of European Competition and State Aid Law written by Ferdinand Wollenschläger and published by Kluwer Law International B.V.. This book was released on 2020-01-09 with total page 439 pages. Available in PDF, EPUB and Kindle. Book excerpt: Private Enforcement of European Competition and State Aid Law Current Challenges and the Way Forward Edited by: Ferdinand Wollenschläger, Wolfgang Wurmnest & Thomas M.J. Möllers The overlapping European Union (EU) regimes of competition law and State aid law both provide mechanisms allowing private plaintiffs to claim compensation for losses or damages. It is thus of significant practical value to provide, as this book does, analysis and guidance on achieving enforcement of such claims, written by renowned authorities in the two fields. The book examines the two areas of law both from an EU perspective and from the perspectives of private enforcement in France, Germany, Italy, the Netherlands, Spain and the United Kingdom. In country reports for these major jurisdictions, as well as in more general and comparative chapters, the authors focus on such issues as the following: impediments to private enforcement; which entity is liable for damages; binding effect of decisions of competition authorities; limitation of actions; collective actions and pooling of claims; enforcement of the standstill obligation (Article 108(3) TFEU); remedies and information deficits; cooperation and coordination between national courts and the European Commission; transposition of the so-called Damages Directive (Directive 2014/104/EU) by the EU Member States; extent to which the strengthening of private enforcement of competition law has a spillover effect on State aid law; and prospects for harmonisation of State aid law. A concluding section identifies enforcement deficits and proposes ways to improve the existing legal framework. As an in-depth assessment of key obstacles and best practices in private enforcement actions, this highly informative and practical volume facilitates choice of the best forum for competition and State aid law cases. Academics and practitioners engaged with this important area of European law will appreciate the authors’ awareness of the economic need and legal particularities which could generate an effective European system of private enforcement of legitimate claims under EU competition and State aid law.
Book Synopsis Judicial Review of Competition Law Enforcement in the EU Member States and the UK by : Maciej Bernatt
Download or read book Judicial Review of Competition Law Enforcement in the EU Member States and the UK written by Maciej Bernatt and published by Kluwer Law International B.V.. This book was released on 2024-09-17 with total page 1034 pages. Available in PDF, EPUB and Kindle. Book excerpt: International Competition Law Series#91 Enforcement of competition law often calls for a complex economic and legal assessment, and the review of those enforcement decisions usually falls to national courts. In this connection, however, European competition law and legal scholarship have offered scant guidance on how judicial review should and does function. This book, the first comprehensive, systematic, and comparative empirical study of judicial review of competition law public enforcement in the EU and the UK, provides a thorough understanding of the practical operation of the role of judicial review in competition enforcement. A country-by-country analysis, along with a detailed introduction and an incisive comparative summary, covers all publicly available judicial review judgments – 5,707 in all – of final public enforcement actions in relation to Articles 101 and 102 TFEU and relevant national provisions in the twenty-seven EU Member States and the UK rendered between 1 May 2004 and 30 April 2021. The data presented draws on a rich database built for the purpose of this study by twenty-eight national teams of competition law academics and practitioners. For each jurisdiction, the analysis focuses on such aspects as the following: structure of the national enforcement system; number of judgments rendered; success rate; types of appellants; competition rules subject to review; grounds of review; use of preliminary references; appeals involving leniency and/or settlements; and role of third parties. Numerous graphs, figures, and tables support the presentation. In the light it sheds on trends in judicial review of competition law enforcement on a comparative basis, and in its data-driven assessment of how the decentralised judicial review of EU competition law meets EU integration aims, this important study will be of inestimable value to competition lawyers, policymakers, and academics in developing a confident understanding of precisely how judicial review in this area operates in each of the EU Member States and the UK. In addition, the book provides a significant contribution not only with respect to EU and national competition laws but also, more broadly, to comparative administrative law scholarship in Europe.
Book Synopsis Antitrust Settlements by : Giovanna Massarotto
Download or read book Antitrust Settlements written by Giovanna Massarotto and published by Kluwer Law International B.V.. This book was released on 2019-10-17 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Competition enforcement authorities use settlements as a tool to ensure compliance with antitrust law. Companies can make commitments to remedy breaches, ensuring that they avoid litigation and potential fines and reputational damage. The author of this highly original and innovative book shows that, rather than fines or arguing principles of competition law in litigation, antitrust settlements (namely U.S. consent decrees and EU commitment decisions) hold the key to globally effective enforcement, particularly in the digital and blockchain era. Antitrust law does not necessarily need to be abolished, but rather should be fully exploited as an economic regulation led by antitrust settlements. In supporting her thesis, the author examines such elements of competition enforcement as the following: drawbacks of allowing the courts to regulate markets; whether antitrust settlements sacrifice antitrust deterrence; how settlements rapidly and surgically regulate markets; comparative analysis between U.S. consent decrees and EU commitment decisions; economic analysis on the adoption of antitrust settlements in both the U.S. and EU markets from 2013 to 2018; fundamental role of antitrust settlements in regulating the current digital markets; and comprehensive description on how to use antitrust settlements to regulate the data industry. With its thorough guidance on U.S. consent decrees and EU commitment decisions from their functioning to their characteristics and procedure—and its extensive treatment of the main antitrust remedies available and used in enforcing of antitrust law in both the U.S. and EU—the book provides both an economic and a legal analysis of the functioning and the scope of antitrust settlements. It assesses the influence of decisions on companies’ behavior and agencies’ practice, using economic analysis to show the procompetitive or anticompetitive effects of remedies, with special attention to digital markets. Because markets have become so dynamic and unpredictable that is difficult to preserve efficiency, the author says, there is a little room for law—economic regulation is a better fit. This book is a springboard to further investigate how a simple antitrust enforcement tool, having turned competition law into an economic regulation policy, can drive our economy, leading both the antitrust and regulatory interventions in tackling today’s market challenges.
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.
Author :Ingrid Margrethe Halvorsen Barlund Publisher :Kluwer Law International B.V. ISBN 13 :9403517255 Total Pages :432 pages Book Rating :4.4/5 (35 download)
Book Synopsis Leniency in EU Competition Law by : Ingrid Margrethe Halvorsen Barlund
Download or read book Leniency in EU Competition Law written by Ingrid Margrethe Halvorsen Barlund and published by Kluwer Law International B.V.. This book was released on 2020-06-18 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leniency has emerged as one of the main enforcement instruments used by competition authorities to combat cartels. Offering immunity from punishment is believed to destabilise already existing cartels and deter undertakings from entering into such arrangements. This book offers the first in-depth analysis of the scope of leniency in European Union (EU) competition law, considering three crucial ramifications – ensuring a leniency applicant can self-report with confidence, retaining the right to compensation of those who have suffered losses due to the cartel and furthering the objective of undistorted competition within the internal market. With thorough insight into the interaction between the Commission’s Leniency Notice and public and private enforcement, the author fully explains such aspects of the subject as the following: who is eligible for leniency; liability of an immunity recipient; the EU fining system; disclosure of leniency evidence; scope of public authorities reaching out to cartel infringers; the immunity recipient and follow-on damages claimants; the immunity recipient and subsequent leniency applicants; effect of the Damages Directive; and the European Economic Area dimension. The author offers cogent suggestions about how the shortcomings of the Commission’s leniency offer can be ameliorated and which regulatory steps should be taken to give the policy greater leverage. The author calls for increased harmonisation at national level in the EU and compares leniency practice in US antitrust law. As a comprehensive analysis of the practical application of current policy and procedure in EU cartel enforcement, the book clearly shows the ways in which the scope of leniency is manifest in the interaction between public and private enforcement, evaluating which interaction is most effective. Its practical character will be recognised and welcomed by competition law practitioners and policymakers, who will strengthen their grasp of leniency procedure and clearly discern implications for competition infringement cases.
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 Global Competition Enforcement by : Paulo Burnier da Silveira
Download or read book Global Competition Enforcement written by Paulo Burnier da Silveira and published by Kluwer Law International B.V.. This book was released on 2019-10-17 with total page 319 pages. Available in PDF, EPUB and Kindle. Book excerpt: Global Competition Enforcement New Players, New Challenges Edited by Paulo Burnier da Silveira & William Evan Kovacic In a short span of years, the landscape of global competition has changed significantly. In particular, international cooperation in competition law enforcement has greatly strengthened the battle against abuse of dominance, cartels, anticompetitive mergers and related political corruption. This thoroughly researched book explains the current situation regarding joint investigations, identifies common problems and considers possible solutions and future developments. In addition to covering issues of competition policy, its authors look in detail at practice in both merger and conduct investigations in a variety of countries. The following aspects of the subject and more are examined in depth: the interface between antitrust and anti-corruption; the digital economy’s challenges to competition authorities; convergent aims and rules among different competition authorities; regional organizations with competition mandates; competition neutrality and state-owned enterprises; and leniency programmes. Although necessarily there is considerable information on major antitrust regimes like those of the United States and the European Union, chapters by local experts highlight lessons to be learned from the work of competition authorities in five continents including Argentina, Australia, Brazil, China, Colombia, India, Japan, Mauritius, Mexico, Peru and South Africa. The contributors include competition enforcers, regulators, academics, practitioners and leading commentators from a range of jurisdictions. Adding up to an authoritative analysis from the enforcer’s perspective, the studies presented in the book clarify the approaches and priorities of competition enforcement authorities – including those of major emerging economies – and provide expert guidance on dealing with transnational investigations. Antitrust lawyers, corporate counsel and interested academics as well as policymakers will benefit immeasurably from this book’s wealth of informative detail.
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 Directory of EU Case Law on State Aids by : Cees Dekker
Download or read book Directory of EU Case Law on State Aids written by Cees Dekker and published by Kluwer Law International B.V.. This book was released on 2024-09-24 with total page 909 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. The book covers the relevant case law of both courts. There is additional material on many subjects, among which the concept of State aid, direct taxation and the State aid provisions, particularly on tax rulings, 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) European Commission and World Trade Organization 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.
