Download or read book Research and Development in the Pharmaceutical Industry A CBO Study written by Congressional Budget Office and published by Lulu.com. This book was released on 2013-06-09 with total page 65 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perceptions that the pace of new-drug development has slowed and that the pharmaceutical industry is highly profitable have sparked concerns that significant problems loom for future drug development. This Congressional Budget Office (CBO) study-prepared at the request of the Senate Majority Leader-reviews basic facts about the drug industry's recent spending on research and development (R&D) and its output of new drugs. The study also examines issues relating to the costs of R&D, the federal government's role in pharmaceutical research, the performance of the pharmaceutical industry in developing innovative drugs, and the role of expected profits in private firms' decisions about investing in drug R&D. In keeping with CBO's mandate to provide objective, impartial analysis, the study makes no recommendations. David H. Austin prepared this report under the supervision of Joseph Kile and David Moore. Colin Baker provided valuable consultation...

Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.

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.

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 Competition Policy and Intellectual Property in Today s Global Economy written by Robert D. Anderson and published by Cambridge University Press. This book was released on 2021-08-05 with total page 925 pages. Available in PDF, EPUB and Kindle. Book excerpt: The fast-evolving relationship between the promotion of welfare-enhancing competition and the balanced protection of intellectual property (IP) rights has attracted the attention of policymakers, analysts and scholars. This interest is inevitable in an environment that lays ever greater emphasis on the management of knowledge and innovation and on mechanisms to ensure that the public derives the expected social and economic benefits from this innovation and the spread of knowledge. This book looks at the positive linkage between IP and competition in jurisdictions around the world, surveying developments and policy issues from an international and comparative perspective. It includes analysis of key doctrinal and policy issues by leading academics and practitioners from around the globe and a cutting-edge survey of related developments across both developed and developing economies. It also situates current policy developments at the national level in the context of multilateral developments, at WIPO, WTO and elsewhere.

Download or read book Analysis of Turkish Pharmaceutical Sector written by Mehmet ATASEVER and published by Matasever. This book was released on 2016-12-01 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Analysis of Turkish Pharmaceutical Sector" is a comprehensive book that analyzes Turkish pharmaceutical industry, its financial structure and developments affecting industry from different perspectives. The book examines how pharmaceutical sector developed in Turkey after the policies followed since 2003, financing of the sector, pharmaceutical expenditures via detailed analyses and investigates the current situation, strategies and objectives of the sector. Pharmaceutical expenditures projected in the book covers expenditure statistics of 2002 -2013 period prepared by Turkey Statistical Institute (TurkStat).

Download or read book The Changing Economics of Medical Technology written by Institute of Medicine and published by National Academies Press. This book was released on 1991-02-01 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: Americans praise medical technology for saving lives and improving health. Yet, new technology is often cited as a key factor in skyrocketing medical costs. This volume, second in the Medical Innovation at the Crossroads series, examines how economic incentives for innovation are changing and what that means for the future of health care. Up-to-date with a wide variety of examples and case studies, this book explores how payment, patent, and regulatory policiesâ€"as well as the involvement of numerous government agenciesâ€"affect the introduction and use of new pharmaceuticals, medical devices, and surgical procedures. The volume also includes detailed comparisons of policies and patterns of technological innovation in Western Europe and Japan. This fact-filled and practical book will be of interest to economists, policymakers, health administrators, health care practitioners, and the concerned public.

Download or read book Intellectual Property Law and Policy Volume 12 written by Hugh Hansen and published by Bloomsbury Publishing. This book was released on 2013-05-22 with total page 488 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the 17th Annual volume in the series collecting the presentations and discussion from the Annual Fordham IP Conference. The contributions, by leading world experts, analyse the most pressing issues in copyright, trademark and patent law as seen from the perspectives of the USA, the EU, Asia and WIPO. This volume, in common with its predecessors, makes a valuable and lasting contribution to the discourse in IP law, as well as trade and competition law. The contents, while always informative, are also critical and questioning of new developments and policy concerns. Praise for the series: "This must be one of the most enjoyable and thought-provoking conferences in the IP field. The high quality of the speakers is matched by the intense, audience-led debates and challenges which follow." The Honourable Mr Justice Laddie, Royal Courts of Justice, London "Faculty for this conference are always well-known 'names', well respected leaders in their fields, speaking with a combination of candor and timeliness that is unrivaled by any other forum of its kind." Honorable Marybeth Peters, Register of Copyrights, United States Copyright Office.

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.

Download or read book Research Handbook on Intellectual Property and the Life Sciences written by Duncan Matthews and published by Edward Elgar Publishing. This book was released on 2017-06-30 with total page 529 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Download or read book The Law and Economics of Article 102 TFEU written by Robert O'Donoghue KC and published by Bloomsbury Publishing. This book was released on 2020-09-03 with total page 1695 pages. Available in PDF, EPUB and Kindle. Book excerpt: “A reference book in this area of EU competition law and a must-have companion for academics, enforcers and practitioners alike, as well as EU and national judges.” Judge Nils Wahl, Court of Justice of the European Union This seminal text offers an authoritative and integrated treatment of the legal and economic principles that underpin the application of Article 102 TFEU to the behaviour of dominant firms. Traditional concerns of monopoly behaviour, such as predatory pricing, refusals to deal, excessive pricing, tying and bundling, discount practices and unlawful discrimination are treated in detail through a review of the applicable economic principles, the case law and decisional practice and more recent economic and legal writings. In addition, the major constituent elements of Article 102 TFEU, such as market definition, dominance, effect on trade and applicable remedies are considered at length. The third edition involves a net addition of over 250 pages, with a substantial new chapter on Abuses In Digital Platforms, an extensively revised chapter on standards, and virtually all chapters incorporating substantial revisions reflecting key cases such as Intel, MEO, Google Android, Google Shopping, AdSense, and Qualcomm.

Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2020-07-28 with total page 352 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study seeks to reinforce the understanding of the interplay between the distinct policy domains of health, trade and intellectual property, and of how they affect medical innovation and access to medical technologies. The second edition comprehensively reviews new developments in key areas since the initial launch of the study in 2013.

Download or read book Competition and Intellectual Property Law in Ukraine written by Heiko Richter and published by Springer Nature. This book was released on 2023-01-22 with total page 607 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume provides the most comprehensive contemporary academic writing on Ukrainian competition and intellectual property law in English. Especially over the last few years, these areas have been in considerable flux, a main driver being the EU–Ukraine Association Agreement. The chapters cover a broad range of different topics and share a forward-looking perspective. They also outline the basic background that is necessary to understand the context of the issue discussed, especially with regards to the legal system of Ukraine. The publication is the result of a two-year project, and it is addressed to a wide range of international scholars, practitioners, and policy makers. It aims to make the state-of-the-art in Ukrainian legal scholarship visible and accessible to the international research community and to stimulate global debates in academia and politics. Therefore, it may be of interest and use to anyone who is interested in competition and intellectual property law, and/or in Ukraine.

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.

Download or read book Handbook of EU Competition Law written by Walter Frenz and published by Springer. This book was released on 2015-12-18 with total page 1518 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook offers detailed descriptions of EU competition law, including mergers and public authorities. Above all, it analyzes and discusses recent decisions of the ECJ and the General Court. Presenting systematically structured and theoretically founded content, the book also includes recommendations for practitioners. Special attention is paid to the scope of penalties and the influence on fundamental rights. Rounding out the book, the conflict between safeguarding confidential information and the effectiveness of private and public enforcement is discussed intensively in the context of the new Directive 2014/104/EU.

Download or read book Evergreening Patent Exclusivity in Pharmaceutical Products written by Frantzeska Papadopoulou and published by Bloomsbury Publishing. This book was released on 2021-09-23 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book analyses 4 central pieces of EU pharmaceutical regulation: the Orphan Drugs Regulation, the Paediatric Regulation, the Supplementary Protection Certificate Regulation, and the ATMP (Advanced Therapy Medicinal Products) Regulation. These four regulatory instruments constitute focal points in the pharmaceutical industry's approach to modern business and legal strategy. Their central role is justified by the way these regulatory instruments interact with each other and with the patent system, and by the considerable impact they (as a whole) have for the evergreening of exclusive rights on pharmaceutical products. The book guides the reader through the latest case law and legislative developments and discusses how these influence strategic legal and business choices in the pharmaceutical industry. It brings to the forefront the often-overlooked significance of the legislative architecture of the EU pharmaceutical regulatory framework, and evaluates its results through the lens of the efficiency test. The book is an important resource for academics and practitioners interested in updated case law and an in-depth analysis of these four regulations. It is also important for those interested in legislative studies, evaluation of legislation and a critical approach to legislative architecture.

Download or read book 2009 Annual Review of Antitrust Law Developments written by American Bar Association Editors and published by American Bar Association. This book was released on 2011-07-16 with total page 462 pages. Available in PDF, EPUB and Kindle. Book excerpt: For over 37 years, Antitrust Law Developments and its annual supplements have been recognized as the single most authoritative and comprehensive set of research tools for antitrust practitioners. The 2009 Annual Review of Antitrust Law Developments summarizes developments during 2009 in the courts, at the agencies, and in Congress.