Competition And Patent Law In The Pharmaceutical Sector

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Pharmaceutical Innovation, Competition and Patent Law

Josef Drexl,Nari Lee
Pharmaceutical Innovation Competition and Patent Law Book PDF

Author : Josef Drexl,Nari Lee
Publisher : Edward Elgar Publishing
Page : 347 pages
File Size : 51,6 Mb
Release : 2013-01-01
Category : Law
ISBN : 9780857932464

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Pharmaceutical Innovation, Competition and Patent Law by Josef Drexl,Nari Lee Pdf

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.

Competition and Patent Law in the Pharmaceutical Sector

Giovanni Pitruzzella,Gabriella Muscolo
Competition and Patent Law in the Pharmaceutical Sector Book PDF

Author : Giovanni Pitruzzella,Gabriella Muscolo
Publisher : Kluwer Law International
Page : 0 pages
File Size : 42,8 Mb
Release : 2016
Category : Antitrust law
ISBN : 9041159274

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Competition and Patent Law in the Pharmaceutical Sector by Giovanni Pitruzzella,Gabriella Muscolo Pdf

Editors --Contributors --Foreword --Preface --Pharmaceutical Patents and Competition Issues --What Is Going on in National Systems?

Competition Law and IP Rights in Pharmaceuticals and Biotechnology

Björn Lundqvist,Timo Minssen,Justin Pierce
Competition Law and IP Rights in Pharmaceuticals and Biotechnology Book PDF

Author : Björn Lundqvist,Timo Minssen,Justin Pierce
Publisher : Oxford University Press, USA
Page : 576 pages
File Size : 41,5 Mb
Release : 2031-05-30
Category : Law
ISBN : 0198724829

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Competition Law and IP Rights in Pharmaceuticals and Biotechnology by Björn Lundqvist,Timo Minssen,Justin Pierce Pdf

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

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

Amalia Athanasiadou
Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law Book PDF

Author : Amalia Athanasiadou
Publisher : Kluwer Law International B.V.
Page : 520 pages
File Size : 48,8 Mb
Release : 2018-08-14
Category : Law
ISBN : 9789403501147

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Patent Settlements in the Pharmaceutical Industry under US Antitrust and EU Competition Law by Amalia Athanasiadou Pdf

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.

Strategic Patenting and Evergreening in Pharmaceutical Sector: Competition Law as a Panacea

Monika Mulchandani
Strategic Patenting and Evergreening in Pharmaceutical Sector Competition Law as a Panacea Book PDF

Author : Monika Mulchandani
Publisher : Unknown
Page : 58 pages
File Size : 50,8 Mb
Release : 2020-10-06
Category : Law
ISBN : 1636480071

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Strategic Patenting and Evergreening in Pharmaceutical Sector: Competition Law as a Panacea by Monika Mulchandani Pdf

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.

Competition Law and Patents

Irina Haracoglou
Competition Law and Patents Book PDF

Author : Irina Haracoglou
Publisher : Edward Elgar Publishing
Page : 272 pages
File Size : 41,8 Mb
Release : 2008-01-01
Category : Law
ISBN : 9781848440111

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Competition Law and Patents by Irina Haracoglou Pdf

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.

Antitrust in Pharmaceutical Markets & Geographical Rules of Origin

Pierre Kobel,Pranvera Këllezi,Bruce Kilpatrick
Antitrust in Pharmaceutical Markets Geographical Rules of Origin Book PDF

Author : Pierre Kobel,Pranvera Këllezi,Bruce Kilpatrick
Publisher : Springer
Page : 497 pages
File Size : 55,5 Mb
Release : 2017-09-20
Category : Law
ISBN : 9783319558134

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Antitrust in Pharmaceutical Markets & Geographical Rules of Origin by Pierre Kobel,Pranvera Këllezi,Bruce Kilpatrick Pdf

This book gathers international and national reports from across the globe on key questions in the field of antitrust and intellectual property. The first part discusses the application of competition law in the pharmaceutical sector, which continues to be a focus for anti-trust authorities around the world. A detailed international report explores the extent to which the application of the competition rules in the pharmaceutical sector should be affected by the specific characteristics of those products and markets (including consumer protection rules, the need to promote innovation, the need to protect public budgets, and other public interest considerations). It provides an excellent comparative study of this complex subject, which lies at the interface between competition law and intellectual property law. The second part of the book gathers contributions from various jurisdictions on the topic of “What rules should govern claims by suppliers about the national or geographic origin of their goods or services?” This section presents an international report, which offers an unparalleled comparative analysis of this topic, bringing together common themes and contrasting the various national provisions dealing with indications of origin, amongst other things. The book also includes the resolutions passed by the General Assembly of the International League of Competition Law (LIDC) following a debate on each of these topics, which include proposed solutions and recommendations. The LIDC is a long-standing international association that focuses on the interface between competition law and intellectual property law, including unfair competition issues.

Contemporary Issues in Pharmaceutical Patent Law

Bryan Mercurio,Daria Kim
Contemporary Issues in Pharmaceutical Patent Law Book PDF

Author : Bryan Mercurio,Daria Kim
Publisher : Routledge
Page : 271 pages
File Size : 46,5 Mb
Release : 2017-02-17
Category : Law
ISBN : 9781317389781

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Contemporary Issues in Pharmaceutical Patent Law by Bryan Mercurio,Daria Kim Pdf

This collection reflects on contemporary and contentious issues in international rulemaking in regards to pharmaceutical patent law. With chapters from both well-established and rising scholars, the collection contributes to the understanding of the regulatory framework governing pharmaceutical patents as an integrated discipline through the assessment of relevant laws, trends and policy options. Focusing on patent law and related pharmaceutical regulations, the collection addresses the pressing issues governments face in an attempt to resolve policy dilemmas involving competing interests, needs and objectives. The common theme running throughout the collection is the need for policy and law makers to think and act in a systemic manner and to be more reflective and responsive in finding new solutions within and outside the patent system to the long-standing problems as well as emerging challenges

Competition Law and Policy in the Japanese Pharmaceutical Sector

Akira Negishi,Masako Wakui,Naoko Mariyama
Competition Law and Policy in the Japanese Pharmaceutical Sector Book PDF

Author : Akira Negishi,Masako Wakui,Naoko Mariyama
Publisher : Springer Nature
Page : 252 pages
File Size : 45,7 Mb
Release : 2022-02-08
Category : Law
ISBN : 9789811678141

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Competition Law and Policy in the Japanese Pharmaceutical Sector by Akira Negishi,Masako Wakui,Naoko Mariyama Pdf

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

EU Law of Competition and Trade in the Pharmaceutical Sector

Pablo Figueroa,Alejandro Guerrero
EU Law of Competition and Trade in the Pharmaceutical Sector Book PDF

Author : Pablo Figueroa,Alejandro Guerrero
Publisher : Edward Elgar Publishing
Page : 758 pages
File Size : 48,5 Mb
Release : 2019
Category : Business & Economics
ISBN : 9781785362613

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EU Law of Competition and Trade in the Pharmaceutical Sector by Pablo Figueroa,Alejandro Guerrero Pdf

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.

Blocking Patents in European Competition Law

Angelika S. Murer
Blocking Patents in European Competition Law Book PDF

Author : Angelika S. Murer
Publisher : Kluwer Law International B.V.
Page : 386 pages
File Size : 41,8 Mb
Release : 2021-12-03
Category : Law
ISBN : 9789403538150

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Blocking Patents in European Competition Law by Angelika S. Murer Pdf

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.

Regulating for Competition

Leigh Hancher
Regulating for Competition Book PDF

Author : Leigh Hancher
Publisher : Oxford University Press, USA
Page : 456 pages
File Size : 42,7 Mb
Release : 1990
Category : Law
ISBN : UOM:39015019827057

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Regulating for Competition by Leigh Hancher Pdf

The pharmaceutical industry is one of the most closely regulated sectors of the Western economies. In this study, Hancher provides one of the first comprehensive analyses of the regulatory systems in France and the United Kingdom, with particular focus on safety, control of price, profit, and promotional restrictions. She offers an examination of regulation as a dynamic process, exploring its impact on the operating environment of major research-based firms, and comparing the ways in which different legal cultures may provide different opportunities or impose different forms of constraint on policy makers.

The Interplay Between Competition Law and Intellectual Property

Gabriella Muscolo,Marina Tavassi
The Interplay Between Competition Law and Intellectual Property Book PDF

Author : Gabriella Muscolo,Marina Tavassi
Publisher : Kluwer Law International B.V.
Page : 566 pages
File Size : 40,6 Mb
Release : 2019-01-17
Category : Law
ISBN : 9789041186904

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The Interplay Between Competition Law and Intellectual Property by Gabriella Muscolo,Marina Tavassi Pdf

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

The Commercialization of Pharmaceutical Patents in China

James Hou
The Commercialization of Pharmaceutical Patents in China Book PDF

Author : James Hou
Publisher : Edward Elgar Publishing
Page : 256 pages
File Size : 53,7 Mb
Release : 2021-03-26
Category : Law
ISBN : 9781789908237

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The Commercialization of Pharmaceutical Patents in China by James Hou Pdf

Presenting detailed analysis of the industrialization of pharmaceutical patents in China, this timely book explores a range of related topics including a comparison of the ideal and existing state of the pharmaceutical market and patent industrialization. It argues that the core purpose of the industrialization of pharmaceutical patents is to promote the development of the local pharmaceutical industry whilst also protecting society’s right to safe and effective medication.

Patent Rights in Pharmaceuticals in Developing Countries

Jakkrit Kuanpoth
Patent Rights in Pharmaceuticals in Developing Countries Book PDF

Author : Jakkrit Kuanpoth
Publisher : Edward Elgar Publishing
Page : 257 pages
File Size : 41,7 Mb
Release : 2010-01-01
Category : Medical
ISBN : 9781849808958

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Patent Rights in Pharmaceuticals in Developing Countries by Jakkrit Kuanpoth Pdf

The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policy-making in this area.