Contemporary Issues In Pharmaceutical Patent Law

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Contemporary Issues in Pharmaceutical Patent Law

Author : Bryan Mercurio,Daria Kim
Publisher : Taylor & Francis
Page : 249 pages
File Size : 55,9 Mb
Release : 2017-02-17
Category : Law
ISBN : 9781317389798

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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

Pharmaceutical Patents in Europe

Author : Bengt Domeij
Publisher : BRILL
Page : 365 pages
File Size : 44,6 Mb
Release : 2021-10-25
Category : Law
ISBN : 9789004481473

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Pharmaceutical Patents in Europe by Bengt Domeij Pdf

The pharmaceutical industry and patent legislation are inextricably linked. Pharmaceutical companies could not exist without some guarantee that they can recoup the cost of developing a new product. European patent law offers this opportunity, as it allows companies to exclude competition for a specific product for a fixed time scale. In Pharmaceutical Patents in Europe the current legal patent situation is examined by a detailed analysis of case law from the European Patent Office (EPO), the international body created with the signing of the European Patent Convention (EPC). Aspects of European patent law not primarily regulated in the EPC, for example Supplementary Protection Certificates and infringement matters, are examined in the setting provided by EC law and domestic laws of European states. This book is written for the reader who understands the main characteristics of patent law and is looking for a practitioner's text on the European pharmaceutical patent law scene. Moreover, the author's remarks can help all readers to look at the field with fresh eyes.

Competition and Patent Law in the Pharmaceutical Sector

Author : Giovanni Pitruzzella,Gabriella Muscolo
Publisher : Kluwer Law International
Page : 0 pages
File Size : 55,7 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?

Pharmaceutical Patent Issues

Author : Orrin G. Hatch
Publisher : DIANE Publishing
Page : 304 pages
File Size : 43,5 Mb
Release : 2000-04
Category : Electronic
ISBN : 0788187759

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Pharmaceutical Patent Issues by Orrin G. Hatch Pdf

Witnesses: Michael Kantor, U.S. Trade Rep.; William Brock, former U.S. Trade Rep.; Gerald Mossinghoff, Pharmaceutical Research & Mfrs. of Amer.; Charles Cooper, Shaw, Pittman, Potts & Trowbridge; James Firman, Generic Drug Equity Coalition, & pres., Nat. Council of the Aging; Judith Simpson, United Patients' Assoc. for Pulmonary Hypertension; Robert Gunter, Nat. Pharm. Alliance, & Novo-Pharm; John Klein, Generic Pharm. Ind. Assoc.; Bruce Downey, Barr Labs.; Eran Broshy, Boston Consulting Group; David Beier, Genentech, for the Biotech. Industry Org.; Henry Grabowski, Duke Univ.; Daniel Perry, Alliance for Aging Research; & Dixie Horning, Gray Panthers.

Pharmaceutical Innovation, Competition and Patent Law

Author : Josef Drexl,Nari Lee
Publisher : Edward Elgar Publishing
Page : 347 pages
File Size : 52,8 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.

Medical Patent Law - the Challenges of Medical Treatment

Author : E. Ventose
Publisher : Edward Elgar Publishing
Page : 491 pages
File Size : 50,7 Mb
Release : 2011-10-01
Category : Law
ISBN : 9780857938015

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Medical Patent Law - the Challenges of Medical Treatment by E. Ventose Pdf

Ventose makes a fresh, lively and incredibly thorough contribution to the literature in this work. He canvasses the European, English and American authorities in a systematic, methodical and dare I say surgical manner. The book is a must read for practitioners, academics and students alike interested in patentable subject matter, public policy and medico-legal ethics. It will be a welcome addition to any legal collection. Emir Aly Crowne, University of Windsor, Barrister & Solicitor, Law Society of Upper Canada and Co-Founder and Co-Chair, Harold G. Fox Intellectual Property Moot Medical patents are a matter of life and death. Such patents have a critical impact upon patient care, medical research, and the administration of healthcare (and, indeed, are in part responsible for ballooning health care budgets). This comprehensive book by Eddy D. Ventose provides a systematic comparative analysis of medical patents. The work explores the historical taboo against patenting methods of human treatment; charts the spectrum of policy positions on medical patents, ranging from permissive to prohibitive; and examines contemporary battles over patenting methods of medical correlation in the Supreme Court of United States. Matthew Rimmer, The Australian National University College of Law and ACIPA, Australia This book provides a detailed and comparative examination of medical patent law and the issues at the heart of the medical treatment exclusion for therapeutic treatments, surgical treatments and diagnostic methods. It firsts considers the historical basis for exclusion and the development of law and policy in Europe, the United States and other commonwealth countries. The book goes on to provide a detailed analysis of the issues related to new medical technologies, such as gene therapy, dosage regimes, and medical diagnostics, in light of the medical treatment exclusion. Medical Patent Law will strongly appeal to patent agents and attorneys, solicitors and barristers working in patent and intellectual property law and medical law worldwide, as well as medical practitioners and healthcare professionals; scientists, researchers and managers in the chemicals, medical; pharmaceuticals and biotechnology industries. Postgraduates on LLM medical law and intellectual property courses and academics specializing in medical law or patent law, will also find much to interest them.

Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health?

Author : Van Anh Le
Publisher : Springer Nature
Page : 192 pages
File Size : 45,8 Mb
Release : 2021-10-06
Category : Political Science
ISBN : 9783030841935

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Compulsory Patent Licensing and Access to Medicines: A Silver Bullet Approach to Public Health? by Van Anh Le Pdf

This timely monograph focuses on India and Brazil’s use of compulsory licensing, one of the most significant and controversial TRIPS flexibilities. This is a topical work at this critical time when the COVID-19 has stirred up the debate about compulsory licensing and access to medicines. A closer look into the historical use of compulsory licences in certain countries can offer some takeaways for the current situation. The author studies historical developments and political conditions of the patent system and compulsory licensing from the earliest stage to the modern arena, with a great emphasis on TRIPS. After conducting a cross-national study of India and Brazil, the book moves on to evaluate the different philosophies on compulsory licensing of multilateral organizations such as the EU, the WIPO, the WTO, and NGOs. This important book will strongly appeal to intellectual property students, academics, policymakers, and lawyers practicing in the area. It will also be of interest to academics working in the areas of international law, development, and public health as well as state actors and others with relevant concerns working in multilateral organizations.

Coalitions and Compliance

Author : Kenneth C. Shadlen
Publisher : Oxford University Press
Page : 328 pages
File Size : 43,7 Mb
Release : 2017-08-05
Category : Political Science
ISBN : 9780192534842

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Coalitions and Compliance by Kenneth C. Shadlen Pdf

Coalitions and Compliance examines how international changes can reconfigure domestic politics. Since the late 1980s, developing countries have been subject to intense pressures regarding intellectual property rights. These pressures have been exceptionally controversial in the area of pharmaceuticals. Historically, fearing the economic and social costs of providing private property rights over knowledge, developing countries did not allow drugs to be patented. Now they must do so, an obligation with significant implications for industrial development and public health. This book analyses different forms of compliance with this new imperative in Latin America, comparing the politics of pharmaceutical patenting in Argentina, Brazil, and Mexico. Coalitions and Compliance focuses on two periods of patent politics: initial conflicts over how to introduce drug patents, and then subsequent conflicts over how these new patent systems function. In contrast to explanations of national policy choice based on external pressures, domestic institutions, or Presidents' ideological orientations, this book attributes cross-national and longitudinal variation to the ways that changing social structures constrain or enable political leaders' strategies to construct and sustain supportive coalitions. The analysis begins with assessment of the relative resources and capabilities of the transnational and national pharmaceutical sectors, and these rival actors' efforts to attract allies. Emphasis is placed on two ways that social structures are transformed so as to affect coalition-building possibilities: how exporters fearing the loss of preferential market access may be converted into allies of transnational drug firms, and differential patterns of adjustment among state and societal actors that are inspired by the introduction of new policies. It is within the changing structural conditions produced by these two processes that political leaders build coalitions in support of different forms of compliance.

TRIPS and Access to Medicines

Author : Renata Curzel
Publisher : Kluwer Law International B.V.
Page : 325 pages
File Size : 54,5 Mb
Release : 2020-12-10
Category : Law
ISBN : 9789403528748

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TRIPS and Access to Medicines by Renata Curzel Pdf

Although ideally a patent system for pharmaceuticals should serve to incentivize research into the development of new medicines, the COVID-19 pandemic has exposed the equal importance of drug access and affordability. This book, by focusing on the Brazilian rule which makes the grant of pharmaceutical patents dependent on the prior consent of the National Health Surveillance Agency (ANVISA), shows how the Brazilian model affords an example for other countries to follow in dealing with tensions between patent protection and the right to healthcare. Based on an empirical study in which the author examined 147 reports issued by ANVISA as a basis for its decisions, the book deals with such central questions concerning the interface of regulation and innovation in the patent system as the following: compatibility between ANVISA’s prior consent mechanism and the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement; how “evergreening” and “trivial patents” undermine public health and access to medicines; ways of correcting abuses of patent rights and controlling quality of patents; and the discourse on health as a human right. Along with her examination of ANVISA reports, the author analyzes how Article 229-C LPI, which introduced the need of ANVISA’s prior consent to the patent grant of pharmaceuticals in Brazil, has been interpreted in Brazilian case law. Interviews with Brazilian experts are also included. In its commitment to harmonizing patent rights and the right to access of affordable medicines, Brazil’s patent system for pharmaceuticals stands out as a workable response to the basic problem of access to medicines in the developing world. By describing the successes and failures in the Brazilian policy of promoting drug access, this book helps policymakers in developing and emerging countries to better explore TRIPS flexibilities when dealing with similar problems, and provides practitioners in the law of the World Trade Organization, patent law, competition law, and health law with a guide to how a more equitable pharmaceutical patenting system could work in practice.

Drugs, Patents and Policy

Author : Bryan Mercurio
Publisher : Unknown
Page : 241 pages
File Size : 40,8 Mb
Release : 2018-06-28
Category : Business & Economics
ISBN : 9781316512340

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Drugs, Patents and Policy by Bryan Mercurio Pdf

A comprehensive review of Hong Kong's pharmaceutical patent law that will influence debate and inform public policy.

Patent Games in the Global South

Author : Amaka Vanni
Publisher : Bloomsbury Publishing
Page : 240 pages
File Size : 45,8 Mb
Release : 2020-02-06
Category : Law
ISBN : 9781509927401

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Patent Games in the Global South by Amaka Vanni Pdf

In this thought-provoking analysis, the author takes three examples of emerging markets (Brazil, India, and Nigeria) and tells their stories of pharmaceutical patent law-making. Adopting historiographical and socio-legal approaches, focus is drawn to the role of history, social networks and how relationships between a variety of actors shape the framing of, and subsequently the responses to, national implementation of international patent law. In doing so, the book reveals why the experience of Nigeria – a country active in opposing the inclusion of IP to the WTO framework during the Uruguay Rounds – is so different from that of Brazil and India. This book makes an original and useful contribution to the further understanding of how both states and non-state actors conceptualise, establish and interpret pharmaceutical patents law, and its domestic implications on medicines access, public health and development. Patent Games in the Global South was awarded the 2018 SIEL–Hart Prize in International Economic Law.

Human Rights and the WTO

Author : Holger Hestermeyer
Publisher : Oxford University Press, USA
Page : 424 pages
File Size : 42,5 Mb
Release : 2007
Category : Law
ISBN : UCSD:31822034750844

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Human Rights and the WTO by Holger Hestermeyer Pdf

This book examines one of the most controversial aspects of the world trading system: patents and access to medication, and offers approaches to tackle the issue of how to better accommodate human rights in the trading system.

Pharmaceutical and Biotech Patent Law

Author : Arnold & Porter Kaye Scholer Llp
Publisher : Unknown
Page : 1204 pages
File Size : 49,8 Mb
Release : 2019-06-07
Category : Bioethics
ISBN : 1402431384

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Pharmaceutical and Biotech Patent Law by Arnold & Porter Kaye Scholer Llp Pdf

Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.

Pharmaceutical Patent Protection and World Trade Law

Author : Jae Sundaram
Publisher : Routledge
Page : 240 pages
File Size : 42,6 Mb
Release : 2020-08-14
Category : Electronic
ISBN : 0367590913

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Pharmaceutical Patent Protection and World Trade Law by Jae Sundaram Pdf

Patents, including pharmaceutical patents, enjoy extended protection for twenty years under the TRIPs Agreement. The Agreement has resulted in creating a two-tier system of the World Trade Organisation Member States, and its implementation has seen the price of pharmaceutical products skyrocket, putting essential medicines beyond the reach of the common man. The hardest hit populations come from the developing and least developed countries, which have either a weak healthcare system or no healthcare at all, where access to essential and affordable medicines is extremely difficult to achieve. Pharmaceutical Patent Protection and World Trade Law studies the problems faced by these countries in obtaining access to affordable medicines for their citizens in light of the TRIPS Agreement. It explores the opportunities that are still open for some developing countries to utilise the flexibilities available under the TRIPS Agreement in order to mitigate the damage caused by it. The book also examines the interrelationship between the world governing bodies, and the right to health contained in some of the developing country's national constitutions.

The Commercialization of Pharmaceutical Patents in China

Author : James Hou
Publisher : Edward Elgar Publishing
Page : 352 pages
File Size : 49,8 Mb
Release : 2021-03-28
Category : Electronic
ISBN : 1789908221

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The Commercialization of Pharmaceutical Patents in China by James Hou Pdf

Presenting detailed analysis of the industrialization and commercialization 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 whist also protecting society's right to safe and effective medication. Chapters examine the special application issues of patent law in relation to the field of pharmaceuticals, compare the Chinese and American legal systems and their approach to pharmaceutical patents, and provide in depth political and legal analysis of the industry. James Hou suggests methods by which the Chinese legal system can seek to improve its governance of pharmaceutical patents and balance the conflicts of interest arising between new drug developers, established drug manufacturers and the end users. Featuring comprehensive coverage of patents in the Chinese pharmaceutical industry, this book will be a key resource for scholars and students of commercial, pharmaceutical and intellectual property law, whilst also being of interest to industry talents discovering the potential of their own innovations.