Second Generation Patents In Pharmaceutical Innovation

Author : Hyewon Ahn
Publisher : Unknown
Page : 355 pages
File Size : 47,5 Mb
Release : 2014-08-21
Category : LAW
ISBN : 3845250860

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Second Generation Patents in Pharmaceutical Innovation by Hyewon Ahn Pdf

Die Entwicklung neuer Medikamente und deren Verbesserungen sind entscheidend, um deutliche Fortschritte in der Gesundheitsversorgung zu gewnhrleisten. Der Entwicklungsprozess ist lang und teuer, insbesondere der Aufwand, der betrieben werden muss, um den hohen Regulierungsanforderungen gerecht zu werden. Im Gegensatz dazu verursacht die Nachahmung von Medikamenten vernachlnssigbare Kosten und birgt deutlich weniger Risiken. Dies ist einer der Grnde, warum der Patentschutz fr die die pharmazeutische Industrie von so groer Bedeutung ist. Trotz des bestehenden Patentsystems ist gerade wnhrend des letzten Jahrzehnts die Zahl der neuen Medikamente pro Jahr zurckgegangen. Im Vergleich dazu hat sich die Zahl der Patente und Produkte der zweiten Generation drastisch erhAht. Der Pharmaindustrie wird vorgeworfen, ihre ursprngliche Aufgabe, die Entwicklung neuer Medikamente, zu vernachlnssigen, indem sie Produkte der zweiten Generation erzeugt und die Einfhrung von Generika verhindert. Die Dissertation berprft, ob diese Bedenken gerechtfertigt sind, und wenn ja, ob oder wie das Patentsystem den Konflikt zwischen Pharma-Unternehmen und der Gesellschaft im Hinblick auf eine bedarfsgerechte Arzneimittelversorgung lAsen kann. a The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society. aReiheMunich Intellectual Property Law Center - MIPLC - Band 19"

Author : Josef Drexl,Nari Lee
Publisher : Edward Elgar Publishing
Page : 347 pages
File Size : 55,5 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.

Author : Hyewon Ahn
Publisher : Nomos Verlagsgesellschaft
Page : 0 pages
File Size : 45,9 Mb
Release : 2014
Category : Drug development
ISBN : 3848708744

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Second Generation Patents in Pharmaceutical Innovation by Hyewon Ahn Pdf

The development of new medications and improvements thereof are crucial to ensure continued gains in health. The development process is long and costly, and mainly to produce the information to meet high regulatory requirements. In contrast, imitation involves negligible costs and much reduced risks. This is one of the reasons the pharmaceutical industry depends greatly on patent protection. Despite the existing patent system, however, the number of new medications per year has decreased, especially during the last decade. In comparison, the number of second generation patents and products has been drastically increased. This industry is accused both of neglecting its real mission of providing new medications while generating second generation products, and of preventing the entry of generics. The dissertation reviewed whether the concerns are justified, and, if so, whether or how the patent system can improve the situation that confronts pharmaceutical companies and society.

Author : Anonim
Publisher : Unknown
Page : 88 pages
File Size : 55,5 Mb
Release : 1981
Category : Drugs
ISBN : UCR:31210024829986

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Patent-term Extension and the Pharmaceutical Industry by Anonim Pdf

Author : Burcu Kiliç
Publisher : Edward Elgar Publishing
Page : 285 pages
File Size : 54,8 Mb
Release : 2014-07-31
Category : Law
ISBN : 9781782544135

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Boosting Pharmaceutical Innovation in the Post-TRIPS Era by Burcu Kiliç Pdf

Boosting Pharmaceutical Innovation In The Post-TRIPS Era investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, it identifies the key issues relevant to the revival of local pharmaceutical industries.

Author : Callesen Klinge, Ulla
Publisher : Edward Elgar Publishing
Page : 287 pages
File Size : 50,5 Mb
Release : 2022-10-07
Category : Law
ISBN : 9781803927381

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Pharmaceutical Patents under the SPC Regulation by Callesen Klinge, Ulla Pdf

Written by an experienced European Patent Attorney and scholar, this book sets out in detail the framework for protection of pharmaceutical innovation under the SPC Regulation. With a focus on both biotechnological innovation and secondary innovation, and through extensive reference to the case law, Ulla Klinge surveys the court’s evolving interpretation of legal and technical eligibility for this extended term of protection. This book provides clear and pragmatic tools to reflect and guide future practice, while offering key explanations and insights as to why and how technological developments challenge the legal SPC framework.

Author : Carlos M. Correa
Publisher : Unknown
Page : 337 pages
File Size : 41,9 Mb
Release : 2011
Category : Electronic
ISBN : 9291620394

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Pharmaceutical Innovation, Incremental Patenting and Compulsory Licensing by Carlos M. Correa Pdf

Author : World Intellectual Property Organization,María José Abud,Carsten Fink,Bronwyn Hall,Christian Helmers
Publisher : WIPO
Page : 83 pages
File Size : 41,9 Mb
Release : 2013
Category : Law
ISBN : 8210379456XXX

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The Use of Intellectual Property in Chile by World Intellectual Property Organization,María José Abud,Carsten Fink,Bronwyn Hall,Christian Helmers Pdf

This study describes patterns and trends of intellectual property (IP) use in Chile, drawing on a new database containing all patent, trademark, utility model, and design filings received by the Chilean IP office over the period 1991-2010. Among other things, the study offers insights into the drivers of filing growth, the origin of filings, the distribution of applicants, the importance of different applicant types, the share of filings by different economic sectors, the relevance of IP bundles, and the patenting behavior of Chilean applicants overseas.

Author : Ellen F. M. 't Hoen
Publisher : Unknown
Page : 136 pages
File Size : 55,8 Mb
Release : 2009
Category : Agreement on Trade-Related Aspects of Intellectual Property Rights
ISBN : 9079700061

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The Global Politics of Pharmaceutical Monopoly Power by Ellen F. M. 't Hoen Pdf

In The Global Politics of Pharmaceutical Monopoly Power, researcher and global advocate Ellen 't Hoen explains how new global rules for pharmaceutical patenting impact access to medicines in the developing world. The book gives an account of the current debates on intellectual property, access to medicines, and medical innovation, and provides historical context that explains how the current system emerged. This book supports major policy changes in the management of pharmaceutical patents and the way medical innovation is financed in order to protect public health and, in particular, promote access to essential medicines for all. The Open Society Institute provided support to translate this report into Russian.

Author : National Research Council,Policy and Global Affairs,Board on Science, Technology, and Economic Policy,Committee on Intellectual Property Rights in the Knowledge-Based Economy
Publisher : National Academies Press
Page : 352 pages
File Size : 51,9 Mb
Release : 2003-09-11
Category : Political Science
ISBN : 9780309086363

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Patents in the Knowledge-Based Economy by National Research Council,Policy and Global Affairs,Board on Science, Technology, and Economic Policy,Committee on Intellectual Property Rights in the Knowledge-Based Economy Pdf

This volume assembles papers commissioned by the National Research Council's Board on Science, Technology, and Economic Policy (STEP) to inform judgments about the significant institutional and policy changes in the patent system made over the past two decades. The chapters fall into three areas. The first four chapters consider the determinants and effects of changes in patent "quality." Quality refers to whether patents issued by the U.S. Patent and Trademark Office (USPTO) meet the statutory standards of patentability, including novelty, nonobviousness, and utility. The fifth and sixth chapters consider the growth in patent litigation, which may itself be a function of changes in the quality of contested patents. The final three chapters explore controversies associated with the extension of patents into new domains of technology, including biomedicine, software, and business methods.

Author : J¿nos Fischer,Christian Klein,Wayne E. Childers
Publisher : John Wiley & Sons
Page : 472 pages
File Size : 42,8 Mb
Release : 2018-06-05
Category : Medical
ISBN : 9783527343034

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Successful Drug Discovery, Volume 3 by J¿nos Fischer,Christian Klein,Wayne E. Childers Pdf

With its focus on drugs so recently introduced that they have yet to be found in any other textbooks or general references, the information and insight found here makes this a genuinely unique handbook and reference. Following the successful approach of the previous volumes in the series, inventors and primary developers of successful drugs from both industry and academia tell the story of the drug's discovery and describe the sometimes twisted route from the first drug candidate molecule to the final marketed drug. The 11 case studies selected describe recent drugs ranging across many therapeutic fields and provide a representative cross-section of present-day drug developments. Backed by plenty of data and chemical information, the insight and experience of today's top drug creators makes this one of the most useful training manuals that a junior medicinal chemist may hope to find. The International Union of Pure and Applied Chemistry has endorsed and sponsored this project because of its high educational merit.

Author : Robin Feldman,Evan Frondorf
Publisher : Cambridge University Press
Page : 165 pages
File Size : 55,7 Mb
Release : 2017-06-09
Category : Law
ISBN : 9781107168480

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Drug Wars by Robin Feldman,Evan Frondorf Pdf

In this book, Feldman and Frondorf explain how companies employ strategies that block generic medicines from the market and keep prices high.

Author : Sadao Nagaoka
Publisher : Springer Nature
Page : 333 pages
File Size : 41,7 Mb
Release : 2019-10-24
Category : Science
ISBN : 9789811389061

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Drug Discovery in Japan by Sadao Nagaoka Pdf

This book analyzes the drug-discovery process in Japan, based on detailed case studies of 12 groups of 15 innovative drugs. It covers the first statin in the world up to the recent major breakthrough in cancer therapy, the recent immune checkpoint inhibitor, the scientific discovery for which a 2018 Nobel Prize in Physiology or Medicine was awarded to Prof. Tasuku Honjo, Kyoto University. The book shows the pervasive high uncertainty in drug discovery: frequent occurrences of unexpected difficulties, discontinuations, serendipities, and good luck, significantly because drug discovery starts when the underlying science is incomplete. Thus, there exist dynamic interactions between scientific progress and drug discovery. High uncertainty also makes the value of an entrepreneurial scientist high. Such scientists fill the knowledge gaps by absorbing external scientific progress and by relentless pursuit of possibilities through their own research, often including unauthorized research, to overcome crises. Further, high uncertainty and its resolution significantly characterize the evolution of competition in the drug industry. The patent system promotes innovation under high uncertainty not only by enhancing appropriability of R&D investment but also by facilitating the combination of knowledge and capabilities among different firms through disclosure. Understanding such a process significantly benefits the creation of innovation management and policy practices.

Author : Jonathan Griffiths,Tuomas Mylly
Publisher : Oxford University Press
Page : 401 pages
File Size : 53,5 Mb
Release : 2022-02-14
Category : Law
ISBN : 9780198863168

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Global Intellectual Property Protection and New Constitutionalism by Jonathan Griffiths,Tuomas Mylly Pdf

The constitutionalization of intellectual property law is often framed as a benign and progressive integration of intellectual property with fundamental rights. Yet this is not a full or even an adequate picture of the ongoing constitutionalization processes affecting IP. This collection of essays, written by international experts and covering a range of different areas of intellectual property law, takes a broader approach to the process. Drawing on constitutional theory, and particularly on ideas of "new constitutionalism", the chapters engage with the complex array of contemporary legal constraints on intellectual property law-making. Such constraints arising in international intellectual property law, human rights law (including human rights protection for right-holders), investment treaties, and forms of private ordering. This collection aims to illuminate the complex role of this constitutional framework, by analysing the overlaps, complementarities, and conflicts between such forms of protection and seeking to establish the effects that this assemblage of global and regional norms has on legal reform projects and interpretations of IP law. Some chapters take a broad theoretical perspective on these processes. Others focus on specific situations in which the relationship between intellectual property law and broader constitutional norms is significant. These contexts range from Art 17 of the EU's Digital Single Market Directive, to the implementation of harmonized trade secrets protection, from the role of Canada's Charter of Rights to the impact of the social model of property in Brazil.

Author : Srividhya Ragavan,Amaka Vanni
Publisher : Routledge
Page : 522 pages
File Size : 40,5 Mb
Release : 2021-07-28
Category : Law
ISBN : 9781000398700

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Intellectual Property Law and Access to Medicines by Srividhya Ragavan,Amaka Vanni Pdf

The history of patent harmonization is a story of dynamic actors, whose interactions with established structures shaped the patent regime. From the inception of the trade regime to include intellectual property (IP) rights to the present, this book documents the role of different sets of actors – states, transnational business corporations, or civil society groups – and their influence on the structures – such as national and international agreements, organizations, and private entities – that have caused changes to healthcare and access to medication. Presenting the debates over patents, trade, and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), as it galvanized non-state and nonbusiness actors, the book highlights how an alternative framing and understanding of pharmaceutical patent rights emerged: as a public issue, instead of a trade or IP issue. The book thus offers an important analysis of the legal and political dynamics through which the contest for access to lifesaving medication has been, and will continue to be, fought. In addition to academics working in the areas of international law, development, and public health, this book will also be of interest to policy makers, state actors, and others with relevant concerns working in nongovernmental and international organizations.