Second Generation Patents in Pharmaceutical Innovation

Second Generation Patents in Pharmaceutical Innovation PDF

Author: Hyewon Ahn

Publisher:

Published: 2014-08-21

Total Pages: 355

ISBN-13: 9783845250861

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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"

Second Generation Patents in Pharmaceutical Innovation

Second Generation Patents in Pharmaceutical Innovation PDF

Author: Hyewon Ahn

Publisher: Nomos Verlagsgesellschaft

Published: 2014

Total Pages: 0

ISBN-13: 9783848708741

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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.

Pharmaceutical Innovation, Competition and Patent Law

Pharmaceutical Innovation, Competition and Patent Law PDF

Author: Josef Drexl

Publisher: Edward Elgar Publishing

Published: 2013-01-01

Total Pages: 347

ISBN-13: 0857932462

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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.

Boosting Pharmaceutical Innovation in the Post-TRIPS Era

Boosting Pharmaceutical Innovation in the Post-TRIPS Era PDF

Author: Burcu Kiliç

Publisher: Edward Elgar Publishing

Published: 2014-07-31

Total Pages: 285

ISBN-13: 1782544135

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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.

Pharmaceutical Patents under the SPC Regulation

Pharmaceutical Patents under the SPC Regulation PDF

Author: Callesen Klinge, Ulla

Publisher: Edward Elgar Publishing

Published: 2022-10-07

Total Pages: 287

ISBN-13: 1803927380

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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.

Leading Pharmaceutical Innovation

Leading Pharmaceutical Innovation PDF

Author: Oliver Gassmann

Publisher: Springer

Published: 2018-05-10

Total Pages: 179

ISBN-13: 3319668331

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Pharmaceutical giants have been doubling their investments in drug development, only to see new drug approvals to remain constant for the past decade. This book investigates and highlights a set of proactive strategies, aimed at generating sustainable competitive advantage for its protagonists based on value-generating business practices. We focus on three sources of pharmaceutical innovation: new management methods in the drug development pipeline, new technologies as enablers for cutting-edge R&D, and new forms of internationalisation, such as outside-in innovation in the early phases of R&D.

Intellectual Property, Pharmaceuticals and Public Health

Intellectual Property, Pharmaceuticals and Public Health PDF

Author: Kenneth C. Shadlen

Publisher: Edward Elgar Publishing

Published: 2011-01-01

Total Pages: 353

ISBN-13: 0857938614

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'This impressive collection offers fascinating new perspectives on the impact of pharmaceutical patents on access to medicines in developing countries. The volume's editors have put together an important book that sets out clearly the challenges to public health in a wide range of national contexts. The book will be a valuable text for all scholars and decision-makers interested in the global politics of intellectual property rights and public health.' – Duncan Matthews, Queen Mary, University of London, UK This up-to-date book examines pharmaceutical development, access to medicines, and the protection of public health in the context of two fundamental changes that the global political economy has undergone since the 1970s, the globalization of trade and production and the increased harmonization of national regulations on intellectual property rights. With authors from eleven different countries presenting case studies of national experiences in Africa, Asia and the Americas, the book analyzes national strategies to promote pharmaceutical innovation, while at the same time assuring widespread access to medicines through generic pharmaceutical production and generic pharmaceutical importation. The expert chapters focus on patents as well as an array of regulatory instruments, including pricing and drug registration policies. Presenting in-depth analysis and original empirical research, this book will strongly appeal to academics and students of intellectual property, international health, international political economy, international development and law.

Overdose

Overdose PDF

Author: Richard Allen Epstein

Publisher: Yale University Press

Published: 2006-01-01

Total Pages: 295

ISBN-13: 0300116640

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This book is the first to offer a comprehensive examination of the pharmaceutical industry by following the tortuous course of a new drug as it progresses from early development to final delivery. Richard A. Epstein looks closely at the regulatory framework that surrounds all aspects of making pharmaceutical products today, and he assesses which current legal and regulatory practices make sense and which have gone awry. While critics of pharmaceutical companies call for ever more stringent controls on virtually every aspect of drug development and approval, Epstein cautions that the effect of such an approach will be to stifle pharmaceutical innovation and slow the delivery of beneficial treatments to the patients who need them. The author considers an array of challenges that confront the industry--conflicts of interest among government, academe, and the drug companies; intellectual property rights that govern patents; FDA regulation; pricing disputes; marketing practices; and liability issues, including those brought to light in the recent VIOXX case. Epstein argues that to ensure the continuing creativity, efficiency, and success of the pharmaceutical industry, the best system will feature strong property rights and clearly enforceable contracts, with minimal regulatory and judicial interference.