Evergreening Patent Exclusivity In Pharmaceutical Products

Author : Frantzeska Papadopoulou
Publisher : Bloomsbury Publishing
Page : 298 pages
File Size : 43,8 Mb
Release : 2021-09-23
Category : Law
ISBN : 9781509950294

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Evergreening Patent Exclusivity in Pharmaceutical Products by Frantzeska Papadopoulou Pdf

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.

Author : Martin A. Voet
Publisher : BrownWalker Press
Page : 240 pages
File Size : 48,7 Mb
Release : 2020-05-01
Category : Law
ISBN : 9781627347464

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The Generic Challenge by Martin A. Voet Pdf

This Sixth Edition of The Generic Challenge provides important new updates on current regulatory, legal and commercial issues affecting brand and generic pharmaceutical products, including new laws establishing generics for biologics, and changes brought about by the recently enacted America Invents Act. It explains clearly and understandably the roles of patents, FDA regulation of drugs and the Hatch Waxman Act in commercial drug development in light of generic challenges and how improvements in innovative drug products provide benefits to patients while extending the commercial lives of the drugs. There is simply no other book of its kind on this important subject.

Author : Monika Mulchandani
Publisher : Unknown
Page : 58 pages
File Size : 51,8 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.

Author : Frantzeska Papadopoulou
Publisher : Bloomsbury Publishing
Page : 368 pages
File Size : 50,5 Mb
Release : 2021-09-23
Category : Law
ISBN : 9781509950300

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Evergreening Patent Exclusivity in Pharmaceutical Products by Frantzeska Papadopoulou Pdf

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.

Author : Robin Feldman,Evan Frondorf
Publisher : Cambridge University Press
Page : 165 pages
File Size : 51,8 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 : National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies
Publisher : National Academies Press
Page : 235 pages
File Size : 46,5 Mb
Release : 2018-03-01
Category : Medical
ISBN : 9780309468084

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Making Medicines Affordable by National Academies of Sciences, Engineering, and Medicine,Health and Medicine Division,Board on Health Care Services,Committee on Ensuring Patient Access to Affordable Drug Therapies Pdf

Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.

Author : Kung-Chung Liu,Uday S. Racherla
Publisher : Springer Nature
Page : 513 pages
File Size : 48,8 Mb
Release : 2019-09-06
Category : Law
ISBN : 9789811381027

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Innovation, Economic Development, and Intellectual Property in India and China by Kung-Chung Liu,Uday S. Racherla Pdf

This open access book analyses intellectual property codification and innovation governance in the development of six key industries in India and China. These industries are reflective of the innovation and economic development of the two economies, or of vital importance to them: the IT Industry; the film industry; the pharmaceutical industry; plant varieties and food security; the automobile industry; and peer production and the sharing economy. The analysis extends beyond the domain of IP law, and includes economics and policy analysis. The overarching concern that cuts through all chapters is an inquiry into why certain industries have developed in one country and not in the other, including: the role that state innovation policy and/or IP policy played in such development; the nature of the state innovation policy/IP policy; and whether such policy has been causal, facilitating, crippling, co-relational, or simply irrelevant. The book asks what India and China can learn from each other, and whether there is any possibility of synergy. The book provides a real-life understanding of how IP laws interact with innovation and economic development in the six selected economic sectors in China and India. The reader can also draw lessons from the success or failure of these sectors.

Author : Monica Donghi
Publisher : Nomos Verlagsgesellschaft
Page : 0 pages
File Size : 47,8 Mb
Release : 2014
Category : Drugs
ISBN : 3848709910

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Patent Strategy in Pharmaceutical Industry by Monica Donghi Pdf

This book investigates lifecycle management strategies used by pharmaceutical companies attempting to maximize the value of their product portfolio. Such strategies are sometimes referred to by generic drug companies as "evergreening". The analysis focuses on two of these strategies, namely product improvements and product line extensions. In particular, an evaluation of the patents that follow the basic one and that accompany the development of a drug from research to market is attempted. Two "blockbuster" drugs, Taxotere and Xalatan, were randomly chosen to carry out such analysis. The patent portfolio of the originator companies is outlined and some important patents for each area of research (e.g. formulations, combinations, delivery devices) are shortly described. Patent filing trends for the two drugs, both in regards of the originator and in regards of other competing companies (amongst these also the generics) are schematically shown.

Author : Anonim
Publisher : DIANE Publishing
Page : 129 pages
File Size : 45,5 Mb
Release : 2002
Category : Electronic
ISBN : 9781428951938

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Generic drug entry prior to patent expiration an FTC study by Anonim Pdf

Author : John R. Thomas
Publisher : DIANE Publishing
Page : 21 pages
File Size : 47,8 Mb
Release : 2011
Category : Law
ISBN : 9781437928181

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Intellectual Property in Industrial Designs by John R. Thomas Pdf

This is a print on demand edition of a hard to find publication. Under current intellectual property laws, industrial designs (ID) may potentially be protected through design patents, trade dress, and copyright. In addition, the Vessel Hull Design Protection Actestablished a specialized, or sui generis, intellectual property right for the protection of boat hull designs. Some experts argue that the present intellectual property regime does not adequately protect ID. Contents of this report: (1) ID and Intellectual Property: Copyright; Trade Dress; Design Patents; Vessel Hull Design Protection; (2) Current Issues in ID Protection: Intellectual Property Rights in Fashion Designs; U.S. Adherence to the Hague Convention; Auto Spare Parts; Judicial Developments Concerning ID Patents; (3) Issues in Innovation and Competition.

Author : World Intellectual Property Organization,María José Abud,Carsten Fink,Bronwyn Hall,Christian Helmers
Publisher : WIPO
Page : 83 pages
File Size : 49,8 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 : Kerry Ten Kate,Sarah A Laird
Publisher : Routledge
Page : 818 pages
File Size : 53,7 Mb
Release : 2019-09-18
Category : Nature
ISBN : 9781000699845

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The Commercial Use of Biodiversity by Kerry Ten Kate,Sarah A Laird Pdf

Originally published in 1999 The Commercial Use of Biodiversity examines how biodiversity and the genetic material it contains are now as valuable resources. Access to genetic resources and their commercial development involve a wide range of parties such as conservation and research institutes, local communities, government agencies and companies. Equitable partnerships are not only crucial to conservation and economic development but are also in the interests of business and often required by law. In this authoritative and comprehensive volume, the authors explain the provisions of the Convention on Biological Diversity on access and benefit-sharing, the effect of national laws to implement these, and aspects of typical contracts for the transfer of materials. They provide a unique sector-by-sector analysis of how genetic resources are used, the scientific, technological and regulatory trends and the different markets in Pharmaceuticals, Botanical Medicines, Crop Development, Horticulture, Crop Protection, Biotechnology (in fields other than healthcare and agriculture) and Personal Care and Cosmetics Products. This will be an essential sourcebook for all those in the commercial chain, from raw material collection to product discovery, development and marketing, for governments and policy-makers drafting laws on access and for all the institutions, communities and individuals involved in the conservation, use, study and commercialisation of genetic resources.

Author : Shashank Upadhye
Publisher : Unknown
Page : 643 pages
File Size : 54,5 Mb
Release : 2008
Category : Generic drugs
ISBN : 0314991441

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Generic Pharmaceutical Patent and FDA Law by Shashank Upadhye Pdf

Author : Ellen F. M. 't Hoen
Publisher : Unknown
Page : 136 pages
File Size : 45,6 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 : Fritz Machlup
Publisher : Unknown
Page : 100 pages
File Size : 45,6 Mb
Release : 1958
Category : Patents
ISBN : UOM:39015016875901

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An Economic Review of the Patent System by Fritz Machlup Pdf

At head of title: 85th Cong., 2d sess. Committee print. Bibliography: p. 81-86.