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Author: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
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Book Description
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: Martin A. Voet
Publisher: BrownWalker Press
ISBN: 1627347461
Category : Law
Languages : en
Pages : 240
Get Book Here
Book Description
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: Julio J. Nogués
Publisher: World Bank Publications
ISBN:
Category : Developing countries
Languages : en
Pages : 46
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Book Description
Lengthen effective patent protection in industrial countries and press developing countries to introduce patent protection. These two tactics have become important parts of the R&D-intensive pharmaceutical industry's strategy to regain losses in market share associated with more stringent drug safety regulations and increased competition from generic drug companies.
Author: Joseph M. Gabriel
Publisher: University of Chicago Press
ISBN: 022610821X
Category : History
Languages : en
Pages : 345
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Book Description
During most of the nineteenth century, physicians and pharmacists alike considered medical patenting and the use of trademarks by drug manufacturers unethical forms of monopoly; physicians who prescribed patented drugs could be, and were, ostracized from the medical community. In the decades following the Civil War, however, complex changes in patent and trademark law intersected with the changing sensibilities of both physicians and pharmacists to make intellectual property rights in drug manufacturing scientifically and ethically legitimate. By World War I, patented and trademarked drugs had become essential to the practice of good medicine, aiding in the rise of the American pharmaceutical industry and forever altering the course of medicine. Drawing on a wealth of previously unused archival material, Medical Monopoly combines legal, medical, and business history to offer a sweeping new interpretation of the origins of the complex and often troubling relationship between the pharmaceutical industry and medical practice today. Joseph M. Gabriel provides the first detailed history of patent and trademark law as it relates to the nineteenth-century pharmaceutical industry as well as a unique interpretation of medical ethics, therapeutic reform, and the efforts to regulate the market in pharmaceuticals before World War I. His book will be of interest not only to historians of medicine and science and intellectual property scholars but also to anyone following contemporary debates about the pharmaceutical industry, the patenting of scientific discoveries, and the role of advertising in the marketplace.
Author: George B. Griffenhagen
Publisher: Good Press
ISBN:
Category : Fiction
Languages : en
Pages : 71
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Book Description
"Old English Patent Medicines in America" examines the use and influence of English patent medicines in America during the 18th and 19th centuries, shedding light on their cultural and economic significance.
Author: Thomas Owen
Publisher:
ISBN:
Category : Drug accessibility
Languages : en
Pages : 352
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Book Description
Author: Cynthia Ho
Publisher: Oxford University Press
ISBN: 0199750181
Category : Law
Languages : en
Pages : 429
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Book Description
Access to medicine is a topic of widespread interest. However, some issues that impact such access are presently inadequately understood. In particular, international laws require most nations to provide patents on drugs, resulting in premium prices that limit access. In Access to Medicine in the Global Economy, Professor Cynthia Ho explains such laws and their impact for a diverse group of readers, from scholars and policy makers to students in a variety of disciplines. This book explains and interprets important international agreements, beginning with the landmark Agreement on Trade Related Aspects of Intellectual Property (TRIPS), but also including more recent free trade agreements and the pending Anti-Counterfeiting Trade Agreement (ACTA). Professor Ho addresses controversial topics, such as when a nation can provide a compulsory license, as well as whether a nation may suspend in-transit generic goods. The book also discusses how patent-like rights (such as "data exclusivity") prevent lower-cost generic medicines from entering into the marketplace and provides strategies for minimizing the harm of such rights. Clear explanations and diagrams, frequently asked questions, and case studies make these topics accessible to any reader. The case studies also provide a theory of patent perspectives that helps explain why access to medicine, though a universal goal, remains elusive in practice. The book aims to provide an important first step toward eventual workable solutions by promoting a better understanding of existing and future laws that impact access to medicine.
Author: Emmanuel Kolawole Oke
Publisher: Cambridge University Press
ISBN: 1108472109
Category : Law
Languages : en
Pages : 185
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Book Description
An exploration of the tension between human rights and patent law, with reference to developing countries' access to affordable medicines.
Author: Sherry S. Marcellin
Publisher: Routledge
ISBN: 1317020790
Category : Political Science
Languages : en
Pages : 226
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Book Description
This book provides a fresh, multidisciplinary, and exciting look at the making and remaking of pharmaceutical patents at the GATT/WTO, by utilising a Coxian political economy of continuity and change in the global political economy (GPE). Marcellin focuses on the role of the transnational drug industry in the making of the patent provisions in the original TRIPS Agreement and consequently, the role of the African Group at the WTO in the remaking of those patent provisions.
Author:
Publisher:
ISBN:
Category : Drugs
Languages : en
Pages : 88
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Book Description
Author: POKU ADUSEI
Publisher: Springer Science & Business Media
ISBN: 3642325157
Category : Law
Languages : en
Pages : 312
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Book Description
This book critically investigates the patent protection of medication in light of the threats posed by HIV/AIDS, malaria and tuberculosis epidemics to the citizens of countries in Sub-Saharan Africa (hereinafter “SSA” or “Africa”). The book outlines the systemic problems associated with the prevailing globalized patent regime and the regime’s inability to promote access to life-saving medication at affordable prices in SSA. It argues that for pharmaceutical patents to retain their relevance in SSA countries, human development concepts must be integrated into global patent law- and policy-making. An integrative approach implies developing additional public health and human development exceptions/limitations to the exercise of patent rights with the goal of scaling up access to medication that can treat epidemics in SSA. By drawing on multiple perspectives of laws, institutions, practices, and politics, the book suggests that SSA countries adopt an evidence-based approach to implementing global patent standards in domestic jurisdictions. This evidence-based approach would include mechanisms like local need assessments and the use of empirical data to shape domestic patent law-making endeavors. The approach also implies revising patent rules and policies with a pro-poor and pro-health emphasis, so that medication will be more affordable and accessible to the citizens of SSA countries. It also suggests considering the opinions of individuals and pro-access institutions in enacting crucial pieces of health-related statutes in SSA countries. The approach in this book is sensitive to the public health needs of the citizens affected by epidemics and to the imperative of building local manufacturing facilities for pharmaceutical research and development in SSA.
