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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.
Book Synopsis The Generic Challenge by : Martin A. Voet
Download or read book The Generic Challenge written by Martin A. Voet and published by BrownWalker Press. This book was released on 2020-05-01 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
Book Synopsis Private Patents and Public Health by : Ellen F. M. 't Hoen
Download or read book Private Patents and Public Health written by Ellen F. M. 't Hoen and published by . This book was released on 2016 with total page 181 pages. Available in PDF, EPUB and Kindle. Book excerpt: Millions of people around the world do not have access to the medicines they need to treat disease or alleviate suffering. Strict patent regimes introduced following the establishment of the World Trade Organization in 1995 interfere with widespread access to medicines by creating monopolies that keep medicines prices well out of reach for many. 0The AIDS crisis in the late nineties brought access to medicines challenges to the public?s attention, when millions of people in developing countries died from an illness for which medicines existed, but were not available or affordable. Faced with an unprecedented health crisis ? 8,000 people dying daily ? the public health community launched an unprecedented global effort that eventually resulted in the large-scale availability of low-priced generic HIV medicines. 0But now, high prices of new medicines - for example, for cancer, tuberculosis and hepatitis C - are limiting access to treatment in low-, middle and high-income countries alike. Patent-based monopolies affect almost all medicines developed since 1995 in most countries, and global health policy is now at a critical juncture if the world is to avoid new access to medicines crises. 0This book discusses lessons learned from the HIV/AIDS crisis, and asks whether actions taken to extend access and save lives are exclusive to HIV or can be applied more broadly to new global access challenges.
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.
Book Synopsis Patents and Pharmaceutical Drugs by : Julio J. Nogués
Download or read book Patents and Pharmaceutical Drugs written by Julio J. Nogués and published by World Bank Publications. This book was released on 1990 with total page 46 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
"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.
Book Synopsis Old English Patent Medicines in America by : George B. Griffenhagen
Download or read book Old English Patent Medicines in America written by George B. Griffenhagen and published by Good Press. This book was released on 2019-12-10 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: "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.
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.
Book Synopsis Medical Monopoly by : Joseph M. Gabriel
Download or read book Medical Monopoly written by Joseph M. Gabriel and published by University of Chicago Press. This book was released on 2014-10-24 with total page 345 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
A major feature of the HIV/AIDS crisis has been the dispute over intellectual property protection and medicines access. Weaving together contemporary media theory and interdisciplinary research with news analysis and interviews with journalists and civil society campaigners, the book illuminates the intersecting constitutive relationships between global crises, global governance, and global media.
Book Synopsis Patents, Pills, and the Press by : Thomas Owen
Download or read book Patents, Pills, and the Press written by Thomas Owen and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: A major feature of the HIV/AIDS crisis has been the dispute over intellectual property protection and medicines access. Weaving together contemporary media theory and interdisciplinary research with news analysis and interviews with journalists and civil society campaigners, the book illuminates the intersecting constitutive relationships between global crises, global governance, and global media.
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.
Book Synopsis Access to Medicine in the Global Economy by : Cynthia Ho
Download or read book Access to Medicine in the Global Economy written by Cynthia Ho and published by Oxford University Press. This book was released on 2011-04-05 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Patent law is crucial to encourage technological innovation. But as the patent system currently stands, diverse industries from pharmaceuticals to software to semiconductors are all governed by the same rules even though they innovate very differently. The result is a crisis in the patent system, where patents calibrated to the needs of prescription drugs wreak havoc on information technologies and vice versa. According to Dan L. Burk and Mark A. Lemley in The Patent Crisis and How the Courts Can Solve It, courts should use the tools the patent system already gives them to treat patents in different industries differently. Industry tailoring is the only way to provide an appropriate level of incentive for each industry. Burk and Lemley illustrate the barriers to innovation created by the catch-all standards in the current system. Legal tools already present in the patent statute, they contend, offer a solution—courts can tailor patent law, through interpretations and applications, to suit the needs of various types of businesses. The Patent Crisis and How the Courts Can Solve It will be essential reading for those seeking to understand the nexus of economics, business, and law in the twenty-first century.
Book Synopsis The Patent Crisis and How the Courts Can Solve It by : Dan L. Burk
Download or read book The Patent Crisis and How the Courts Can Solve It written by Dan L. Burk and published by University of Chicago Press. This book was released on 2009-08-01 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: Patent law is crucial to encourage technological innovation. But as the patent system currently stands, diverse industries from pharmaceuticals to software to semiconductors are all governed by the same rules even though they innovate very differently. The result is a crisis in the patent system, where patents calibrated to the needs of prescription drugs wreak havoc on information technologies and vice versa. According to Dan L. Burk and Mark A. Lemley in The Patent Crisis and How the Courts Can Solve It, courts should use the tools the patent system already gives them to treat patents in different industries differently. Industry tailoring is the only way to provide an appropriate level of incentive for each industry. Burk and Lemley illustrate the barriers to innovation created by the catch-all standards in the current system. Legal tools already present in the patent statute, they contend, offer a solution—courts can tailor patent law, through interpretations and applications, to suit the needs of various types of businesses. The Patent Crisis and How the Courts Can Solve It will be essential reading for those seeking to understand the nexus of economics, business, and law in the twenty-first century.
An exploration of the tension between human rights and patent law, with reference to developing countries' access to affordable medicines.
Book Synopsis Patents, Human Rights, and Access to Medicine by : Emmanuel Kolawole Oke
Download or read book Patents, Human Rights, and Access to Medicine written by Emmanuel Kolawole Oke and published by Cambridge University Press. This book was released on 2022-03-03 with total page 185 pages. Available in PDF, EPUB and Kindle. Book excerpt: An exploration of the tension between human rights and patent law, with reference to developing countries' access to affordable medicines.
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.
Book Synopsis Patenting of Pharmaceuticals and Development in Sub-Saharan Africa by : POKU ADUSEI
Download or read book Patenting of Pharmaceuticals and Development in Sub-Saharan Africa written by POKU ADUSEI and published by Springer Science & Business Media. This book was released on 2012-10-24 with total page 312 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
