Download or read book Pharmaceutical and Biotech Patent Law written by Arnold & Porter Kaye Scholer Llp and published by . This book was released on 2019-06-07 with total page 1204 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical and Biotech Patent Law provides you with the legal, scientific, and technical information you need to help clients obtain, defend, and challenge patents in these important business areas. This practical guide shows you how to craft problem-free patent applications, including how to partner with the government to bring patented inventions quickly to the marketplace - invalidate competitors' patents by proving that they fail to meet key requirements - protect against various forms of patent infringement - and successfully rebut charges of infringement. It includes detailed checklists that help you resolve thorny patent problems in the complex pharmaceutical and biotech fields, and is regularly updated to reflect Federal Circuit rulings and other significant court decisions.
Download or read book Patents for Chemicals Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press, USA. This book was released on 2004 with total page 552 pages. Available in PDF, EPUB and Kindle. Book excerpt: Previous editions, 1st and 2nd, published under titles : 1st (1982) Patents for chemists ; 2nd (1986) Patents in chemistry and biotechnology ; 3rd edition published in 1999.
Download or read book Patents for Chemicals Pharmaceuticals and Biotechnology written by Philip W. Grubb and published by Oxford University Press, USA. This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The nature and origins of patent rights -- Historical developments -- Harmonization of patent law -- What can be patented -- Filing a patent application -- Obtaining a granted patent : patent cooperation treaty procedure -- Obtaining a granted patent : European patent office procedure -- Obtaining a granted patent : national procedures -- Maintaining a patent in force and extending the patent term -- Enforcing patent rights -- Invalidity and amendment of granted patents -- Chemical inventions -- Pharmaceutical inventions -- Biotechnological inventions -- Patenting of genes, plants, and animals -- The patent practitioner and his function -- Drafting the patent specification -- Drafting the claims -- Prosecution of the patent application to grant -- Inventorship, ownership, and compensation -- Commercial exploitation of patents -- How to catch the infringer and how not to be caught -- Patent aspects of licensing -- Patents and competition law : United Kingdom and European Union -- Patents and competition law : United States
Download or read book Economic Regulation and Its Reform written by Nancy L. Rose and published by University of Chicago Press. This book was released on 2014-08-29 with total page 619 pages. Available in PDF, EPUB and Kindle. Book excerpt: The past thirty years have witnessed a transformation of government economic intervention in broad segments of industry throughout the world. Many industries historically subject to economic price and entry controls have been largely deregulated, including natural gas, trucking, airlines, and commercial banking. However, recent concerns about market power in restructured electricity markets, airline industry instability amid chronic financial stress, and the challenges created by the repeal of the Glass-Steagall Act, which allowed commercial banks to participate in investment banking, have led to calls for renewed market intervention. Economic Regulation and Its Reform collects research by a group of distinguished scholars who explore these and other issues surrounding government economic intervention. Determining the consequences of such intervention requires a careful assessment of the costs and benefits of imperfect regulation. Moreover, government interventions may take a variety of forms, from relatively nonintrusive performance-based regulations to more aggressive antitrust and competition policies and barriers to entry. This volume introduces the key issues surrounding economic regulation, provides an assessment of the economic effects of regulatory reforms over the past three decades, and examines how these insights bear on some of today’s most significant concerns in regulatory policy.
Download or read book Drafting Agreements in the Biotechnology and Pharmaceutical Industries written by Mark Anderson and published by OUP Oxford. This book was released on 2009-04-02 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Provides precedent agreements in relation to the main types of commercial transaction encountered in biotechnology and pharmaceutical industries. Each agreement is accompanied by detailed commentary on legal, commercial and practice issues incorporating commentary highlighting key differences between English law and other key EU jurisdictions
Download or read book Guide to EU Pharmaceutical Regulatory Law written by Sally Shorthose and published by Kluwer Law International B.V.. This book was released on 2017-02-17 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: In the European Union (EU) and its Member States, as elsewhere, the marketing of pharmaceuticals has become subject to an increasingly complex web of legislation and regulation, resulting from the intense scrutiny necessary to ensure such essential products are not only efficacious but safe. This useful volume lays out this system with extraordinary clarity and logic. Adopting a Europe-wide perspective on the law governing pharmaceuticals, expert authors from the law firm Bird & Bird LLP map the life cycle of a medicinal product or medical device from development to clinical trials to product launch and ongoing pharmacovigilance, offering comprehensive and unambiguous guidance at every stage. A brief overview of how the proposed exit from the EU by the UK will affect the regulatory regime is also included. Following an introductory overview focusing on the regulatory framework for pharmaceuticals in Europe – from its underlying rationales to the relevant committees and agencies – each of fifteen incisive chapters examines a particular process or subject. Among the many topics and issues covered are the following: - obtaining a marketing authorisation; - stages and standards for creating a product dossier; - clinical trials; - how and when an abridged procedure can be used; - criteria for conditional marketing authorisations; - generic products and ‘essential similarity’; - paediatric use and the requisite additional trials; - biologicals and ‘biosimilars’; - homeopathic and herbal medicines; - reporting procedures; - pharmacovigilance; - parallel trade; - relevant competition law and intellectual property rights; and - advertising. In addition, national variation charts in many of the chapters illustrate eight major jurisdictions (Belgium, France, Germany, Italy, The Netherlands, Spain, Sweden, and the UK). Sample forms and URLs for the most important Directives are included. Pharmaceutical lawyers and regulatory advisers, both in-house and in private practice, will welcome this unique book. It offers immeasurable value for all who need to understand the process of bringing a medicinal product or medical device to market and the continuing rights and obligations.
Download or read book Pharmaceutical Innovation Competition and Patent Law written by Josef Drexl and published by Edward Elgar Publishing. This book was released on 2013-01-01 with total page 347 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book A Practical Guide to FDA s Food and Drug Law and Regulation Seventh Edition written by Stephen M. Kanovsky and published by . This book was released on 2020-09 with total page 672 pages. Available in PDF, EPUB and Kindle. Book excerpt: FDLI's popular reference book, A Practical Guide to FDA's Food and Drug Law and Regulation, Seventh Edition, provides an introduction to the laws and regulations governing development, marketing, and sale of FDA-regulated products, including topics on food, drugs, medical devices, biologics, dietary supplements, cosmetics, new animal drugs, cannabis, and tobacco and nicotine products. Structured to serve as a reference and as a teaching tool, the book offers practical legal and regulatory fundamentals, and each chapter builds sequentially from the last to provide an accessible overview of the key topics relevant to practitioners of food and drug law and regulation. This book is a standard legal text in law schools and graduate regulatory programs and has been cited as a reference in judicial opinions (including the U.S. Supreme Court). This Seventh Edition includes new sections on controlled substances, compounded drugs, and cannabis and cannabis-derived compounds. It also incorporates the latest amendments to the Federal Food, Drug, and Cosmetic Act, as well as FDA regulations and guidances.
Download or read book Biotechnology and the Patent System written by Claude E. Barfield and published by A E I Press. This book was released on 2007 with total page 116 pages. Available in PDF, EPUB and Kindle. Book excerpt: American patent law has reached an unprecedented crossroads, prodded by a landmark Supreme Court decision this spring and the prospect of sweeping new federal legislation this fall. At this critical time, Biotechnology and the Patent System: Balancing Innovation and Property Rights provides a timely look at the complex issues involved in making patent law for cutting-edge high-tech industries such as the biotechnology and computer software sectors.
Download or read book Patent Rights in Pharmaceuticals in Developing Countries written by Jakkrit Kuanpoth and published by Edward Elgar Publishing. This book was released on 2010-01-01 with total page 257 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book engages with a broad range of new case studies, providing a detailed examination of options for the resolution of access-to-medicine issues at global, national and local levels. In addition, the book reflects the significant progress in international and national patent law and in international policy-making in this area.
Download or read book Pharmaceuticals Biotechnology and the Law written by Trevor Bird & Bird LLP and published by Springer. This book was released on 1991-12-12 with total page 845 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book The Business of Healthcare Innovation written by Lawton R. Burns and published by Cambridge University Press. This book was released on 2005-08-25 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: The first wide-ranging analysis of business trends in the manufacturing segment of the health care industry.
Download or read book Career Opportunities in Biotechnology and Drug Development written by Toby Freedman and published by CSHL Press. This book was released on 2008 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.
Download or read book Intellectual Property Pharmaceuticals and Public Health written by Kenneth C. Shadlen and published by Edward Elgar Publishing. This book was released on 2011-01-01 with total page 353 pages. Available in PDF, EPUB and Kindle. Book excerpt: '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.
Download or read book U S Biotechnology Patent Law written by Jorge A. Goldstein and published by . This book was released on 2016 with total page 382 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Deadly Monopolies written by Harriet A. Washington and published by Anchor. This book was released on 2012-11-13 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: From the award-winning author of Medical Apartheid, an exposé of the rush to own and exploit the raw materials of life—including yours. Think your body is your own to control and dispose of as you wish? Think again. The United States Patent Office has granted at least 40,000 patents on genes controlling the most basic processes of human life, and more are pending. If you undergo surgery in many hospitals you must sign away ownership rights to your excised tissues, even if they turn out to have medical and fiscal value. Life itself is rapidly becoming a wholly owned subsidiary of the medical-industrial complex. Deadly Monopolies is a powerful, disturbing, and deeply researched book that illuminates this “life patent” gold rush and its harmful, and even lethal, consequences for public health. Like the bestselling The Immortal Life of Henrietta Lacks, it reveals in shocking detail just how far the profit motive has encroached in colonizing human life and compromising medical ethics.
Download or read book Industrial Pharmaceutical Biotechnology written by Heinrich Klefenz and published by Wiley-VCH. This book was released on 2002-04-22 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: This volume focuses on pharmaceutical biotechnology as a key area of life sciences. The complete range of concepts, processes and technologies of biotechnology is applied in modern industrial pharmaceutical research, development and production. The results of genome sequencing and studies of biological-genetic function are combined with chemical, micro-electronic and microsystem technology to produce medical devices and diagnostic biochips. A multitude of biologically active molecules is expanded by additional novel structures created with newly arranged gene clusters and bio-catalytic chemical processes. New organisational structures in the co-operation of institutes, companies and networks enable faster knowledge and product development and immediate application of the results of research and process development. This book is the ideal source of information for scientists and engineers in research and development, for decision-makers in biotech, pharma and chemical corporations, as well as for research institutes, but also for founders of biotech companies and people working for venture capital corporations.
