Biotechnology and Software Patent Law


Book Description

'The art of editing is to bring contributions together, which melt into one book. This is what Emanuela Arezzo and Gustavo Ghidini have achieved with their own critical mind by composing a book of papers, in which internationally renowned experts measure the tensions created for the patent system by the needs and problems of protecting biotechnological and software inventions. All together, they present a comparative law challenge to the very fundaments of patent protection. As such, they are or may become a "must read".' Hanns Ullrich, College of Europe, Bruges, Belgium 'Arezzo and Ghidini have put together a fine collection of essays addressing developments in patent law from general themes to emerging ones in the infotech and biotech sectors. It is notable that the international array of authors includes contributions from both established and rising young scholars, all of them ably tackling difficult issues that merit our attention.' Rudolph J.R. Peritz, New York Law School, US The new millennium has carried several challenges for patent law. This up-to-date book provides readers with an important overview of the most critical issues patent law is still facing today at the beginning of the twenty first century, on both sides of the Atlantic. New technological sectors have emerged, each one with its own features with regard to innovation process and pace. From the most controversial cases in biotech to the most recent decisions in the field of software and business methods patent, patent law has tried to stretch its boundaries in a way to accommodate such new and controversial subject matters into its realm. Biotechnology and Software Patent Law will strongly appeal to postgraduate students specializing in IP law, international law, commercial and business law, competition law as well as IP scholars, academics and lawyers.




U.S. Biotechnology Patent Law


Book Description




Pharmaceutical Biotechnology


Book Description

This second edition of a very successful book is thoroughly updated with existing chapters completely rewritten while the content has more than doubled from 16 to 36 chapters. As with the first edition, the focus is on industrial pharmaceutical research, written by a team of industry experts from around the world, while quality and safety management, drug approval and regulation, patenting issues, and biotechnology fundamentals are also covered. In addition, this new edition now not only includes biotech drug development but also the use of biopharmaceuticals in diagnostics and vaccinations. With a foreword by Robert Langer, Kenneth J Germeshausen Professor of Chemical and Biomedical Engineering at MIT and member of the National Academy of Engineering and the National Academy of Sciences.




Private Patents and Public Health


Book Description

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.




Intellectual Property and Biotechnology


Book Description

Dr Rimmer s book is a marvellous introduction to a crucial topic of our time. He writes engagingly, provocatively and always with good humour. A highly technical and complex area of law has been reduced to clear descriptions and searching analysis. Truly, this is an important book on an essential topic that will help define the ethics of a future that includes nothing less than the future of our species. From the foreword by the Hon Justice Michael Kirby AC CMG, the High Court of Australia . . . the author has done an excellent job by explaining the subject in an open and accessible manner. This book is a timely and very thought-provoking analysis of patent law and biotechnology. . . The book is a unique theoretical contribution to the controversial public debate over commercialization of biological inventions. . . there is an extensive bibliography. . . a valuable resource for further reading. The book will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists. Journal of Intellectual Property Rights Rimmer s book is highly recommended for anyone interested in the issues and debate related to biological inventions, regardless of which side the reader is on. Stefan M. Miller, Journal of Commercial Biotechnology . . . this book gives an excellent account of the most celebrated biotechnology cases from three continents, and for this alone is to be thoroughly recommended. David Rogers, European Intellectual Property Review Rimmer has put a great deal of thought and effort into this series of chapters. For those looking at how to reform, direct and develop laws in relation to biotechnology, this book is brimming with ideas, suggestions and recommendations of what to do next. Rebecca Halford-Harrison, Chartered Institute of Patent Attorneys . . . an excellent introduction to a wide range of legal thinking in an increasingly controversial and relevant area to humankind. Sharon Givoni, Australian Intellectual Property Law Bulletin Rimmer s new book is a timely and very thought-provoking analysis of patent law and biotechnology and asks a very serious question: can a 19th century patent system adequately deal with a 21st century industry? Kate McDonald, Australian Life Scientist This book documents and evaluates the dramatic expansion of intellectual property law to accommodate various forms of biotechnology from micro-organisms, plants, and animals to human genes and stem cells. It makes a unique theoretical contribution to the controversial public debate over the commercialization of biological inventions. The author also considers the contradictions between the Supreme Court of Canada rulings in respect of the Harvard oncomouse, and genetically modified canola. He explores law, policy, and practice in both Australia and New Zealand in respect to gene patents and non-coding DNA. This study charts the rebellion against the European Union Biotechnology Directive particularly in respect of Myriad Genetics BRCA1 and BRCA2 patents, and stem cell patent applications. The book also considers whether patent law will accommodate frontier technologies such as bioinformatics, haplotype mapping, proteomics, pharmacogenomics, and nanotechnology. Intellectual Property and Biotechnology will be of prime interest to lawyers and patent attorneys, scientists and researchers, business managers and technology transfer specialists.




Patent Law


Book Description

This authoritative, one-stop source of practical information on patent law fundamentals is stocked with forms, diagrams, flowcharts, and hypothetical Q&As. "Patent Law" gives you a hands-on knowledge of the rights, obligations, and limits of all parties - laws governing different types of patents -- basics of patent office prosecution -- tests used to determine the validity of inventions, direct infringement, and third-party liability -- and the steps involved in preparing specifications and patent claims.




The Role of NIH in Drug Development Innovation and Its Impact on Patient Access


Book Description

To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.




Drug Wars


Book Description

While the shockingly high prices of prescription drugs continue to dominate the news, the strategies used by pharmaceutical companies to prevent generic competition are poorly understood, even by the lawmakers responsible for regulating them. In this groundbreaking work, Robin Feldman and Evan Frondorf illuminate the inner workings of the pharmaceutical market and show how drug companies twist health policy to achieve goals contrary to the public interest. In highly engaging prose, they offer specific examples of how generic competition has been stifled for years, with costs climbing into the billions and everyday consumers paying the price. Drug Wars is a guide to the current landscape, a roadmap for reform, and a warning of what is to come. It should be read by policymakers, academics, patients, and anyone else concerned with the soaring costs of prescription drugs.




Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade


Book Description

This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.




Intellectual Property and Competition Law


Book Description

The book ends with a comprehensive selection of the relevant bibliography. This part is all the more valuable to the reader as Ghidini does not simply list the relevant literature but puts it in it general context and comments on it. Ghidini s book is a fascinating trip through the system of IP laws. Beatriz Conde Gallego, Intellectual Property and Competition Law Intellectual Property and Competition Law by Gustavo Ghidini provides a persuasively presented descriptive analysis of a distinctively European perspective on intellectual property law and its relationship to competition law. Professor Ghidini expertly presents the evolution of intellectual property laws and its contemporary manifestations with respect to the expansion copyright law in technological fields and the inevitability conflict with patent law, the attempt at creating monopolies (such as in biotechnology), and so much more. A seminal work of impressive and articulate scholarship, Intellectual Property and Competition Law should be considered mandatory reading for students and researchers in the field of intellectual property rights and a very strongly recommended addition to academic library International Economics and Judicial Studies reference collections. The Economics Shelf, Midwest Book Review . . . the provocative nature of this book is one of its great strengths, as are its cohesiveness and erudition. Mel Marquis, European Competition Law Review We in the United States have much to learn not only from Gustavo Ghidini s careful analysis of modern trends in the European IP regime but also from his thoughtful development of the thesis that free competition should be understood as the overarching principle guiding both IP protection and what we call antitrust law. Rudolph J.R. Peritz, New York Law School, author of Competition Policy in America and American Antitrust Institute, US This rich and challenging book offers a critical appraisal of the relationship between intellectual property law and competition law, from a particularly European perspective. Gustavo Ghidini highlights the deficiencies in studying each of these areas of law independently and argues for a more holistic approach, insisting that it is more useful, and indeed essential, to consider them as interdependent. He does this first by examining how competition and intellectual property (IP) converge, diverge, and inform one another. Secondly, he assesses how IP law can be interpreted through the guiding principles of competition law antitrust and unfair competition and within the overarching principle of free competition. The book traces the evolution of modern IP law, which it claims is marked heavily both by over-protectionist trends such as the extension of copyright law to technological fields, where it trespasses on the territory of patent law and by attempts to monopolize the achievements of basic research, such as in the example of biotechnology. Through an examination of such emerging issues as access to standards of information and patenting of genetic materials, the author makes a clear case for a reading of IP law that promotes dynamic processes of innovation by competition , and competition by innovation , with related benefits to consumer welfare such as wider choices, greater access to culture and information, and lower prices. Advanced students and researchers in all areas of intellectual property will find this book a stimulating alternative to traditional interpretations of the subject.