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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.
This book offers a valuable contribution to contemporary legal literature, providing deep insights into the interface between law and genetics, highlighting emerging issues and providing meaningful solutions to current problems. It will be of interest to a broad readership, including academics, lawyers, policy makers and scholars engaged in interdisciplinary research. In the context of examining and analyzing the legal and social implications arising from the recent conjunction of biotechnology and intellectual property rights, the book particularly focuses on human genes and gene variations. Emphasis is placed on “patent law,” as a considerable percentage of genetic inventions are covered by patents. The book presents a comparative and critical examination of patent laws and practices related to biotechnology patents in the United States, Canada, European Union and India, in order to gather the common issues and the differences between them. The international patent approach regarding biotechnology is also analyzed in light of the constant conflict between differentiation and harmonization of patent laws. The book highlights the potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes, and essential biological processes under TRIPS. Also analyzed are the social and policy implications of patents relating to genetic research tools and genetic testing. The intricacies involved in providing effective intellectual property protection to bioinformatics and genomic databases are also examined. Bearing in mind the collaborative nature of bioinformatics and genomic databases, the book evaluates the pros and cons of open biotechnology and assesses the implications of extending intellectual property rights to human genetic resources, before explaining the ownership puzzle concerning human genetic material used in genetic research.
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.
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.
In todayês technological world, biotechnology is one of the most innovative and highly invested-in industries for research, in the field of science. This book analyses the forms and limitations of patent protection recognition for biotechnological inve
The Law and Strategy of Biotechnology Patents is a compendium of articles that sets to address and unravel the complexities of the laws and issues that apply to biotechnology inventions. The purpose of the book is to explain patent law, with special emphasis on the central role of patent claims, statutory subject matter, novelty, non-obviousness, disclosure considerations, and operation of the judicial system in relation to patents. The text also unveils the extent to which biotechnology merges established law with new requirements. Lawyers, inventors, researchers, technology development and transfer agents, venture capitalists, investment bankers, entrepreneurs, and researchers will find this book an important source of information and knowledge.
Patents protecting biotechnological invention are becoming ever more important. Because biotechnology has many differences with respect to other technologies, lessons learned in other fields of technology cannot simply be transferred to adopt a suitable strategy for dealing with biotechnology inventions. In this volume, general aspects of biopatent law will be discussed. This involves questions of patentability, including ethical issues and issues of technicality, as well as questions of patent exhaustion in cases were reproducible subject matter, like cells or seeds, is protected. Moreover, active and passive patent strategies are addressed. Further, insight will be given into patent lifetime management and additional protective measures, like supplementary protection certificates and data exclusivity. Here, strategies are discussed how market exclusivity can be extended as long as possible, which is particularly important for biopharmaceutical drugs, which create high R&D costs.
Exploring the relationship between competition law and technology pools, this book provides general-purpose details of the biotechnology patent pool scheme while discussing historical developments, approaches of the US Department of Justice, Federal Trade Commission, and the European Union Competition Commission via EU regulations. In addition to these regulatory approaches and evolution in concept and theory of technology pools, this book illustrates relationship issues including tying arrangements and essential facility consideration vis-à-vis technology pools. It analyzes the modalities of forming such pools in the area of biotechnology, specifically illustrating that the formation of technology pools is possible and can be safely undertaken, and proposes a viable solution and structure. Patent pools in the biotechnology industry will pave the way towards open collaborative research, reducing patent thickets. Formation of such pools will increase access to various technology and patents otherwise out of bounds, resulting in a reduction of licensing costs and a spur in the development of new solutions. Most importantly, such pools will reduce the frequency of patent toll gates, making the entire spectrum of research interesting from the perspective of researchers as well as investors. This book will be an aid to researchers studying intellectual property, patents, and biotechnology, as well as to interest groups including funding agencies, venture funds, angel investors, and proponents of the open-source movement.