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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.
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.
"The book...is, in fact, a short text on the many practical problems...associated with translating the explosion in basic biotechnological research into the next Green Revolution," explains Economic Botany. The book is "a concise and accurate narrative, that also manages to be interesting and personal...a splendid little book." Biotechnology states, "Because of the clarity with which it is written, this thin volume makes a major contribution to improving public understanding of genetic engineering's potential for enlarging the world's food supply...and can be profitably read by practically anyone interested in application of molecular biology to improvement of productivity in agriculture."
The patenting and licensing of human genetic material and proteins represents an extension of intellectual property (IP) rights to naturally occurring biological material and scientific information, much of it well upstream of drugs and other disease therapies. This report concludes that IP restrictions rarely impose significant burdens on biomedical research, but there are reasons to be apprehensive about their future impact on scientific advances in this area. The report recommends 13 actions that policy-makers, courts, universities, and health and patent officials should take to prevent the increasingly complex web of IP protections from getting in the way of potential breakthroughs in genomic and proteomic research. It endorses the National Institutes of Health guidelines for technology licensing, data sharing, and research material exchanges and says that oversight of compliance should be strengthened. It recommends enactment of a statutory exception from infringement liability for research on a patented invention and raising the bar somewhat to qualify for a patent on upstream research discoveries in biotechnology. With respect to genetic diagnostic tests to detect patient mutations associated with certain diseases, the report urges patent holders to allow others to perform the tests for purposes of verifying the results.
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
Following decades in which China's approach to technology has been to imitate, the country is now transforming itself to become innovation-oriented. This pioneering study examines whether patents play a similar role in promoting innovation in China as they do in the West, exploring the interplay between patents and China's biotechnology and pharmaceutical industries in particular.
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.
Advances in modern biotechnology have produced profound and far-reaching implications for the relationship between humans, animals and the environment. As a result, a debate has arisen surrounding the legal, moral and social problems connected with this technology, a central part of the debate focusing on the role of moral considerations in the patent system as a form of regulation. This fully revised and updated book examines this role and asks why in the context of biotechnological inventions, morality has become an important issue. It takes account of recent developments, including reference to the situation in Australia. By examining such specific recent cases, the author elucidates the moral concerns associated with modern biotechnology, thus providing an important contribution to the debate and a valuable resource for all those working in this exciting field.