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 critiques the decision-making process in Article 53(a) of the European Patent Convention. To date, such decisions have been taken at high levels of expertise without much public involvement. The book eschews traditional solutions, such as those found within legislative, judicial and patent office realms and instead develops a radical blueprint for how these decisions can be put to the public. By examining wide-scale models of participatory democracy and deliberation, this book fills a significant gap in the literature. It will be invaluable for patent lawyers, academics, practitioners and intellectual property and patent officials.
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.
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.
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.
'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.
It s really excellent: an invaluable source of information and highly readable too. Sir John Sulston, University of Manchester, UK and Winner of the 2002 Nobel Prize in Physiology or Medicine . . . this is a book that every policymaker even remotely connected to issues of patents, economics, and biotech should read. This book is essential ammunition for those who oppose gene patenting, and lays out the legal case expertly. David Koepsell, Delft University of Technology, The Netherlands, reviewed in SCRIPTed The book is of interest to judges, patent attorneys and lawyers and policy-makers in this field. . . The first part is a fascinating and well researched historical study of patenting. . . The second part of the book is interesting and the author raises some very important points. . . a very valuable contribution to the debate of the scope of patent monopolies. David Rogers, Legal Member, Boards of Appeal, European Patent Office, Germany, reviewed in European Intellectual Property Review Gene Cartels is a truly magisterial and important book. It shows how we need to bring together the discrete threads around intellectual property law (ie patent, copyright, etc) so there can be a clear spotlight on the important public policy issues. Terry Cutler, Principal, Cutler & Company and Chair, Review of the National Innovation System, Australia . . . provides an estimable addition to a growing library of texts diagnosing the maladies of the existing IPR system and offering well attested cures. [It] demands the widest possible readership not just amongst the IPR community, but amongst economists and social scientists, policy officials in both developed and developing countries, and business people everywhere. John A. Mathews, LUISS Guido Carli University, Italy Gene Cartels is a valuable book for the scientist providing, in an elegantly scholarly style, deep insights into the origins, history, evolution and current status of patent systems. It also discloses features that can lead, in effect, to a misuse of power. From the foreword by Baruch S. Blumberg, Fox Chase Cancer Center, Philadelphia and University of Pennsylvania, US and Winner of the Nobel Prize in Physiology or Medicine 1976 Starting with the 13th century, this book explores how patents have been used as an economic protectionist tool, developing and evolving to the point where thousands of patents have been ultimately granted not over inventions, but over isolated or purified biological materials. DNA, invented by no man and once thought to be free to all men and reserved exclusively to none , has become cartelised in the hands of multinational corporations. The author questions whether the continuing grant of patents can be justified when they are now used to suppress, rather than promote, research and development in the life sciences. Luigi Palombi demonstrates that patents are about inventions and not isolated biological materials, which consequently have no bona fide purpose in the innovations of biotechnological science. This book will be important reading for anyone who has an interest in the role that patents have played in economic development particularly historians, economists and scientists. It will also be of great interest to law academics, lawyers, judges and policymakers.
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.
Biotechnology is a field that inspires complex legal and ethical debates on an international scale. Taking a fresh approach to the subject, Matthias Herdegen provides a comprehensive assessment of the regulation of biotechnology processes and products from an international and comparative perspective.
