This book explores the interplay between regulation and emerging technologies in the context of synthetic biology, a developing field that promises great benefits, and has already yielded fuels and medicines made with designer micro-organisms. For all its promise, however, it also poses various risks. Investigating the distinctiveness of synthetic biology and the regulatory issues that arise, Alison McLennan questions whether synthetic biology can be regulated within existing structures or whether new mechanisms are needed.
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Edited by Duncan Matthews and Herbert Zech
Intellectual property (IP) is a key component of the life sciences, one of the most dynamic and innovative fields of technology today. At the same time, the relationship between IP and the life sciences raises new public policy dilemmas. The Research Handbook on Intellectual Property and the Life Sciences comprises contributions by leading experts from academia and industry to provide in-depth analyses of key topics including pharmaceuticals, diagnostics and genes, plant innovations, stem cells, the role of competition law and access to medicines. The Research Handbook focuses on the relationship between IP and the life sciences in Europe and the United States, complemented by country-specific case studies on Australia, Brazil, China, India, Japan, Kenya, South Africa and Thailand to provide a truly international perspective.
The Requirement of Industrial Application
Marta Díaz Pozo
This book constitutes a fascinating and in-depth analysis of the significance of the requirement of industrial application within gene patenting and how this influences innovation in Europe and the US. The author addresses an area normally overlooked in biotechnology patenting due to the predominance of the ethical debate, and in doing so produces a unique approach to dealing with concerns in this field.
The Role of Competition Law in Collaborations between Public Research Organizations and Industry
One of the major shortcomings of the current drug discovery and development process is the inability to bridge the gap between early stage discoveries and pre-clinical research in order to advance innovations beyond the discovery phase. This book examines a drug discovery and development model, where the respective expertise of academia and industry are brought together to take promising discoveries through to proof of concept, providing a means to de-risk the drug discovery and development process.
As our understanding of genetics increases, its use in criminal justice becomes more attractive. This timely book examines the use of genetic information both in criminal investigations and during the trial process. It discusses current scientific understanding and considers some potential legal, ethical and sociological issues with the use of genetic information. Topics include rights of privacy and consent in obtaining DNA samples, evidentiary issues in court, the impact of genetic evidence on punishment theory and sentencing, and genetic discrimination.
The US and European Experience
In today’s 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 inventions, with particular regard to patentability of life.
Real-Life Lessons for the Developing World
This timely book investigates the concept of innovation and illustrates the crucial role that patent strategies play within processes of pharmaceutical innovation. Drawing on extensive country and company case studies, it identifies the key issues relevant to the revival of local pharmaceutical industries. Based on an understanding of the post-TRIPS environment and case studies of national innovation strategies, it specifically addresses an important question – to what extent can lessons from national experiences be transferred to current policy developments for innovation in the pharmaceutical industry in a developing country context?
Graham Dukes, John Braithwaite and J. P. Moloney
The pharmaceutical industry exists to serve the community, but over the years it has engaged massively in corporate crime, with the public footing the bill. This readable study by experts in medicine, law, criminology and public health documents the problems, ranging from false advertising and counterfeiting to corruption waste and overpricing, with unacceptable pressures on doctors, politicians, patients and the media. Uniquely, the book goes on to present a realistic and worldwide solution for the future, with positive policies encouraging honest dealing as well as partial privatization of enforcement and greater emphasis on creative research to develop the medicines that society needs most.
Law, Technology and Public Contestations in Europe
This book examines the EU regulatory framework in the Genetic Modification of agriculture and food to see how adequately EU law treats serious contestations about the development and use of GMOs. Since linkages between law, technology and public contestations could have a crucial dimension in the shaping of democratic societies, the space EU law provides for publics outside of the scientific experts to shape the regulation of GMOs becomes significant. By examining the employment of the precautionary principle and (the advices from) public bioethics committees in GMO regulation, this book examines the policy claim of public participation as a mechanism to represent and mediate public contestations about the use and regulation of GMOs.
A Trilateral Perspective
Edited by Josef Drexl and Nari Lee
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.