This innovative book explores the complex interplay between intellectual property for biotechnological innovations and human rights. Examining the clash between the drive to incentivise innovations that can fulfil human needs and the desire to grant global access to healthcare technologies, it presents thoughtful solutions to the challenges of protecting the human rights of all parties impacted by biotechnological patents and other relevant IP rights.
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.
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
Biotechnology is a recognized research area that has increasingly advanced into new technologies and modern practices raising several legal, ethical and regulatory issues. The revolutionary speed of biotech innovations has had a significant impact on the protection of the rights of the individual. Fundamental rights provide a framework within which the justification of limitations and restrictions to biotechnology innovations and research results have to be assessed. The legal regulation of scientific research and scientific investigations impact more and more directly on the freedom of research and therapies as well as on the broad diffusion of knowledge. Closely related is also the debated question of the technological manipulation of life and the boundary of scientific knowledge with regard to the topical question of genetic invention patents and their side effects on access to scientific information and health care opportunities. Drawing on expertise from different disciplines, the volume comprises invited papers and plenary presentations given at the conference entitled “Biotech Innovations & Fundamental Rights” that took place on Januray 20-21 2011 at the Department of Juridical Sciences of the University of Ferrara. Each contribution covers a different aspect of the legal and scientific issues involved in regulation of biotechnology. In particular the focus of attention has been given to genetic research, genetic data, freedom of scientific research in genetics and biotech patents.
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.
Intellectual property rights have, from their inception, been shaped by international treaties. National legislators have had to look at the international scene to gain some insight into the prevailing intellectual property standards. This trend was less prominent in the field of patent law and it was only with the coming into effect of the TRIPS Agreement that key international standards with regard to patents were established. In that regard, TRIPS seemed to constitute einen Meilenstein von enormer Bedeutung, (a major milestone) since, for the first time in patent history, it introduced a worldwide framework of minimum standards with regard to the grant, scope and use of patent rights. The present paper describes the global standards for the patenting of biotechnological inventions and offers an in-depth and critical comparison against those of European and national regimes. Chapter 1 describes the TRIPS rules for the patenting of biotechnological inventions and hereby centres on six key issues: plants and animals, the human body, ethics, human rights, traditional knowledge and health. Chapter 2 examines the European patent biotech framework and revolves around the same topics. It will be seen that this examination demonstrates clearly that European patent law has adapted itself to the new reality of biotechnology in many ways, but that various issues remain unsettled and so call for further reflection and debate. In Chapter 3, a number of national patent systems for biotechnological inventions are considered, focusing on the same six topics. This review reveals that it comes as a real challenge for European Union Member States' legislators to reconcile international or European objectives and national aspirations when adapting their patent laws to the new technology of genetic engineering.
SpringerBriefs in Biotech Patents presents timely reports on intellectual properties (IP) issues and patent aspects in the field of biotechnology. This volume focus on particular aspects of the US patent law, which can have tremendous differences compared to the European law. This includes questions of biopatent prosecution, novelty, inventive step, written disclosure and sufficiency of enablement as well as questions of law enforcement of biotech patents.
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.
