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.

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.

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 explores the intersection between artificial intelligence and two intellectual property rights: copyright and patents. The increasing use of artificial intelligence for generating creative and innovative output has an impact on copyright and patent laws around the world. The book aims to map and analyse that impact. The author considers how artificial intelligence systems may aid, or in some cases substitute for, human creators and inventors in the creative process. It is from this angle that the copyright and patent regimes in four jurisdictions (Europe, the United States, Australia and Japan) are investigated in depth. The author describes how these jurisdictions look at works and inventions generated through a process where artificial intelligence is present or prevalent, and examines how copyright and patent regimes should adapt to the reality of artificially intelligent creators and inventors. As the use of artificial intelligence to generate creative and innovative products becomes more common, this book will be a valuable resource to researchers, academics and policy makers alike.

In this book, scholars with different disciplinary and national backgrounds argue for possible answers and analyse case studies on current issues of governance in biomedical research. These issues comprise among others the research-care distinction, risk evaluation in early human trials, handling of incidental findings, nocebo effects, cluster randomized trials, publication bias, or consent in biobank research. This book demonstrates how new technologies and research possibilities multiply or intensify already known governance challenges, leaving room for ethical analysis and complex moral choices. Clinical researchers, research ethics committee members and research ethicists have all to deal with such challenges on a daily basis. While general reflection on core concepts of research ethics is seldom pointless, those confronted with hard moral choices do need more practical and contextualized reflection on the said issues. This book particularly provides such contextualized reflections and aims to inform all those who study, conduct, regulate, fund, or participate in biomedical research.

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.

This book analyses the governance foundations of innovation, brands, inventions, secrets and expression, which are the keys to a century based on knowledge. They are reflected in legal rights that have been fermenting over centuries of national policy deliberations on intellectual property rights, constantly in flux in the face of new advances in science, but overall a trend towards greater protectionism. As countries are challenged by the strictures of international agreements, often extorted through imbalanced power relationships, they seek their own national means for beneficial differentiation from the new global norms, whilst complying with international obligations. This book deals with the outcomes of regional governance of intellectual property, which often creates ripples in the search for harmony in the laws that form the basis for the future of intellectual property. The work has contributions that come from developing and developed nations, showing a common theme of the struggle to find the balance in an area of law that often does not provide clearcut solutions to real world environments. There are many intellectual property struggles illustrated in this work: patent at the boundaries of nature and invention, the need for drug development, which is driven by profit based on the patent monopoly; copyright, the expression of original thought, seeking to maximise exposure facilitated by the internet, but a system that facilitates rampant copying; trade marks, supporting company branding, seeks to exploit global branding through naming domains names; and other areas concomitant to the globalisation of intellectual property governance, such as foreign direct investment. This book holds up a mirror to the issues of world governance of intellectual property rights in this century, asking whether the direction we are currently following is in the best interest of global citizens, and showing the divergence that constraints are stimulating on a national level.