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Perspectives Of Regulatory Bodies On Intellectual Property For 3d Printed Medical Products
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Book Synopsis Perspectives of regulatory bodies on intellectual property for 3D-printed medical products by : Philipp Neudert
Download or read book Perspectives of regulatory bodies on intellectual property for 3D-printed medical products written by Philipp Neudert and published by GRIN Verlag. This book was released on 2021-10-14 with total page 26 pages. Available in PDF, EPUB and Kindle. Book excerpt: Academic Paper from the year 2021 in the subject Law - IT law, grade: 1,3, Technical University of Munich (MCTS), language: English, abstract: This paper investigates the perspective of the European Patent Office (EPO) on intellectual property rights, particularly patents, for 3D-printed medical products. As a powerful regulatory body, the EPO is a key stakeholder in the regulation and handling of emerging technologies. As such a technology, 3D-printing may call policymakers to adapt the regulatory framework to deal with the specialities of 3D-printing and to increase legal certainty. Policymakers can profit from its insights for various reasons: What kind of new regulation may be needed largely depends on how executive organs such as EPO (attempt to) handle the respective technology. Also, insights from practitioners may help policymakers to identify issues that have been neglected by existing legislation – such as the implications of emerging technologies like 3D-printing.
Book Synopsis 3D Printing of Pharmaceuticals by : Abdul W. Basit
Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2018-08-06 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul’s research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.
Book Synopsis 3D Printing, Intellectual Property and Innovation by : Rosa Maria Ballardini
Download or read book 3D Printing, Intellectual Property and Innovation written by Rosa Maria Ballardini and published by Kluwer Law International B.V.. This book was released on 2016-04-24 with total page 448 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing (or, more correctly, additive manufacturing) is the general term for those software-driven technologies that create physical objects by successive layering of materials. Due to recent advances in the quality of objects produced and to lower processing costs, the increasing dispersion and availability of these technologies have major implications not only for manufacturers and distributors but also for users and consumers, raising unprecedented challenges for intellectual property protection and enforcement. This is the first and only book to discuss 3D printing technology from a multidisciplinary perspective that encompasses law, economics, engineering, technology, and policy. Originating in a collaborative study spearheaded by the Hanken School of Economics, the Aalto University and the University of Helsinki in Finland and engaging an international consortium of legal, design and production engineering experts, with substantial contributions from industrial partners, the book fully exposes and examines the fundamental questions related to the nexus of intellectual property law, emerging technologies, 3D printing, business innovation, and policy issues. Twenty-five legal, technical, and business experts contribute sixteen peer-reviewed chapters, each focusing on a specific area, that collectively evaluate the tensions created by 3D printing technology in the context of the global economy. The topics covered include: • current and future business models for 3D printing applications; • intellectual property rights in 3D printing; • essential patents and technical standards in additive manufacturing; • patent and bioprinting; • private use and 3D printing; • copyright licences on the user-generated content (UGC) in 3D printing; • copyright implications of 3D scanning; and • non-traditional trademark infringement in the 3D printing context. Specific industrial applications – including aeronautics, automotive industries, construction equipment, toy and jewellery making, medical devices, tissue engineering, and regenerative medicine – are all touched upon in the course of analyses. In a legal context, the central focus is on the technology’s implications for US and European intellectual property law, anchored in a comparison of relevant laws and cases in several legal systems. This work is a matchless resource for patent, copyright, and trademark attorneys and other corporate counsel, innovation economists, industrial designers and engineers, and academics and policymakers concerned with this complex topic.
Book Synopsis 3D Printing in Medicine by : Deepak M. Kalaskar
Download or read book 3D Printing in Medicine written by Deepak M. Kalaskar and published by Woodhead Publishing. This book was released on 2022-10-18 with total page 424 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D Printing in Medicine, Second Edition examines the rapidly growing market of 3D-printed biomaterials and their clinical applications. With a particular focus on both commercial and premarket tools, the book looks at their applications within medicine and the future outlook for the field. The chapters are written by field experts actively engaged in educational and research activities at the top universities in the world. The earlier chapters cover the fundamentals of 3D printing, including topics such as materials and hardware. The later chapters go on to cover innovative applications within medicine such as computational analysis of 3D printed constructs, personalized 3D printing - including 3D cell and organ printing and the role of AI - with a subsequent look at the applications of high-resolution printing, 3D printing in diagnostics, drug development, 4D printing, and much more. This updated new edition features completely revised content, with additional new chapters covering organs-on-chips, bioprinting regulations and standards, intellectual properties, and socio-ethical implications of organs-on-demand. Reviews a broad range of biomedical applications of 3D printing biomaterials and technologies Provides an interdisciplinary look at 3D printing in medicine, bridging the gap between engineering and clinical fields Includes completely updated content with additional new chapters, covering topics such as organs-on-chips, bioprinting regulations, intellectual properties, medical standards in 3D printing, and more
Book Synopsis Ethical Challenges of Organ Transplantation by : Solveig Lena Hansen
Download or read book Ethical Challenges of Organ Transplantation written by Solveig Lena Hansen and published by transcript Verlag. This book was released on 2021-09-30 with total page 359 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection features comprehensive overviews of the various ethical challenges in organ transplantation. International readings well-grounded in the latest developments in the life sciences are organized into systematic sections and engage with one another, offering complementary views. All core issues in the global ethical debate are covered: donating and procuring organs, allocating and receiving organs, as well as considering alternatives. Due to its systematic structure, the volume provides an excellent orientation for researchers, students, and practitioners alike to enable a deeper understanding of some of the most controversial issues in modern medicine.
Book Synopsis 3D printing and the intellectual property system by : World Intellectual Property Organization
Download or read book 3D printing and the intellectual property system written by World Intellectual Property Organization and published by WIPO. This book was released on 2015 with total page 28 pages. Available in PDF, EPUB and Kindle. Book excerpt: Three-dimensional (3D) printing – or “additive manufacturing” – technologies differ from traditional molding and casting manufacturing processes in that they build 3D objects by successively creating layers of material on top of each other. Rooted in manufacturing research of the 1980s, 3D printing has evolved into a broad set of technologies that could fundamentally alter production processes in a wide set of technology areas. This report investigates, from the perspective of an intellectual property scholar, how 3D printing technology has developed over the last few decades, how intellectual property rights have shaped this breakthrough innovation and how 3D printing technologies could challenge the intellectual property rights system in the future.
Book Synopsis Socio-Legal Aspects of the 3D Printing Revolution by : Angela Daly
Download or read book Socio-Legal Aspects of the 3D Printing Revolution written by Angela Daly and published by Springer. This book was released on 2016-05-20 with total page 122 pages. Available in PDF, EPUB and Kindle. Book excerpt: Additive manufacturing or ‘3D printing’ has emerged into the mainstream in the last few years, with much hype about its revolutionary potential as the latest ‘disruptive technology’ to destroy existing business models, empower individuals and evade any kind of government control. This book examines the trajectory of 3D printing in practice and how it interacts with various areas of law, including intellectual property, product liability, gun laws, data privacy and fundamental/constitutional rights. A particular comparison is made between 3D printing and the Internet as this has been, legally-speaking, another ‘disruptive technology’ and also one on which 3D printing is partially dependent. This book is the first expert analysis of 3D printing from a legal perspective and provides a critical assessment of the extent to which existing legal regimes can be successfully applied to, and enforced vis-à-vis, 3D printing.
Book Synopsis 3D Printing and Intellectual Property Futures by : Thomas Birtchnell
Download or read book 3D Printing and Intellectual Property Futures written by Thomas Birtchnell and published by . This book was released on 2018 with total page 80 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis The Oxford Handbook of Law, Regulation and Technology by : Roger Brownsword
Download or read book The Oxford Handbook of Law, Regulation and Technology written by Roger Brownsword and published by Oxford University Press. This book was released on 2017 with total page 1361 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book brings together leading scholars from law and other disciplines to explore the relationship between law, technological innovation, and regulatory governance.
Book Synopsis Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade by : World Intellectual Property Organization
Download or read book Promoting Access to Medical Technologies and Innovation - Intersections between Public Health, Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
Book Synopsis 3D Printing and Beyond by : Dinusha Mendis
Download or read book 3D Printing and Beyond written by Dinusha Mendis and published by Edward Elgar Publishing. This book was released on 2019 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: This ground-breaking and timely contribution is the first and most comprehensive edited collection to address the implications for Intellectual Property (IP) law in the context of 3D Printing and Additive Manufacturing. Providing a coverage of IP law in three main jurisdictions including the UK, USA and Australia. 3D Printing and Beyond brings together a team of distinguished IP experts and is an indispensable starting point for researchers with an interest in IP, emerging technologies and 3D printing.
Book Synopsis Health Technologies and Innovations to Effectively Respond to the COVID-19 Pandemic by : Björn Wolfgang Schuller
Download or read book Health Technologies and Innovations to Effectively Respond to the COVID-19 Pandemic written by Björn Wolfgang Schuller and published by Frontiers Media SA. This book was released on 2022-03-10 with total page 197 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Book Synopsis FDA and Intellectual Property Strategies for Medical Device Technologies by : Gerald B. Halt (Jr.)
Download or read book FDA and Intellectual Property Strategies for Medical Device Technologies written by Gerald B. Halt (Jr.) and published by . This book was released on 2019 with total page 333 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book offers comprehensive, easy to understand guidance for medical device technology innovators on how to work through the United States FDA regulatory review process, while also providing insight on the various intellectual property concerns that many medical device innovators face. In the first portion of this book, readers are introduced to important concepts concerning FDA compliance for medical devices, as well as strategies for successfully navigating the FDA regulatory review process. Specifically, the first portion discusses the expansive range of medical devices and then walks through the most common routes to market: the PMA and 510(k) application processes. In the second portion of this book, readers are introduced to the various types of intellectual property rights that are available for medical device technology inventions and innovations, and can explore ways to overcome unique intellectual property challenges faced by many medical device technology innovators. In the third portion of the book, specific strategies are discussed to navigate the interface between the FDA regulatory process and the process of obtaining intellectual property protection. This book also includes a number of descriptive examples, case studies and scenarios to illustrate the topics discussed, and is intended for use by medical device designers, developers and innovators. Investigates the FDA approval process as it pertains to medical device technology Address some of the major FDA hurdles that medical device innovators often face while seeking approval Discusses the interplay between FDA regulatory review of medical device technology and intellectual property strategy Explores the benefits of protecting, managing and enforcing intellectual property obtained for medical device technology so that innovators can obtain the best possible commercial results from their IP ownership Uses real case studies to illustrate concepts covered.
Book Synopsis Constitutional Challenges in the Algorithmic Society by : Hans-W. Micklitz
Download or read book Constitutional Challenges in the Algorithmic Society written by Hans-W. Micklitz and published by Cambridge University Press. This book was released on 2021-12-02 with total page 341 pages. Available in PDF, EPUB and Kindle. Book excerpt: New technologies have always challenged the social, economic, legal, and ideological status quo. Constitutional law is no less impacted by such technologically driven transformations, as the state must formulate a legal response to new technologies and their market applications, as well as the state's own use of new technology. In particular, the development of data collection, data mining, and algorithmic analysis by public and private actors present unique challenges to public law at the doctrinal as well as the theoretical level. This collection, aimed at legal scholars and practitioners, describes the constitutional challenges created by the algorithmic society. It offers an important synthesis of the state of play in law and technology studies, addressing the challenges for fundamental rights and democracy, the role of policy and regulation, and the responsibilities of private actors. This title is also available as Open Access on Cambridge Core.
Book Synopsis Governing Intellectual Property Rights Within Publicly Funded Biobanks by : Rajam Neethu
Download or read book Governing Intellectual Property Rights Within Publicly Funded Biobanks written by Rajam Neethu and published by Kluwer Law International B.V.. This book was released on 2019-06-21 with total page 342 pages. Available in PDF, EPUB and Kindle. Book excerpt: Governing Intellectual Property Rights Within Publicly Funded Biobanks R. Neethu The boom in biobanks and health databases as research infrastructures have evoked various legal and ethical debates. Since then numerous new developments have emerged such as digitalization, big-data research and artificial intelligence which has important implications for biobank-based research and collaborations. This new paradigm offers new legal challenges for commercial involvement particularly within a publicly funded setting. In this innovative book, the author shows that securing maximum social benefit out of the knowledge emanating from the use of biobank resources lies in managing intellectual property inputs and outputs effectively in keeping with the values core to such research. Focusing on the challenges of involving intellectual property rights (IPRs) particularly in the precompetitive phase of biobank-based research, the book offers an extensive understanding of the role of different IPRs and identifies the gaps in the law and its implications for biobanks. The analysis covers important aspects in relation to biobanks such as: Digital integration and biomedical data storage; Ownership of biological samples; Commercialization and benefit sharing; Partnership models; Public sector research; Disposition of samples; Consent; Cross-border exchange; Trade secrecy; Privacy; Regulatory stewardship; Business strategies; Ethical considerations over biological resources; Patenting of inventions relating to personalized medicine; Ethical parameters within patent law; and Rights regarding genetic data and databases. The book includes observations, case studies and interviews conducted by the author. In conclusion, the author offers cogent recommendations for legal interoperability of IP rules and research practices designed to enhance the ability of biobanks to share, access and reuse data. This book is the first of its kind to explore the organizational and legislative choices for biobanks particularly while engaging in the protection of research results and technology transfer within a publicly funded setting. It will be of substantial interest to all stakeholders in biobanking, especially policymakers, biobankers and researchers working in the field of health law as well as for legal practitioners, academics and patient interest groups.
Book Synopsis Intellectual Property Rights and Emerging Technology by : Hing Kai Chan
Download or read book Intellectual Property Rights and Emerging Technology written by Hing Kai Chan and published by Routledge. This book was released on 2018-08-06 with total page 200 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing poses many challenges to the traditional law of intellectual property (IP). This book develops a technical method to help overcome some of these legal challenges and difficulties. This is a collection of materials from empirical interviews, workshops and publications that have been carried out in one of the world's leading research projects into the legal impact of 3D printing. The project was designed to establish what legal challenges 3D printing companies thought they faced, and having done that, to establish a technical framework for a solution.
Book Synopsis 3D Printing of Pharmaceuticals by : Abdul W. Basit
Download or read book 3D Printing of Pharmaceuticals written by Abdul W. Basit and published by Springer. This book was released on 2019-08-30 with total page 254 pages. Available in PDF, EPUB and Kindle. Book excerpt: 3D printing is forecast to revolutionise the pharmaceutical sector, changing the face of medicine development, manufacture and use. Potential applications range from pre-clinical drug development and dosage form design through to the fabrication of functionalised implants and regenerative medicine. Within clinical pharmacy practice, printing technologies may finally lead to the concept of personalised medicines becoming a reality. This volume aims to be the definitive resource for anyone thinking of developing or using 3D printing technologies in the pharmaceutical sector, with a strong focus on the translation of printing technologies to a clinical setting. This text brings together leading experts to provide extensive information on an array of 3D printing techniques, reviewing the current printing technologies in the pharmaceutical manufacturing supply chain, in particular, highlighting the state-of-the-art applications in medicine and discussing modern drug product manufacture from a regulatory perspective. This book is a highly valuable resource for a range of demographics, including academic researchers and the pharmaceutical industry, providing a comprehensive inventory detailing the current and future applications of 3D printing in pharmaceuticals. Abdul W. Basit is Professor of Pharmaceutics at the UCL School of Pharmacy, University College London. Abdul's research sits at the interface between pharmaceutical science and gastroenterology, forging links between basic science and clinical outcomes. He leads a large and multidisciplinary research group, and the goal of his work is to further the understanding of gastrointestinal physiology by fundamental research. So far, this knowledge has been translated into the design of new technologies and improved disease treatments, many of which are currently in late-stage clinical trials. He has published over 350 papers, book chapters and abstracts and delivered more than 250 invited research presentations. Abdul is also a serial entrepreneur and has filed 25 patents and founded 3 pharmaceutical companies (Kuecept, Intract Pharma, FabRx). Abdul is a frequent speaker at international conferences, serves as a consultant to many pharmaceutical companies and is on the advisory boards of scientific journals, healthcare organisations and charitable bodies. He is the European Editor of the International Journal of Pharmaceutics. Abdul was the recipient of the Young Investigator Award in Pharmaceutics and Pharmaceutical Technology from the American Association of Pharmaceutical Scientists (AAPS) and is the only non-North American scientist to receive this award. He was also the recipient of the Academy of Pharmaceutical Sciences (APS) award. Simon Gaisford holds a Chair in Pharmaceutics and is Head of the Department of Pharmaceutics at the UCL School of Pharmacy, University College London. He has published 110 papers, 8 book chapters and 4 authored books. His research is focused on novel technologies for manufacturing medicines, particularly using ink-jet printing and 3D printing, and he is an expert in the physico-chemical characterisation of compounds and formulations with thermal methods and calorimetry.
