Kantaros Antreas, Ganetsos Theodore, Petrescu Florian Ion Tiberiu, Alysandratou Elli
Department of Industrial Design and Production Engineering, University of West Attica, 12244 Athens, Greece.
"Theory of Mechanisms and Robots" Department, Faculty of Industrial Engineering and Robotics, Bucharest Polytechnic University, 060042 Bucharest, Romania.
Bioengineering (Basel). 2025 Jan 15;12(1):76. doi: 10.3390/bioengineering12010076.
Bioprinting, an innovative combination of biotechnology and additive manufacturing, has emerged as a transformative technology in healthcare, enabling the fabrication of functional tissues, organs, and patient-specific implants. The implementation of the aforementioned, however, introduces unique intellectual property (IP) challenges that extend beyond conventional biotechnology. The study explores three critical areas of concern: IP protection for bioprinting hardware and bioinks, ownership and ethical management of digital files derived from biological data, and the implications of commercializing bioprinted tissues and organs. Employing a multidisciplinary approach, the paper analyzes existing IP frameworks, highlights their limitations when applied to bioprinting, and examines ethical dilemmas, such as ownership of bioprinted human tissues and the commodification of biological innovations. Findings suggest that current IP laws inadequately address the complexities of bioprinting, particularly in managing the intersection of proprietary technologies and ethical considerations. The study underscores the need for adaptive legal and ethical frameworks to balance innovation with equitable access and sustainability. Recommendations include the development of tailored IP policies for bioprinting and enhanced international collaboration to harmonize legal protections across jurisdictions. This work aims to provide a comprehensive foundation for stakeholders to navigate the rapidly evolving landscape of bioprinting IP.
生物打印作为生物技术与增材制造的创新结合,已成为医疗保健领域的变革性技术,能够制造功能性组织、器官和患者特异性植入物。然而,上述技术的实施带来了超越传统生物技术的独特知识产权(IP)挑战。该研究探讨了三个关键关注领域:生物打印硬件和生物墨水的知识产权保护、源自生物数据的数字文件的所有权和伦理管理,以及生物打印组织和器官商业化的影响。本文采用多学科方法,分析了现有的知识产权框架,强调了其应用于生物打印时的局限性,并审视了伦理困境,如生物打印人体组织的所有权和生物创新的商品化。研究结果表明,现行知识产权法未能充分应对生物打印的复杂性,尤其是在管理专有技术与伦理考量的交叉方面。该研究强调需要适应性的法律和伦理框架,以平衡创新与公平获取及可持续性。建议包括制定针对生物打印的定制知识产权政策,以及加强国际合作以协调不同司法管辖区的法律保护。这项工作旨在为利益相关者在快速发展的生物打印知识产权领域中导航提供全面的基础。