Bernardo Alvarez María Angela
Rev Derecho Genoma Hum. 2014 Jul-Dec(41):123-40.
The roots of synthetic biology--the redesign of biological molecules, structures and organisms--can be traced to the research developed by Jacques L. Monod and François Jacob in 1961. This field has undergone significant growth in the past ten years and its emergence has raised the question of whether the patent system is suitable to protect inventions in emergent areas as synthetic biology. The article will analyze the numerous scientific, socio-economic, ethical and legal challenges faced by synthetic biology, introducing the European Patent Law related to biotechnology as the minimum common framework and considering if more changes are needed to adequately protect the inventor rights, while taking into account the arrival of a new research culture, characterized by embracing open-innovation and open-source initiatives. The discussion will review some biotechnological patent law cases and summarize questions as whether isolated molecules of DNA are eligible for patent or the patentability of living matter, under the terms of Directive 98/44/EC. The article will finally consider the impact of synthetic biology on the European patent system.
合成生物学的根源——对生物分子、结构和生物体的重新设计——可以追溯到1961年雅克·L·莫诺德和弗朗索瓦·雅各布开展的研究。在过去十年中，该领域取得了显著发展，其出现引发了专利制度是否适合保护合成生物学等新兴领域发明的问题。本文将分析合成生物学面临的众多科学、社会经济、伦理和法律挑战，介绍与生物技术相关的欧洲专利法作为最低共同框架，并考虑是否需要更多变革以充分保护发明者权利，同时考虑到以开放创新和开源倡议为特征的新研究文化的到来。讨论将回顾一些生物技术专利法案例，并根据98/44/EC号指令的条款总结诸如分离的DNA分子是否有资格获得专利或活体物质的可专利性等问题。本文最后将考虑合成生物学对欧洲专利制度的影响。
