Abstract:

Synthetic biology is an emerging interdisciplinary field which combines the principles of engineering and biology, aiming at the (re-) design, modification and fabrication of new and existing biological systems. The techniques developed by synthetic biology are revolutionizing biotechnology and the pharmaceutical industry. From the perspective of patent analysis, this article reviews the technological history of synthetic biology and its applications. The development of synthetic biology techniques can be divided into four stages. 1) The first stage before 2005, is represented by the application of gene regulatory circuits in the field of metabolic engineering, and large-scale production of artemisinin precursor in E.coli was achieved. 2) During the second stage from 2005 to 2011, basic research on improving engineered natural and artificial cells was developed rapidly, however the number of patent applications did not increase significantly, but new tools and methods continued to accumulate, reflecting the early development characteristics of "engineering biology". 3) In the third stage from 2011 to 2015, with the development of novel genome editing, as well as the incorporation of those fundamentals into synthetic biology tools, patent application was doubled. 4) At the fourth stage since 2015, the design-build-test (DBT) cycle of synthetic biology has been extended to the design-build-test-learn (DBTL) cycle, therefore enabling broader convergence and interoperability of semiconductor synthetic biology, engineering biology and other emerging frontiers. After going through the above four development stages, a number of synthetic biology companies have grown up, and many traditional pharmaceutical companies have also invested in the field of synthetic biology for drug development, generating a variety of patents related to gene synthesis, gene therapy, cell therapy, biological materials, genome editing, et al. Through the analysis of representative synthetic biology enterprises' product development and their corresponding patent layout, we highlight the main technical modules and application fields of synthetic biology technologies. Based on the systematic analysis of these key technologies and patents, we develope a break-up and comprehensive analysis framework to clarify the characteristics of synthetic biology for competitive landscapes and predict their technological trends. Especially, we developed a synthetic biology knowledge map to systematically present a landscape for synthetic biology development. By translating patent information into competitive intelligence, this study also investigated the impact of synthetic biology applications on various aspects of industry and society. Finally, this article summarizes and speculates the development of synthetic biology, including the development of enabling technology platforms and tools, definition and use of standard essential patents (SEPs), and relationship between intellectual property management and product accessment.

Key words: synthetic biology, patent analysis, knowledge map, intellectual property, convergence

摘要：

合成生物学以工程化的理念，通过标准化、自动化、智能化技术，对现有自然生物体系进行改造和优化，甚至从头设计创建具有特定功能的“人造生命”，正在彻底改变研究的理念和模式。本文从专利分析的角度，对合成生物学技术及其应用的发展历程进行了解析；通过典型企业的合成生物学产品开发及其对应技术的专利布局分析，梳理了合成生物学的主要技术模块及其应用领域；基于关键技术和应用专利的系统分析，初步构建了贯穿技术发展价值链的分解和综合的分析框架，从而将专利信息转化为竞争情报，阐明合成生物学全球竞争格局的特征，预测技术发展趋势，分析合成生物学发展对行业和社会的影响。最后，本文对合成生物学使能技术平台和工具的开发、标准必要专利的界定和使用、知识产权管理与产品准入的关系等进行了展望。

关键词: 合成生物学, 专利分析, 知识图谱, 知识产权, 会聚