Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions

WANG Cong; ZHANG Xionghui; ZHAO Jianmin; ZHANG Yanfei; MENG Yu

doi:10.12211/2096-8280.2025-093

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Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions

Invited Review | 更新时间：2026-05-22

- Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions
- Synthetic Biology Journal Vol. 7, Issue 2, Pages: 375-389(2026)
- 作者机构：
  
  1.国家合成生物技术创新中心，天津 300308
  2.天津国家合成生物技术创新中心有限公司，天津 300308
  3.国家知识产权局专利局专利审查协作天津中心，天津 300304
  4.中国科学院天津工业生物技术研究所，天津 300308
- 作者简介：
- 基金信息：
- DOI：10.12211/2096-8280.2025-093
  CLC： D923.4
- Received：09 October 2025，
  
  Revised：2026-03-13，
  
  Published：30 April 2026
- 稿件说明：
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王聪，张雄辉，赵建民，张燕飞，孟宇. 合成生物制造知识产权保护体系的现状、问题与建议［J］. 合成生物学， 2026， 7（2）： 375-389

WANG Cong， ZHANG Xionghui， ZHAO Jianmin， ZHANG Yanfei， Meng Yu. Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions［J］. Synthetic Biology Journal， 2026， 7（2）： 375-389
王聪，张雄辉，赵建民，张燕飞，孟宇. 合成生物制造知识产权保护体系的现状、问题与建议［J］. 合成生物学， 2026， 7（2）： 375-389 DOI： 10.12211/2096-8280.2025-093.

WANG Cong， ZHANG Xionghui， ZHAO Jianmin， ZHANG Yanfei， Meng Yu. Intellectual property protection for synthetic biomanufacturing： current status， challenges， and suggestions［J］. Synthetic Biology Journal， 2026， 7（2）： 375-389 DOI： 10.12211/2096-8280.2025-093.

摘要

合成生物学作为21世纪前沿科技领域，正驱动医药、农业和工业等多个行业的变革，已成为全球主要经济体的战略竞争焦点。知识产权保护是激励创新和保障产业健康发展的重要机制，然而，现有体系在面对合成生物制造技术的颠覆性特征时，显露出一定的滞后与模糊。本文系统分析了全球合成生物制造知识产权保护的现状，比较了美国、欧盟、日本、韩国及中国在政策与司法实践方面的差异与动向，识别出我国在该领域面临的核心问题。针对上述问题，从顶层设计、司法保护、行政保护、技术支撑和产业生态五个维度，提出一系列完善我国合成生物制造知识产权保护体系的系统性对策，包括制定国家战略、完善司法指引、建立审批联动机制、推动数据赋能与技术标准化、营造协同知识产权生态等，以构建符合我国技术创新特点、产业发展阶段、具备国际竞争力且能有效激励创新的知识产权治理体系。

Abstract

Synthetic biology

as a cutting-edge technological field of the 21st century

is driving transformative changes across various industries such as pharmaceuticals

agriculture

and manufacturing. Biomanufacturing through synthetic biology and biological processes utilizes renewable resources as raw materials to produce a wide range of products

which is characterized by its environmental friendliness

efficiency

and sustainability

and becoming a strategic focus of competition among major global economies. Intellectual property protection serves as a critical mechanism for inspiring innovations

and thus ensuring the healthy development of industries. However

the existing system is often ambiguities and lag behind the development of biomanufacturing technologies related to synthetic biology. This paper systematically analyzes the current state of global intellectual property protection for biomanufacturing with synthetic biology

highlighting a protection model primarily based on patents and trade rules

supplemented by various policies such as intellectual properties for copyright

data

and new plant varieties. It also compares differences in policies and judicial practices among the United States

European Union

Japan

South Korea

and China. The study further identifies major challenges in intellectual property protection for this field

including the underexploitation of intellectual property as a barrier between innovation and industry

insufficient application of patent data in R&D and AI training

limited applicability of essential and standard patents and patent pools

lacking of integration between regulatory approval systems and intellectual property protection

dilemmas with intellectual property protection for pilot-scale platforms

and difficulties in evidence collection and infringement determination. To address these issues

this paper proposes a series of systematic strategies to improve China’s intellectual property protection system for manufacturing with synthetic biology for five dimensions: top-level designs

judicial protection

administrative systems

technological support

and industrial ecosystems

which include formulating national policies

refining judicial guidelines

establishing approval linkage mechanisms

promoting data empowerment and technological standardization

and fostering a collaborative intellectual property ecosystem. The aim is to build an intellectual property governance system that aligns with the industry's development for international competitiveness

and effectively incentive innovation.

关键词

Keywords

references

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Related Institution

Faculty of Synthetic Biology， Shenzhen University of Advanced Technology

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