Synthetic biomanufacturing intellectual property protection system： current status， issues， and recommendation

WANG Cong; ZHANG Xionghui; ZHAO Jianmin; ZHANY Yanfei; Meng Yu

doi:10.12211/2096-8280.2025-093

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Synthetic biomanufacturing intellectual property protection system： current status， issues， and recommendation

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- Synthetic biomanufacturing intellectual property protection system： current status， issues， and recommendation
- Synthetic Biology Journal Pages: 1-15(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，
  
  Online First：18 March 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. DOI： 10.12211/2096-8280.2025-093

WANG Cong， ZHANG Xionghui， ZHAO Jianmin， ZHANY Yanfei， Meng Yu. Synthetic biomanufacturing intellectual property protection system： current status， issues， and recommendation［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2025-093
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. DOI： 10.12211/2096-8280.2025-093 DOI：

WANG Cong， ZHANG Xionghui， ZHAO Jianmin， ZHANY Yanfei， Meng Yu. Synthetic biomanufacturing intellectual property protection system： current status， issues， and recommendation［J］. Synthetic Biology Journal， 2026， 7. DOI： 10.12211/2096-8280.2025-093 DOI：

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、日韩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. Synthetic biology manufacturing utilizes renewable resources as raw materials to produce a wide range of products through biological processes

characterized by its cleanliness

efficiency

and sustainability. It has become a strategic focus of competition among major global economies. Intellectual property protection serves as a critical mechanism for incentivizing innovation and ensuring the healthy development of industries. However

the existing system reveals certain delays and ambiguities when confronted with the disruptive nature of synthetic biology manufacturing technologies.This paper systematically analyzes the current state of global intellectual property protection for synthetic biology manufacturing

highlighting a protection model primarily based on patents and trade secrets

supplemented by various forms such as copyright

data intellectual property

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

the European Union

Japan

South Korea

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

including the underutilization of intellectual property as a bridge between innovation and industry

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

limited applicability of standard essential patents and patent pools

lack of integration between regulatory approval systems and intellectual property protection

intellectual property dilemmas in pilot-scale platforms

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

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

judicial protection

administrative systems

technological support

and industrial ecosystem. These strategies include formulating national strategies

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 stage

possesses international competitiveness

and effectively incentivizes innovation.

关键词

Keywords

references

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