目的 系统剖析全球中药领域的知识产权格局，重点比较中国、美国、日本、韩国及德国5个国家的专利布局特征与竞争态势，进而为促进我国中药产业的高质量发展与国际化进程提供策略参考。方法 依托壹专利（Patyee）数据库，检索并获取全球及上述5国的中药相关专利数据。综合运用定量与定性分析方法，从专利申请趋势、地域分布、申请主体构成、核心技术主题聚焦以及跨国布局策略等多个维度进行深入剖析。结果 尽管国内中药专利申请总量庞大（约36万件），但通过《专利合作条约》（Patent Cooperation Treaty，PCT）途径提交的国际专利申请占比较低（仅1.37%），海外布局明显不足。从技术主题分布看，全球范围内（包括中国）涉及中药质量检测与标准化技术的专利均相对稀缺，匹配现代产业化与国际化对质量可控性的高标准需求还有差距。在申请主体方面，中国44%的中药专利由个人持有，企业作为申请主体的占比仅为34%，个人化传承为主、企业化研发有待提升；相比之下，美国、日本、德国的中药相关专利主要由具备完整产业链的跨国制药企业或日化巨头主导。结论 为实现中药知识产权的高质量国际化发展，中国亟待构建系统化的海外专利布局战略，形成覆盖研发、质控、生产与营销的全产业链专利保护体系。核心任务在于将国内的技术积累优势转化为国际认可的技术标准，并通过强化产学研用各主体间的协同创新，推动中医药从传统经验模式向现代循证创新范式转型。

Objective This study aims to systematically analyze the intellectual property landscape of traditional Chinese medicine (TCM) globally, with a focus on comparing the patent layout characteristics and competitive dynamics in five key countries: China, the United States, Japan, South Korea, and Germany. The goal is to provide strategic references for promoting the high-quality development and internationalization of China's TCM industry. Methods Leveraging the Patyee database, this research retrieved and obtained TCM-related patent data globally and from the aforementioned five countries. Employing a combination of quantitative and qualitative analysis methods, an in-depth examination was conducted from multiple dimensions, including patent application trends, geographical distribution, applicant types, core technological topics, and international layout strategies. Results The research findings indicate that despite a vast number of domestic TCM patent applications (approximately 360 000), the proportion of international applications filed via the Patent Cooperation Treaty (PCT) is relatively low (only 1.37%), revealing a significant deficiency in overseas layout. Regarding the distribution of technological topics, patents related to TCM quality control and standardization technologies are relatively scarce globally (including in China), leaving a gap in meeting the high standards of quality controllability required for modern industrialization and internationalization. In terms of applicant types, 44% of TCM patents in China are held by individuals, while enterprises account for only 34%, reflecting a pattern of individual-led inheritance with enterprise-driven R&D yet to be enhanced. In contrast, TCM-related patent activities in the United States, Japan, and Germany are predominantly driven by multinational pharmaceutical companies or consumer goods giants with complete industrial chains. Conclusion To achieve high-quality internationalization of TCM intellectual property, China urgently needs to establish a systematic overseas patent layout strategy, forming a patent protection system covering the entire industrial chain of R&D, quality control, production, and marketing. The core task is to transform domestic technological advantages into internationally recognized technical standards and to promote the transformation of TCM from a traditional empirical model to a modern, evidence-based innovation paradigm by strengthening collaborative innovation among industry, academia, research, and users.

R288

江苏省知识产权高价值专利培育项目（GJ20231160_01）；南京市知识产权强链项目（K2022q03）