国家在不同时期赋予了中药品种保护制度不同的责任，弥补专利制度的不足，从药品监督管理制度转型为促进中药品种高质量创新发展的中药知识产权专门保护制度应是其出路。传承与创新并行、临床价值主导、利益平衡、中药特点与国际惯例兼顾应是其构建原则。在制度构建时，除中药材外，在中成药基础上应将中药饮片纳入保护范畴，应将分级保护改为分类保护以符合国际理念及《药品注册管理办法》（2020年）对中药的分类规定，将企业增设为权利主体，赋以生产权以流转性的同时增设“国家中药保护品种”标志使用权，保护期限应调整至5～15年，以与国际社会一些药品知识产权特有保护制度相符。

Our country has assigned different responsibilities to the protection system for varieties of traditional Chinese medicines (TCM) at different times. To make up for the deficiencies of the patent system, transform from a drug supervision and management system to a sui generis system for TCM, which promotes high-quality innovation and development of TCM varieties, should be its way out. The both focus on inheritance and innovation, clinical value dominance, balance of interests, and taking into account the characteristics of TCM and international practices should be the principles of the construction. In system construction, TCM decoction pieces should be included in the protection scope alongside ready-made TCM (beyond raw materials), and graded protection should be replaced by classified protection to align with international concepts and the classification rules of the Measures for the Administration of Drug Registration (2020). Enterprises should be added as rights holders, the production rights of TCM varieties should be alienable, and “National Protected Variety of TCM” mark right should be added. The protection period should be adjusted to 5—15 years to conform to specific intellectual property protection systems for pharmaceuticals in the international community.

R288

国家中医药管理局2024年度深化医改中医药政策研究自选课题（YGZXKT2024147）；2024年度浙江省知识产权软科学研究项目（Z1202430）