韩欣悦 聂洪涛

中圖分类号 R95;G306 文献标志码 A 文章编号 1001-0408（2021）18-2177-07

DOI 10.6039/j.issn.1001-0408.2021.18.01

摘 要 目的：为我国构建与国际接轨的专利链接制度、平衡原研药企业与仿制药企业之间的利益冲突提供参考。方法：介绍美国专利链接相关配套制度，结合国内外药品专利保护的发展现状和有关制度，分析我国药品专利管理制度中存在的问题，并提出完善建议。结果与结论：美国专利链接制度包括桔皮书制度、仿制药专利声明制度、仿制药审批等待期以及首仿药市场独占期制度等内容。医药产品领域创新性与可及性面临着“公地悲剧”与“反公地悲剧”两难困境。我国药品专利保护存在着研发创新能力不足制约着医药产业发展、法律法规不完善不利于医药专利纠纷的解决等诸多问题。建议我国可采取建立专利药品数字化信息库、规范现有的仿制药专利声明制度、促进专利诉讼周期与审批等待期的相互协调、增加医药产业自主创新能力等措施，促进医药创新与药品可及性的相互协调，共同推动药品知识产权立法的完善和医疗卫生事业的发展。

关键词 药品专利;创新性;可及性;利益平衡;原研药;仿制药;专利链接制度

Benefit Balance and System Construction of Innovation and Accessibility of Pharmaceutical Products in China：Taking the Patent Linking System as an Example

HAN Xinyue，NIE Hongtao（School of Law， Xian University of Finance and Economics， Xian 710100， China）

ABSTRACT   OBJECTIVE： To provide reference for constructing a patent linking system in line with international standards and balancing the interest conflict between original drug enterprises and generic drug enterprises. METHODS：The relevant supporting systems of patent link in the United States were introduced; combined with the development status and relevant systems of drug patent protection at home and abroad， the existing problems of Chinas drug patent management system were analyzed to put forward suggestions for improvement. RESULTS & CONCLUSIONS：The United States patent linking system included Orange book system， generic drug patent declaration system， generic drug approval waiting period and market monopoly period system of the first generic drug. The innovation and accessibility in the field of pharmaceutical products were facing the dilemma of “commons tragedy” and “anti commons tragedy”. There were many problems in Chinas drug patent protection， such as insufficient R&D and innovation ability inhibited the development of the pharmaceutical industry， imperfect laws and regulations were not conducive to the settlement of medical professional disputes. It is suggested to establish a digital information database of patented drugs， standardize the existing generic drug patent declaration system， promote the coordination between patent litigation cycle and approval waiting period， increase the independent innovation ability of the pharmaceutical industry， promote the coordination between pharmaceutical innovation and drug accessibility， and jointly promote the improvement of intellectual property legislation and the development of medical and health undertakings.

KEYWORDS   Drug patent; Innovation; Accessibility; Interest balance; Original drugs; Generic drugs; Patent linking system

随着全球化进程的深入推进，国际间人口、贸易的流动更加频繁，公共健康危机的波及范围也越来越广[1]。近年来，严重急性呼吸综合征（SARS）、禽流感、甲型H1N1流感、新型冠状病毒肺炎等流行性疾病相继出现，给人们的生命和财产造成严重损害，阻碍了人们生产生活的正常进行。……