海峡两岸药品专利链接制度比较及其衔接  

A Comparative Study of Cross-Straits Pharmaceutical Patent Linkage Rules and Their Convergence

作　　者：丁丽瑛[1] 钟皓珺 Ding Liying;Zhong Haojun

机构地区：[1]厦门大学法学院,福建厦门361005

出　　处：《台湾研究集刊》2022年第6期105-120,共16页Taiwan Research Journal

摘　　要：为了构建更加健全的药品专利保护制度,妥善解决与美国的贸易摩擦,两岸先后进行了相关立法的修订,正式引入药品专利链接制度。目前,海峡两岸仿制药在药品市场供应链上均占有较大比例,两岸药品制造企业在仿制药领域具有共同市场利益,在药品专利链接方面制度趋同,推进两岸制度衔接具有现实基础。推进两岸上市药品专利链接信息共享项目合作和平台建设,探索两岸在首仿药市场独占期保护领域的合作空间,引入仲裁作为解决药品专利链接纠纷的可选择路径,增设药品专利链接程序中的反垄断审查,均有助于推动两岸药品产业融合发展,保障两岸民众的共同福祉,为壮大中华民族经济作出贡献。In order to build a comprehensive drug patent protection system and properly solve the trade frictions with the United States, Chinese mainland and the Taiwan region have successively revised relevant legislation, and formally established the pharmaceutical patent linkage. At present, generic drugs produced on both sides of the straits have a great market share in the supply chain. Drug manufacturers across the Straits have common market interests. The pharmaceutical patent linkage systems across the Straits are similar. All these factors constitute a realistic basis for promoting cross-Straits system convergence, which entails the following measures: Promoting the cooperation and platform construction to facilitate information sharing in pharmaceutical patents linkage across the Straits;exploring the space for cooperation between the mainland and Taiwan in the protection field of the generic drug market exclusivity period;introducing arbitration as an alternative solution to resolve pharmaceutical patent linkage disputes;and establishing anti-monopoly review in the procedure of pharmaceutical patent linkage. All these methods would not only deepen the integrated development of the drug industry across the Straits, but also ensure the common well-being of people across the Straits and contribute to the growth of the Chinese national economy.

关 键 词：海峡两岸 药品专利链接 制度衔接 

分 类 号：D923.42[政治法律—民商法学]