摘要
反向支付协议是药品专利链接制度的天然副产品,我国现行药品专利链接制度缺乏首仿药市场独占期“失权”条款和反向支付协议的备案审查规定,为其产生提供了肥沃的制度土壤。反垄断法及其配套法规也没有明确反向支付协议反垄断审查的基本原则及具体规则,且缺乏反垄断执法所需的部门间衔接机制,对其规制乏力。加强对反向支付协议的规制一方面应完善药品专利链接制度:增设首仿药市场独占期“失权”条款和反向支付协议备案审查规定,通过制度内部优化减少反向支付协议的产生;另一方面应当明确合理原则为反垄断审查原则并确立反垄断审查的具体规则以统一反向支付协议反垄断审查的裁判标准,并建立法院、专利行政部门与反垄断执法机构之间的衔接机制保障对反向支付协议反垄断审查的专业性和有效性。如此才能促进我国药品专利链接制度的有效运行并实现其既鼓励药品创新也促进医药市场良性竞争的立法目标。
The reverse payment agreement is a natural by-product of the drug patent linkage system.The current drug patent linkage system in China lacks the“loss of rights”clause in the exclusive period of the first generic drug market and the record review provisions of the reverse payment agreement,which provides a fertile institutional soil for its emergence.The anti-monopoly law and its corresponding regulations and laws also do not clarify the basic principles and specific rules for the anti-monopoly review of reverse payment agreements,and lack the inter-departmental convergence mechanism required for antimonopoly law enforcement,which makes the regulation of them ineffective.To strengthen the regulation of reverse payment agreement,on one hand,it should improve the drug patent linkage system by adding provisions on the“loss of rights”during the period of exclusivity in the market of the first generic drug and provisions on the filing and review of reverse payment agreements,so as to reduce the generation of reverse payment agreements through internal optimization of the system;on the other hand,it is necessary to clarify the principle of reasonalization as the principle of anti-monopoly review and establish specific rules for anti-monopoly review to unify the judgment standards of anti-monopoly review of reverse payment agreements,and establish a cohesive mechanism between courts,patent administrative departments and anti-monopoly law enforcement agencies to ensure the professionalism and effectiveness of anti-monopoly review of reverse payment agreements.Only in this way can the effective operation of China’s drug patent linkage system be promoted and its legislative goal of encouraging drug innovation and promoting healthy competition in the pharmaceutical market be realized.
作者
谭雨欢
胡潇潇
TAN Yuhuan;HU Xiaoxiao(School of Political Science and Law,Central South University of Forestry and Technology,Changsha 410004)
出处
《中国发明与专利》
2023年第3期66-72,共7页
China Invention & Patent
基金
国家社科基金项目“专利到期药物仿制上市法律保障机制研究”(项目编号:18BFX168)
中南林业科技大学研究生科技创新基金项目“药品专利权滥用法律规制研究”的研究成果。
关键词
药品专利链接
反向支付协议
反垄断规制
合理原则
drug patent linkage system
reverse payment agreement
anti-monopoly regulation
reasonable principle
