摘要
上市药品专利信息登记是药品专利链接制度的重要组成部分和运行基础。我国上市药品专利信息登记制度存在四个方面的问题,一是药品专利信息登记制度相关条款不周延,存在法律漏洞,二是药品专利信息登记缺乏审查、监督机制,三是药品专利信息登记后缺乏异议程序,四是不当登记的法律责任不明确。我国上市药品专利信息登记制度的设计和运行应当兼顾效率与公平,维护利益平衡,促进医药市场良性竞争。完善我国上市药品专利信息登记应当从制度内部进行优化以化解固有矛盾;坚持形式审查原则,赋予药品监督管理部门删除、修改不当登记的药品专利信息的权力;设立药品监督管理部门和专利行政部门之间的职能衔接机构,从行政和司法两个方面建立不当登记的异议程序;明确不当登记的法律责任,增加违法成本,遏制对上市药品专利信息登记制度的滥用。如此才能保持药品专利信息登记的真实性、准确性和完整性,保障药品专利链接制度有效运行,实现药品专利纠纷的早期解决,达致药品专利链接制度既激励药品创新也鼓励专利到期后仿制药及时上市提升药品可及性的立法目标。
The registration of patent information of approved drugs is an important part and operational basis of drug patent linkage system.There are four problems in the system of China on the registration of patent information of approved drugs.First,the relevant provisions are not comprehensive and with legal loopholes;second,there is a lack of examination and supervision mechanism;third,there is a lack of objection procedure after the drug patent information is registered;fourth,the legal liability for improper registration is not clear.The design and operation of the system of China on the registration of patent information of approved drugs should be carried out by taking into account efficiency and fairness,thus maintaining a balance of interests and promoting healthy competition in the pharmaceutical market.To improve the registration of drug patent information in China,optimization should be made within the system to resolve the inherent contradictions;the principle of formal review should be insisted on and power to delete and modify drug patent information improperly registered should be granted to drug supervision and management authorities;the functional linkage agency between the drug supervision and management authority and the patent administration agency should be set up and the objection procedure for improper registration should be established from both administrative and judicial aspects;the legal liability for improper registration should be clarified to increase the cost of acting illegally and curb the abuse of drug patent registration system.Therefore,it is possible to maintain the authenticity,accuracy and completeness of the drug patent information registration,guarantee the effective operation of drug patent linkage system,realize the early resolution of drug patent disputes,achieve the legislative goal of the drug patent linkage system of both stimulating drug innovation and encouraging the timely approval of generic drugs after the patent expires so as to improve drug accessibility.
出处
《政治与法律》
CSSCI
北大核心
2022年第6期126-142,共17页
Political Science and Law
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)
湖南省社科基金项目“推动专利到期药物仿制上市法律对策研究”(项目编号:17YBA427)的研究成果
关键词
药品专利链接
上市药品专利信息登记
不当登记
异议程序
利益平衡
Drug Patent Linkage
Drug Patent Information Registration
Improper Registration
Objection Procedure
Balance of Interests
