药品专利链接制度国际发展及中国选择

International Practice and China’s Choice of Drug Patent Linkage System

药品专利链接制度作为美国力推的药品专利制度,从引进之初便备受争议。该制度虽然强化了原研药专利的保护水平,但可能会对仿制药的上市产生消极影响。在比较法上,不同国家对药品专利链接制度的态度存在较大差异,发达国家力推而发展中国家反对。出于落实中美贸易协定以及鼓励我国原研药产业发展的目的,我国在《专利法》第四次修订中引入了药品专利链接制度。药品专利链接制度顺应了我国医药产业发展的需要,但在实践中存在信息登记缺乏有效监督、等待期制度僵化等问题。对此,我国应当在鼓励创新的同时,尽可能地对原研药企业通过专利链接制度获得的权利进行限制,以平衡原研药与仿制药企业之间的利益。具体实施程序的制定上,我国需要完善药品专利信息登记和药品上市通知制度,加强各方协作,明晰权责分配,提高纠纷解决效率。同时还需要对等待期制度进行细化,在保障纠纷解决的同时尽可能加快仿制药上市,在鼓励原研药产业发展的同时尽可能保障仿制药企业的利益。

As the drug patent system promoted by the United States,the drug patent linkage system has been controversial since its introduction.It strengthens the protection of original drug patents but may have a negative impact on the listing of generic drugs.In terms of comparative law,there are great differences in the attitudes of different countries to the drug patent linkage system:developed countries promote its development while developing countries oppose its development.For the purpose of implementing the Sino-US trade agreement and encouraging the development of China’s original drug industry,China introduced the drug patent linkage system in the fourth revision of the Patent Law of the People’s Republic of China.The drug patent linkage system meets the development needs of China’s pharmaceutical industry,but in practice there are problems such as the lack of effective supervision of information registration and the rigidity of the system concerning the waiting period.In this regard,while encouraging innovation,China should limit as much as possible the rights obtained by original drug companies through the patent linkage system to balance the interests of original drug companies and generic drug companies.In terms of the formulation of specific implementation procedures,it is necessary to improve the drug patent information registration and drug listing notification system,strengthen the cooperation of all parties,clarify the allocation of rights and responsibilities,and improve the efficiency of dispute resolution.At the same time,it is necessary to specify the waiting period system,to speed up the listing of generic drugs while ensuring dispute resolution,and to protect the interests of generic drug companies while encouraging the development of the original drug industry.