Abstract：Generic drug patent challenge is the core content of the drug patent linkage system and the main institutional motivation triggering disputes over patent ownership during the drug registration and approval stage.Currently, there is a controversy over the definition of the legal attributes of patent challenge, with the two views of artificial infringement and confirmed non-infringement spilt on each end.The former is based on the theory of legal fiction and contributory cause of intellectual property infringement, and has the function of balancing internal and external interests.Under the examination of the logical structure standard and the same legal interests standard, the artificial infringement and the Bolar exemption have formed a relationship of general law with special law.By analyzing and learning from the relevant legislation of patent challenge in the US and Korean, it is recommended that China introduce artificial infringement, confirm the generic drug patent challenge as artificial infringement in legislation and add it as the special provision of the Bolar exemption.In response to the risk of rights expansion of artificial infringement, a restrictive path should be adopted to clarify the types of patent declarations, the scope of objects and legal consequences under its jurisdiction.At the same time, the CFDA should be endowed with the authority to verify the waiting period and perfect the regulatory measures for the above.
冯振龙, 周莹. 仿制药专利挑战行为拟制侵权的合理性证成及制度建构[J]. 中国科技论坛, 2023(4): 142-150.
Feng Zhenlong, Zhou Ying. Rationalization and Institutional Construction of Artificial Infringement of Generic Drug Patent Challenge. , 2023(4): 142-150.
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