Research On The Comparison Of Drug Patent Links Between China And The United States

In 2020,Article 76 of the Patent Law of the People’s Republic of China added the content of the early resolution mechanism for drug patent disputes.In 2021,the State Drug Administration and the China National Intellectual Property Administration jointly issued the Implementation Measures for the Early Resolution Mechanism for Drug Patent Disputes(for trial implementation),marking the official implementation of the drug patent linkage system in China.The drug patent linkage system can strengthen the innovation ability of original drug research enterprises,accelerate the listing of generic drugs,and meet the accessibility of public drugs,which is a favorable system for balancing the interests of the three parties.By comparing it with the mature drug patent linkage system in the United States,it can be seen that China’s overall framework design is similar to that of the United States,with the difference being in the provisions of some details.China’s relevant regulations have made improvements with Chinese characteristics based on its national conditions,such as the registration of traditional Chinese medicine types,a 9-month waiting period system,a dual track judicial and administrative system,and a 12 month market monopoly period.However,China’s current drug patent linkage system is still in its early stages of development and has not undergone much judicial and administrative practice testing.The drug registration part is not perfect enough,and the legal responsibility for improper registration is not clearly defined.The legal responsibility for not timely delivering patent declaration notices is not clear,and the legal basis for proposing patent challenges is not clear,such as "pseudo infringement".Insufficient attention is paid to the review of both parties’ reverse payment settlement agreements.Based on the national conditions of China and the experience of the drug patent linkage system in the United States,corresponding suggestions is proposed.For drug patent registrations that have undergone multiple changes,time nodes should be marked to distinguish and clarify the legal liability for improper registration,improve the legal consequences of failure to notify in a timely manner,and propose the legal basis for patent challenges by proposing infringement.Both parties should also review the reverse payment settlement agreement,and if necessary,cancel the market monopoly qualification of generic drug enterprises.This article elaborates on the comparison of drug patent linkage systems between China and the United States,and the research conducted is beneficial for guiding practice and improving relevant systems.