The Establishment And Supervision Of The Chinese Drug Patent Link System Under New Situation

Drug is a kind of special commodity, directly related to human health.The drug patent system can guarantee the return of technologicalinnovation, research and development. Strict administrative examinationand approval management can control security, effectiveness and quality ofdrugs. With the speeding up of the internationalization of our countrymedicine industry and the continuous improvement of the drug registrationmanagement regulations system, the number of case about patentinfringement dispute is increasing. Drug patent protection issuesincreasingly become the focus in drug registration for examination andapproval. The establishment of the drug patents link system effectivelylinks the drug registration and patent protection for the purpose ofbalancing the relationship between promoting innovations and protectingpublic health. In the process of drug registration, the patent infringementshould be fully considered and the development of generic drugs shouldalso be encouraged for increasing the accessibility of medication. Since 2002,‘drug registration management approach’ has been revised twiceon drug patent link system. However, there is much room to improve. So,in the future, more attention should be paid on how to improve drug patentlink system and regulatory functions of the government.In this paper, through clarifying the formation and development ofdrug registration management regulations system and deeply analyzing thecurrent situation of development of pharmaceutical industry in China, weelaborate the background of Chinese drug patent link system. By analyzingthe case of hengrui-sanofi patent dispute, we point out the flaw of currentdrug patents link system in China. For instance, the description of patentstatus is not clear; the reliability of patent claims is questioned; patentdispute lack effective remedies; the rule that " two years before theexpiration of the patent right "is invalid,; the system of drug patent rightextension has not been established; the exclusive period of data protectionis not targeted, Drawing lessons from the United States, this paper providesuggestions respectively from entity and operating level.