Intellectual Property System Related to Biologics Early Registration in the United States
QI Yun1, YANG Yue2, XING Hua1*
1. School of Business Administration, Shenyang Pharmaceutical University, Shenyang 110016, China; 2. School of Pharmaceutical Sciences, Tsinghua University, Beijing 100084, China
Abstract：OBJECTIVE To explore and analyze the intellectual property protection system related to the registration of biological products in the United States. METHODS Domestic and foreign documents were consulted, the background of the US "Biologics Price Competition and Innovation Act" was reviewed, the use of the patent dance system in the United States was sorted to resolve various patent disputes. RESULTS The data protection system is parallel to patents. The application for biosimilar drugs is submitted within the 12-year protection period. Before the FDA has not approved it, the patent dance system uses the information exchange process between the biosimilar drug company and the original research company to identify relevant patents and the scope of patent litigation shall be determined through good faith negotiation, minimize the pressure of patent litigation, strive to resolve patent disputes before biosimilars are marketed, and accelerate the listing of biosimilars, so as to improve the availability of medicines to the public. CONCLUSION The particularity of biological products causes the early resolution of patent issues to be more complicated than chemical drugs, and it is not appropriate to use the same model as chemical drugs to resolve disputes.
齐云, 杨悦, 邢花. 美国生物制品注册早期相关知识产权制度研究[J]. 中国药学杂志, 2022, 57(3): 242-248.
QI Yun, YANG Yue, XING Hua. Intellectual Property System Related to Biologics Early Registration in the United States. Chinese Pharmaceutical Journal, 2022, 57(3): 242-248.
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2022, Vol. 57 
