Research on the Patent Dispute Resolution Procedure During the Registration Application of Biosimilars in the United States

OBJECTIVE To propose suggestions for improving the patent dispute settlement procedure of biosimilars in China. METHODS Intensive studied the legal basis and implementation way of the patent dispute resolution procedure for biosimilars in the United States. And the typical case was selected to analyze the focus issues. RESULTS The patent dance system in the United States was helpful for early intervention and settlement of patent disputes of biosimilars, and was equipped with complete supporting measures. CONCLUSION To improve the patent dispute resolution of biosimilars in China, it is suggested to establish the procedure of patent dispute resolution of biosimilars, introduce the system of artificial infringement, and establish the catalogue of listed products of biological products in China.