Exploring Drug Patent Linkage and the First ANDA Litigation in China

Abstract

Introduction Drug patent linkage is an important mechanism for the early resolution of patent disputes in the pharmaceutical field. Since its establishment in China in mid-2021, the patent linkage system has drawn national and international attention. Areas covered : Starting with the development of patent linkage in China, this paper provides an overview of the patent linkage system in connection with the first Abbreviated New Drug Application (ANDA) litigation in China, in which the first-instance and second-instance trials were efficiently finished within the period for the stay of generic approval, and the Intellectual Property Tribunal of China’s Supreme People’s Court made a final decision in August 2022. The U.S. and Chinese patent linkage systems are compared. In addition, current judicial and administrative proceedings of the patent linkage system in China are examined. Expert Opinion The legal framework and infrastructures required for the patent linkage system, including a platform for patent listing, patent certification, stay on generic approval, and first generic exclusivity, have been established in China. Furthermore, the New Drug Application (NDA) holders and ANDA filers are effectively utilizing the system. Accordingly, it has been found that the patent linkage system in China is running efficiently.