Brooklyn Journal of International Law


Jerry I-H Hsiao

First Page



In 2019, as an effort to join the Trans-Pacific Partnership (TPP) Agreement (now Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP)), Taiwan has implemented the patent linkage system which covers both small molecule generic drugs and large molecule biosimilar into the Pharmaceutical Affair Act. The system modeled after the U.S.’s patent linkage system designed for small molecule drugs under the Hatch Waxman Act (HWA). Based on the experience of the patent linkage system under the HWA, biosimilar industry representatives in Taiwan contended that the adoption of the patent linkage system will be detrimental to the development of local industry. By adopting patent linkage system, foreign biologics company would implement evergreening strategies to delay the marketing of locally produced biosimilar, conduct improper patent listing, and to abuse the granting of automatic stays. This article critically evaluates whether Taiwan’s patent linkage system could serve the dual goal of fostering biologic innovation and promoting biosimilar industry development by examining patent linkage systems for biosimialrs in the U.S, South Korea and Taiwan. This article argues that this dual goal could be achieved if the method of manufacturing patents could be included in patent listings and through a wider institutional collaboration between Taiwan Food and Drug Regulation Agency and Taiwan Intellectual Property Office.