Taiwan jurisdiction report: New patent linkage system

It is expected that the patent linkage system will be implemented by early 2019 following the enactment of the amended Pharmaceutical Affairs Act.

Figure 1 is a flowchart drawn in accordance with the draft of “the Enforcement Rules for Patent Linkage” completed by Taiwan’s Food and Drug Administration (FDA). The draft provides details of how to file an application for recording patent information relating to a patent to be listed in the linkage system so as to prevent Taiwan’s FDA granting regulatory authorisation to a generic medicine.