IP Practice: “Update of Patent Linkage System for Pharmaceutical Products in Taiwan”
We are pleased to announce the February 2018 issue of Sonderhoff & Einsel Taiwan IP Newsletter.
The Legislative Yuan (equivalent to the Japanese national Diet) passed a proposal for the partial revision of the Pharmaceutical Affairs Law on December 29, 2017. The revision and newly established articles are 26 in all, and data protection for new indications and a patent linkage system were introduced in accordance with this revision proposal. Patent linkage is a system whereby a country links drug marketing approval of a generic drug to the status of the patents related to the originator’s product.
The newly established patent linkage system in Taiwan is positioned to be a part of Taiwan’s Trade and Investment Framework Agreement (TIFA) and the Trans-Pacific Partnership (TPP), and involves the disclosure and registration of patent information on new drugs, declaration and announcement by generic drug applicants, challenges to patent rights and related correspondence, temporary suspension of the issuance of generic drug licences, and market exclusivity of generic drug manufacturers who first obtained a drug license.
For details, please check the following PDF.