At the beginning of January 2018, a patent linkage system was
promulgated and introduced into the Pharmaceutical Affairs
Act. After almost 19 months, Taiwan's Government announced
on August 6, 2019 that the patent linkage system shall be
implemented from August 20, 2019.
Patent Listing
According to the amended Pharmaceutical Affairs Act and related
bylaws, to prevent Taiwan's FDA from granting regulatory
authorization to a generic medicine, owner of a new drug approval
(rather than the patentee) has the right to file an
application for recording information relating to a patent to be
listed in a patent linkage system run by Taiwan's FDA.
The application must be filed within 45 days from the date the
certificate of a new drug approval is received.
However, if the certificate of a new drug approval is
issued before the patent linkage registration system takes effect,
the new drug approval holder is allowed to list its patent(s) by
November 20, 2019 (i.e. within
