Pharmaceuticals and agricultural drugs cannot be marketed for
sale in Taiwan before a regulatory approval is obtained. Thus, in
order to compensate for the delay resulting from clinical tests or
obtaining regulatory approval, Taiwan's Patent Act has embraced
a patent term extension system. In accordance with Article 53 of
the Patent Act, if the practice of an invention patent relating to
pharmaceutical or pesticide composition or the manufacturing method
therefor is subject to regulatory approval and if the approval is
obtained after publication of the grant of the patent, the patentee
may apply for a patent term extension based upon the first
certificate of regulatory approval.
In general, only one single extension is obtainable, and a
certificate of regulatory approval can be based upon to apply for
an extension just for once. Moreover, the duration of a patent
extension is not allowed to go beyond the duration during which the
patent cannot be practiced due to the
