The patent term for protection of an invention patent in Taiwan is 20 years from the filing date of its patent application. However, the duration of a pharmaceutical or agrochemical patent may often be reduced, since a regulatory approval must be obtained before marketing the product. Therefore, Taiwan provides an extension of a patent term to compensate for the time lost in obtaining the marketing approval from the relevant authorities. Pursuant to Article 53 to 57 of Taiwan Patent Act (in which these related articles were amended on December 21, 2011 and enforced on January 1, 2013) and Regulations for Ratifying Patent Term Extension (which recently amended on April 11, 2018 and enforced with retrospective effect from April 1, 2018), a concise summary for the related provisions of patent term extension are as follows:
- A request for patent term extension is applicable to an invention of pharmaceutical (except for veterinary pharmaceutical) or agrochemical product, or their manufacturing processes after examination and grant of a patent thereon, which a regulatory approval is required for the commercial practice of said patent.
- An applicant who files a request for patent term extension can be a patentee or an exclusive licensee (evidencing documents are necessary if the license is not recorded).
- A request must be filed within 3 months upon receipt of a first regulatory approval and no later than 6 months prior to expiration of the patent term.
- If the holder of first regulatory approval is not the patentee, the applicant who files the patent term extension should provide relevant documents proving both have the same juridical identity or have completed the license process when filing the patent term extension.
- One patent term extension is allowable only for one patent right, and one regulatory approval can be used only once for requesting one patent term extension.
- The scope of extension is limited to the active ingredients and use as stated in the regulatory approval (i.e. a scope to be covered by the patent claims but not all the entire scope of patent claims).
- The calculation of patent term extension is based on a unit of days (including the time of domestic/foreign trials and their examining period, and deducting the period attributable to the applicant who files the extension), and the extension shall not exceed 5 years.
- A request for patent term extension must be submitted by a written application with supporting documents, plus an official fee of NT$9000.
- If any person finds that the grant of patent term extension has violated the extension requirements or provisions, an invalidation petition can be filed together with exhibits. The extension shall be deemed non-existent ab initio if a decision made on invalidation of the patent term extension is irrevocably sustained (yet if the invalidation is based on the reason that the granted term of extension has exceeded the period during which the patent cannot be put into practice, then only the exceeding period shall be deemed to be non-extended).
In Taiwan, since only one extension of patent term based on one regulatory approval will be granted for each invention patent and divisional applications cannot be filed after publication, the patent applicant should consider to file divisional application(s) when the patent application is still pending or within the statutory period upon receipt of the Notice of Allowance, so that a separate extension of patent term can be filed for each of the parent application and its divisional application(s) later on.
