Patent Act Article 53

Extension of patent termWhere a regulatory approval shall be obtained in accordance with other laws and regulations for the exploitation of an invention patent involving a pharmaceutical or agrichemical, or the manufacturing process thereof, if such regulatory approval is obtained after the publication of the concerned invention patent, the patentee may apply for one and only one extension of the patent term of said invention patent based on the first regulatory approval. The said regulatory approval is allowed to be used only once for seeking patent term extension.The extension of the patent term approved under the preceding paragraph shall not exceed the length of time when the patent cannot be exploited because of the filing of a request for the regulatory approval with the central competent authorities in charge of the business. If the time needed to obtain the said regulatory approval exceeds five (5) years, the granted patent term extension shall still be five (5) years.The term "pharmaceutical" as set forth in Paragraph 1 does not include any veterinary drug.When requesting for patent term extension as provided in the Paragraph 1, a request form and document(s) of proof must be submitted to the Specific Patent Agency within three (3) months after obtaining the first regulatory approval; no request for patent term extension shall be filed within six (6) months prior to the expiry of the original patent term.When making a decision on an application for patent term extension, the Specific Patent Agency shall take into consideration the impact on public health and shall coordinate with the central competent authorities in charge of the business to formulate the regulations concerned.