The Rules for Approving the Extension of Patent Term (hereinafter, the “Rules”), which consist of 10 articles and came into effect on April 1, 2018, were jointly amended on April 11, 2018 by the Ministry of Economic Affairs via the MOEA-Jing-Zhi-10704601450 Directive, the Ministry of Health and Wealth via the Wei-Shou-Shi-1071402972 Directive, the Council of Agriculture via the Nong-Ke-1070709474 Directive. The amendments are highlighted below:
First, the amendments exempt the need to attach supporting document for any overseas approval of an extension.
Since the period of a domestic or overseas field trial or clinical trial which is conducted by an applicant to obtain a pesticide license or drug license is limited to that required for the patent authority’s confirmation with the competent authorities to determine if such period is required for the issuance of the licenses, whether the applicant seeking to apply for an extension of the patent term based on the period in which any overseas field trial or clinical trial is conducted has previously applied overseas to extend the patent term and whether such application has been granted is no longer important. In addition, there is no need to submit supporting documents for such approved extension. Therefore, Articles 5 and 7 of the Rules are amended to remove the requirement that supporting documents evidencing the approval of an extension to the patent term in another country during the period shall be submitted.
In addition, the restriction that in case of field trials which have no sequential relationship, only the one with the longest time may be used to apply for an extension of the patent term is lifted.
Under Article 5 of the Guidelines for Field Trials of Pesticides, a field trial conducted for the purpose of obtaining a pesticide license shall be conducted domestically or at least three overseas field trials or their trial data shall be provided. The requirement before the amendment only allowed an extension applicant who was required by law to conduct at least one field trial to select a trial requiring a longer period of time for the purpose of application in the absence of sequential relationship among various trials and did not allow patent extension application for every single trial. Therefore, to carry out the objectives of the patent term extension system, Article 6 of the Rules is amended to remove the requirement that in case of field trials without sequential relationship, only the trial requiring the longest amount of time may be used to apply for an extension of the patent term.