August 2023
Teresa Huang and Albert Yen
The Ministry of Economic Affairs, the Ministry of Health and Welfare (hereinafter, the “MOHW”), and the Council of Agriculture jointly issued the Amendments to Articles 4 and 10 of the Regulations Governing the Determination of Patent Term Extension on June 28, 2023 (hereinafter, the “Regulations”), which became effective on July 1, 2023.
These Amendments took into account the following factors: under Article 4 of the current Regulations, when the patent authority (namely the Intellectual Property Office under the Ministry of Economic Affairs; hereinafter, the “IPO”) reviews applications for pharmaceutical patent term extension, it is required to submit domestic and foreign clinical trial data to the central competent authority in charge of the business (i.e., the MOHW) for confirmation as “clinical trials necessary for issuing a drug license.” However, the MOHW’s amended Data Exclusivity Period and Domestic and Foreign Clinical Trial Data Form, announced on November 2, 2021, has included the review of domestic and foreign clinical trials necessary for issuing a drug license. This potentially creates an overlap and redundant process in the above-mentioned current provisions. To streamline the related procedures, these Amendments remove certain portion of the text of Article 4 of the current Regulations, allowing the IPO to directly calculate the “domestic and foreign clinical trial period” based on the domestic and foreign clinical trial data submitted by the applicant and confirmed by the MOHW during its review, without the need to separately submit the data to the MOHW for confirmation.
These Amendments also specify in the reasoning column that if the MOHW implements electronic convenience measures for confirming the domestic and foreign clinical trials necessary for issuing a drug license in the future, the IPO may also adopt the domestic and foreign clinical trial data so confirmed. Additionally, if the domestic and foreign clinical trial data conducted by the applicant to obtain a drug license does not fall within the scope of the aforementioned Data Exclusivity Period and Domestic and Foreign Clinical Trial Data Form confirmed by the MOHW, or if the IPO still has concerns on the data form confirmed, the IPO may still request confirmation by the MOHW if ambiguity arises.
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