Pharmaceutical Patent Term Extension in Taiwan: Simplified Examination Procedure
The Amendments to Articles 4 and 10 of the Regulations Governing the Determination of Patent Term Extension (hereinafter, the “Regulations”), which were jointly issued by the Ministries of Economic Affairs, Health and Welfare (hereinafter, the “MOHW”), and Agriculture on June 28, 2023, went into effect on July 1, 2023.
The following factors were taken into consideration when making these amendments: According to Article 4 of the current Regulations, when the patent authority (specifically, the Intellectual Property Office under the Ministry of Economic Affairs; hereinafter, the “IPO”) reviews applications for pharmaceutical patent term extensions, it is necessary 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 trial” However, the examination of domestic and international clinical trials required for the issuance of a drug license has been included to the MOHW’s modified Data Exclusivity Period and Domestic and international Clinical Trial Data Form, which was both released on November 2, 2021.
The aforementioned present provisions might be made unnecessary and subject to overlap as a result. These Amendments remove some of the text from Article 4 of the current Regulations to simplify the associated processes. This allows the IPO to calculate the “domestic and foreign clinical trial period” based on the domestic and foreign clinical trial data submitted by the applicant and verified by the MOHW during its review, rather than having to submit the data to the MOHW separately for confirmation.
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– You could also read 04 Often Questions About Filing Trademark In Taiwan here.
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