According to Taiwan’s Patent Term Extension Regulations (the “Extension Regulations”), patent term extension may compensate for the examination period for domestic regulatory drug approval. However, any “time period attributable to the Applicant’s omission of act” must be deducted therefrom.
The current Patent Examination Guidelines of Taiwan further stipulate that the “time period attributable to the Applicant’s omission of act” includes, for instance: (1) any remediation period arising from failure to meet the requirements of the Ministry of Health and Welfare (MOHW) regarding drug approval examination, including incomplete documentation and failure to pay official fee; and (2) the “period for collecting the approval,” which is calculated from the day following the date of service of the collection notice until the day prior to the actual collection of the drug approval.
Accordingly, the established practice of the Taiwan Intellectual Property Office (TIPO) has been to categorize the “period for collecting the approval” as a “time period attributable to the Applicant’s omission of act” and deduct it from the patent term extension. This interpretation was upheld by the Intellectual Property & Commercial Court (the IPC Court) in two judgments made in 2024; please refer to our firm’s previous report for details:
However, the IPC Court has recently shifted its opinion following the remand of its previous decisions by the Supreme Administrative Court. In response to the remand instructions, the IPC Court now holds that the “period for collecting the approval” cannot be deemed a “time period attributable to the Applicant’s omission of act” in the absence of relevant factual evidence. See:
- IPC Court Judgment 114-Xing-Zhuan-Geng-(1)-Zi No. 6 (February 2026)
- IPC Court Judgment 113-Xing-Zhuan-Geng-(2)-Zi No. 1 (December 2025)
- IPC Court Judgment 114-Xing-Zhuan-Geng-(2)-Zi No. 2 (December 2025)
The three judgments challenged the Patent Examination Guidelines’ blanket treatment of the “period for collecting the approval” as a “time period attributable to the Applicant’s omission of act.” Thy each required TIPO to clarify, through further investigation, whether the applicant’s delay in collect the drug approval resulted from causes attributable to the applicant, such as the need to correct labels, package inserts, or packaging due to the applicant’s own errors, or its failure to timely pay the official fee or submit the requirement materials. Absent such clarification, such period should not be directly deducted from the patent term extension period, the IPC Court held.
As two of these cases have been appealed again to the Supreme Administrative Court, and the relevant provisions of the Patent Examination Guidelines remain unamended, TIPO may continue its established practice for the time being.
Nevertheless, patent owners are advised to take into account the reasoning set forth in these recent judgments and provide more detailed explanations regarding the “period for collecting the approval” during a PTE examination proceeding to secure a longer patent term extension.