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Amendment to the Regulations Governing the Determination of Patent Term Extention Come into Effect on July 1, 2023


TIPO previously required applicants seeking to extend patent terms on pharmaceutical products or manufacturing methods to submit documentation for the duration of all domestic and/or international clinical trials. Documentation was then sent to the Food and Drug Administration (FDA) of the Ministry of Health and Welfare (MOHW), the central competent authority, to confirm the clinical trial period required for issuing a drug license.

On November 2, 2021, the MOHW announced an amendment to the Form for Data Exclusivity and Domestic and International Clinical Trials. The amendment included clinical trial data required for issuing a drug license within the scope of examination. To streamline administrative procedures and improve the efficiency of patent examinations, TIPO announced amendments to the Regulations Governing the Determination of Patent Term Extension on June 28, 2023, which came into effect on July 1 in the same year.

According to Article 4 and Article 10 amendments, if the FDA has confirmed the examination data (regarding the period of domestic and/or international clinical trials required for issuing a drug license) submitted by the applicant, then TIPO is no longer required to send the same data in question to the aforementioned authority.

  • Publish Date : 2023-07-14
  • Update : 2023-07-14
  • Organization : International Legal Affairs Office
  • Visitors : 455

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