Patent term extension (PTE) in Taiwan includes both the period for conducting clinical trials domestically and/or abroad and the period for reviewing the application for regulatory approval by the health authority.[1] As required by the TIPO’s Patent Examination Guidelines,[2] when the clinical trial is conducted abroad, the trial period shall be defined by a study initiation date and a study completion date provided by the standardized reporting format under the ICH guidelines[3]. The study completion date means an earlier date of the last patient completed rather than a later date on which a report concluding said study is finished and presented. TIPO’s interpretation has raised some questions because adopting an earlier end date inevitably excludes the period of producing the report from being counted towards the PTE.

  Roche and MSD (collectively referred to as “the patentees”) filed PTE applications to the TIPO sometime before 2018. In 2019, the TIPO made two decisions to grant PTEs, but both were shorter than the lengths requested by the patentees. This was primarily because TIPO identified the end date of the foreign clinical trial period as being the study completion date, as mentioned previously. Opposing this, the patentees argued that it would only be fair if the end date was a later time point, that is the date on which a written report presenting the outcomes of a study is complete. Not satisfied with the TIPO’s decisions, the patentees filed administrative appeals and subsequently lawsuits.

  In June 2020, the IPC Court issued two separate but consistent trial judgments[4], ruling in favor of the patentee by finding that the study’s end date was the reporting date rather than the study completion date. The IPC pinpointed that fact that before the study report is complete, no regulatory approval will be issued. In other words, the patent right cannot either be exercised during the period in which a report is being prepared. Hence, from the perspective of the policy of the PTE institution, both the period of conducting a study and the period of preparing its report should be counted towards PTE. The TIPO appealed, insisting that the end date should be merely the date the study was completed.

  In 2022, the Supreme Administrative Court (SAC) as the appellate forum vacated the trial judgments of both cases. The SAC did not specify which end date was correct but dictated to seek advice from the optimal agency in the particular field. In the opinion of the SAC, the competent authority for issuing regulatory approval for domestic or foreign clinical trials was the Ministry of Health and Welfare (MOHW). Hence, MOHW was the governmental body with the most capable expertise in medical affairs to ascertain the length of a study’s duration. The TIPO should thus consult the MOHW in order to correctly determine the length instead of doing so by merely taking the study completion date. Similarly, under the rationale above, the IPC Court in the trial judgment also erred in failing to consult the MOHW when determining the correct clinical trial period. The lower court’s straight adoption of the reporting date seemed similarly arbitrary.

  Following up in September 2023, in adherence to the reasoning of the SAC, the IPC Court in remand rendered two other judgements. Opining in favor of the patentees, the IPC Court determined that the period for producing a report concluding a foreign clinical trial should be included in the PTE. The IPC Court reasoned firstly that the exclusion in the TIPO’s Patent Examination Guidelines of the time spent for producing study reports unduly narrowed the policy purpose of the PTE, that is to adequately compensate for the time during which a patent stays unenforceable. Secondly, while the TIPO recognized the date of receipt of a clinical trial report as the end date of the study being conducted in Taiwan, the fact that it denied the reporting date as the end date in the present cases where the study was made overseas was deemed to be unfair. Thirdly, and most crucially, a clinical trial report that organizes, analyzes and demonstrates statistical data is an essential document to accompany an application for regulatory approval to the MOHW to better enable them to determine whether the drug product fulfills the requirements of biosafety, efficacy and other factors. Only when a conclusive study report is presented will the MOHW be able to decide whether or not to grant approval. Therefore, the clinical trial period to be countable toward PTE should end at the reporting date instead of the study completion date. In other words, in addition to the duration of conducting a study, the duration required to produce a study report was justifiably considered to be a part of the foreign clinical trial period to be countable toward PTE.

  In accordance with the IPC Court’s holding, the PTE became five years in the Roche case, a total of 307 days more than the period previously granted by the TIPO; in the MSD case, the PTE was 624 days in total, amounting to an additional 113 days.

  To encapsulate, the SAC emphasized that the foreign clinical trial period for PTE depends on whether the study is sufficient to enable the MOHW to issue regulatory approval. Production of an analytical report to edit raw data seems to be a necessary endeavor. In the latest judgments, the IPC Court interpreted the reporting date as the time when the necessary data can finally be presented for the MOHW to be able to decide the issuance of an approval. Despite it is unclear whether the TIPO had further appealed the IPC Court’s interpretation by the time this article went to press, it should more likely than not assure that a significant portion of the time spent on producing study reports can be counted towards PTE in the future.

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