搜尋

年度搜尋：
專業領域：
時間區間：
~
關鍵字：

View of Supreme Court on Foreign Clinical Trial Period in Patent Term Extension Application

08/01/2018

Kate Shu-Yin Chu

Article 4 of the Regulations for Governing Patent Term Extensions, which was amended and took effect on 1 April 2018, stipulates that “the patent term extension period for a pharmaceutical, or its manufacturing process patent, includes (1) the foreign clinical trials and domestic clinical trial periods needed for issuance of drug market approval by the Central Authority; and (2) the period needed for local regulatory review;” “the above-mentioned foreign clinical trials and domestic clinical trial periods are limited to those necessary for issuance of market approval by the Central Authority.” Regarding the calculation of the foreign clinical trial period, the Patent Examination Guidelines Governing Patent Term Extensions (“PTE Guidelines”) which were amended and took effect on 1 April 2018, provide that “if a foreign clinical trial is used as a basis to file for a patent term extension, the points of the foreign clinical trial should be explained. For example, the clinical trial name, the trial number, the trial drug, the trial stage, etc.; and the study start date and study completion date described in the clinical trial report needs to have met the requirements of the International conference on harmonization for registration of pharmaceuticals for human use, and are considered as the start date and end date of a foreign clinical trial.” According to the PTE Guidelines, the end date of a foreign clinical trial should be the “study completion date.”

However, the Supreme Civil Court made Decision 106 Tai Shang Zi No. 1904 on 31 May 2018, holding that the end date of a foreign clinical trial should be the “report date” rather than the “study completion date.” The main reason thereof is that “the results of a clinical trial cannot be obtained immediately after study completion. Meaningful results can be obtained only after professional analysis and data processing; then, the results are used by the Central Authority for determining eligibility for market approval. Therefore, the “clinical trial period” mentioned in the Regulations should be calculated from the start date of the clinical trial to the date when the trial results can be presented. Obviously, the view of the Supreme Civil Court is different from the Intellectual Property Office (“IPO”). However, the decision is a civil judgment rather than an administrative judgment which has binding effect on the government authority's decisions. Hence, whether or not the IPO would change its opinion needs to be further observed.

Newsletter

搜尋