In a newsletter entitled “Definition of the Period of Foreign Clinical Trials for Patent Term Extension” published in the third quarter of 2018 on our website, we launched a report on Civil Judgment No. 1904 rendered in 2017 by the Supreme Court which remanded a case relating to a patent term extension application filed on the basis of a foreign clinical trial to the IP Court for reconsideration. The Supreme Court found that it was inappropriate of the IP Office or the IP Court to treat the date the last patient's trial was completed as the “end date" of the trial.
However, that a civil judgment does not have binding on any administrative organs in Taiwan prevented the IP Office from taking a proactive action to revise the “Regulations for Ratifying Extension of Patent Term”, according to Article 4 of which the length of the patent term extension allowed may include the duration of home and/or foreign clinical trials. Nor was there seen any revision to the “Patent Examination Guideline” which clearly states that:
When filing a patent term extension application based on a foreign clinical trial, the applicant shall state the key points of the clinical trial plan, such as the name of the pilot plan, plan number, experimental drug, trial stage, etc., and record in a clinical trial report drafted in accordance with the ICH specifications the start and end dates of the trial, namely, the duration within which the trial is performed.
Apparently, under this rule, the last date of the trial referred to in a clinical trial report shall serve as the “end date” of the trial in the calculation of the duration of a clinical trial
Not being satisfied with the IP Office’s Decisions rendered in reliance upon the current Patent Examination Guideline in 2019 on two patent term extension applications, the patentees pursued respective administrative litigations before the IP Court.
On June 30 of this year, the IP Court made its adjudications. It followed the Supreme Court's opinion that the “report date” rather than the “last date” of a foreign clinical trial defined in a clinical trial report shall be deemed the “end date” of the trial. The reasons are mainly as follows:
|It is by no means available to obtain a drug license in the absence of a clinical trial report. Accordingly, not only the duration within which a home or a foreign clinical trial is performed but also the duration within which a relevant clinical trial report is produced shall be included in the calculation of the duration of a clinical trial based on which a patent term extension may be granted.
It remains to be seen as to whether the IP Office is soon to revise the “Regulations for Ratifying Extension of Patent Term” or the “Patent Examination Guideline.” In the interim, the patentee could have in mind that there will be chances to obtain a longer patent term extension by pursuing administrative litigation, if necessity arises.