For the pharmaceutical industry, the duration of patent term extensions not only correlates closely with the market interests of patent drug manufacturers but also significantly impacts the timing of generic drug market entry. According to Article 53.2 of the Patent Act, and Article 4 of the Patent Term Extension Regulations, the upper time limit for an approved extension period is five years and cannot go beyond the period during which the invention cannot be implemented due to the need to obtain a drug regulatory permit from the competent authority i.e., the Ministry of Health and Welfare (the MHW). This time period includes that for domestic and foreign clinical trials required to obtain the drug regulatory permit, as well as the examination period for domestic drug regulatory permit.
There are currently divided opinions regarding how the end date for foreign clinical trial periods should be calculated. Although the current patent examination standards adopted by the Intellectual Property Office treat the “study completion date” specified in the foreign clinical trial report as the end date, The Judgments of the Intellectual Property and Commercial Court (the IPC Court), the Supreme Court, and the Supreme Administrative Court (the SAC), in prior cases, have all held slightly different views.
For instance, in the case of Merck Sharp & Dohme B.V. and F. Hoffmann-La Roche AG having a dispute on a patent term extension as we reported in October 2022, the SAC’s Judgment rendered in 2022 found that the responsibility for determining the foreign clinical trial period lies with the MHW. According to the SAC, it was obviously inappropriate of the lower court, i.e. IPC Court, to straightforwardly treat the “clinical trial report date” as the “end date” without delving into any details. Hence, it annulled the original Judgment and remanded it to the IPC Court for retrial.
The IPC Court, after exchanging literal opinions with the MHW concerning the examination process and content of clinical trial reports, rendered two Judgments on August 23, 2023. Both judgments upheld the original point of view of the IPC Court, affirming that the “clinical trial report date” should be regarded as the “end date of foreign clinical trial” so as to align with the legislative intent of the patent term extension system.
In the two Judgments, the IPC court held that, when the MHW examines applications for drug regulatory permit, it doesn't touch upon the “foreign clinical trial period.” Instead, it evaluates the efficacy and safety of the drug based on the clinical trial data submitted by the new drug applicant, analyzed and interpreted it with professional knowledge. As for the current examination procedure for new drug, the new drug applicant is required to submit foreign clinical trial report data, including statistical analysis to meet the format requirements. Otherwise, the MHW would reject the application before conducting any substantive examination. This is because clinical trials do not immediately yield conclusions after drug administration (i.e., the “completion date”). Instead, they require professional analysis and interpretation of data before presenting the trial results set out in a report which may serve as the basis for evaluation by the MHW regarding the safety and efficacy of the drug. Therefore, the time period for doing clinical trials and producing clinical trial reports should both be included in the period of foreign clinical trials necessary for the MHW to issue drug regulatory permits, during which the patent holder genuinely cannot implement the invention. Hence, the foreign clinical trial period required for the MHW to issue drug regulatory permits should terminate on the “trial report date.”
Additionally, in one of the two Judgments, IPC Court further found that the current examination standards treat the “end date of domestic clinical trial periods” as the “date of consent to record the various clinical trial reports by the MHW,” whereas the end date for foreign clinical trial is the “study completion date” specified in the clinical trial report. This was specifically pointed out by IPC Court to be inconsistent with the principle of equality. The main reason is that, no matter whether domestic or foreign clinical trials are conducted, their common purpose is to ensure the efficacy and safety of new drugs. In addition, conducting clinical trials and preparing clinical trial reports both aim at providing clinical trial results for drug regulatory permits by the MHW, and both time periods represent those periods during which the invention cannot be implemented. Therefore, one and the same principle should be adopted no matter whether a clinical trial is conducted domestically or abroad.
The aforementioned two Judgments establish that the IPC court still recognizes the “clinical trial report date” as the end date for the duration of foreign clinical trials, rather than the “clinical trial completion date” currently used as the examination criterion. Such point of view seems to be more advantageous to patent holders. However, before these judgments are finalized, the Intellectual Property Office does not have any plan to amend its examination standards. Therefore, if a patent holder intends to seek an extension of the patent term and wishes to include the period of foreign clinical trials in the period during which the invention could not be implemented, it is advisable to specify the “clinical trial report date” as the “end date” so as to pursue a longer extension period. If, however, it does not turn out successful, administrative remedies can be pursued to challenge the current decision-making process of the Intellectual Property Office so as to obtain the most favorable extension of patent protection. Additionally, it is crucial to closely monitor potential developments following the two Judgments.