According to Article 53.2 of the Patent Act and Article 4 of the Patent Term Extension Regulations (hereinafter referred to as the “Extension Regulations”), the approved extension period is limited to a maximum of 5 years and must not exceed the time period during which the invention could not be practiced due to the necessity of obtaining a drug permit license from the competent authority (i.e., the Ministry of Health and Welfare, MHW). This time period includes the time period required for conducting domestic and foreign clinical trials to obtain the drug permit license issued by the competent authority, as well as the period for the domestic drug registration examination process.
According to the current Patent Examination Guidelines (hereinafter referred to as the “Examination Guidelines”) published by the Intellectual Property Office (hereinafter referred to as the “IP Office”), the “study completion date” specified in a foreign clinical trial report shall be treated as the “end date” of the period of the foreign clinical trials. This approach, however, is at variance with the current standpoint held by the courts.
In August 2023, the Intellectual Property and Commercial Court (hereinafter referred to as the IPC Court) maintained its opinion in two administrative litigation cases remanded by the Supreme Administrative Court that the “ the trial report date “ should be deemed the end date of the foreign clinical trial period to align with the legislative intent of the patent term extension system. For key points regarding these two cases, please refer to the December 2023 report posted on our firm’s website.
The IP Office appealed the two cases to the Supreme Administrative Court by IP Office, and the dispute continues to be escalated pending the final decision from the Supreme Administrative Court. For instance, Roche and Gilead have both filed administrative litigations challenging the number of days granted for the extension of their patent terms. The IPC Court, in its rulings on April 25 and July 26, 2024, under 112-Xing-Zhuan-Su-Zi No. 33 and 112-Xing-Zhuan-Su-Zi No. 54, respectively, upheld its view that the “the trial report date” should be adopted. A brief summary is provided below.
1. 112-Xing-Zhuan-Su-Zi No.33 Ruling (rendered on April 25, 2024)
The plaintiff, Roche, in the first place, submitted an interim test report as an integral part of the data for the drug registration examination. During the time period for examination, the final clinical trial was completed, and the relevant report was submitted for examination. The IP Office determined that the “data cut-off date” should be considered the end date of the foreign clinical trial period for this case, supported by the following general principles provided by the MHW:
The end date of the foreign clinical trial period is determined in the following manner:
For completed clinical trials: (i) The clinical trial completion date, as defined by ICH E3 (the date on which the last person completed the trial), shall be adopted. (ii) For ongoing clinical trials, the “data cut-off” date as stated in the interim clinical trial report shall be adopted.
However, the IPC Court in this case held that:
- The “data cut-off date” in a clinical trial merely refers to the date up to which the clinical trial data is sliced for the purpose of the interim report. The data obtained before this date still requires further observation, recording, and interpretation regarding the experimental results. Therefore, it is evident that the outcome of the clinical trial has not yet been fully realized by the “data cut-off date,” and thus, “the data cut-off date” should not be treated as the date on which the clinical trial results are generated.
- The Center for Drug Evaluation or the MHW has determined that the applicant is accountable for providing the statistical analysis results at the time of applying for a drug permit license to support the quality, safety, and efficacy of the drug. These statistical analysis results are necessary for the competent authority to review and decide on the approval of the drug for market entry. This indicates that the foreign clinical trial period required for the issuance of the drug permit license should not end on the data cut-off date. It must also include the subsequent time period during which the clinical trial data is statistically analyzed and the results are documented in a clinical trial report. Therefore, the time period required for the foreign clinical trials leading to the issuance of the drug permit license should logically end on the “report date” specified in the clinical trial report.
2. 112-Xing-Zhuan-Su-Zi No. 54 Ruling (Rendered on July 26, 2024)
The IPC Court in this case held that:
- The current Patent Examination Guidelines regulate that the end date of a foreign clinical trial period is the “trial completion date,” which clearly does not include the time period required for the preparation of the clinical trial report necessary to obtain a drug permit license. This overly restricts the meaning of the time period during which the invention could not be practiced “due to the necessity of obtaining a drug permit license” as stipulated in Article 53 of the Patent Act. It imposes additional limitations not provided by law, and hence contradicts the purpose of Article 53 of the Patent Act, intended to compensate for the time period during which pharmaceutical and agrochemical invention patents could not be practiced due to the mandatory examination process required to obtain a drug permit license. This restriction undermines the rights of patent holders and is inconsistent with the principle of legal reservation under Article 23 of the Constitution.
- The above provision in the current Patent Examination Guidelines also violates the principle of “equity.” The purposes of conducting domestic or foreign clinical trials are at no variance, i.e. to ensure the efficacy and safety of new drugs, thereby protecting the health and medication safety of the public. This necessity justifies compensating the patent holder for the time period during which the invention could not be practiced due to the need to obtain a drug permit license. The considerations for both domestic and foreign clinical trials should be the same based on the principle of equity.
- In general, only relevant clinical trial data is available on the “trial completion date,” on which date the clinical trial results have not yet been generated. After the trial completion date, relevant professionals must continue to interpret, organize, analyze, and statistically process the trial data. Therefore, the report date specified in the clinical trial report that presents the clinical trial result should be deemed as the “end date” of the “foreign clinical trial period.” It is apparently improper to rigidly adhere to the definition adopted by ICH E3 that the “end date” shall be the “trial completion date.”
- The trial commencement date, the trial completion date, and the trial report completion date defined by ICH are merely items that should be recorded on the cover page of the clinical trial report. These dates are not part of the examination data required for the issuance of a drug permit license.
Furthermore, in this administrative litigation case, there was another dispute between the two parties, i.e. in case a bridging study for which a complete trial has not yet completed is not available before issuance of the drug permit license, could the time period from the commencement date of the bringing study up to one day before the drug permit license is obtained be included in the approved extension period? On this issue, the IPC Court held that since the MHW had indicated that the complete trial report for this study was not submitted as part of the drug registration application and was not required for the issuance of the drug permit license in question, and since the drug permit license was issued before the complete trial report was received, the time period for this study should not be included in the approved extension period granted to the plaintiff, Gilead.
In the two administrative litigation cases, both pharmaceutical companies contended that the applicant is not to blame for his inaction before the time limit to “supplement documentation” and “collect the drug permit license,” and therefore the time periods in this regard should not be deducted from the extension period. However, both Rulings refused to accept this argument.
Regarding the time period for supplementing documentation, the two Rulings pointed out that:
- The regulations, such as the Guidelines for Drug Registration, clearly specify the documents required for applying for drug registration. The MHW has also issued a “Refused to File” (RFT) checklist and key points for examining various types of drug registration applications. Additionally, the official website of the Center for Drug Evaluation has provided relevant guidelines for new drug registration, the required application documents, pre-submission precautions, and FAQs and the like. Therefore, the applicant for drug registration is expected to exercise due diligence to minimize or even avoid the occurrence of situations requiring supplementing documentation.
- When the competent authority examines a drug registration application and issues a notification for the applicant to supplement documents due to incomplete submissions or failure to meet the standards for obtaining a drug permit license, it is to ensure that the application complies with regulatory requirements and to verify that the documents submitted by the applicant are sufficient to support the quality, safety, and efficacy of the drug. Therefore, any delay in obtaining the drug permit license caused by the belated filing of documentation should, in principle, be considered an inaction attributable to the applicant and the time period during which any requisite documents were not filed should be deducted from the granted extension period.
As for the time period needed for collecting the drug permit license (calculated from the next date of receipt of the notice of drug permit license collection until one day before the drug permit license is actually collected), the two Rulings also concluded that it should be deducted. The reasoning is as follows:
- According to the drug permit license registration examination process, the plaintiff would have already been informed of the approval of the drug permit license in question before receiving the notice of the drug permit license collection.
- The procedure for completing the drug permit license collection formalities is stipulated in Article 27 of the Guidelines for Drug Registration. The applicant for drug registration is able to prepare the necessary materials, such as labels, package inserts, and outer packaging, in advance according to the guidelines. This is part of the cooperative obligation that the applicant for drug registration is expected to fulfill. Therefore, any delay in the drug permit license collection due to the time needed by the plaintiff to prepare these materials should be attributed to the plaintiff.
In summary, regarding the approval of patent term extension, should the “trial report date” or the “trial completion date” be determined as the end date of a foreign clinical trial period? After the aforementioned two Rulings were rendered, the influence of the standpoint of the IPC Court has been further solidified. However, at the same time, the IP Office appears to maintain its stance of adhering to the point of view that the “trial completion date” matters according the current Examination Guidelines and it is generally anticipated that an appeal may be filed. The controversy over the determination of the end date of the foreign clinical trial period remains unresolved, and our firm will continue to monitor the development on this issue.