In a recent decision, the Korean IP High Court held that the period of clinical trial conducted in a foreign country is eligible for purposes of patent term extension if the foreign clinical data is, in fact, considered in granting the import approval of the relevant medicine (IP High Court Case Nos. 2022 Heo 3533, 3557 (consolidated) dated July 5, 2023; appeal before the Supreme Court currently pending).

▶Calculation of Extendible Period for Patent Term Extension

According to Article 89 of the Korean Patent Act ("KPA"), a pharmaceutical invention requiring approval to practice the patented invention may have its patent term extended for a period of up to five (5) years, for a duration taken to complete the effectiveness and safety tests thereof necessary to obtain the approval.

The KIPO’s regulation governing the patent term extension system stipulates that the extendible period is calculated by (i) the period of time needed to perform a clinical test under the approval of the Ministry of Food and Drug Safety (“MFDS”), plus (ii) the period of time needed for the administrative review at the MFDS, and subtracting (iii) any period of delay attributable to the patentee.

As such, the KIPO's regulation limits the clinical trials eligible for calculating the extendible period to those conducted with the approval of the MFDS. Consequently, under the Korean patent practice, it has been commonly considered that the period of clinical trial conducted in a foreign country cannot be included in the extendible period.

▶Background of the Case

This case involved an invalidation litigation for term extension of a patent regarding the Galvus® tablet, a medicine for treatment of diabetes. During the MFDS approval process of Galvus®, the material events took place as follows:

The term extension of the subject patent was granted to cover the entire period from the patent registration to the patentee's submission of the application for the DMF review to the MFDS. However, Korean generic companies challenged the validity of the patent term extension, while arguing that the period from the day after the end of the clinical trial in Korea to the day before applying for the DMF review ("contested period") should be excluded from the extended period because of the delay by the patentee. In addition, the generic companies asserted that the contested period should not be included in the extended period inasmuch as it was the foreign clinical trial, not the Korean clinical trial, that was conducted during the period.

The Trial Board dismissed the petition on the ground that the contested period was not considered as a period of delay attributable to the patentee. The generic companies appealed the Trial Board ruling to the IP High Court.

▶IP High Court Decision

On appeal, the IP High Court noted that there was no statutory requirement for the timing of applying for the DMF review, since the Korean Pharmaceutical Affairs Act merely regulates that the application of the DMF review should be submitted at the time of applying for a drug approval, and there is no provision that the application for the DMF review should be submitted before or at the end of the domestic clinical trial. Accordingly, the IP High Court held that the contested period was not considered as delayed time attributable to the patentee and thus included in the extendible period for patent term extension.

In particular, the IP High Court noted that the effectiveness and safety tests necessary for approval provided in Article 89 of the KPA covers foreign clinical trials, inasmuch as the submission of foreign clinical trial data is also required to apply for import approval of drugs.

Under the circumstances, there is no reasonable basis to discriminate or exclude the period of conducting a foreign clinical trial, which is required to obtain an import license of the drug concerned from the MFDS.

▶Significance of the Decision

The above decision is significant in the sense that it allows a period of foreign clinical trial, even if not conducted under the MFDS jurisdiction, if the foreign clinical data is, in fact, required in obtaining the import approval of the drug from the MFDS, to be eligible for patent term extension. The Korean and foreign pharmaceutical companies as well as the KIPO are keenly waiting for the final decision on the issue, currently on appeal before the Supreme Court.