Lee International

The patent term extension (PTE) is available for the duration in which the patentee could not work the patented invention while seeking to obtain regulatory approval.  However, any delay attributable to the patentee would be excluded from the extendable patent term.  According to the KIPO examination practices, the time spent by the patentee in supplementing data in response to the requests from the Ministry of Food and Drug Safety (MFDS) during the approval process is deemed as a delay attributable to the patentee and is excluded from the extendable patent term.  Specifically, considering that the MFDS' regulatory review for approval is simultaneously conducted across multiple review departments, only the period in which the regulatory review could not be conducted in all MFDS review departments due to the patentee’s data supplementation has been considered as a delay attributable to the patentee (Supreme Court Case Nos. 2017 Hu 844, 2017 Hu 882, etc.).

However, in a recent decision, the Intellectual Property High Court (IPHC) held that the period of patentee's data supplementation following the MFDS' request should not be conclusively presumed a delay attributable to the patentee (IPHC Case Nos. 2022 Heo 3533 and 3557 (consolidated), issued on July 5, 2023).  This interpretation of “a delay attributable to the patentee” is more favorable to the patentee compared to previous practices.  The decision’s rationale is outlined as follows:

i)       The Korean Patent Act or its Enforcement Decree, which stipulates the eligibility and requirements for the PTE, do not contain any provisions presuming or considering the patentee's data supplementation period as a delay attributable to the patentee.

ii)      To consider the patentee's data supplementation period as a delay attributable to the patentee, there must be a substantial causal relationship between the patentee's delay due to data supplementation and the actual delay in approval.

iii)     The substantial causal relationship can be determined by assessing whether the patentee neglects the duty of care generally required in social norms, thereby causing the delay in approval.  It cannot be asserted that the patentee has a duty of care to ensure simultaneous conduct of all review procedures within the MFDS by submitting all necessary materials at the time of approval request.  It is not socially expected for the patentee to figure out what materials are required for the MFDS review at the time of approval request.

This case is currently under appeal to the Supreme Court, and it is uncertain whether the Supreme Court will uphold the IPHC decision.  If the Supreme Court issues a decision upholding the IPHC decision, there will be considerable confusion as the calculation of the extendable patent term will depend on whether the delay caused by the patentee’s data supplementation is actually attributable to the patentee.