Current Status of Patent Term Extension (PTE) in Korea

The Korean Patent Act (KPA) stipulates PTE for patents in the pharmaceutical and agrochemical fields, which is similar to SPC in Europe.

The so-called “new substance’s first approval requirement” was introduced in Korea in 2013. This requirement is similar to “first permitted commercial marketing” under 35 USC §156 (a)(5)(A) in the US and “first authorisation” under Regulation (EC) No 469/2009 Article 3(d)in Europe.

Under this requirement, any subsequent approvals for the same active ingredient (such as an approval for combination of already-approved active ingredients or an approval for second medicinal use) cannot be a basis for PTE.

In addition, in Korea, multiple patents can be eligible for PTE as long as they are related to an approved pharmaceutical product. However, KIPO is considering a revision to this provision so that only one patent is eligible for PTE, like in the US.

According to Article 95 of the KPA, the scope of right during the extended patent term is limited to the approved product and its approved uses. The limitation to approved uses is the key difference of the Korean system from the US PTE and European SPC systems.

In respect of the approved product, in the so-called “Vesicare decision” (Supreme Court’s Decision No 2017Da245798, rendered on 17 January 2019), the Korean Supreme Court established the standard that the extended patent can be enforced against different salts, free base, etc, of the API of the approved drug.

However, there is still no Supreme Court decision regarding “approved uses”, and only a few cases exist.

On this issue, the IPTAB has found the following:

In 2021, the Seoul Central District Court denied a preliminary injunction request by the patentee, a multinational pharmaceutical company, on the ground that the generic product whose requested indication was non-valvular atrial fibrillation (NVAF) does not infringe the patent at issue when the applicable approved indication for the PTE was the treatment of venous thromboembolism (VTE).

From these cases, the basic position of Korean courts and the IPTAB is that “identicalness of the target disease” is the standard for determining the scope of use.

This differs significantly from Europe and the US where, as noted above, the patent right can be enforced for any newly approved uses during the extended patent term.

The current method for calculating the PTE term adopted by KIPO is very restrictive. The PTE period consists of the clinical trial period and MFDS (Korean FDA) review period and, in this sense, the calculation is similar to that of the US PTE system, which consists of the clinical phase and the FDA approval phase.

However, KIPO limits the clinical trial to only domestic trials and the period of the trial is also limited to the period from the first patient in (FPI) to the last patient out (LPO), not the period from the clinical trial protocol approval to the filing of marketing approval application (MAA). The MFDS’s review period is also limited to the time period during which the MFDS actually reviewed documents for marketing approval (MA), not the period from MAA date to MA date.

Further, the system makes it difficult for patentees to challenge such calculation by KIPO because, if KIPO rejects the requested PTE period calculation, no PTE is granted (the “all-or nothing” rule).

According to the statistics, the average PTE period of extended pharmaceutical patents in Korea (about 1.5 years) is less than half of such periods in the US, Europe and Japan (JPMA Newsletter, January 2017, No 177).

As above, under the Korean PTE system, the scope of the extended rights and the calculation method of the PTE period are different from those in the US and Europe and can be said to be unfavourable to patentees.

With respect to the calculation of the PTE period, there have been discussions on how to resolve the “all-or-nothing” rule problem, but there has been no concrete action from KIPO.

Recently, KIPO announced a revision to the current PTE system, but its focus was to introduce a 14-year cap like the US (ie, the extended period cannot exceed 14 years from the MA date) and, as mentioned above, to allow only one patent to be extended in the future.

To date, KIPO’s planned revisions are limited to procedural matters, such as the introduction of the 14-year cap.

The more fundamental issues in the PTE system, namely, the scope of the extended patent rights and the method of calculating the PTE period, have not yet been addressed despite the industry’s demands.

Most of all, from the patentee’s point of view, it is questionable whether the current system is consistent with the basic purpose of the KPA and the PTE system in that, unlike in the US and Europe, the patentee cannot enforce the patent right for all uses approved for the original drug, even if the patent is extended. This is a fundamental issue considering that the first approved indication is not directly related to the patent invention (which are mainly product inventions) in most cases, nor to the basis of the PTE (the period during which the patent invention could not be practiced).

Because the KIPO’s planned revisions are based on similar requirements in the US and Europe, it is expected that there will be demands from patentees to improve the Korean system in a way that is substantively similar to those in the US and Europe. Further discussions and changes should be closely monitored.