Background

Korea’s current patent term extension (PTE) system allows multiple patents for the same pharmaceutical product to be eligible for PTE. Also, there is no additional restriction on the PTE duration other than the 5-year cap, which is implemented in many other countries, including the US, Europe and Japan.

This is the same as the Japanese PTE system, but contrasts with the 15-year/14-year cap from the MA date in Europe and the US respectively and with only one patent eligible for PTE in Europe and the US.

In early 2023, KIPO announced a plan to revise the current PTE system, which focuses on introducing a 14-year cap like the US (meaning that the extended term cannot exceed 14 years from the MA date) and allowing PTE for only one patent based on an MA. Thereafter, on April 6, 2023, 18 members of the National Assembly introduced a bill to amend the Korean Patent Act as KIPO proposed.

Progress since the introduction of the proposed amendment bill in the Korean National Assembly

As expected, domestic pharmaceutical organizations such as KPBMA have expressed its support for the bill, while organizations representing original drug companies such as KRPIA, JPMA, PhrMA, IFPMA, INTERPAT, among others, have voiced their opposition.

There were further suggestions from the original drug companies, which called for improving the method of calculating the PTE term and the scope of rights during the extended patent term on the grounds that the PTE term and the scope of rights are narrower than those in the US, Europe, and Japan.

Further, one of the suggestions addressed the route for responding to the KIPO’s rejection of the requested PTE term by appealing only the rejected portion of the requested PTE term. Under the current PTE system, there is no practical way for patentees to object to the KIPO’ rejection of the requested PTE term other than amending the term in sync with that allowed by KIPO. This is one of the reasons for the shorter PTE term being allowed in Korea compared to other jurisdictions.

A review report on the bill and these interested parties’ opinions were prepared in July 2023, and the bill was referred to the subcommittee of the Ministry of Trade, Industry and Energy in the Korean National Assembly.

However, as a number of organizations having stakes in the matter had presented sharply differing opinions as above, the committee apparently did not reach a conclusion thereon until the 21^st National Assembly session expired in May 2024. Accordingly, the bill was automatically discarded.

Added vigilance necessary for the developments in the Korean PTE system

As explained above, although the proposed amendment bill in 2023 was automatically discarded when the tenure of the previous National Assembly ended in May, it is possible that any form of amendment to the current PTE system, including the reintroduction of the same bill, may be pursued by the new members of the National Assembly whose tenure started in May 2024.

If amendments to the current Korean PTE system move forward in any form, the impact on the pharmaceutical industry is likely to be significant, depending on the content.

Therefore, pharmaceutical companies should keep an eye on the movements surrounding the PTE system and consider actively voicing their opinions, if necessary.