South Korea amends regulations on patent term extension (PTE)

South Korea has currently amended the relevant provisions of the Patent Law regarding the extension of patent terms. From July 22, 2025, the new patent term extension system (Patent Term Extension, PTE) will officially apply to drug patent applications from that date onwards.

According to the current Korean Patent Law, only one PTE request can be filed for each patent, and only based on the first drug license obtained in Korea for the new chemical entity of a new drug, but there is no limit on the number of PTEs that can be approved based on one drug license. The new regulations after the amendment have modified the limit on the number of PTEs, and only one patent can file a PTE request for each drug license.

According to the relevant provisions of the current Korean Patent Law, a PTE request can extend the patent term by up to 5 years, but there is no limit on how many PTE requests can be made for a patent. The new regulations after the amendment clearly stipulate that the patent term of a patent can be extended to a maximum of 14 years from the date of issuance of the drug license.