Notice on the Amendment to the Patent Term Extension (PTE) System in South Korea

An amendment of the Patent Act was passed earlier this year concerning the Patent Term Extension (PTE) system. This will take effect on July 22, 2025 (six months after promulgation) and will apply to PTE applications filed for pharmaceuticals that receive regulatory approval on or after the effective date.

1. Key Amendments

Under the current Patent Act(Article 89) provides that when regulatory approval is required to implement a patented invention, such as in the field of pharmaceuticals, the patent term may be extended once by a period equivalent to the time period during which the patent could not be practiced due to the regulatory approval process, up to a maximum of five years.

The current law does not impose an additional limit on the extension period beyond the maximum of five years, and if multiple patents are associated with a single regulatory approval, each patent may gain an individual extension.

Now, with the amended law, only one patent may be extended per regulatory approval, and the total extended patent term cannot exceed 14 years from the date of approval. PTE applications that do not meet these criteria will be rejected.

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2. Comparison with Systems in the U.S., Europe, and Japan

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Korea’s PTE system had previously resembled that of Japan. However, with the current amendment, the Korean system will shift to a framework more closely aligned with those of the U.S. and Europe.

3. Implications

This amendment is expected to weaken the exclusive rights of original pharmaceutical patent holders to a certain extent. Conversely, it is likely to facilitate earlier market entry for domestic generic pharmaceutical companies, intensifying market competition.

Original pharmaceutical patent holders should carefully select which patent to extend, considering such factors as the likelihood of prevailing in possible infringement litigation and the inclusion of claims that are difficult for competitors to design around. Additionally, in order to counter generic competition, a comprehensive strategy for patents and regulations should be adopted beyond PTE, including data exclusivity, reevaluation strategies demonstrating the medical superiority of the original product over competitors, and securing follow-up patents.​