SOUTH KOREA Trends and Developments Contributed by: Keum Nang Park, Eileen Jaiyoung Shin, Jeonghoon Hong and Soo Yeon Park, Lee & Ko
PTE, pegylation may result in a clearly different medicinal use/effect in some cases. In these specific cases, patentees may still argue for new active substance status even in the face of the Korean Supreme Court ruling. The Korean Supreme Court’s decision was grounded on the foundation that the pegylated drug in question merely offered a different pharmacokinetic pro- file while maintaining the same medicinal use. PTE period The KIPO’s calculation of the PTE period based on its Public Notification rules and regulations is notably restrictive and results in much shorter PTE periods compared to other jurisdictions. It is important to note, however, that it has not always been calculated that way. Earlier KIPO public notifications allowed for a wider range of PTE periods, and, through a string of amend- ments to its public notifications, the KIPO has established a practice of increasingly limiting PTE periods. Currently, in the Galvus® PTE case, the dis- puted issues are closely related to the KIPO’s amendment to the calculation method of the PTE period. In that case, the PTE of the patent at issue was granted under the KIPO’s public notification, issued in 2000( “KIPorO’s Former Public Notification” ), and the granted PTE period is being hotly contested. Since the PTE period under the KIPO’s Former Public Notification was substantially the same as that of the Japanese PTE system, the granted PTE period was longer than the period allow- able under the current Public Notification. This PTE disparity was what prompted some generic companies to challenge the validity of the PTE of the Galvus® patent.
After more than eight years of twists and turns, the case is now pending before the Korean Supreme Court. Since the IP High Court found all periods granted for PTE to be valid, if the Supreme Court upholds this appellate deci- sion, the KIPO’s practice on PTE period calcu- lation and the relevant provisions of the Public Notification may be amended going forward to expand the allowable time periods for PTE pur- poses. Such a move will be welcome news for global patent owners with Korean patent interests. On a separate but related issue regarding Korea’s PTE period, according to the amended Patent Act, from the second half of 2025, Korea, like the United States, will be subject to a 14-year cap if the term of the extended patent exceeds 14 years from the date of approval of the drug product. The requirement for patentees to select only one patent to file a PTE application will be implemented in conjunction with this 14-year cap. If the expected PTE term of each patent is the same as each other and is not limited by the 14-year cap, a longer exclusivity may be expected by the PTE of a later patent. In general practice, formulation or crystalline-form patents have a later term expiry date. Like many other jurisdictions around the world, the substance/ compound patent is generally the strongest in terms of validity of rights. Thus, in connection with the above two require- ments, which will be newly implemented from the second half of 2025, pharmaceutical pat- ent holders in Korea should comprehensively consider various factors from the perspective of pharmaceutical patent protection, including the degree of strength of each patent right that
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