SOUTH KOREA Law and Practice Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
the initial MA of the drug but also to the indications added through subsequent approvals. Generic manu ‑ facturers have argued that the extended term of the pharmaceutical patent only applies to the indications approved at the time of the initial MA of the drug and does not apply to the indications added later; thus, their use does not constitute infringement of the pat ‑ ent. In recent Intellectual Property High Court decision 2024Heo13541, the Intellectual Property High Court rejected the arguments of the generic manufacturers and determined that the indications added through subsequent approvals are substantially the same therapeutic effects as the indications approved at the time of the initial authorisation; therefore, the extend ‑ ed term of the pharmaceutical patent also applies to the indications added through subsequent approvals. Thus, generic manufacturers’ use constitutes patent infringement. This ruling was affirmed by the Supreme Court on 15 May 2025 (Case No 2025Hu10142), which dismissed the appeal and upheld the Intellectual Property High Court’s decision. Parallel Imports Under the Korean Pharmaceutical Affairs Act, only entities that have obtained import approval for phar ‑ maceuticals are permitted to sell them. As a result, there are no known court precedents in Korea where patent infringement issues have arisen due to parallel imports, as such an act would be illegal. 2.2 Regulatory Data and Market Exclusivity On 20 February 2024, an amendment to the Korean Pharmaceutical Affairs Act was promulgated, which abolished the current drug review system and estab ‑ lished a new system explicitly protecting drug data for the MA. The amendment took effect on 21 February 2025, one year after its promulgation. Under the amendment, the periods of data exclusivity are as follows: • orphan drug – ten years from the date of MA (with an additional one-year extension if a paediatric indication is added); • new drug – six years from the date of MA; • drug requiring submission of new clinical trial data due to a material change to a drug already approved (eg, modifications to improve safety,
efficacy or usefulness) – six years from the date of MA; and • other drugs requiring submission of new clinical trial data and for which the need for data protec ‑ tion is acknowledged – four years from the date of the updated MA. 2.3 Acceptable Pre-Launch Preparations The Korean Patent Act allows the production of phar ‑ maceutical products for research and experimen ‑ tal purposes, even if not conducted specifically for obtaining MA (Article 96 (1) of the Patent Act). Korean case law has established that the Bolar exemption applies to the manufacture and storage of pharma ‑ ceutical products for bioequivalence testing. 2.4 Publicly Available Drug and Patent Information The Ministry of Food and Drug Safety (MFDS) pro ‑ vides information on registered patents for each prod ‑ uct called the “Green List”, which is equivalent to the Orange Book. This information is publicly accessible. Under the approval-patent linkage system, when a generic manufacturer submits an MA application, such manufacturer must notify the patent holder of the MA applicant’s information within 20 days of the MA application submission. 2.5 Reimbursement and Pricing/Linkage Markets Under Korea’s approval-patent linkage system, gener ‑ ic/biosimilar manufacturers cannot obtain an MA while a relevant patent remains in force, unless it success ‑ fully challenges a Green-Listed patent or obtains a licence from the patent holder. Any patent that is rec ‑ ognised as relevant to an eligible original medicinal product may be Green-Listed, and different criteria are not applied depending on the category of the patent. The pricing and reimbursement process takes place after MA and, unlike the MA process, is not specifi ‑ cally tied to patent status. In Korea, the pricing and reimbursement process is done by drug, but not by indication.
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