Life Sciences and Pharma IP 2026

SOUTH KOREA Law and Practice Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC

• the accused product operates based on a solution principle that is a substantially identical to that of the patented invention; • the accused product achieves substantially the same effect as the patented invention, although some elements are different; and • the modifications made to the accused products would have been obvious to a POSITA (person of ordinary skill in the art). However, DoE infringement may not be found if (i) an accused product incorporates technology that was publicly disclosed prior to the filing of the patented invention, or that a POSITA could readily conceive of from the publicly known technology; or (ii) the pros ‑ ecution history of the patented invention indicates that the modified element of the invention under consid ‑ eration was deliberately excluded from the claims of the patented invention. 1.11 Clearing the Way Under Korea’s approval-patent linkage system, gener ‑ ic/biosimilar manufacturers cannot obtain marketing approval for the duration of a patent, unless they suc ‑ cessfully challenge a Green-Listed patent (the Green List is similar to the Orange Book in the USA) or obtain a licence from the patent holder. Korea also provides a generic exclusivity incentive of nine months grant ‑ ed to the first generic manufacturer that successfully challenges a patent under the approval-patent linkage system. For example, a generic manufacturer must be the first to submit an MA application and to file either a patent invalidation trial or a negative patent scope action in order to secure first generic exclusivity (Article 50 (7) of the Pharmaceutical Affairs Act). Thus, this generic exclusivity incentive encourages generic manufacturers to challenge patents. 1.12 Experts In Korean patent litigation, expert evidence is often presented by the parties. Each party may request testimony or submit opinions from a qualified expert they select. Oral testimony is not always required, as expert statements may also be submitted in written form. In addition to party-appointed experts, a Korean court can separately appoint a neutral expert at an early

stage of the proceeding to assist the judge in under ‑ standing the technical aspects of the case. Please also note that specialised IP courts typically have technical advisers on secondment from the Korean Intellectual Property Office. Expert Evidence in PI Proceedings Expert evidence can be used in PI proceedings, but due to procedural restrictions under the Korean Civil Procedure Act, oral testimony in court is generally not allowed in PI proceedings. As a result, expert evi ‑ dence is usually submitted in written form. Expert Evidence in Main Proceedings In the main proceeding, unlike the PI proceeding, expert evidence can be presented through both oral testimony in court and written statements. 1.13 Use of Experiments Under Korean law, there is no specific procedure or requirement for the submission of experimental results, but parties to a litigation may submit experi ‑ mental results as evidence to support their claims. Such experimental results are typically conducted by technical experts and submitted in written expert statements. In addition to submitting the results of experiments conducted by the parties themselves as evidence, if the parties wish to have the experiments conducted by a court-appointed expert, they must file an applica ‑ tion for an expert with the court under the Korean Civil Procedure Act. Such application for court-appointed experiments is not available in PI proceedings, but Korea does not have a discovery/disclosure process similar to that of the USA. Instead, under Korean pat ‑ ent law, the plaintiff may request the court to order the defendant to produce evidence to prove patent infringement and damages. However, unlike the broad scope of discovery in the USA, Korea does not allow the plaintiff access to all of the defendant’s docu ‑ ments, and the defendant is only required to produce the specific documents ordered by the court. only in the main proceedings. 1.14 Discovery/Disclosure

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