SOUTH KOREA Law and Practice Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
1.15 Defences and Exceptions to Patent Infringement Common defences raised by generic/biosimilar manu ‑ facturers in patent infringement cases include non- infringement, invalidity and practising the invention before the filing of the patent. The court will consider both non-infringement and invalidity arguments. If it is clear that no infringement occurred, the case may be dismissed solely on the basis of non-infringement, without addressing the validity of the patent. If the pat ‑ ent is found to be invalid in an invalidity action before the IPTAB, there is a high likelihood that the action will be dismissed by the civil infringement court. 1.16 Stays and Relevance of Parallel Proceedings Korea does not have a formal system for staying liti ‑ gation due to parallel proceedings. However, judges have discretion in managing such situations. Some judges may choose to delay a case while awaiting the results of an invalidity proceeding before the IPTAB if a decision is expected within a few months, while others may proceed without waiting for the IPTAB’s ruling. Korean courts typically do not pause cases based on foreign proceedings. If a parallel proceeding is concluded or a foreign court has rendered a decision before the Korean court’s rul ‑ ing, the outcome of those proceedings may be con ‑ sidered as persuasive but non-binding evidence. 1.17 Patent Amendment Under Korean patent law, patent correction (also known as patent amendment) is an IPTAB process that allows a patent holder to amend the claims, descriptions or drawings of a granted patent. This process is designed to correct errors or clarify ambi ‑ guities in the patent. Corrections can also be requested during patent infringement litigation or invalidation trials to strength ‑ en the patent’s enforceability. For clarity, a patent cor ‑ rection must be requested through the IPTAB under a separate proceeding and cannot be directly filed with the court during an infringement lawsuit. As a result, claim correction cannot be conditionally presented at the infringement court.
If an IPTAB trial decision on a correction (amendment) of a patent specification or other relevant documents becomes final and binding after the conclusion of fact-finding hearings in an invalidation action or a civil patent infringement lawsuit, the correction shall be deemed retroactively effective pursuant to Article 136 (10) of the Korean Patent Act. As a result, the invalida ‑ tion IPTAB court or the civil patent infringement court will decide the case based on the corrected version of the claims and/or specification. 1.18 Court Arbiter The first instances of patent infringement lawsuits are handled by five courts, which have IP special ‑ ised courts: the Seoul Central District Court, as well as the Daejeon, Daegu, Busan and Gwangju District Courts. Appeals in patent infringement cases and IPTAB actions (eg, cancellation of trial decisions for invalidity or scope confirmation) fall under the exclu ‑ sive jurisdiction of the Intellectual Property High Court. In Korea, there are no specific rules governing the infringement of pharmaceutical products. Thus, as with general patent infringement, the sale, manufac ‑ ture, use, export, import or offering for sale of generic drugs constitutes patent infringement. In practice, pharmaceutical patent infringement law ‑ suits are typically filed after the MA application. When submitting an MA application, a generic/biosimilar company is required to provide a patent certifica ‑ tion to the originator of the MA application under the regulatory approval-patent linkage system, similar to Paragraph IV certification under the Hatch-Waxman Act. Consequently, the originator often files a patent infringement lawsuit after receiving the patent certifi ‑ cation – eg, shortly after the time the generic/biosimi ‑ lar company’s MA application is filed. Skinny Labelling In Korea, the issue regarding skinny labelling is whether the extended term of a pharmaceutical patent applies not only to the indications approved at the time of 2. Generic Market Entry 2.1 Infringing Acts Infringing Acts
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