SOUTH KOREA Law and Practice Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
Requirements for Filing PIs A patentee or registered exclusive licensee of a grant ‑ ed patent may file a PI, and there are no other special
and testing to obtain MA approval is excluded from acts of infringement. Consequently, similar to the US Hatch-Waxman Act, an originator cannot initiate a patent infringement lawsuit prior to the filing of the MA application. When submitting an MA application, a generic/bio ‑ similar company is required to provide a patent certi ‑ fication to the originator of the MA application under the regulatory approval-patent linkage system. This certification process usually prompts the originator to file a patent infringement lawsuit, typically shortly after the generic/biosimilar company submits its MA application. PIs are not granted based solely on the filing of MA applications. The patentee must demonstrate that the generic/biosimilar manufacturer is actually producing, selling or importing the drug in a manner that infringes the patent, or that there is a substantial likelihood that it will infringe the patent in the future. 1.4 Structure of Main Proceedings on Infringement/Validity Infringement and validity proceedings are bifurcated. However, an infringement court can hear and deter ‑ mine the validity of a patent without regard to the validity proceedings, and infringement proceedings do not need to be stayed until the validity proceedings are completed. Although it is up to the infringement court’s discretion, most infringement courts typically stay the infringement case upon the filing of a strong invalidation or revocation case. 1.5 Timing for Main Proceedings on Pursuant to Article 766 of the Korean Civil Code, a patentee’s right to claim damages is time-barred after three years from the date the patentee became aware of the infringement or ten years from the date the infringement occurred. Infringement/Validity Statute of Limitations Notification of Infringement/Validity Proceedings Once a complaint for infringement is filed with a Kore ‑ an court, the court notifies the defendant by registered mail. If the defendant is a foreign entity, the plaintiff must provide a translated version of the complaint,
requirements for filing a PI. Procedures and Timeline
PI proceedings typically take about six to 12 months, where one to three hearing sessions can be held. Briefing is allowed prior to each oral hearing. These oral hearings often include technical explanations to clarify issues for the court. Korean law does not pro ‑ vide a process for filing protective letters. Notification of PI Once a petition for PI is filed, the Korean court serves the petition for PI on the alleged infringer by registered mail. The hearing will not proceed until the alleged infringer has been served. After the alleged infringer has been served with the PI petition by registered mail, the case is usually managed via the court’s e-fil ‑ ing system. Evidence and Defence in PIs For a PI to be granted, both the right to be preserved and the necessity of preservation must be established. The patent holder must demonstrate that the patent is valid and is being infringed or will be infringed in the near future – ie, establish urgency. The alleged infringer may submit evidence and argu ‑ ments in defence against PIs. PIs may be denied under the following circumstances: • the patent is likely to be invalidated in an invalida ‑ tion trial or a revocation action of an administrative decision; • a favourable declaratory judgment is made regard ‑ ing the scope of the patent to the generic manu ‑ facturer; or • the remaining patent term is too short (indicating a lack of necessity for preservation). Life Sciences Cases The filing of a marketing authorisation (MA) application typically serves as the trigger point for seeking a PI against a generic or biosimilar manufacturer. Under Korean law (Article 96 (1)1 of the Patent Act), the use of a patented invention for the purpose of research
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