SOUTH KOREA Law and Practice Contributed by: Samuel Lee, Ye In Han, Inkyoung Choi and Jaeyoung Seol, Bae, Kim & Lee LLC
3. Biosimilar Market Entry 3.1 Infringing Acts 2.1 Infringing Acts applies equally to biologics or bio ‑
ucts. In the past, it was possible to extend the term for multiple patents covering the same drug product, but recent amendments to the Korean Patent Act now allow only one patent to be extended per product. SPC Waiver Korean law does not currently provide a supplemen ‑ tary protection certificate (SPC) manufacturing waiver or an equivalent legal mechanism. 4.2 Paediatric Extensions Korea does not provide PTEs specifically for paediat ‑ ric drugs, nor does it grant a paediatric-specific data exclusivity period under current law. 4.3 Paediatric-Use Marketing Authorisations In Korea, MAs are not available for already-authorised medicines that have no remaining patent or SPC (or equivalent PTE) but are developed specifically for pae ‑ diatric use. 4.4 Orphan Medicines Extensions Korea gives a ten-year data exclusivity for orphan medicines. Under Korean law, it is not possible for a patent holder (or exclusive licensee) to request an undertaking from the alleged infringer to pay damages in exchange for a PI. To obtain a PI, a security deposit is typically required to cover any damages that may be incurred by an alleged infringer. The PI becomes enforceable upon submission of proof of the bond deposit. Once the PI is granted, a court-appointed enforcement officer will take custody of the defendant’s infringing products in accordance with the terms of the PI. In Korea, the mere filing of an objection by the defend ‑ ant against a PI does not automatically suspend the execution of the PI. Unless the court accepts the defendant’s objection to the PI, the execution of the PI cannot be suspended, even if the defendant pro ‑ vides a security deposit. 5. Relief Available for Patent Infringement 5.1 Preliminary Injunctive Relief
similar patents; there are no differences. 3.2 Data and Regulatory Exclusivity
2.2 Regulatory Data and Market Exclusivity applies equally to biologics or biosimilar patents; there are no differences. 3.3 Acceptable Pre-Launch Preparations 2.3 Acceptable Pre-Launch Preparations applies equally to biologics or biosimilar patents; there are no differences. 3.4 Publicly Available Drug and Patent Information 2.4 Publicly Available Drug and Patent Information applies equally to biologics or biosimilar patents; there are no differences. 3.5 Reimbursement and Pricing/Linkage Markets 2.5 Reimbursement and Pricing/Linkage Markets applies equally to biologics or biosimilar patents; there are no differences. 4. Patent Term Extensions for Pharmaceutical Products 4.1 Supplementary Protection Certificates Korean Patent Term Extension According to Article 95 of the Korean Patent Act, a patent term extension (PTE) allows for the extension of a patent term by a maximum of five years if a delay in obtaining regulatory approval for a pharmaceutical or agrochemical product has significantly impacted the time for commercial sale, essentially providing addi ‑ tional protection for the time spent waiting for MA. The PTE can only be applied once per patent and is subject to certain conditions regarding the “new sub ‑ stance” requirement of the product involved. Where different products are covered by a single pat ‑ ent, the patent term may be extended based on the longest regulatory approval period among the prod ‑
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