Pharmaceutical Affairs Act Article 48-13

If the patentee or the exclusive licensee intends to file a patent infringement complaint on the basis of the listed patent(s) after its receipt of the notification stipulated by Paragraph 1 of Article 48-12, it shall file the complaint within 45 days after the next day to its receipt of said notification and notify the central competent health authority.The central competent health authority shall stay the issuance of the drug license for twelve (12) months as of the next day to the new drug license holder’s receipt of the notification stipulated in Paragraph 1 of Article 48-12. However, if there are any of the following matters, the central competent health authority may issue the drug license if said application is examined to comply with the regulations under this Act:1. The patentee or the exclusive licensee, after its receipt of the notification stipulated by Paragraphs 1 of Article 48-12, fails to file an infringement complaint within the 45-day period.2. The patentee or the exclusive license files an infringement complaint based on the patents that are not those listed before the date of the application for the generic drug license.3. The patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof is overruled by the court according to Paragraph 1 or 2 of Article 249 of the Code of Civil Procedure.4. The court has determined that all of the patents pending in the infringement lawsuit shall be revoked, or a non-infringement judgment is obtained by the applicant for the generic drug license.5. All the patents under the declaration stipulated in Subparagraph 4 of Article 48-9 made by the applicant for the generic drug license are determined as invalid by the competent patent authority in a cancellation action.6. A settlement or mediation has been reached by the parties.7. All the patents under the declaration stipulated in Subparagraph 4 of Article 48-9 made by the applicant for the generic drug license have been extinguished.The period [for notification] stipulated in Subparagraph 1, Paragraph 2 hereof shall be commenced upon the receipt of the notification by the patentee(s) or the exclusive licensee(s), whichever is later.If the patentee or the exclusive licensee obtains a final and binding judgment confirming infringement of the listed patent(s) within the 12-month period stipulated in Paragraph 2 hereof, the central competent health authority shall issue the generic drug license after said patent(s) extinguishes.Where the patent infringement complaint filed by the patentee or the exclusive licensee pursuant to Paragraph 1 hereof, if by reason of being an improper exercise of patent right ab initio, the stay of drug license issuance has caused damages to the applicant of a generic drug license, such patentee or the exclusive licensee shall be held liable for compensation.