Pharmaceutical Affairs Act Article 48-5

If the new drug license holder obtains the approval of an application for an invention patent(s) from the competent patent authority after the approval of said new drug license from the central competent health authority, and such patent(s) is subject to the scope of drug patent set forth in Paragraph 2 of Article 48-3, the patent information thereof shall be submitted within 45 days after the next day to the patent issuance in accordance with Article 48-4. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.