Regulations for the Patent Linkage of Drugs Article 5
When the holder of the new drug permit license submits the patent information, based on Article 48-3 and 48-4 stipulated in the Act, the holder shall upload, along with the completed form provided in Annex I, the following scanned documents and information to the Registration System for Patent Linkage of Drugs (hereinafter referred to as the Registration System), established by the Central Competent Health Authority:1. Certification of the invention patent(s) or the Patent Gazette that publishes the drug patent.2. The evidence of designation for anyone who has a designated agent.3. The evidence of the agreement approval of the patentee or the exclusive licensee; the evidence that the patent has been exclusively licensed.4. Any other documents or information which is sufficient to prove the validity of the submitted documents and information.Except for polymorphism referred to Paragraph 2 in Article 3, the drug patent information submitted in the preceding Paragraph shall be limited to the scope set forth in patent claim(s). In case of more than one drug patent, the patent information shall be submitted one by one. If the invention patent refers to medical use, the number of claims and their corresponding indications stated in the new drug permit license shall be concurrently provided.The Central Competent Health Authority may, if necessary, order the holder of the new drug permit license to provide the original copies of the documents and information set forth in Paragraph 1.Annex I:Submit of patent information of new drug & third person.PDF