Regulations for the Patent Linkage of Drugs Article 17
The application for a generic drug permit license, in compliance with the provisions in Item 2 of Paragraph 2 of Article 48-2 in the Act, should include the following matters:1. The valid patent(s) registered under an approved reference new drug in the Registration System is merely a patent for medical use under Item 3 of Paragraph 2 of Article 48-3 in the Act.2. The number of claims and indications of the patent stipulated in the preceding Item.3. Indications involved in the application for a generic drug and the intentions that the reference drug patent(s) limited to medical use have not been infringed upon.The format and content of the preceding Paragraph is regulated in Annex II.