Regulations for the Patent Linkage of Drugs Article 9
The application for a generic drug permit license shall be exempt from, if evidence is provided, the provisions regulated in Article 48-9 of the Act under the following circumstances:1. In which the applicant for the application for a drug permit license is the same as the owner of the reference new drug permit license.2. In which the application for a drug permit license is submitted after it is authorized by the new drug patentee or the exclusive licensee.3. In which the reference new drug permit license is revoked, repealed, or cancelled.
中文原文 西藥專利連結施行辦法第9條
學名藥藥品許可證申請案有下列情事之一，且附具證據者，免依本法第四十八條之九規定辦理：
一、藥品許可證申請案之申請人與對照新藥藥品許可證所有人相同。
二、藥品許可證申請案經新藥藥品專利權人或專屬被授權人授權後提出。
三、對照新藥之藥品許可證經撤銷、廢止或註銷。
一、藥品許可證申請案之申請人與對照新藥藥品許可證所有人相同。
二、藥品許可證申請案經新藥藥品專利權人或專屬被授權人授權後提出。
三、對照新藥之藥品許可證經撤銷、廢止或註銷。