Pharmaceutical Affairs Act Article 48-4
The “patent information” stipulated in Article 48-3 shall include the following items:1. Certification number of the invention patent(s); if the invention patent refers to medical use, the number of claims shall be concurrently provided.2. The expiration date of the patent(s).3. The patentee’s name, nationality, place of domicile, or business office; for a patentee having a legal representative, the name of the legal representative shall be listed. If said patent has been exclusively licensed and has been recorded in accordance with the Patent Act, the aforementioned information of the exclusive licensee shall be listed.4. If the patentee or the exclusive licensee in Subparagraph 3 hereunder does not have a domicile or a business office in the R.O.C., an agent thereof shall be appointed. The appointed agent’s name, place of domicile, or business office shall be submitted.If the new drug license holder is different from the patentee, the patentee’s consent shall be obtained when submitting the patent information; if the patent has been exclusively licensed and has been recorded in accordance with the Patent Act, it is only required to obtain the exclusive licensee’s consent.
中文原文 藥事法第48-4條
前條所定專利資訊如下：
一、發明專利權之專利證書號數；發明專利權為醫藥用途者，應一併敘明請求項項號。
二、專利權期滿之日。
三、專利權人之姓名或名稱、國籍、住所、居所或營業所；有代表人者，其姓名。
該專利權有專屬授權，且依專利法辦理登記者，為其專屬被授權人之上述資料。
四、前款之專利權人或專屬被授權人於中華民國無住所、居所或營業所者，應指定代理人，並提報代理人之姓名、住所、居所或營業所。
新藥藥品許可證所有人與專利權人不同者，於提報專利資訊時，應取得專利權人之同意；該專利權有專屬授權，且依專利法辦理登記者，僅需取得專屬被授權人之同意。
一、發明專利權之專利證書號數；發明專利權為醫藥用途者，應一併敘明請求項項號。
二、專利權期滿之日。
三、專利權人之姓名或名稱、國籍、住所、居所或營業所；有代表人者，其姓名。
該專利權有專屬授權，且依專利法辦理登記者，為其專屬被授權人之上述資料。
四、前款之專利權人或專屬被授權人於中華民國無住所、居所或營業所者，應指定代理人，並提報代理人之姓名、住所、居所或營業所。
新藥藥品許可證所有人與專利權人不同者，於提報專利資訊時，應取得專利權人之同意；該專利權有專屬授權，且依專利法辦理登記者，僅需取得專屬被授權人之同意。