Pharmaceutical Affairs Act Article 48-3
If a new drug license holder deems it necessary to submit the patent information regarding the new drug, the holder shall submit relevant documents and information to the central competent health authority within 45 days after the next day of the receipt of the drug license. If the holder fails to file such submission within the stipulated period, the regulations under this Chapter do not apply.The drug patent stipulated under Paragraph 1 hereof shall be limited to the following:1. Substance.2. Composition or Formulation.3. Medical use.
中文原文 藥事法第48-3條
新藥藥品許可證所有人認有提報藥品專利權專利資訊之必要者,應自藥品許可證領取之次日起四十五日內,檢附相關文件及資料,向中央衛生主管機關為之;逾期提報者,不適用本章規定。
前項藥品專利權,以下列發明為限:
一、物質。
二、組合物或配方。
三、醫藥用途。
前項藥品專利權,以下列發明為限:
一、物質。
二、組合物或配方。
三、醫藥用途。