Pharmaceutical Affairs Act Article 48-9
The applicant for a generic drug license shall, with respect to the patent(s) of the approved new drug listed by the said new drug license holder, declare one of the following item(s) when applying for a generic drug license:1. No patent information on said new drug has been listed.2. The patent(s) corresponding to said new drug has been extinguished.3. The central competent health authority will issue the generic drug license after the patent(s) corresponding to said new drug are extinguished.4. The patent(s) corresponding to said new drugs shall be revoked, or the patent(s) corresponding to said new drugs will not be infringed by the generic drug subject to the application for drug license.
中文原文 藥事法第48-9條
學名藥藥品許可證申請人，應於申請藥品許可證時，就新藥藥品許可證所有人已核准新藥所登載之專利權，向中央衛生主管機關為下列各款情事之一之聲明：
一、該新藥未有任何專利資訊之登載。
二、該新藥對應之專利權已消滅。
三、該新藥對應之專利權消滅後，始由中央衛生主管機關核發藥品許可證。
四、該新藥對應之專利權應撤銷，或申請藥品許可證之學名藥未侵害該新藥對應之專利權。
一、該新藥未有任何專利資訊之登載。
二、該新藥對應之專利權已消滅。
三、該新藥對應之專利權消滅後，始由中央衛生主管機關核發藥品許可證。
四、該新藥對應之專利權應撤銷，或申請藥品許可證之學名藥未侵害該新藥對應之專利權。