Regulations for the Deposit of Biological Material for Patent Application Article 5
The “biological material with required quantity” referred to in Subparagraph 3, Paragraph 1 of Article 2 is set forth below:1. for bacteria, actinobacteria, yeasts, molds, mushrooms, bacteriophages, and plasmids in transformed host, 6 vials of culture samples shall be deposited and each shall contain the amount necessary for performing viability test;2. for viruses, animal cell lines, plant cell lines, hybridoma, and biological materials with special cultivation conditions, 25 vials of culture samples shall be deposited and each shall contain the amount necessary for performing viability test;3. for plasmids deposited in nucleic acid form, at least 10 micrograms shall be deposited and be evenly distributed in 25 vials of culture samples; each vial of sample shall contain the amount necessary for performing viability test; and4. for other biological materials requiring deposit, the amount to be deposited shall be determined by the Depository.In case the plasmids referred to in Subparagraph 3 of the preceding paragraph are deposited in nucleic acid form, the Depository, if it deems necessary, may notify the depositor to provide 6 vials of hosts in an appropriate preservation form and each vial of culture samples shall contain the amount necessary for performing viability test.
中文原文 有關專利申請之生物材料寄存辦法第5條
第二條第一項第三款所稱必要數量之生物材料規定如下：
一、細菌、放線菌、酵母菌、黴菌、蕈類、噬菌體及以轉殖於宿主方式寄存之質體，應寄存六管，且各管應有存活試驗必要量。
二、病毒、動物細胞株、植物細胞株、融合瘤及培養條件特殊之生物材料，應寄存二十五管，且各管應有存活試驗必要量。
三、以核酸方式寄存之質體至少十微克，並平均分裝於二十五管，且各管應有存活試驗必要量。
四、其他應寄存之生物材料，應寄存之數量由寄存機構認定。
前項第三款以核酸方式寄存之質體，寄存機構認為必要時，得通知申請寄存者提供適當保存形式之宿主六管，且各管應有存活試驗必要量。
一、細菌、放線菌、酵母菌、黴菌、蕈類、噬菌體及以轉殖於宿主方式寄存之質體，應寄存六管，且各管應有存活試驗必要量。
二、病毒、動物細胞株、植物細胞株、融合瘤及培養條件特殊之生物材料，應寄存二十五管，且各管應有存活試驗必要量。
三、以核酸方式寄存之質體至少十微克，並平均分裝於二十五管，且各管應有存活試驗必要量。
四、其他應寄存之生物材料，應寄存之數量由寄存機構認定。
前項第三款以核酸方式寄存之質體，寄存機構認為必要時，得通知申請寄存者提供適當保存形式之宿主六管，且各管應有存活試驗必要量。