1 
 Regulations for  the Deposit of Biological Material  for Patent Application  
 
1. Promulgated and entered into force on June 21, 2002.  
2. Revised and promulgated on December 10, 2003; entered  into force on 
July 1, 2004.  
3. Revised and promulgated on December 4, 2012; entered into force  on 
January 1, 2013 . 
4. Revised and promulgated on June  4, 201 5; entered into force  on June 18 , 
2015. 
 
Article 1  
 These regulations are formulated  pursuant to Paragraph 6 , 
Article 27 of the Patent Act (hereinafter referred to as “ the 
Act”). 
Article 2  
 A request  for deposit of biological material may  be filed by 
providing  the following items to the depository  institution 
(hereinafter referred to as “the Depository”)  designated by the 
Specific Patent Agency : 
1. a request  form (Appendix II)  indicat ing the name, 
domicile, residence  of the depositor; in case of a juristic 
person  or an organization with a representative, 
indicat ing the name thereof , representative’s name, and 
business establishment;  
2. basic information of the biological material (Appendi x 
III); 
3. the biological material with required quantity ; and  
4. deposit f ees. 
In case the biological material referred to in the preceding 
paragraph is import ed, the import permit shall also be 
provided . 
In case a request  referred to in  Paragraph 1 is filed by  an 
appoint ed agent , the document specifying the power of 
attorney  shall also be provided  along with  the request . 
Article 3  
 The b iological materials accepted for deposit include 
bacteria, actinobacteria,  yeasts,  molds, mushrooms, plasmids, 2 
 bacteriophages , viruses, animal cell lines, plant cell lines, 
hybridoma, and other biological materials requiring deposit.   
Article 4  
 The d eposited biological materials shall be preserved in 
freeze -dried or frozen form, and the container requirements for 
depositing bi ological materials are set forth in Appendix I.  
However , the biological materials that cannot be preserved in  
freeze -dried or frozen form  may be preserved by other 
appropriate preservation methods determined by the 
Depository.      
The biological material s referred to in the preceding 
paragraph shall be transported under an appropriate 
temperature and in an appropriate way to maintain their  
viability  and properties, and to prevent them  from being 
released  to the environment during transport.  
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 v iruses, animal cell lines, plant cell lines, hybridoma, 
and biological materials with special cultivation 
conditions , 25 vials of culture samples shall be 
depo sited and each  shall contain the amount necessary 
for performing viability test ; 
3. for p lasmids 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 cont ain the amount  necessary for 
performing viability test ; and 
4. for o ther biological materials requiring deposit , the 
amount  to be deposited shall be determined by the 3 
 Depository.  
In case the plasmids referred to in Subparagraph  3 of the 
preceding paragraph are deposited in nucleic acid form,  the 
Depository , if it deem s 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 t est. 
Article 6  
 The Depository shall reject a request  for deposit under any 
of the following  circumstances:  
1. the request for deposit is not filed pursuant to Article 2 ; 
2. the biological material is not provided in an appropriate 
form and with  necessary  quant ity pursuant to the 
provisions from Article 4 to the preceding article ; 
3. the biological material is under restriction by laws, 
except for the one having obtained the permit; or  
4. the biological material obviously has been 
contaminated, or  cannot be accepted f or deposit due to 
scientific reasons.  
The Depository shall notify  the deposit or in advance of the 
reasons for  rejection and allow the depositor  to respond within 
a time limit . 
Article 7  
 The Depository shall perform viability tests within 1 
month after  the date that all the  required items of a request  for 
deposit referred to in Article 2 ha ve been submitted in full , and 
issue a certificate of deposit to the deposit or whose biological 
material has been proven to be viable.  
The certificate of deposit referre d to in the preceding 
paragraph shall indicate the following items:  
1. the name  and address of the Depository ; 
2. the name and residence, domicile, or business 
establishment of the deposit or; 
3. the date of the deposit accepted by the Depository ; 
4. the accession numb er given by the Depository ; 
5. the identification number or symbol given by the 4 
 deposit or to the biological material ; 
6. the scientific name of the biological material shown in 
the request form; and  
7. the date of the viability test.     
In case the biological mater ial cannot be proven to be 
viable after  performing the viability test referred to in 
Paragraph 1, the deposit or shall provide  the relevant 
information of the biological material or its culture medium 
within the time limit  specified  by the Depository.  
Article 8  
 After perfo rming the viability test referred to in the 
preceding article, the Depository may perform additional 
viability tests to the deposited biological material, when 
necessary for reasons of storing  the biological material, or upon 
request by t he deposit or. 
In case a  culture  medium with special components is 
required for the viability test referred to in the preceding 
article or preceding p aragraph, the Depository may inform the 
deposit or to provide such  medium when necessary.      
Article 9  
 The Depository shall issue a viability statement  under the 
following circumstances:  
1. after performing the viability test referred to in 
Paragraph 1 of Article 7 , the biological material cannot 
be proven to be viable ; 
2. upon request by the depositor ; and 
3. upon re quest from  one who is not the depositor but is 
entitled to be furnished with  the biological  material 
pursuant to Article 13.  
The viability statement referred to in the preceding 
paragraph shall indicate the  following items:  
1. the name  and address of the Depo sitory ; 
2. the name  and the residence, domicile, or business 
establishment of the deposit or; 
3. the date of deposit accepted by the Depository ; 
4. the accession number given by the Depository ; 5 
 5. the date of the viability test ; and  
6. the viability test result that  indic ates whether the 
biological material is viable or not.  
In case the viability test shows the biological material is 
not viable, the viability statement shall additionally indicate 
the conditions under which the viability test has been 
performed and the rele vant information.  
Article 10  
 The duration of deposit of a biological material deposited 
in the Depository is 30 years.  
The Depository shall preserve the biological material for at 
least five years additional ly after the date a request for 
furnishing the biological material is made prior to  the end of 
the duration referred to in the preceding paragraph.  
After the end of the duration referred to in the preceding 
two paragraphs, the Depository may destroy the deposited 
biological material.  
Article 11  
 The d epositor may not withdraw the deposit in the time 
period prescribed in the preceding article; however, this shall 
not apply where the withdrawal is made prior to the issuance 
of the certificate of deposit by the Depository in accordance 
with Paragraph 1 of  Article 7.  
The depositor withdrawing the deposit pursuant to the 
proviso of the preceding paragraph (Appendix V) may request 
a refund of the paid deposit fee; however, the cost occurred 
from the performed viability test should be deducted 
therefrom.  
For the deposit withdrawn pursuant to the proviso of 
Paragraph 1, the Depository shall return the deposited 
biological material or destroy it and inform the depositor.  
Article 12  
 The Depository is under the obligation to keep confidential 
the deposited biolo gical  materials and relevant information. 
With the exception of  the situation set forth in  Article 13, the 
Depository shall not release deposited biological materials and 
relevant information to any third party.  6 
 Article 13  
 The Depository shall furnish the deposited biological 
materials to the following requesters : 
1. the Specific Patent Agency ; 
2. the depositors or one with the consent of the depositor ; 
and 
3. one eligible for such request under Article 14 . 
After furnishing the biological materials pursuant to the  
preceding paragraph, the Depository shall notify  the depositor 
in writing for the fact of furnishing, except for furnishing to the 
depositor.     
When furnishing the biological materials pursuant to 
Paragraph 1, the Depository shall at the same time  provid e the 
scientific name s of the biological materials given by the 
depositor.  
Upon request by the requester , the Depository shall 
provide the cultivation or  preservation conditions performed 
by the Depository.  
Article 14  
 To practice an invention involving  the deposited biological 
material s for research  and experimental purposes, one may 
request the  Depository for furnishing the biological material s 
under any of the following circumstances:  
1. the patent application  for invention involving  a 
biological material  has been  allowed and published ; 
2. the one who has received a written notification from the 
invention patent applicant  referred to in Paragraph 1 , 
Article 41 of the Act; or  
3. the one who has requested  a re-examination  referred  
to in Article 48 of the Act after  the patent application 
was rejected.  
The biological material s   acquired pursuant to the 
preceding paragraph  shall not  be provided to others  for use .  
For a request  for furnishing the biological material s 
pursuant to Paragraph 1, the following document s shall be 
provided : 7 
 1. a request form (Appendix I V); 
2. a photocopy  of the publication of the allowed patent  
application , of the written notification  from the 
invention patent applica nt, or of the written decision of 
rejection from  the Specific Patent Agency;  
3. a declaration of utilizing the biological material s only 
for research and  experimental purposes ; and  
4. a declaration that the biological material s are not to be 
provided  to others.  
Article 15  
 For a request for furnishing biological materials pursuant 
to Article  13, the Depository may refuse  to furnish the 
biological materials on account  that the requester  does not 
possess the knowledge or the equipment for handling the 
biological materials and may damage or threaten the 
environment, plants, or the health of huma ns or animals.  
Article 16  
 One who obtained the biological materials that are 
pathogenic or may damage the  environment pursuant to 
Article 13, shall destroy the biological materials immediately 
after use, and shall notify  the Depository  of the destruction . 
Article 17  
 Where the Depository cannot continue furnishing the 
deposited biological materials because  the deposit ed biological 
materials that had  originally been found viable were no longer  
nonviable, or due to other circumstances, the date of re-depos it 
may be deemed  the original deposit date if the requester  
replaces the biological materials within 3 months after having 
receiv ed the notification of non -viability from the Depository.  
Where the depositor cannot replace the biological 
materials within th e time period prescribed in the preceding 
paragraph  due to the properties of the biological materials or 
other legitimate reason s, the period referred to in the 
preceding  paragraph may be extended once such extension has 
been approved by  the Depository.  
For replacing  the biological materials pursuant to the 
preceding two paragraphs,  the depositor shall provide  an 8 
 affidavit alleging that the replacement is the same as the 
original deposit.   
Where the replaced  biological materials are not received 
by the Depo sitory within  the specified time limit  referred to in 
the preceding paragraphs, the date of deposit shall be the date  
on which the Depository receives  a replacement of biological 
materials.  
Where the depositor does not replace  the biological 
materials purs uant to  Paragraph 1 to 3, the Depository shall 
notify  the Specific Patent Agency . 
Article 18  
 Where the Depository has performed a viability test or 
preservation using the method provided or agreed by the 
depositor, the Depository has no obligation for co mpensation if 
the biological materials cannot be preserved properly or are no 
longer available for furnishing.  
Article 19  
 Any person requesting  for a deposit shall pay the deposit 
fee according to the following:  
1. NT$38,400 per request for bacteria, actino bacteria, 
yeasts, molds, mushrooms, plasmids, and 
bacteriophages ; 
2. NT$52,800 per request for animal cell lines, plant cell 
lines, hybridoma, viruses, and other biological 
materials ; and  
3. for the biological material s referred to in the preceding 
two subparagr aphs  with special preservation condition , 
the deposit fee  pertaining to  properties of the biological 
materials , preservation materials , and equipment 
required  is to be determined  based upon the agreement 
between the depositor  and Depository.     
In case th e biological materials referred to in the preceding 
paragraph cannot be proven to be viable , the depositor may 
request  for a refund of the paid deposit fee of which  the 
viability test fee refer red to in Article 20 should be de ducted  
therefrom .     9 
 Article  20 
 Any person requesting  to the Depository for issuance of a 
viability statement  pursuant to Paragraph 1  of Article 9 shall 
pay the deposit fee according to the following:  
1. NT$2,400  per request  for bacteria, actinobacteria, yeasts, 
molds, mushrooms, and p lasmids transformed in hosts ; 
2. NT$4,800 per request for plasmids and bacteriophats in 
nucleic acid form, animal cell  lines, plant cell lines, 
hybridoma, bacteriophages,  viruses, and other 
biological materials ; and  
3. for the biological material s referred to in  the preceding 
two subparagraphs  with special cultivation condition , 
the deposit fee , up to  NT$120,000, is to be determined 
by the Depository based on  properties of the biological 
materials , cultivation materials , and equipment 
required .  
Article 21  
 Any person requesting  to the Depository for furnishing 
the biological materials pursuant to Paragraph 1 of Article 13  
shall pay the deposit fee according to the following : 
1. NT$2,400 per request for bacteria, actinobacteria, yeasts, 
molds, mushrooms, plasmids, a nd bacteriophages ; 
2. NT$4,800 per request for animal cell lines, plant cell 
lines, hybridoma, viruses, and other biological 
materials ; and  
3. for the biological material s referred to in the preceding 
two subparagraphs with special cultivation condition, 
the dep osit fee,  up to NT$120,000, is to be determined 
by the Depository based on properties of the biological 
materials , cultivation materials , and equipment 
required.  
Article 22  
 A request to the Depository for providing cultivation or 
preservation condition o f a biological material pursuant to 
Paragraph 4 of Article 1 3 shall cost  NT$360. 
A request  for issuance  of replacement or a substitution of 
the certificate of deposit shall cost  NT$360. 10 
 Article 23  
 The appendixes referred to in the se Regulations  may be 
amended and promulgated by the Specific Patent Agency  
when necessary.  
Article 24  
 For a patent applicat ion for invention involving  a 
biological  material or the utilization of a biological material 
filed after the implementation of the amended Act , in the ev ent 
that the request for  deposit of biological material has been filed 
prior to the implementation of the amended Act  and the 
certificate of deposit submitted by the patent applicant 
pursuant to Paragraph 2 or 3 , Article 27 of the Act does not 
contain the viability test report, the applicant for invention 
paten t shall submit the viability test report within the time 
period set by the Specific Patent Agency . If the report is not 
submitted within the specified time period , the deposit shall be 
deemed not to have been made.  
Article 25  These Regulations shall enter  into force on January 1, 2013.  
The amendment of these  Regulations shall enter into force 
on June 18, 2015.