Article 1

The regulations are enacted pursuant to Paragraph 4 of Article 26 of the Patent Law (hereinafter referred to as the “Law”).

Article 2

An application for deposit of a microorganism shall be filed by submitting the following items to a depositary designated by the Patent Authority (hereinafter referred to as the “Depositary ”):

1.  An application form which indicates the name and the residence or domicile of the depositor; in case of a legal entity or an organization with a representative, indicates its name, representative’s name, and office address.

2.  Basic information of the microorganism.

3.  The microorganism with required quantity.

4.  Fees.

In case of importing the microorganism referred to in the preceding Paragraph, the import permit shall be submitted.

In case of authorizing a patent agent to perform the application referred to in Paragraph one, the power-of-agent shall be submitted when the application is filed.

Article 3

Microorganisms accepted for deposit include bacteria, actinomycetes, yeasts, molds, mushrooms, plasmids, bacteriophages, viruses, animal cell lines, plant cell lines, hybridoma, and other microorganisms requiring for deposit.

Article 4

Deposited microorganisms shall be preserved in freeze-dried or frozen form.  Nevertheless, microorganisms that can not be preserved in freeze-dried or frozen form may be preserved in active culture form.

The microorganism referred to in the preceding Paragraph shall be transported under an appropriate temperature and in an appropriate way to maintain its activity and properties, and to prevent it from releasing to the environment during transportation.

Article 5

Microorganisms preserved in freeze-dried form shall deposit 6 freeze-dried ampoules that shall contain an amount necessary for performing viability test in each ampoule.

Article 6

Microorganisms preserved in frozen form shall deposit 6 frozen vials that shall contain an amount necessary for performing viability test in each vial, except for the following circumstances:

1.              Viruses, animal cell lines, plant cell lines, hybridoma, and microorganisms with special cultivation conditions shall deposit 25 frozen vials which shall contain an amount necessary for performing viability test in each vial.

2.              Plasmids in nucleic acid form shall be deposited at least 10 micrograms and evenly distribute in 25 frozen vials, while 50 micrograms is required for bacteriophages and viruses in nucleic acid form.

In case of plasmids, bacteriophages and viruses in nucleic acid form, a Depositary, when deems necessary, may inform applicants to provide 6 freeze-dried ampoules or frozen vials of hosts in an appropriate preservation form which shall contain an amount necessary for performing viability test in each ampoule or vial.

Article 7

Microorganisms preserved in active culture form shall deposit 6 slants that shall contain an amount necessary for performing viability test in each slant.

Article 8

A Depositary shall reject a deposit application under any of the following circumstances:

1.              The deposit application is not filed pursuant to the provision of Article 2.

2.              The microorganism is not provided in an appropriate form and for necessary quantity pursuant to the provisions from Article 4 to the preceding Article.

3.              The microorganism is under restriction by laws, except for one having been granted special permission.

4.              The microorganism obviously has degenerated, has been contaminated, or can not be accepted for deposit due to scientific reasons.

The Depositary, before rejection, shall inform the applicant of the reasons for rejection and allow the applicant to respond within a period of time.

Article 9

A Depositary shall issue a deposit certificate to an applicant whose deposit has been accepted.

The deposit certificate referred to in the preceding Paragraph shall indicate the following items:

1.              The name and address of the Depositary.

2.              The name and address of the depositor.

3.              The date of the deposit accepted by the Depositary.

4.              The accession number given by the Depositary to the deposit.

5.              The identification number or symbol given by the depositor to the microorganism.

6.              The scientific name of the microorganism shown in the application form.

Article 10

A Depositary shall perform viability tests to a deposited microorganism,

1.              within 1 month from the date of issuing the deposit certificate,

2.              when necessary for reasons of preserving the microorganism, or

3.              upon request by the depositor.

Article 11

In case medium with special components is required for a viability test, the Depositary may inform the depositor to provide the medium when necessary.

In case the microorganism can not be proven to be viable by performing the viability test referred to in Item 1 of the preceding Article, the depositor shall supplement the relevant information of the microorganism or its cultivation materials within the time period required by the Depositary.

Failing to accomplish the supplement pursuant the provision of the preceding Paragraph, or failing to prove the microorganism to be viable by the viability test performed after the supplement, Depositary shall inform the depositor and the Patent Authority.

Article 12

A Depositary shall issue a viability test report under the following circumstances:

1.              after performing the viability test referred to in Item 1 of Article 10,

2.              upon request by the depositor, or

3.              upon request by one who is not the depositor but is entitled to the microorganism furnished pursuant to Article 16.

The viability test report referred to in the preceding Paragraph shall indicate the following items:

1.              The name and address of the Depositary.

2.              The name and address of the depositor.

3.              The date of deposit accepted by the Depositary.

4.              The accession number given by the Depositary to the deposit.

5.              The date of performing the viability test.

6.              The viability test result showing whether the microorganism is viable or not.

In case the viability test shows the microorganism is not viable, the viability test report shall additionally indicate the conditions under which the viability test has been performed and the relevant information.

Article 13

The duration of a microorganism deposited in a Depositary is 30 years.

A Depositary shall preserve the microorganism for at least additional five years after the date of a request for furnishing the microorganism before 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 Depositary may destroy the deposited microorganism.

Article 14

An applicant may withdraw a deposit before the decision of the corresponding patent application being issued.

For the deposit withdraw pursuant to the preceding Paragraph, the Depositary shall destroy the deposited microorganism, and shall inform the depositor and the Patent Authority.

Article 15

A Depositary is under the obligation to keep confidentiality for deposited microorganisms and relevant information.  Except for the provision of Article 16, a Depositary shall not release deposited microorganisms and relevant information to any third party.

Article 16

A Depositary shall furnish deposited microorganisms to the following applicant:

1.      The Patent Authority.

2.      The depositors or one with the consent of the depositor.

3.      One permissible under Article 17.

After furnishing pursuant to the preceding Paragraph, the Depositary shall inform the depositor in writing for the fact of furnishing, except for furnishing to the depositor itself.

When furnishing pursuant to Paragraph 1, the Depositary shall at the same time provide the scientific name of the microorganisms given by the depositor.

Upon request by the applicant, the Depositary shall provide the cultivation or preservation conditions performed by the Depositary.

Article 17

To practice an invention corresponded to deposited microorganisms for research and experimental purposes, one may apply to Depositary for furnishing the microorganisms under any of the following circumstances:

1.      The invention patent application corresponded to the microorganisms has been allowed and published.

2.      The one has received a written notification from the invention patent applicant referred to in the provision of Paragraph 1 of Article 36-5 of the Law.

3.      The one has filed for a re-examination or responded to a written decision referred to in the provision of Article 40 of the Law after the patent application is rejected.

The microorganisms obtained referred to in the provision of Paragraph 1 shall not be provided to others.

To apply for furnishing the microorganisms pursuant to the provision of Paragraph 1, the following document shall be submitted:

1.      An application form

2.      A duplicate of the publication of the allowed patent, of the written notification from the invention patent application, or of the written decision for rejection from the Patent Authority.

3.      A declaration of utilizing the microorganisms only for research and experimental purposes.

4.      A declaration of not to provide the microorganisms to others.

Article 18

For an application for furnishing microorganisms pursuant to the provision of Article 16, a Depositary may reject for furnishing the microorganisms based on the fact that the applicant does not possess knowledge or equipment to handle the microorganisms which may damage or threaten the health of the environment, plants, human, or animals.

Article 19

One who obtained microorganisms that are pathogenic and may damage the environment pursuant to the provision of Article 16, shall destroy the microorganisms immediately after use, and shall inform the Depositary.

Article 20

Where a Depositary can not continue furnishing a microorganism for the reasons that the microorganism has been viable and is no longer viable, or other circumstances, and where the depositor supplements the microorganism within the 3 months period counted from receiving the supplementing notification from the Depositary, the date of deposit may remain the original deposit date.

Where the depositor can not supplement the microorganisms within the period referred to in the preceding Paragraph due to the properties of the microorganism or other good cause, the period referred to in the preceding Paragraph may be extended upon the approval of the Depositary.

For supplementing the microorganisms pursuant to the preceding two Paragraphs, the depositor shall submit a declaration alleging that the supplemented microorganism is the same as that originally deposited.

Where the supplemented microorganism is not received by the Depositary within the period referred to in the previous Paragraphs, the date of deposit shall be the date which Depositary receives the supplemented microorganism.

Where the depositor does not supplement the microorganism pursuant to Paragraphs one to three, the Depositary shall inform the Patent Authority.

Article 21

Where a Depositary has performed a viability test or preservation using the method provided or agreed by a depositor, but the microorganism can not be preserved properly or is no longer available for furnishing, the Depositary has no obligation for compensation.

Article 22

An application for a deposit shall pay the following deposit fee:

1.  NT 36,000 for each bacteria, actinomycetes, yeasts, molds, mushrooms, plasmids, and bacteriophages.

2.  NT 48,000 for each animal cell lines, plant cell lines, hybridoma, viruses, and other microorganisms.

3.  A varied rate determined by a Depositary based on properties of the microorganism, preservation materials, and equipment required, upon the agreement of the depositor, for a microorganism referred to in the preceding two Items with special preservation condition.

Article 23

An application to Depositary for issuance of a viability test report pursuant to the provision of Paragraph 1 of Article 12 shall pay the following fee:

1.  NT 2,400 for each bacteria, actinomycetes, yeasts, molds, mushrooms, plasmids, and bacteriophages

2.  NT 4,800 for each plasmids and bacteriophats in nucleic acid form, animal cell lines, plant cell lines, hybridoma, viruses, and other microorganisms

3.  A varied rate, NT 120,000 at the most, determined by a Depositary based on properties of the microorganism, cultivation materials, and equipment required, for a microorganism referred to in the preceding two Items with special cultivation condition

Article 24

An application to a Depositary for furnishing a microorganism pursuant to the provision of Paragraph 1 of Article 16 shall pay the following fee:

1.  NT 2,400 for each bacteria, actinomycetes, yeasts, molds, mushrooms, plasmids, and bacteriophages.

2.  NT 4,800 for each animal cell lines, plant cell lines, hybridoma, viruses, and other microorganisms.

3.  A varied rate, NT 120,000 at the most, determined by a Depositary based on properties of the microorganism, cultivation materials, and equipment required, for a microorganism referred to in the preceding two Items with special cultivation condition.

Article 25

A request to a Depositary for providing cultivation or preservation condition of a microorganism pursuant to the provision of Paragraph 4 of Article 16 shall pay the fee of NT 360.

An application for re-issuance of a deposit certificate shall pay the fee of NT 360.

Article 26

For an application pursuant to the regulations, sizes and requirements of ampoules/vials/tubes and relevant forms are shown in appendix 1 to appendix 5.

The appendixes referred to in the preceding Paragraph may be amended and published by the Patent Authority when necessary.

Article 27

The regulations shall come into force as of the date of promulgation.

Appendix I

sizes and requirements of ampoules/vials/tubes

for an application of microorganism deposit

1.  freeze-dried ampoules

ampoules of single or double layers with a length below 10 cm and a diameter below 1.6 cm.

2.  frozen vials

vials with flat bottom and screwed cap having a height with 4 to 5 cm and a diameter with 1.0 to 1.3 cm.

3.  test tubes

test tubes for active cultures with a height with 8 to 16.5 cm and a diameter with 1.0 to 1.6 cm.

Appendix II

Application Form

(Before filling out the form, please read the application guidelines.  Please do not fill in the items marked with ※.)

I. Applicant

□ Individual depositor

□ Organizational depositor

II. Agent (where applicable)

III. Microorganism Deposited

IV. Microorganism Preservation Form for Deposited Microorganism

□Freeze-dried form:                           freeze-dried ampoules

□Frozen form:

□                          frozen vials

□Nucleic acid form:                         micrograms

  evenly distributed in                          frozen vials

  □Host □                        frozen vials/□                         freeze-dried ampoules

□active culture form:                                    slants (accepted for the microorganism can not be preserved in freeze-dried or frozen form)

V. Attachment

□Fees:   □Deposit fee                           □NT 36,000 □NT 48,000 □Other           

   □Viability test issuance fee       □NT 2,400    □NT 4,800    □Other           

□Power-of-agent

□Basic information of microorganism

□Import permit for the deposited microorganism

□Microorganism

□Others                                             

VI. Declaration

1. Method for viability test and preservation performed by the Depositary

□  The Depositary shall perform viability test and preservation only by the method provided by the applicant.

□  The Depositary may perform viability test and preservation by the method provided by the applicant or by more advanced one.

2. This depositor hereby files an application with (Depositary) for depositing the microorganism identified in this application form, and agrees to follow the regulations concerning microorganism deposit and the guidelines set forth by (Depositary) for deposit purposes.

Appendix III

Basic Information of Microorganism

I. Identity of the Microorganism

II. Condition for Cultivation, Preservation, and Viability Test

1. culture medium                                                                                                              

2. growth temperature                                                                                                   ℃

3. aerobic/anerobic property                                                                                              

4. the best long-term preservation method

□Frozen

□Freeze-dried

□Other                                                                                                                        

5. Please describe the medium formulation, formulation of protective agents for preservation, temperature lowering procedure for preservation, etc. in an additional page.

6. For deposit of a mutant, please describe the mutagen the isolating method in an additional page.

7. For deposit of a plasmid, virus, or bacteriophage, please describe the transformation or transfection method and the purification method of it’s nucleic acid material with an addition page.  For deposit in nucleic form, please indicate its concentration or titer.

III. Properties hazardous to health or the environment

Is the deposited microorganism hazardous to health or the environment?

□Yes, to □human, □animals, □plants, □others                                                    

The hazardous properties is described as follows (an additional page may be used)                   

□The applicant is not aware of such properties.

IV. Other Information

1. Synonymous name of the microorganism                                                                        

2. Scientific name of related hosts                                                                                       

3. History of the microorganism

(1) Isolated by                                                  Date                                                       

(2) Isolated from                                               Site                                                        

(3) Identified by                                                Date                                                        

(4) Has the microorganism been deposited in other depositary?

□No.

□Yes, the name of the depositary is                                                                              

The accession number given by the depositary is                                                

(5) Has the microorganism been modified artificially?                                                                                        

4.  Characteristics of the microorganism (an additional page may be used)                                                                                                                                                                                                                                                                                                                                                                                                                          

Appendix IV

Application Form for Furnishing Microorganism

I.  Microorganism requested for furnishing

□The microorganism requested for furnishing

□The cultivation or preservation conditions performed by the Depositary is requested.

II. Applicant

III. Declaration

□The applicant declares that the microorganism will be utilized solely for research and experimental purposes, and shall not be utilized for commercial purposes.  The applicant understands that any breach will incur punishment by relevant laws.

□The applicant declares that the microorganism will not be further provided to others.  The applicant understands that any breach will incur punishment by relevant laws.

□The applicant understands that the microorganism is pathogenic or may damage the environment.  The applicant declares that the microorganism will be utilized solely for research and experimental purposes, and will not be released out of laboratories. The applicant promises to destroy the microorganism immediately after using and will inform (Depositary).  The applicant understands that any breach will incur punishment by relevant laws.

IV. Attachment

□Fees:   □Microorganism furnishing fee       □NT 2,400                      □NT 4,800     □other           

   □Fee of NT 360 for request for providing cultivation or preservation condition of the microorganism

□A duplicate of the publication of allowed patent corresponded to the microorganism

□A duplicate of the laid-open publication corresponded to the microorganism

□A duplicate of the written notification from the invention patent application

□A duplicate of the written decision for rejection from the Patent Authority

□A document proving that the depositor has agreed for furnishing

□Others                                             

V. Declaration

For research and experimental purposes, the applicant hereby files an application with (Depositary) for furnishing the microorganism identified in this application form, and agrees to follow the regulations concerning utilization of the furnished microorganism.

Appendix V

Application form for withdrawal of deposit

I. Microorganism to be Withdraw from Deposit

II. Applicant

III. Agent (where applicable)