Budapest Notification No. 139
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication of the People's Republic of China Relating to the Acquisition of the Status of International Depositary Authority by the China General Microbiological Culture Collection Center (CGMCC) and by the China Center for Type Culture Collection (CCTCC)

The Director General of the World Intellectual Property Organization (WIPO) presents his compliments to the Minister for Foreign Affairs and has the honor to notify him of the receipt, on March 30, 1995, of a written communication, dated March 30, 1995, from the Government of the People's Republic of China, relating to the China General Microbiological Culture Collection Center (CGMCC) and the China Center for Type Culture Collection (CCTCC), indicating that the said depositary institutions are located on the territory of the People's Republic of China and including a declaration of assurances to the effect that the said institutions comply and will continue to comply with the requirements concerning the acquisition of the status of international depositary authority as specified in Article 6(2) of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done at Budapest on April 28, 1977, and amended on September 26, 1980.

The China General Microbiological Culture Collection Center (CGMCC) and the China Center for Type Culture Collection (CCTCC) will acquire the status of international depositary authority under the Budapest Treaty as from July 1, 1995, the date indicated in the said communication for the acquisition of such status.

May 12, 1995

Text of the Written Communication of the Government of the People's Republic of China, dated March 30, 1995, Relating to the Acquisition of the Status of International Depositary Authority by the China General Microbiological Culture Collection Center (CGMCC) and the China Center for Type Culture Collection (CCTCC)

COMMUNICATION

Pursuant to Article 7(1) of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of April 28, 1977, I have the honor, in my capacity as Director General of the Patent Office of the People's Republic of China, which is the competent authority of industrial property matters for the People's Republic of China, to submit the candidature of the China General Microbiological Culture Center (CGMCC) and the China Center for Type Culture Collection (CCTCC) for the grant of the status of international depositary authority.

This Director General certifies that the China General Microbiological Culture Center and the China Center for Type Culture Collection comply, and will continue to comply in future, with the requirements set forth in Article 6(2) of the said Budapest Treaty, being both financially supported by the Chinese Government.

The CGMCC and the CCTCC would like to begin to operate as international depositary authorities for microorganisms according to the provisions of the Budapest Treaty as of July 1, 1995.

The technical specifications and the legal status of the CGMCC and the CCTCC in the form of a memorandum are appended for your reference.

China General Microbiological Culture Collection Center (CGMCC)

1. Legal Status

In order to conserve the microbial resources and promote the development of state biological science and technology, the China Committee for Culture Collection of Microorganisms (CCCCM) was established under the recommendation and sponsorship of the State Science and Technology Commission of the People's Republic of China and the Chinese Academy of Sciences and others in 1979. Now CCCCM includes seven members. As the largest member, CGMCC is the central culture collection in the cooperative network of various collections in China. The origins of the CGMCC go back to 1958 when the Institute of Microbiology, the Academia Sinica, was created. In 1985, the Patent Office of the People's Republic of China designated two culture collections for preserving the microorganisms for the purposes of patent procedure. CGMCC is one of the two. CGMCC is affiliated to the World Federation of Culture Collections (WFCC).

The CGMCC is engaged in microbial collection, preservation, administration, distribution and taxonomy. It is financed by the Chinese Government. CGMCC possesses strong forces in microbial preservation and taxonomy. It is equipped for work with pathogenic microorganisms but excepting pathogens belonging to Risk Group 1 (Chinese classification). The current holdings of microorganisms, including bacteria, actinomycetes, yeasts, filamentous fungi and basediomycetes, comprise some 10,300 strains which are growing at an annual rate of 500-1000 strains. Up to now, CGMCC contains 220 strains of microorganisms for the purposes of patent procedure, which are from the United States, Switzerland, Canada, Italy, the United Kingdom, Japan and China. Cultures are routinely preserved by ultra-low temperature freezing by liquid nitrogen and freeze-drying, and some strains by subculturing. The CGMCC has a very solid foundation and possesses a lot of specialists in microbial taxonomy. These specialists have done researches in taxonomy of bacteria, actinomycetes, yeasts, filamentous fungi, in chemotaxonomy, in systematic taxonomy by carrying out DNA/DNA hybridization, DNA/RNA hybridization, PCR identification, 16s rRNA sequencing and computer-assisted analysis of the results. These specialists have advised and will advise the CGMCC on the holdings of collection, research programs, preservation methods and other technical aspects. CGMCC has established data banks on cultures to manage cultures by use of computers. In CGMCC, about 10 thousand strains of cultures having great bearing on industry, taxonomy, biochemistry, genetics and education, have been distributed to all China annually. Now the CGMCC has a staff of 50 persons. The space taken up by the CGMCC within the institute is about 2000 m².

2. Name and Address

China General Microbiological Culture Collection Center
China Committee for Culture Collection of Microorganisms
P.O. Box 2714, Beijing, 100080
The People's Republic of China

Tel: 2555614
Fax: 2560912

3. Kinds of Microorganisms Accepted for Deposit by the CGMCC

Kinds of microorganisms that may be deposited by the CGMCC are as follows with the exception of pathogenic microorganisms of Risk Group 1 (Chinese classification).

- Bacteria
- Actinomycetes
- Yeasts
- Filamentous fungi
- Anaerobic microorganisms
- Single cell algae
- Mycoplasma
- Viruses
- Bacteriophages
- Plasmids

At present, the CGMCC does not accept temporarily the following biological material for deposit:

- Protozoa
- Animal cell lines
- Plant cell lines
- Plant seed

As a general rule, the CGMCC will accept only strains that can be placed in a culture under conditions technically feasible for the collection concerned and conserved, other than in continuous vegetative activity, without inducing significant changes in the characteristics.

Exceptionally, the CGMCC may accept deposits that cannot be conserved other than by active culture, but acceptance of such a deposit will have to be decided, and the relevant fee determined, on a case-by-case basis after prior negotiation with the potential depositor.

The CGMCC also reserves the right to refuse a deposit of biological material under Article 5 of the Budapest Treaty:

- to refuse a deposit of biological material which is restricted from importing according to Chinese Law;
- to refuse a deposit of biological material whose conservation involves hazards deemed to be excessive;
- to refuse an application which asks the CGMCC to supply the biological material that is restricted from exporting according to Chinese Law.

4. Security and Secrecy

To avoid any loss or destruction, to safeguard the right of depositors, maximum security and secrecy measures are provided:

- conservation of strains in locked containers, freezers and drawers, themselves in locked premises;
- storage of duplicates of the deposited material in a different place;
- a part of the original material submitted by the depositor will be conserved;
- archives of the data related to deposited strains both on standard forms stored under key and on adequately protected computer files (with backup);
- CGMCC will necessarily assume these functions under the Budapest Treaty in an impartial and objective manner and will be available to all depositors on the same conditions;
- CGMCC will only supply subcultures and/or information on deposited strains to depositors and parties referred to in Rule 11 of the Regulations under the Treaty;
- CGMCC will issue to depositors a receipt and a viability statement for each strain accepted under the Treaty;
- CGMCC will issue lists of deposits under the Budapest Treaty in its catalogues only with the express written consent of the depositor.

5. Requirements and Procedures

As a general rule, the CGMCC requires the depositor, in respect of the deposit of a microorganism under the Budapest Treaty,

- to supply all the necessary information requested by the CGMCC;
- to pay all the necessary fees;
- to send the CGMCC five ampoules or agar samples of each strain;
- to submit descriptions of the components of the mixture and at least one of the methods permitting the checking of their presence when a mixture of microorganisms is deposited;
- to prove the authenticity of all the freeze-dried and frozen samples prepared by the CGMCC;
- not to withdraw the deposit during the time required for its period of storage;
- to authorize the CGMCC to supply samples in accordance with the requirements of the patent procedure applicable at the time.

Since on average, the time required for testing the viability of bacterial samples is three days (or up to 14 days), and for fungus strains six days (or up to 30 days), the depositor has to take into account that, in certain cases, viability testing can take a great deal of time, as indicated by the bracketed figures.

Deposits made outside the provisions of the Budapest Treaty may be converted by the original depositor to deposits under the Budapest Treaty, whether or not they were originally made for patent purposes. Any deposit previously made free of charge is subject, on conversion, to the payment of the storage fee specified in this technical memorandum, and also to whatever fees may be payable for successive updating.

The CGMCC shall accept a new deposit under Rule 6(2) of the Budapest Treaty.

6. Schedule of Fees

Other currencies will be converted into US dollar according to the exchange rate of the bank of China.

7. Official Languages

The official language of CGMCC is Chinese, and the Working Languages are Chinese and English.

China Center for Type Culture Collection (CCTCC)

l. Legal status

CCTCC was founded in 1985, its predecessor being the Culture Collection for Teaching and Research. At present CCTCC is part of Wuhan University.

CCTCC is affiliated to the World Federation of Culture Collections (WFCC); its registration number is 611 in the World Directory of Collections of Microorganisms and in the World Data Center. The CCTCC has a collection of about 4,000 strains of microorganisms including cell lines, etc. Among them, about 1,000 strains are patent cultures. The CCTCC likewise can supply information on various microbiological subjects, and can provide certain identification services for some classes of microorganisms, and has a research project for microbiological resources, in particular actinomycetes and the genus Bacillus.

2. Name and Address of the Depositary Institution

China Center for Type Culture Collection (CCTCC)
Wuhan University, Wuhan, 430072
The People's Republic of China

Tel: (027) -7822157, (027) -7822712-2319
Fax: (027)-7813833

3. Detailed Information on the Capability of CCTCC to Comply with the Requirements Specified in Article 6(2) of the Treaty

The work of the CCTCC is done in a number of the Laboratories and in the Administration Office of the Center. The space taken up by the CCTCC within the University is about 600 m2. Besides, as a comprehensive University, the other institutions of Wuhan University have supported CCTCC in all respects.

CCTCC at present has a staff of 10 persons to perform the routine work for culture collection for the purposes of patent procedure and other work. Besides, some scholars and specialists have been invited as scientific advisers for the Center. The staff of CCTCC not only have access to all the services of the University, but in addition have facilities of their own which are necessary for the growing, testing and long-term conservation of microorganisms including cell lines etc. Cultures are routinely preserved by freeze-drying, and some strains by subculturing. It is likewise possible to preserve them at low temperatures in a freezer (-80°C). All of cell lines and some strains of bacteria and fungi are preserved in liquid nitrogen. The plasmids in isolated DNA preparation form submitted for deposit with the CCTCC are preserved in alcohol in a freezer at -80°C. CCTCC has provided sufficient safety measures to minimize the risk of losing microorganisms deposited.

3.1 Preservation of cell lines etc. in locked liquid nitrogen containers, freezers, themselves in locked premises.

3.2 Preservation of strains of microorganisms in ampoules in locked drawers in a cold chamber, itself in locked premises.

3.3 Storage of duplicates of deposited materials in a different place.

3.4 Archives of the data related to deposited strains both on standard forms in a safe in locked room and on adequately protected computer files (with back up).

3.5 Only authorized personnel have access to the samples kept at CCTCC.

3.6 The CCTCC laboratories are equipped for work with pathogenic microorganisms of Risk Group 2.

4. Kinds of Microorganisms that may be deposited

4.1 Algae, animal viruses, bacteria, cell lines, fungi, hybridomas, plant cell cultures, plant viruses, plasmids, phages, plant seeds and yeasts may be deposited in CCTCC. If the microorganism (meaning of the term "microorganism" is interpreted in a broad sense as to the applicability of the Treaty to microorganisms to be deposited under it) is dangerous pathogen, a depositor should consult with the CCTCC in advance, then, CCTCC will decide whether or not the CCTCC can accept the strain for deposit.

4.2 For the time being, the CCTCC does not accept the following microorganisms for deposit:

- deposit of biological material which is restricted from importing according to the Chinese Law;

- deposit of biological material whose conservation involves hazards deemed to be excessive;

- applications which ask the CCTCC to supply the biological material that is restricted from exporting according to Chinese Law.

4.3 Notwithstanding the foregoing, the CCTCC reserves the right to reject or accept for deposit any material which, in the opinion of the Director, represents a risk that is either unacceptable or too difficult to handle.

5. Technical Requirements and Procedure

5.1 Form and Quantity

Bacteria and fungi (including those contained in plasmids) are accepted in freeze-drying form in ampoules or in the form of active culture in agar slant. The depositor should send five ampoules or slants of each strain to CCTCC for deposit. Animal cell lines and viruses are accepted in active form in ampoules, which should be packed by dry ice for transportation. The depositor should send 10 ampoules of each culture to CCTCC for deposit.

Plant cell cultures are accepted in active form according to the agreement between the CCTCC and the depositor. The depositor should send 10 replicates of each culture to CCTCC. Plant seeds are accepted in active form, and the depositor should send 2500 seeds of each plant cultivar to CCTCC for deposit

Plasmids are accepted in host or in isolated DNA preparation, and the depositor should send 5 to 10 samples of each plasmid to CCTCC for deposit, respectively.

5.2 Time required for Viability Testing

The average length of time required for testing the viability of the various microorganisms by the CCTCC is given below, but the depositor should realize that in some cases viability testing may take longer as indicated by the figures in brackets.

* for plasmids, "viability" testing consists of inserting the plasmid into a host, if transformed, the "viability test" is regarded as positive.

6. Administrative Requirements and Procedure

6.1 Language

The official language of the CCTCC is Chinese, and the working languages are Chinese and English.

6.2 Contract

The CCTCC does not enter into any contract with the depositor defining liabilities of either party, except in the case of certain dangerous organisms, where the depositor must agree to accept and handle them at his own risk, and

- to supply all the necessary information required by the CCTCC;
- to pay all the necessary fees;
- not to withdraw the deposit during the time required for its period of storage;
- to authorize the CCTCC to supply samples of deposit in accordance with the requirements of the patent procedure applicable at the time.

6.3 Importation and/or Quarantine Regulations

In the case of a depositor from abroad, the CCTCC shall obtain an import permit from the organizations concerned of the quarantine of China. Obtaining such a permit usually takes one or two weeks. After obtaining the permit, the CCTCC shall inform the depositor or his agent as to how to send the cultures to CCTCC.

6.4 Original Deposit

Depositors have to fill in the application and accession form used by the CCTCC for deposits under the Budapest Treaty, which is model form BP/1.

6.5 Official Notice of Deposit

The receipt and viability statement shall be issued in the "International forms" BP/4 and BP/9, respectively. Attestation of receipt of a later indication and amendment of scientific description and/or proposed taxonomic designation shall be issued in model form BP/8. Notification of the furnishing of samples to third parties shall be issued in model form BP/14. Individual correspondence is used rather than standard forms for other official notifications.

6.6 Unofficial Notifications to the Depositor

When requested, the CCTCC may communicate the date of deposit and the accession number by an informal letter of facsimile or telephone after the culture has been received, but before the official receipts are issued. The CCTCC likewise communicates the finding of the viability test before the viability statement is issued. A fee of $10 is charged for each service for depositors from abroad.

6.7 Supply of Information to Patent Agency

The CCTCC asks, as a rule, the depositor from abroad to provide it with the names and address of his patent agency and/or patent agent. In such cases, the CCTCC shall supply copies of the receipt, the viability statement and other information to both the depositor and his agent.

6.8 Converting a previous deposit

Any deposit previously made free of charge is subject, on conversion, to storage fees normally levied for Budapest Treaty Deposits. The administrative requirements for conversion are the same as those to be met in respect of an original deposit made under the Treaty, except that there is no import and/or quarantine procedures with regard to such deposit.

The date of deposit for such samples shall be that of the conversion, and the CCTCC will issue the conversion statement.

6.9 Making a new Deposit

The depositor is required to fill in model form BP/2 when making a new deposit, and to supply copies of the receipt and statements required by Rule 6.2 of the Regulations under the Treaty. The receipt and viability statement for a new deposit shall be issued in "international forms" BP/5 and BP/9.

7. Furnishing of Samples

7.1 Requests for Samples

The CCTCC shall furnish a sample of any deposited microorganism to the industrial property offices, to the depositor or any party with the authorization of the depositor, or to any parties legally entitled, in accordance with Rule 11 of the Regulations under the Budapest Treaty.

The CCTCC shall provide advices to third parties with a valid state to request a sample, and CCTCC shall provide them with copies of model request form BP/12. When requests are received from abroad, the applicants are deemed to be familiar with the import requirements of their respective country.

All samples of microorganisms, including cell lines etc. furnished by the CCTCC are taken from batches prepared by itself.

7.2 Notification of Depositor

The depositor is informed on model form BP/14 when samples of his microorganisms (including cell lines etc.) have been sent to third parties.

8. Schedule of Fees

9. Guidance for Depositors

The CCTCC shall publish specific information on the deposited microorganism for the guidance of prospective depositors. Before publishing such information, the CCTCC is always willing to provide information by facsimile or correspondence.