Budapest Notification No. 309
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication by the Government of the People's Republic of China Relating to the Acquisition of the Status of International Depositary Authority by the Guangdong Microbial Culture Collection Center (GDMCC)

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 the receipt from the Government of the People's Republic of China, on October 27, 2015, of a written communication dated October 20, 2015, relating to the Guangdong Microbial Culture Collection Center (GDMCC), which states that this Depositary Institution is located on the territory of the People's Republic of China and includes a Declaration of Assurances to the effect that the Institution complies and will continue to comply with the requirements concerning the acquisition of the status of International Depositary Authority 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.

Pursuant to Article 7(1)(b), the Guangdong Microbial Culture Collection Center (GDMCC) shall acquire the status of International Depositary Authority under the Budapest Treaty on January 1, 2016.

December 18, 2015


Text of the communication by the People's Republic of China relating to the acquisition of the status of international depositary authority by the Guangdong Microbial Culture Collection Center (GDMCC)

[Original: English]

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, and amended on September 26, 1980, as Commissioner of the State Intellectual Property Office of the People's Republic of China, I have the honor of informing you that the People's Republic of China nominates the Guangdong Microbial Culture Collection Center (GDMCC) for the status of international depositary authority.

The People's Republic of China offers its assurance that the Guangdong Microbial Culture Collection Center complies, and will continue to comply in future, with the requirements set forth in Article 6(2) of the said Budapest Treaty.

I request that the status of International Depositary Authority of GDMCC according to the provision of the Budapest Treaty will go into effect on January 1, 2016.


ANNEX

Acquiring the status of International Depository Authority for the Guangdong Microbial Culture Collection Center (GDMCC)

1. Legal Status

The GDMCC, established in 1987, is affiliated to Guangdong Institute of Microbiology (GIM), China. The GIM, known as the Central South Mycology Laboratory of Chinese Academy of Sciences before 1972, is affiliated to the Guangdong Academy of Science, China. The GIM is a public academic organization with provincial financial allocations and independent legal qualification. The GDMCC aims to: 1) innovate the techniques of mining and protecting microbial resources and provide technical supports for microbial resources access and protection; 2) isolate, collect and protect the functional microorganisms for life science research and industry development; 3) develop an integrated culture product system and provide the microbial resources sharing services for the research, industry and testing; 4) provide public services of the identification, preservation, quality evaluation and operation skills training on microbes or microbial products.

The GDMCC has become the largest and most professional culture collection center in South China. It has gained an important role, as one of the strategic supporting platforms, in the development of the strategic emerging industries in China. The GDMCC is a member of the World Federation for Culture Collections (WFCC). It is also an active participant in the project of National Infrastructure of Microbial Resources, and has an important position. According to the agreement signed in March 2015 with the State Intellectual Property Office of the People's Republic of China, the GDMCC will be an eligible depositary institution for the deposit of microorganisms for the purposes of patent procedure in China.

The GDMCC started to provide public services in 1990. It has acquired the qualification for the identification and evaluation of microbes and related products from the China Metrology Accreditation and the China National Accreditation Service for Conformity Assessment.

Culture distribution, entrusted research and professional technical training are also provided by the GDMCC. The supplying service of the microbial strains for feed has been authorized by the Ministry of Agriculture of the People's Republic of China.

The current holdings of microorganisms, including bacteria, actinomycetes, yeasts, filamentous fungi and basidiomycetes, comprise about 9,800 strains which are growing at an annual rate of 500-800 strains. The strains held by the GDMCC are of tropical and subtropical characteristics, many of which have a high level of production performance in industry, and a considerable number of them are new species with independent intellectual property rights. These give the GDMCC a very distinct and irreplaceable characteristic. The GDMCC has established a wide range of cooperative relations with many international depositary institutions, such as ATCC, DSMZ and NCTC, etc.

The GDMCC has a strong strength in the mining, preservation, information management and sharing of microbial strains. It developed a number of techniques for strain isolation and the cryopreservation of strains that are hard to be handled, and established an information database management system based on computer. Taking the advantage of the repository of microbial resources, the GDMCC provides public services for Guangdong and even the whole country. These services include resource sharing, entrusted preservation, identification and preparation of lyophilized ampoules. About seven thousand strains of cultures having great bearing on industry, taxonomy, biochemistry, genetics and education, have been distributed to more than 1000 beneficiaries all over China annually. This makes the GDMCC an irreplaceable professional platform for sharing and utilization of microbial resources in South China.

2. Name and Address

Guangdong Microbial Culture Collection Center
Guangdong Institute of Microbiology
No.59 Building, No.100 Xianliezhong Road
Guangzhou 510075
The People's Republic of China

Telephone: (86-20) 8713 7633, 8713 7636, 3765 6629
Facsimile: (86-20) 8768 6803
E-mail: gdmcc@gdim.cn
Internet: http://www.gimcc.net

3. Facilities

The GDMCC has sufficient space and modern facilities for the cultivation, verification and long-term conservation of microorganisms. The space taken up by the GDMCC within the Guangdong Institute of Microbiology is about 1200 square meters. The repository facilities occupy about 300 square meters. The repository space is complemented by 900 square meters of laboratory space. In addition, a separate backup preservation room of about 100 square meters is built in the Guangzhou Science City of about 45 km from the GDMCC. Cultures are routinely maintained via several preservation methods, depending on the kind of microorganism. Bacteria, actinomycetes, yeasts and sporulating filamentous fungi are frozen in liquid nitrogen, deep frozen or lyophilized. Basidiomycetes and other nonsporulating fungi are stored in mineral oil or water. Each strain in the GDMCC is preserved through at least two different methods. The GDMCC keeps all of the collections in rooms with security facilities and only authorized staff members have access to the collections. The GDMCC has established a comprehensive database system where there is a hierarchical authorization set, the staff can only obtain the information of the corresponding permission level. Access to confidential information is limited to the relevant responsible persons.

The detailed information about the repository facilities and the supporting laboratories of the GDMCC is as follows:

3.1 Repository facilities

3.1.1 Lyophilization operating room

This room is equipped with two independent sets of freeze-dried operating system, including the lyophilizer, controlled rate freezer, vacuum pump, gas burner, etc.

3.1.2 Cold storage room

There are two independent cold rooms with door lock, separated by a buffer chamber, which are used for storage of the general cultures and the patent cultures, respectively. There are several stainless steel cabinets for storage of the lyophilized ampoules in each cold room.

The temperature of each cold room is maintained at 4°C to 8°C by two independent automatic cooling systems which automatically alarms and switches to another when machine failure or over temperature occurs. Each cold room is equipped with a dampness-proof camera, which allows the staff to monitor the conditions of the cold storage room at any time.

3.1.3 Liquid nitrogen storage room

There are one liquid nitrogen auto-supply tank and six liquid nitrogen storage tanks. Two of the storage tanks are used for the preservation of the patent cultures. The cultures are kept in cryotubes in the liquid nitrogen storage tanks. The thermal insulation and the air conditioning device ensure that the temperature is maintained at around 25°C in summer. The room is equipped with security facilities.

3.1.4 Deep-freezer room

There are four deep-freezers for the preservation of collections in cryotubes. The thermal insulation and the air conditioning device ensure that the temperature is maintained at around 25°C in summer. The room is equipped with security facilities.

3.1.5 Temporary storage room

There are six low temperature freezers for the temporary storage of the cultures in cryotubes, slants and plates. The thermal insulation and the air conditioning device ensure that the temperature is maintained at around 25°C in summer. The room is equipped with security facilities.

3.1.6 Backup preservation room

The backup preservation room is located in Guangzhou Science City. There are twelve deep-freezers for the preservation of collections in cryotubes. The thermal insulation and the air conditioning device ensure that the temperature is maintained at around 25°C in summer. The room is equipped with security facilities.

3.1.7 Preparation room

This room is used for the preparation of media and reagents, equipped with experimental benches, four electronic scales, two pH meters and storage cabinets for chemical reagent, volatile reagents and finished products.

3.1.8 Washing and sterilizing room

This room, equipped with an autoclave machine, is used for the sterilizing of media and reagents and the washing of tubes, culture dishes and other items.

3.1.9 Bio-clean room

This area is used for inoculation and aseptic operation. There are two sets of independent bio-clean systems with controlled temperature and humidity and wind shower device. There are a total of five inoculation chambers intended for bacteria, actinomycetes, yeasts, sporulating filamentous fungi and basidiomycetes, respectively. This area is equipped with security facilities.

3.1.10 Incubation room

This room is used for the cultivation of various microorganisms, equipped with six constant temperature incubators, four constant temperature shakers, two light incubators, one anaerobic workstation and one carbon dioxide incubator. The thermal insulation and the air conditioning device ensure that the temperature is maintained at around 25°C in summer. The room is equipped with security facilities.

3.2 Supporting laboratories

3.2.1 Microscopy laboratory

This laboratory is used for the microscopic morphology observation, equipped with transmission/ scanning electron microscopy, confocal laser scanning microscopy, high performance optical microscopy, stereo microscopy, etc.

3.2.2 Chemical analysis laboratory

This laboratory is used for the chemical analysis of microbial identification, equipped with liquid chromatography, gas chromatography, high resolution mass spectrometry, LC-MS, GC-MS, etc.

3.2.3 Biochemical identification laboratory

This laboratory is used for microbial biochemical identification, equipped with a temperature-controllable spectrophotometer, an API identification system, a Biolog microbial identification system, etc.

3.2.4 Molecular biology laboratory

This laboratory is used for the molecular identification of microorganisms, equipped with thermocyclers, electrophoresis, gel imaging system, centrifuges, etc.

3.3 Office

There are four offices used by the GDMCC. One, with security facilities, is used for the storage of data and document information, one is the contacting room, and the other two are the staff daily office.

4. Staff

In the practice of more than twenty years, the GDMCC has built up a reasonable management system as well as a high performance team with strong creative ability and young-middle age, which can carry out the scientific and administrative tasks required under the Budapest Treaty. The GDMCC team has a reasonable structure and a clear division of responsibilities. Of the forty-five employees, ten hold senior titles, fifteen hold middle titles, ten hold doctorates in science, and twenty hold master's degrees in science.

There are researcher members who are engaged in the researches of the isolation, identification, function evaluation and preservation of microorganisms, technical members who are qualified and trained to carry out the preservation management as well as the professional service members with high service consciousness. Some of the researcher members rank in the most well-known and active microbiologist or fungi experts in China.

The director of the GDMCC is a committee member of the Committee of Microbial Resources, Chinese Society for Microbiology (CMR-CSM) and the Supervisory Committee of the National Infrastructure of Microbial Resources. These researcher members are specialized in taxonomy of bacteria, actinomycetes, yeasts, filamentous fungi and basidiomycetes in morphologic taxonomy, in chemotaxonomy and in systematic taxonomy by carrying out DNA/DNA hybridization, PCR identification, 16s rDNA sequencing, analysis of cellular fatty acids, respiratory quinones, polar lipids, whole-cell sugar and peptidoglycan structure and computer-assisted analysis of the results. These specialists have advised and will advise the GDMCC on the holdings of collection, preservation, identification, function evaluation and other technical aspects.

The GDMCC has described and published more than seventy-five new species in the international authoritative journals, such as "International Journal of Systematic and Evolutionary Microbiology", "MYCOTAXON", etc., and achieved a reputation in the international depositary institutions.

5. Kinds of Biological Materials that May Be Deposited

The GDMCC will accept for deposit: bacteria and archaea (including those containing plasmids), fungi (including molds and yeasts), bacteriophages, plasmids (both isolated and in hosts), deoxyribonucleic acids (DNAs), unicellular algae, plant cell cultures (including undifferentiated cell cultures, embryogenic plant cell cultures and tissues, in-vitro shoot cultures), human and animal cell cultures (including hybridomas).

At present, the GDMCC does not accept deposits of embryos, parasitic and pathogenic protozoa, animal viruses, plant viruses, and RNA preparations.

The GDMCC does not accept for deposit pathogenic microorganisms of Risk Group 1 & 2 (Chinese classification) and other microorganisms restricted or prohibited by Chinese law or administrative regulations.

As a general rule, the GDMCC will only accept the deposited materials that can be preserved by lyophilization or storage in liquid nitrogen or by some other method of long-term preservation without significant changes in their characteristics.

Exceptionally, the GDMCC may accept deposits which can only be maintained in active culture, but acceptance of such deposits, and relevant fees, must be decided on a case-by-case basis by prior negotiation with the prospective depositor.

The GDMCC reserves the right to refuse to accept a deposit if, in its view, the deposit may be an unacceptable hazard or the deposit may be technically too difficult to process.

6. Working languages

The working languages of the GDMCC are Chinese and English.

7. Requirements and procedures

In accordance with Rule 6.3(a) of the Regulations of the Budapest Treaty, the GDMCC requires the followings before it could accept microorganisms for deposit:

- that the deposit of a microorganism be in appropriate form and in a quantity that enables the GDMCC to fulfill its obligations under the Regulations;

- that the form established by the GDMCC and duly completed by the depositor for the purposes of the administrative procedure be furnished;

- that the written statement referred to in Rule 6.1.(a) or 6.2.(a) be properly completed in English or Chinese;

- that the fee for storage referred to in Rule 12.1(a) be paid;

- that the depositors obtain all necessary permits for the transportation of the deposit.

In accordance with the Regulations of the Budapest Treaty, the GDMCC will:

- check each deposit for viability and morphology and store it;

- issue receipts, viability statements and other official notifications as required;

- comply with the prescribed secrecy requirements in Rule 9.2;

- furnish samples under the conditions of and in conformity with Rule 11.

8. Schedule of Fees

    RMB
(a) Storage 3.000
(b) Issuance of a viability statement 500
(c) Furnishing of a sample 500
(d) Communication of information 200
(e) Application for the import or export license Depends on individual situation

Other currencies will be converted into RMB (Chinese Yuan) according to the exchange rate of the Bank of China.