Budapest Notification No. 204
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication by the Government of India Relating to the Acquisition of the Status of International Depositary Authority by the Microbial Type Culture Centre and Gene Bank (MTCC)

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 from the Government of India, on August 6, 2002, of a written communication dated July 31, 2002, relating to the acquisition of the status of International Depositary Authority by the Microbial Type Culture Centre and Gene Bank (MTCC), which states that this Depositary Institution is located on the territory of India 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 Microbial Type Culture Centre and Gene Bank (MTCC) shall acquire the status of International Depositary Authority under the Budapest Treaty on October 4, 2002, that is, on the sixtieth day succeeding the date of receipt of the communication by the Director General.

October 14, 2002


Text of the Communication from the Government of India Relating to the Appointment of the Microbial Type Culture Centre and Gene Bank (MTCC) as an International Depositary Authority

[Original: English]

In accordance with Article 7(1) of the Treaty, the Ministry of Science and Technology, Department of Biotechnology, through this communication, declares that the Microbial Type Culture Centre and Gene Bank (MTCC) at the Institute of Microbial Technology (IMTECH), Chandigarh, meets and will continue to comply with the requirements specified in Article 6(2) of the Treaty to fulfil all the requirements to be an IDA. It further declares that the MTCC at IMTECH in Chandigarh complies with the requirements provided in Article 7(1) of the Treaty and Rules 3.1(a) and (b) of its Regulations.

Enclosed is the Declaration of Assurances for establishment of an IDA submitted by the IMTECH, Chandigarh, fulfilling all the criteria of the Treaty under Article 6(1) and (2) and Rules 2 and 3 giving details of the requirements of deposits, furnishing of samples, schedule of fees and guidance to depositors.

Geneva, July 31, 2002


Declaration of Assurances

We, the Institute of Microbial Technology, Chandigarh-160 036, hereby submit a proposal through the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, to set up an International Depositary Authority (IDA), under the provisions of the Budapest Treaty for the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, as the Microbial Type Culture Collection and Gene Bank (MTCC), located at the Institute of Microbial Technology, Chandigarh-160 036.

The MTCC has been in operation as a national facility under the overall administrative and financial structure of the Institute of Microbial Technology. The Institute is a constituent laboratory of the Council of Scientific and Industrial Research (CSIR), a society registered under the Societies Registration Act (xxi) of 1860, having its Registered Office at Anusandhan Bhavan, 2, Rafi Marg, New Delhi-110 001, India.

The Institute is headed by a Director appointed by the CSIR. The Curator, scientific and other staff working in the MTCC, are employees of the Institute and are bound by service rules of the CSIR. Part of the budget for operation of the MTCC is given by the Department of Biotechnology, Government of India. The MTCC, therefore, is a part of the Institute and is governed by the rules and regulations of the CSIR.

It is submitted that this proposal is in conformity with the requirements of the relevant clauses of the Budapest Treaty.

Article 6(1)

The proposed International Depositary Authority will be located within the territory of India and the full address is given below:

Microbial Type Culture Collection & Gene Bank (MTCC)
Institute of Microbial Technology (IMTECH)
Sector 39-A
Chandigarh-160 036 (Union Territory)
India
Tel.: (+91-172) 690 562, 695 215
Fax: (+91-172) 690 585, 690 632
E-mail: tapan@imtech.res.in
Web: http://www.imtech.res.in

Article 6(2)(i)

The depositary to be known as the MTCC has had a continued existence since 1987 as a National Culture Collection and it is submitted herewith that it shall have a continued existence as per the requirements of the Budapest Treaty in the future. The Government of India has assured its continuous existence. The Department of Biotechnology (DBT), the Government of India and the Council of Scientific and Industrial Research (CSIR) shall support it financially.

It is submitted that, because of the existence of this culture collection for the past 15 years, all the resource requirements viz. staff, equipment, storage space, inventory controls, are in place.

The Microbial Type Culture Collection and Gene Bank (MTCC) is a national facility supported jointly by the Department of Biotechnology (DBT), the Government of India and the Council of Scientific and Industrial Research (CSIR). It has been serving the scientific community in India and abroad since 1987. It is an affiliate member of the World Federation of Culture Collections (WFCC) and is registered (Registration No. 772) with the World Data Centre for Microorganisms (WDCM). It has excellent facilities for the maintenance and long-term preservation of microorganisms. The MTCC is housed in the Institute of Microbial Technology, Chandigarh, a constituent laboratory of the Council of Scientific and Industrial Research (CSIR). The Institute is located on a sprawling, beautifully landscaped 43-acre campus.

At present, it has more than 5,000 cultures of actinomycetes, bacteria, fungi, yeasts and plasmids. All cultures are preserved by at least two methods, in liquid nitrogen and by freeze-drying. Fungi are also maintained under mineral oil. A few organisms that cannot be freeze-dried are maintained in active forms. For safety, stocks of cultures are maintained in two separate buildings. On an average it supplies per year about 3,000 cultures to academic and research institutes as well as to industry. All available data on each culture are computerized and a database is maintained and regularly updated. All transactions are computerized and traceable. A website on the MTCC and its database will be available on the Internet very soon. It regularly publishes catalogues of strains, the last edition came out in the year 2000.

Since its inception, the MTCC has been providing the following services to the scientific community in India and abroad:

1. Supply of cultures
2. Deposit of cultures (general deposit, safe deposit and deposit for patent procedures)
3. Identification
4. Freeze-drying
5. Educational (conducting training courses/workshops)

Article 6(2)(ii) and Rule 2.2(i): Staff

The MTCC has 12 staff with combined expertise to take care of bacteria, fungi, yeasts, bacteriophages and plasmids. Almost all are full-time permanent staff employed for MTCC-related work. Only two are on contract. Six new permanent staff (3 scientists and 3 technical assistants) are expected to join within a year.

The scientists are also active in research programs related to microbial diversity and microbial taxonomy.

In addition, the Institute staff provides full support for the library, the animal house, administration, finance and accounts, maintenance of buildings, equipment and other services.

The MTCC, therefore, has a strong, highly-skilled scientific staff and modern laboratory facilities and equipment to take care of microorganisms in terms of viability, authenticity and maintenance in an uncontaminated state.

Article 6(2)(ii) and Rule 2.2(i): Facilities

Laboratory

The MTCC occupies an area of about 20,000 square feet of centrally air-conditioned space spread over three floors in a four-storied block of the Institute. In addition, the MTCC also has a separate building of 1,000 square feet of covered area for housing liquid nitrogen plants and an air-conditioned cryopreservation laboratory. There is a provision for expansion if additional laboratory space is required.

The electron microscopy facility and associated sample preparation laboratory are situated separately.

All the laboratories in the MTCC are self-sufficient to carry out respective specialized functions and have modern equipment needed for high-end microbiological works.

Infrastructure support

The Institute provides a 24-hour standby power supply and maintenance of infrastructure (water, electricity, building, etc.) as well as of equipment. The MTCC also utilizes other institutional facilities, like an excellent library, a 24-room guesthouse, an animal house, housing for staff, a boys' and girls' hostel, a cafeteria, transport, a seminar hall and an auditorium.

In addition, three departments of the Institute (administrative, finance and accounts, and stores and purchase) provide necessary resource management assistance.

The MTCC, therefore, has sufficient laboratory space, modern facilities, motivated and skilled staff, and other infrastructure support for housing an IDA.

Special facility for storage of cultures for patent (IDA) procedures

Normally, cultures received for deposit under the Budapest Treaty will be preserved by freeze-drying or in liquid nitrogen.

For maintaining confidentiality and ensuring the security of the deposited cultures, special provision has been made within the MTCC block. A strong room (nearly 200 sq.ft.) having iron grill reinforced walls and fireproof steel door has been made. The necessary facility for long-term storage (refrigerator for keeping freeze-dried ampoules, cryopreservation system with liquid level alarm and an ultra cold freezer) of cultures are in place. The special area has not only central air-conditioning, but it is also backed by a separate AC unit. The inside of the facility, as well as the adjoining area, is under electronic surveillance with a motion sensor, CCTV cameras and an access control system. Access (exit/entry) is limited to the cardholder and is continuously regulated.

The cultures deposited for this purpose and administrative work related to deposits are handled by the Curator. Information related to such deposits is strictly confidential and a separate database is maintained. These cultures are not listed in the Catalogue.

Article 6(2)(iii) and (iv), Article 6(3) and Rule 5

The Microbial Type Culture Collection and Gene Bank (MTCC) located at the Institute of Microbial Technology, Chandigarh-160 036 hereby assures compliance with the provisions of Article 6(2)(iii) and (iv) and the MTCC will be impartial and objective and the facility will be available for the purpose of deposit, to any depositor under the same conditions.

The Government of the Republic of India, through its Department of Biotechnology, Ministry of Science and Technology hereby assures under Article 6(3) that, in case the proposed IDA discontinues, temporarily or definitively to the fullest extent possible samples of all such microorganisms will be transferred promptly and without deterioration to another IDA ("the substitute authority") in compliance with the provisions of Rule 5 of the Regulations.

Article 6(2)(v)

Kinds of microorganisms accepted as deposits

The MTCC will accept bacteria, fungi, yeasts, bacteriophages, plasmids in a host and/or as isolated DNA preparations belonging to Hazard Groups 1 and 2 as per classification of the Indian authority.

Genetically manipulated microorganisms and isolated DNA will be accepted if they can be processed in the S1 or S2 facility or conform to Group 1 or 2 organisms.

The MTCC reserves the right to refuse to accept a deposit if, in its view, the deposit may be an unacceptable hazard or the MTCC may not be in a position to process it. Deposit of bacteria and fungi from other countries pathogenic to plants and animals, which can be processed in the Sl or S2 facility, will be accepted only if cleared by the appropriate authority in India.

The deposited material will generally be preserved by freeze-drying or storage in liquid nitrogen or by other method(s) of long-term preservation.

Time required for viability testing

The MTCC will test viability as quickly as possible. Since some microorganisms grow quite slowly, the time required for viability testing for different microorganisms may vary. The average time that will be required for viability testing is indicated below:

Bacteria, yeast, bacteriophages and plasmids - 4 days to 3 weeks

Actinomycetes, fungi - 7 days to 4 weeks


Appendix I

MICROBIAL TYPE CULTURE COLLECTION AND GENE BANK (MTCC)

Institute of Microbial Technology (IMTECH)
Sector 39-A
Chandigarh-160 036
India
Telephone: (+91-172) 690 562, 695 215
Fax: (+91-172) 690 585, 690 632
E-mail: tapan@imtech.res.in
Web: http://www.imtech.res.in

1. REQUIREMENTS FOR DEPOSIT

(a) Kinds of microorganisms accepted as deposits

The MTCC will accept bacteria, bacteria containing plasmids, fungi, yeasts, bacteriophages, plasmids in a host and/or as isolated DNA preparations belonging to Hazard Groups 1 and 2 as per classification of the Indian authority.

Generally manipulated microorganisms and isolated DNA will be accepted if they can be processed in the S1 or S2 facility or conform to Group 1 or 2 organisms.

The MTCC will reserve the right to refuse to accept a deposit if, in its view, the deposit may be an unacceptable hazard or the MTCC may not be in a position to process it. The deposit of bacteria, fungi and viruses pathogenic to plants and animal viruses from other countries will be accepted only if cleared by the appropriate authority in India.

The deposited material will generally be preserved by freeze-drying or storage in liquid nitrogen or by other method(s) of long-term preservation.

(b) Technical requirements and procedure

(i) Form and quantity

Materials for deposit should be pure (uncontaminated) and should be sent in the following form:

Bacteria and fungi (including yeasts) 10 freeze-dried ampoules and 2 active cultures (on slants). If freeze-dried cultures cannot be submitted the MTCC may do the freeze-drying on payment by the depositor
Bacteriophages 5 x 2 ml quantity with a minimum titre of l x 109 pfu per ml. Suitable host of the bacteriophage also needs to be deposited in active form (2 slants)
Plasmids 5 x 20 micrograms of isolated and purified DNA preparations. Suitable host of the plasmid also needs to be deposited in active form (2 slants)

The deposit should be accompanied by appropriate forms duly completed by the depositor. These forms can be obtained from the MTCC. Separate forms need to be used for bacteria, fungi (including yeasts), bacteriophages and plasmids. A fee for storage (Rule 12.1(a)(i) of the Regulations under the Budapest Treaty) must be paid for each deposit.

(ii) Time required for viability testing

The MTCC will test viability as quickly as possible. Since microorganisms may grow quite slowly, the time required for viability testing for different microorganisms varies. The average time that will be required for viability testing is indicated below:

Bacteria, yeast, bacteriophages and plasmids - 4 days to 3 weeks

Fungi - 7 days to 4 weeks

(iii) Depositor checks and renewal of stocks

The MTCC may prepare, as and when it finds necessary, new batch(es) of lyophilized and frozen (in liquid nitrogen) cultures by subculturing materials supplied by the depositor. The MTCC will send samples of the new batch and the depositor is required to check the authenticity of such microorganisms.

(c) Administrative requirements and procedures

(i) General

Language

The language of communication of the MTCC and of the forms will be English. Communication in Hindi is also acceptable. However, in case of any dispute, the English version will prevail.

Import and/or quarantine regulations

Cultures of microorganisms from outside India may require import clearance and/or be subjected to quarantine regulations. The depositor from outside India should communicate with the MTCC regarding such deposits before dispatching cultures.

(ii) Making the original deposit

Requirements to be met by the depositor

A depositor will be required to send a completed BP/1 Form which is the accession form for a deposit under the Budapest Treaty. For amendments to the scientific description or taxonomic designation a depositor will be required to send a completed BP/7 Form.

Official notification to the depositor

The receipt and viability statement will be issued in English on the mandatory "international forms" BP/4 and BP/9, respectively. The attestation of receipt of an amendment of scientific description or taxonomic designation will be issued on BP/8 Form. The notification of furnishing a sample to third parties will be issued on BP/14 Form.

Unofficial notification to the depositor

If requested, the MTCC may communicate the date of deposit and accession number before the official receipt is issued only after the viability test is completed and a positive result is obtained.

Supply of information to a patent agent

If requested by the depositor, the MTCC will send copies of the receipt and viability statement to both the depositor and his/her patent agent.

(iii) Converting a previous deposit

In case of a deposit made in the MTCC earlier, outside the provisions of the Budapest Treaty, the original depositor may convert the same to a Budapest Treaty deposit. However, if the original deposit was in the general category and is listed in the MTCC catalogue (printed or electronic) and had no restriction for distribution by the MTCC, the depositor will be requested to authorize the MTCC not to restrict distribution of such a deposit and waive his/her right to notification of release of the sample. If this condition is not acceptable then a fresh deposit of the material under the Budapest Treaty will be required. Deposits previously made with the MTCC for patent procedure or for safekeeping also can be converted to deposits under the Budapest Treaty.

Administrative requirements and fees for conversion will be the same as for the original deposit under the Budapest Treaty.

(iv) Making a new deposit

For making a new deposit the completed BP/2 Form will be required along with relevant documents as required under Rule 6.2. A receipt and viability statement for such a deposit will be issued on BP/5 and BP/9 Forms respectively.

2. FURNISHING OF SAMPLES

(a) Request for samples

The MTCC will follow procedures as provided under the provisions of the Budapest Treaty for furnishing samples to third parties. For proof of entitlement BP/12 Form and for request BP/13 Form will be used in furnishing samples. For hazardous microorganisms the requesting party has to provide evidence that the proper facility is available and he/she has the requisite permission to work on such organisms.

A requesting party from outside India also has to provide an import permit if it is required for that country.

The MTCC will furnish samples prepared by it from the deposited sample(s).

(b) Notification of the depositor

A depositor will be notified on BP/14 Form when samples of their deposit have been furnished to third parties.

(c) Cataloguing of Budapest Treaty deposits

Materials deposited under the Budapest Treaty will not be published in the MTCC catalogue (printed or electronic) or displayed on the Internet.

3. SCHEDULE OF FEES

Bacteria, fungi, yeasts, bacteriophages and plasmids Indian Rupees
(a) Storage under Rule 12.1(a)(i) 15,000
(b) Conversion of a deposit 15,000
(c) Extension of duration storage beyond that provided by Rule 9 (per year) 2,000
(d) Issue of viability statement on the basis of test 3,000
(e) Issue of viability statement on the basis of last viability test 1,000
(f) Furnishing of samples 3,000
(g) Communication of information under Rule 7.6 1,000
(h) Attestation referred to in Rule 8.2 1,000

4. GUIDANCE TO DEPOSITORS

The MTCC will be happy to provide written notes or advice to prospective depositors.

Article 6(2)(vi) and Rule 3(v)

The language of communication of the MTCC and of the forms will be in English. Communication in Hindi is also acceptable. However, in case of any dispute, the English version will prevail.

The receipt and viability statement will be issued in English on mandatory "international forms" BP/4 and BP/9, respectively. The attestation of receipt of an amendment of the scientific description or taxonomic designation will be issued on BP/8 Form. The notification of furnishing a sample to third parties will be issued on BP/14 Form.

Article 6(2)(vii) and Rule 2.2(ii)

Cultures deposited under the Budapest Treaty will be processed with confidentiality. Information related to such deposits will be available to authorized persons only.

Article 7(1)(b)

Information on the Depositary institution as provided in the Regulations has been furnished under Article 6(2) above.

The status of International Depositary Authority (IDA) should take effect on the sixtieth day succeeding the date of acceptance of the communication by the Director General of WIPO.

Information regarding compliance with other essential provisions of the Regulations are enclosed as Appendix I.