Budapest Notification No. 272
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication of the Government of the Republic of India Relating to the Acquisition of the Status of International Depositary Authority by Microbial Culture Collection (MCC)

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 the Republic of India, on January 5, 2011, of a written communication dated December 28, 2010, relating to the acquisition of the status of International Depositary Authority by the Microbial Culture Collection (MCC), 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(2)(b), the Microbial Culture Collection (MCC) shall acquire the status of International Depositary Authority under the Budapest Treaty on April 9, 2011, that is, on the sixtieth day following publication of this notification.

February 8, 2011

Text of the Communication of the Government of India Relating to the Acquisition of the Status of International Depositary Authority by Microbial Culture Collection (MCC)

[Original: English]

COMMUNICATION

Microbial Culture Collection centre has been supported by Department of Biotechnology, Ministry of Science and Technology, Government of India as a national facility for maintenance and long term preservation of micro-organisms. This established centre is located at the National Centre for Cell Science, Pune, an Autonomous Institute of Department of Biotechnology.

We are forwarding herewith an application from Director, National Centre for Cell Science, Pune regarding approval for designating the Microbial Culture Collection (MCC) as an International Depository Authority (IDA) under the Budapest Treaty. The enclosed proposal is in conformity with the requirements of the relevant clauses of the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the purposes of Patent Procedure. The proposal has the approval of Secretary, Department of Biotechnology and Hon'ble Minister of Science and Technology, Government of India. Ministry of External Affairs, Government of India has also accorded clearance for this proposal.

ANNEX

Declaration of Assurances

We, the National Centre for Cell Science (NCCS), Pune-411007, 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 on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, as the Microbial Culture Collection (MCC), located in the premises of the National Centre for Cell Science, Pune.

At present the MCC has been in operation as a national facility under the overall administrative and financial structure of the NCCS but in the near future it will have its own independent, autonomous status. The National Centre for Cell Science is an autonomous institute of DBT, and it is a society registered under the Societies Registration Act 1860, having its registered office at University of Pune Campus, Ganeshkhind, Pune-411007, India.

The National Centre for Cell Science is headed by a Director appointed by DBT. The curator, scientific and other staff working in the MCC, are employees of the NCCS and are bound by service rules of NCCS. The budget for operation of the MCC is given by DBT, Government of India. The MCC, at present is a part of the NCCS and is governed by the rules and regulations of the NCCS. However, at a future date DBT plans to grant MCC an independent and autonomous status.

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 Culture Collection (MCC)
National Centre for Cell Science (NCCS)
University of Pune Campus, Ganeshkhind
Pune-411007, Maharashtra
India

Telephone: (+91 20) 25708000
Facsimile: (+91 20) 25692259
E-mail: yogesh@nccs.res.in
Internet: http://www.nccs.res.in

Article 6 (2)(i)

The depositary to be known as the MCC has had a continued existence since 2008 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. Department of Biotechnology, Government of India shall support it financially.

It is submitted that, because of the existence of this culture collection for the past 2 years all resource requirements viz. staff, equipments, storage space, inventory controls are in place.

The MCC is a national facility supported by the DBT. It has been serving the scientific community in India since 2008. It is an affiliate member of the World Federation of Culture Collections (WFCC) and is registered (Registration No. WDCM 930) with the World Data Centre for Microorganisms (WDCM). It has excellent facilities for the maintenance and long term preservation of microorganisms and it attempts to follow OECD guidelines in its operation. The MCC is housed in the NCCS, Pune an autonomous Institute of DBT. The Institute is located inside the Pune University Campus, in a beautifully landscaped 7 acre campus.

At present it has more than 50,000 cultures of actinomycetes, bacteria and fungi. All cultures are preserved by at least two methods, in liquid nitrogen and by freeze-drying and/or at -80°C. A few organisms that cannot be freeze-dried are maintained in active forms. For safety, stocks of cultures are maintained in two separate buildings. 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 MCC and its database will be available on the internet very soon.

MCC proposes to provide 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/workshop)

Article 6(2) (ii) and rule 2.2(i): staff

The MCC at present has staff of 24 with combined expertise to take care of actinomycetes, bacteria, fungi, yeast, and plasmids. All are full-time permanent staff employed for MCC-related work. It has provision for the appointment of total staff of 57 that will include scientific, technical and administrative personnel.

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

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

The MCC, therefore, has a strong, highly-skilled scientific staff and modern laboratory facilities and equipments 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 MCC occupies an area of 5000 square feet of centrally air-conditioned space. In addition, the MCC also has a separate building of 1000 square feet of covered area for housing liquid nitrogen plant. It is proposed to have a separate, independent campus of its own in the coming years and currently efforts are underway to identify a suitable piece of land for the proposed campus.

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

Infrastructure support

The NCCS provides a 24-hours standby power supply and maintenance of infrastructure (water, electricity, building etc) as well as of equipment. The MCC also utilizes other institutional facilities, like an excellent library, a 6-room guesthouse, an animal house, housing for staff, boys and girls hostel, a cafeteria, transport, a seminar hall and an auditorium.

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

The MCC, therefore, has a 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 as glycerol stock at -80°C, by freeze-drying and/or in liquid nitrogen.

For maintaining confidentiality and ensuring the security of the deposited cultures, special provision has been made within the present MCC block. An independent, self sufficient laboratory has been identified for handling and preserving the patent cultures. This will have biometric access control and it will be under electronic surveillance with motion sensors and CCTV cameras. 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. In the proposed campus, the room will have iron grill reinforced walls and fireproof steel door.

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 for these cultures 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 Culture Collection (MCC) located at the National Centre for Cell Science, Pune-411007 hereby assures compliance with the provisions of Article 6(2) (iii) and (iv) and the MCC 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 it's 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 MCC will at present accept bacteria, fungi, yeasts and plasmids in a host and/or as isolated DNA preparations belonging to Hazards Group 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 BSL-1 or BSL-2 facility or conform to Group 1 or 2 organisms.

The MCC reserves the right to refuse to accept a deposit if, in its view, the deposit may be an unacceptable hazard or the MCC may not be in a position to process it.  Deposit of bacteria and fungi pathogenic to plants and animals will be accepted from other countries 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 MCC will test viability as quickly as possible. Since growth rate of microorganisms vary the time required for viability testing for different microorganisms may accordingly vary. The average time that will be required for viability testing is indicated below:

Bacteria, yeast and plasmids - 4 days to 3 weeks

Actinomycetes, fungi - 7 days to 4 weeks

Article 6(2) (vi) and Rule 3.1 (b) (v)

The language of communication of the MCC 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)

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

Article 7(1) (b)

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

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

Schedule of fees

Guidance to depositors

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