Microbial strain deposit
NATIONAL COLLECTION OF AGRICULTURAL AND INDUSTRIAL MICROORGANISMS (NCAIM)
Szent Istvan University, Faculty of Food Sciences
National Collection Of Agricultural And Industrial Microorganisms (NCAIM)
Somloi ut 14-16
Telephone/Fax: (36 1) 305 7322
Internet home page: http://ncaim.etk.szie.hu:8089/NCAIM/index.jsp/
(See Industrial Property, 1986, pp. 203 and 432; 1993, p. 83; Intellectual Property Laws and Treaties, 1999, p. 5.)
1. Requirements for Deposit
(a) Kinds of Microorganisms that May Be Deposited
Bacteria (including Streptomyces) except obligate human pathogenic species (e.g., Corynebacterium diphtheriae, Mycobacterium leprae, Yersinia pestis, etc.); fungi, including yeasts and moulds, except some pathogens (Blastomyces, Coccidioides, Histoplasma, etc.) and certain basidiomycetous and plant pathogenic fungi which cannot be preserved reliably. At present, the NCAIM is not ready to accept viruses, bacteriophages, rickettsiae, algae, protozoa, cell lines and hybridomas. Users will be notified when acceptance of such microorganisms becomes possible.
In general, the NCAIM is willing to accept strains of agriculturally and industrially important bacteria and fungi whose cultivation and preservation do not call for special conditions and which do not involve any health or other hazard to the environment.
(b) Technical Requirements and Procedures
(i) Form and Quantity
The NCAIM accepts microorganisms for deposit as either lyophilized preparations or active cultures. The minimum number of replicates that the depositor must supply when making his deposit is 25 for lyophilized preparations or three for active cultures.
(ii) Time Required for Viability Testing
The average length of time required for testing the viability of microorganisms accepted by the NCAIM is seven days, but depositors should realize that in some cases viability testing may take as long as 14 days.
(iii) Depositor Checks and Renewal of Stocks
Where the microorganism is deposited in active culture, the NCAIM prepares its own batches by subculturing the material supplied by the depositor. The depositor is required to check for authenticity samples of all such batches. The NCAIM does not prepare its own batches of microorganisms that have been supplied as lyophilized preparations by the depositor.
In all cases, the NCAIM renews diminishing stocks of deposited microorganisms by asking the depositor to make a new deposit.
Whichever method is used for preparing batches of samples for distribution, the NCAIM nevertheless stores a portion of the original material supplied by the depositor.
(c) Administrative Requirements and Procedures
Language. The official language of the NCAIM is Hungarian. Communications are also accepted in English.
Contract. The NCAIM does not enter into a written contract with the depositor defining the liabilities of either party. However, by signing the NCAIM deposit form the depositor surrenders any right to withdraw his deposit during the required storage period.
Import and/or Quarantine Regulations. The kinds of microorganisms accepted by the NCAIM are not subject to import or quarantine regulations.
(ii) Making the Original Deposit
Requirements to Be Met by the Depositor. The depositor is required to complete model form BP/1, which is used by the NCAIM as its accession form for Budapest Treaty deposits.
In the event of later indication or amendment of the scientific description and/or proposed taxonomic designation, and a request for attestation that the NCAIM has received such information, the depositor must complete model form BP/7.
Official Notifications to the Depositor. The receipt and viability statement are issued on mandatory "international forms" BP/4 and BP/9, respectively. Attestation of receipt of a later indication or amendment of the scientific description and/or proposed taxonomic designation is issued on model form BP/8. Notification of furnishing of a sample to a third party is issued on form BP/14. The NCAIM uses its own standard letters for other official notifications.
Unofficial Notifications to the Depositor. If requested, the NCAIM will telephone or telefax the date of deposit and accession number after the microorganism has been received, but before the official receipt is issued. The NCAIM will similarly communicate the result of the viability test before the viability statement is issued.
Supply of Information to a Patent Agent. The NCAIM does not routinely ask the depositor for the name and address of his patent agent. However, if requested, the NCAIM will send copies of the receipt and viability statement to both the depositor and his patent agent.
(iii) Converting a Previous Deposit
Deposits made outside the provisions of the Budapest Treaty may be converted by the original depositor to Budapest Treaty deposits, whether or not they were originally deposited for patent purposes. All conversions are subject to the storage fee normally levied for Budapest Treaty deposits, regardless of whether any fee had previously been paid in respect of those deposits.
The administrative requirements for conversion are the same as those to be met in respect of an original deposit made under the Treaty.
(iv) Making a New Deposit
The depositor is required to complete model form BP/2 when making a new deposit and to supply copies of the relevant documents required by Rule 6.2. The receipt and viability statement are issued on mandatory "international forms" BP/5 and BP/9, respectively.
2. Furnishing of Samples
(a) Requests for Samples
The NCAIM advises third parties of the correct procedures to follow in order to make a valid request. In the case of requests of patents granted and published by any industrial property office, the NCAIM will provide requesting parties with copies of model request form BP/13. Notwithstanding any entitlement to receive samples under patent regulations, a requesting party must show, by a business letterhead or requisition form or in some other way, that he is trained in microbiology and has access to a properly equipped laboratory. When responding to requests from overseas, the NCAIM assumes the requesting party has met the import requirements of his own country.
Samples furnished by the NCAIM may be from preparations supplied by the depositor, or from its own preparations, depending on the form in which the microorganism was deposited.
(b) Notification of the Depositor
Depositors are notified on model form BP/14 when samples of their microorganism have been furnished to third parties.
(c) Cataloguing of Budapest Treaty Deposits
The NCAIM does not list Budapest Treaty deposits in its published catalog.
3. Schedule of Fees
(b) Issuance of a receipt in attestation of the deposit (except for the receipt issued free of charge in the case of original or new deposits) if information is requested
(c) For a viability test and for the issuance of a viability statement
(d) For the furnishing of samples on request made after publication of the patent application
4. Guidance for Depositors
The NCAIM does not at present produce a standard letter or guidance notes for prospective depositors.
The NCAIM offers a special service for long-term preservation of microorganisms where the distribution of the strains is restricted at the discretion of the depositor. Microorganisms for Safe Deposit may be sent to and stored with the NCAIM, but they remain the property of the depositor.
- All information concerning the deposit and the nature of the organism are treated in strict confidence.
- Microorganisms for Safe Deposit will not be included in the public collection and the NCAIM catalogue.
- Access to Safe Deposits is only through written request from the depositor.
- It is at the discretion of the depositor to terminate the deposit at any time and ask the NCAIM to destroy the stored cultures.
Please download the appropriate form to be used for Safe Deposits. In case of order, please specify your VAT number.
The fee of the Safe Deposit:
- 30.000 HUF per year/per strain
- minimum 100.000 HUF per product for 5 years but 35000 HUF /strain/5 years
The NCAIM accepts for deposit only those bacteria, yeasts and fungi which belong to riskgroup 1 or 2 according to the council directive 2000/54/EC on the Protection of Workers from Risks Related to Exposure to Biological Agents at Work.
Bacteria and fungi should, where possible, be deposited as actively growing cultures (four separate preparations in the form of test tubes).
This kind of deposit does not comply with the requirements of a patent deposit. If it is projected to use this organism for patent procedures please follow the "Patent deposit" link above.
A new strain accession by NCAIM may be necessary for the following reasons:
(1) a scientist wishes or is obliged to deposit a strain (obliged by taxonomic rules, by editors of journals etc.).
(2) a customer has proposed to add a specific strain to the collection. If the strain fits the criteria for deposit of NCAIM the strain may be included.
(3) a scientist of the collection itself has asked a potential depositor for a strain of educational, industrial, or scientific interest.
A strain can be accepted for deposit if it conforms to the accession criteria of NCAIM. NCAIM accept microorganisms classified in risk group 1 and 2.
Please contact us, prior to sending your strains to determine if they can be accepted by NCAIM. Strains will not be accepted into the collection without prior approval. Please state a small amount (e.g. 10 USD/shipment) in the custom declaration form instead of zero, when sending your strains to us.
In case NCAIM is interested in accessioning a strain, a standard letter and an accession form is sent to the potential depositor inviting inclusion of the strain into the General Collection. The potential depositor is requested to return the completed accession form to the collection at the time the strain is dispatched.
Upon receiving it NCAIM acknowledges the receipt of the strain.