Budapest Notification No. 86
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Communication of the Government of the United Kingdom of Great Britain and Northern Ireland Relating to the Acquisition of the Status of International Depositary Authority by the National Collection of Food Bacteria (NCFB)

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 January 17, 1990, of a written communication, dated January 12, 1990, from the Government of the United Kingdom of Great Britain and Northern Ireland, relating to the National Collection of Food Bacteria (NCFB), indicating that the said depositary institution is located on the territory of the United Kingdom of Great Britain and Northern Ireland and including a declaration of assurances to the effect that the said institution complies 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 National Collection of Food Bacteria (NCFB) will acquire the status of international depositary authority under the Budapest Treaty as from February 28, 1990, the date of publication of the said communication in the February 1990 issue of Industrial Property/La Propriété industrielle.

February 5, 1990

Text of the Written Communication of the Government of the United Kingdom of Great Britain and Northern Ireland, dated January 12, 1990, Relating to the Acquisition of the Status of International Depositary Authority by the National Collection of Food Bacteria (NCFB)

COMMUNICATION

I have the honour to refer to the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, opened for signature at Budapest from 28 April to 31 December 1977. In accordance with the provisions of Article 17 of the said Treaty, the Government of the United Kingdom of Great Britain and Northern Ireland nominate the National Collection of Food Bacteria as an International Depositary Authority. The Government of the United Kingdom furnish their assurances that the National Collection of food bacteria complies and will continue to comply with the requirements specified in Article 6(2) of the Treaty for an International Depositary Authority. The requisite information concerning this nominated Depositary Institution is set out below.

Accordingly I have the further honour to request that you carry out the procedures established by the Treaty and Regulations annexed to it, in connection with the acquisition of the status of International Depositary Authority by the Institution nominated therein.

The National Collection of Food Bacteria is located in the United Kingdom at the AFRC Institute of Food Research, Reading Laboratory, Shinfield, Reading, RG2 9AT, UK. Telephone: 0734 883103, Telex: 9312102022, Telefax: 0734 884763.

The NCFB is the responsibility of the Agricultural and Food Research Council (AFRC), a body established in the United Kingdom by Royal Charter.

The NCFB has been in continuous existence since 1954. It was previously known as the National Collection of Dairy Organisms (NCDO) until 1986. The NCFB has a staff of two, one of whom holds a University Degree and one an equivalent qualification. Additional administrative and technical support staff are available. This staff is fully competent and adequate to perform the scientific and administrative tasks required under the Budapest Treaty. The NCFB is affiliated to the World Federation for Culture Collections and has a recognised reputation for work concerned with the preservation, testing, authentication and distribution of bacteria other than known pathogens. At present the collection contains about 2500 strains of such microorganisms. The NCFB performs its work in an impartial and objective way and will be available for the purposes of Deposit under the Treaty to any Depositor under the same conditions.

The NCFB has all the facilities necessary for the culturing, checking and long term preservation of bacteria. Cultures are maintained routinely by freeze-drying. Patent cultures and records relating to them are stored in locked drawers and files. Only authorised staff have access to them. To minimise the risk of loss, duplicate collections are stored in a building separate from that housing the main collection.

The NCFB is equipped to run in full accordance with the United Kingdom Health and Safety at Work Act, 1974.

Requirements for Deposit

(a) Kinds of Microorganisms that may be Deposited

- Bacteria, including actinomycetes, that can be preserved without significant change to their properties by liquid nitrogen freezing or by lyophilization, and which are allocated to a hazard group no higher than Group 2 as defined by the UK Advisory Committee on dangerous Pathogens (ACDP), 1984; "Categorization of Pathogens According to Hazard and Categories of Containment" (HMSO, London, ISBN 011 883761 3).

- Plasmids, including recombinants, either

(i) cloned into a bacterial or actinomycete host, or
(ii) as naked DNA preparations.

As regards (i) above, the hazard category of the host with or without its plasmid must be no higher than ACDP Group 2. As regards (ii), above, the phenotypic markers of the plasmid must be capable of expression in a bacterial or actinomycete host and must be readily detectable. In all cases, the physical containment requirements must not be higher than level II as defined by the UK Advisory Committee on Genetic Manipulation (ACGM), Guidance Note 15 (Health and Safety Executive, Baynards House, 1 Chepstow Place, London, W2 4TF) and the deposited material must be capable of being preserved without significant change to its properties by liquid nitrogen or lyophilization.

- Bacteriophages that have a hazard rating and containment requirements no greater than those cited above and which can be preserved without significant change to their properties by liquid nitrogen freezing or lyophilization.

Notwithstanding the foregoing, the NCFB reserves the right to refuse to accept any material for deposit which, in the opinion of the Curator, presents an unacceptable hazard or is technically too difficult to handle.

(b) Technical Requirements and Procedures

(i) Form and Quality

Bacteria (including those-containing plasmids) are accepted in any form except agar plate cultures (these are too easily damaged in transit). Bacteriophages should be supplied as cell-free lysates along with a suitable host. NCFB prefers to receive sufficient lysate for direct freezing and distribution but, where, this is not possible, smaller volumes from which NCFB may produce its own lysates are acceptable (see below).

Naked plasmids should be submitted as DNA solutions

The minimum number of replicates to be supplied by the depositor when making his deposit is as follows:

(ii) Time required for Viability Testing

The average length of time required for testing the viability of the various kinds of microorganisms accepted by NCFB is given below, but depositors should realise 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 the host is transformed, the "viability test" is regarded as positive.

(iii) Depositor Checks and Renewal of Stocks

NCFB prepares its own lyophilized batches of bacteria at the time of deposit by subculturing material supplied by the depositor. New batches are prepared from these as necessary thereafter for the renewal of diminishing stocks. NCFB prepares its own frozen batches of bacteriophages by subculturing material supplied by the depositor in those cases where insufficient lysate has been provided for large enough batches to be prepared by direct freezing of the depositor's material. New batches are prepared from these as necessary for the renewal of diminishing stocks.

NCFB prepares frozen batches of naked plasmids direct from material supplied by the depositor. Diminishing stocks are renewed by asking the depositor to make a new deposit. The depositor is required to check for authenticity samples of all lyophilized and frozen batches prepared by NCFB.

Whichever method is used for preparing batches of samples for distribution, NCFB nevertheless freezes and stores a portion of the original material supplied by the depositor.

(c) Administrative Requirements and Procedures

(i) General

Language. The official language of NCFB is English. Communications in any other language are not accepted.

Contract. The NCFB application form which the depositor is required to complete, constitutes a contract by which he is bound:

- to provide all necessary information requested by NCFB;
- to pay all necessary fees;
- to indemnify NCFB against any claims which may be brought against it as a consequence of the release of samples, unless such claims result from negligence on the part of NCFB;
- not to withdraw his deposit during the required storage period;
- to authorize NCFB to furnish samples according to the applicable patent requirements.

When a microorganism has been accepted for deposit, NCFB notifies the depositor and reminds him that he is bound by the terms and conditions of its contract.

(ii) Making the Original Deposit

Requirements to be met by the Depositor. As well as NCFB application form referred to in (i), above, depositors are required to complete the NCFB accession form for patent deposits (copies of both forms attached*) [* Available on request from the NCFB]. NCFB does not require a special form to be completed in the event of a later indication or amendment of the scientific description and/or proposed taxonomic designation, or for a request for attestation that NCFB has received such information.

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 the furnishing of samples to third parties is issued on model form BP/14. NCFB has its own standard forms for notifying the depositor of acceptance of a microorganism (see (i), above) or refusal to accept a microorganism, and for notifying the depositor of the inability of NCFB to furnish samples. Individual letters, rather than standard forms, are used for other official notifications.

Unofficial Notifications to the Depositor. If requested, NCFB will telephone or telex the date of deposit and accession number after the microorganism has been received, but before the official receipt is issued. However, the depositor, is told that such information is provisional, pending the outcome of the viability test. NCFB will similarly communicate the result of the viability test before the viability statement is issued.

Supply of Information to Patent Agent. NCFB routinely asks the depositor for the name and address of his patent agent and, if requested, will supply copies of the receipt, viability statement and any other information 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 made for patent purposes. However, in the case of deposits previously made for scientific purposes and which are already generally available from NCFB, the depositor is requested to authorize the NCFB to continue to make them so available and to waive his right to be notified of the release of samples. If the depositor is unwilling to accede to this request, he must make another deposit of the same organism under the Budapest Treaty. These constraints do not apply to deposits made confidentially for safekeeping. Any deposit previously made free of charge is subject, on conversion, to the storage fee normally levied for Budapest Treaty deposits. With the exceptions noted above, 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 for a new deposit are issued on mandatory "international forms" BP/5 and BP/9.

Furnishing Samples

(a) Requests for Samples

NCFB advises third parties of the correct procedures to follow in order to made a valid request. In the case of requests requiring proof of entitlement, NCFB will provide requesting parties with copies of model request form BP/12 and/or request forms used by individual industrial property offices (where it has been supplied with such forms).

Notwithstanding any entitlement of third parties to receive samples under patent regulation, samples of plant pathogens requiring a permit to be worked with are not released to requesting parties in the United kingdom until NCFB has confirmed that such parties have obtained the necessary permit. Also, samples of all microorganisms are delivered only to recognised microbiological laboratories and not to private addresses. When responding to requests from abroad, NCFB assumes the requesting party has met the import requirements of his own country.

All samples of bacteria furnished by NCFB are from batches of its own preparations; samples of bacteriophages may be from its own preparations or from material supplied by the depositor; samples of plasmids are from material supplied by the depositor.

(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

NCFB lists Budapest Treaty deposits in its published catalogue only with the specific written authorisation of the depositor.

Schedule of Fees

Where applicable, charges are subject to Value Added Tax at the current rate.

Guidance for Depositors

NCFB publishes a leaflet containing guidance notes for prospective depositors.