Budapest Notification No. 233
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure
Communication by the Government of the United Kingdom of Great Britain and Northern Ireland Regarding the Change in the Address, Requirements and Fees of the National Collections of Industrial Food and Marine Bacteria (NCIMB)
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 May 13, 2005, of the communication of the Government of the United Kingdom of Great Britain and Northern Ireland, dated May 11, 2005, regarding the change in the address, requirements and fees of the National Collections of Industrial Food and Marine Bacteria (NCIMB), an international depositary authority under 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 (see Budapest Notification No. 226 of December 15, 2004 and No. 169 of September 23, 1998).
June 20, 2005
Text of the Communication by the Permanent Mission of the Government of the United Kingdom of Great Britain and Northern Ireland Regarding Changes in the Address, Requirements and Fees of the National Collections of Industrial Food and Marine Bacteria (NCIMB)
The Permanent Mission of the United Kingdom of Great Britain and Northern Ireland presents its compliments to the World Intellectual Property Organization (WIPO) and has the honour to refer to the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure which was opened for signature at Budapest from 28 April to 31 December 1997.
In accordance with Article 7 of the Treaty and Rules 3.1(b), 6.3 and 12.2 of the Regulations under the Treaty, the Government of the United Kingdom of Great Britain and Northern Ireland hereby notifies the World Intellectual Property Organization (in the Annex attached) of certain changes that have occurred in the activities of the National Collections of Industrial, Food and Marine Bacteria (NCIMB).
The Permanent Mission has the honour to request that the World Intellectual Property Organization circulate this notification to all Contracting States and intergovernmental industrial property organisations.
The Permanent Mission of the United Kingdom of Great Britain and Northern Ireland to the United Nations avails itself of this opportunity to renew to the World Intellectual Property Organization the assurances of its highest consideration.
Aberdeen AB21 9YA
Telephone: (44-1224) 711 100 or 711 111 (direct dial)
Facsimile: (44-1224) 711 299
1. Requirements for Deposit
(a) Kinds of Microorganisms that May Be Deposited
Bacteria (including actinomycetes), yeasts and bacteriophages up to and including ACDP Group 2 and Class 1 genetically modified microorganisms (GMOs).
Class 2 GMOs may be accepted for deposit but this is on a case by case basis only. In these instances the period for completion of a deposit would be much longer (minimum 45 days) and additional expenses will be incurred for administration charges in fulfilling regulatory requirements.
All deposits should be able to withstand preservation by either freeze-drying or freezing over liquid nitrogen without any significant change to their properties.
NCIMB also accepts orthodox seeds i.e. those can be dried to a low moisture content and stored at -20°C (or lower) without damage. All arable crops and many small seeded tree species produce orthodox seeds.
Recalcitrant seeds, such as those of cocoa, rubber, some tropical fruits and large seeded woody species, which cannot be dried without damage, are not accepted.
The acceptance of seeds by NCIMB and the furnishing of samples thereof are subject at all times to the provisions of the Plant Health (Great Britain) Order 1987, including any future amendments or revisions of the Order.
NCIMB must be notified in advance of all intended deposits of seeds so that it may ensure that all relevant regulations are complied with. Any seeds received without prior notification may be destroyed immediately. Notwithstanding the foregoing, NCIMB 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.
In exceptional circumstances, NCIMB may accept deposits which can only be maintained in active culture, but acceptance of such deposits, and relevant fees, must be decided on an individual basis by prior negotiation with the prospective depositor.
(b) Technical Requirements and Procedures
(i) Form and Quantity
Bacteria and yeasts (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. NCIMB prefers to receive sufficient lysate for direct freezing and distribution but, where this is not possible, smaller volumes from which NCIMB may produce its own lysates are acceptable (see below).
Naked plasmids should be submitted as DNA solutions.
Seeds may be deposited either:
- pre-dried under the IBPGR (International Board for Plant Genetic Resources) recommended conditions appropriate to the species and ready for immediate low-temperature storage, or
- freshly harvested for drying by NCIMB, in which case they should be dispatched immediately after harvesting by express delivery in a hermetically sealed container.
In all cases, seeds should be fresh, healthy, undamaged, and free from soil or plant-derived debris. Less than 5% of the deposit should contain empty seeds.
Normally, a germination rate of at least 85% is required, but deposits may be accepted in certain circumstances where such a regeneration standard is impossible to achieve.
The minimum number of replicates to be supplied by the depositor when making his deposit is as follows:
- Bacteria and yeasts: 2
- Bacteriophages (at least 108 pfu/ml): 2 x 0.5 ml or 1 x 10 ml of cell-free lysate
- Plasmids (DNA at least 20 mcg/ml): 1 x 10 ml
- Seeds: at least 250 seeds are required, but it is in the depositor's interest to send as many more as can be spared. (The IBPGR recommends a minimum of 4,000 for long-term storage and the United States Patent and Trademark Office may soon require a minimum of 2,500).
(ii) Time Required for Viability Testing
The average length of time required for testing the viability of the various kinds of microorganisms accepted by NCIMB is given below, but depositors should realize that in some cases viability testing may take longer, as indicated by the figures in brackets:
- Bacteria and yeasts: 3 days (or up to 14 days)
- Bacteriophages: 3 days (or up to 5 days)
- Plasmids (1): 5 days (longer in slow growing hosts)
- Seeds (2): depends entirely on the kind of seed
1 For plasmids, 'viability' testing consists of inserting the plasmid into a host. If the host is transformed, the 'viability test' is regarded as positive.
2 For seeds, 'viability' testing means testing for germination.
(iii) Depositor Checks and Renewal of Stocks
NCIMB prepares its own lyophilized and frozen 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. NCIMB 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.
NCIMB prepares frozen batches of naked plasmids and dried batches of seeds direct from material supplied by the depositor. Diminishing stocks are renewed by asking the depositor to make a new deposit.
The depositor is requested to check for authenticity samples of all lyophilized and frozen batches prepared by NCIMB.
Whichever method is used for preparing batches of samples for distribution, NCIMB nevertheless freezes and stores a portion of the original material supplied by the depositor, wherever possible.
(c) Administrative Requirements and Procedures
Language. The official language of NCIMB is English. Communications in any other language are not accepted.
Contract. The NCIMB application form which the depositor is required to complete constitutes a contract by which he is bound:
- to provide all necessary information requested by NCIMB;
- to pay all necessary fees;
- to indemnify NCIMB 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 NCIMB;
- not to withdraw his deposit during the required storage period;
- to authorize NCIMB to furnish samples according to the applicable patent requirements.
When a microorganism has been accepted for deposit, NCIMB notifies the depositor and reminds him that he is bound by the terms and conditions of its contract.
Import and/or Quarantine Regulations. Most of the kinds of microorganisms accepted by NCIMB are not subject to import or quarantine regulations. However, non-indigenous plant pathogens and certain seeds require a license to be worked with in Scotland, and prospective depositors of plant pathogens or seeds should contact NCIMB in advance so that the necessary arrangements can be made. Failure to comply with this requirement may result in the immediate destruction by NCIMB of the material submitted. Further information may be obtained from the Department of Agriculture and Fisheries for Scotland, Agricultural Scientific Services, East Craigs, Edinburgh EH12 8NJ, Scotland, United Kingdom.
(ii) Making the Original Deposit
Requirements to Be Met by the Depositor. As well as NCIMB application form referred to in (i), above, depositors are required to complete the NCIMB accession form for patent deposits. NCIMB 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 NCIMB 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 BP/8. Notification of the furnishing of samples to third parties is issued on model form BP/14. NCIMB has its own standard forms for notifying the depositor of acceptance of a microorganism (see (i), above) or of refusal to accept a microorganism, and for notifying the depositor of the inability of NCIMB to furnish samples. Individual letters, rather than standard forms, are used for other official notifications.
Unofficial Notifications to the Depositor. If requested, NCIMB will telephone, fax or email the date of deposit and the accession number after the microorganism has been received, but before the official receipt is issued. However, the depositor is informed that such information is provisional, pending the outcome of the viability test. NCIMB will similarly communicate the result of the viability test before the viability statement is issued.
Supply of Information to a Patent Agent. NCIMB 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 NCIMB, the depositor is requested to authorize NCIMB 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 previously made for patent purposes or 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.
2. Furnishing of Samples
(a) Requests for Samples
NCIMB advises third parties of the correct procedures to follow in order to make a valid request. In the case of requests requiring proof of entitlement, NCIMB 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 regulations, samples of plant pathogens or seeds requiring a permit to be worked with are not released to requesting parties in the United Kingdom until NCIMB has confirmed that such parties have obtained the necessary permit. Also, samples of all microorganisms are delivered only to recognized microbiological laboratories and not to private addresses. When responding to requests from abroad, NCIMB assumes that the requesting party has met the import requirements of his own country.
All samples of bacteria furnished by NCIMB 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 and seeds 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
NCIMB lists Budapest Treaty deposits in its published catalog only with the specific written authorization of the depositor.
3. Schedule of Fees
|(b)||Issuance of a viability statement||90|
|(c)||Furnishing of a sample (plus expedition cost)||65|
Fees are payable to NCIMB. Where applicable, fees are subject to Value Added Tax at the current rate.
Where statutory provisions require NCIMB to obtain a license or certificate prior to accepting a deposit of seeds, the actual cost of obtaining any such license or certificate will be charged to the depositor.
4. Guidance for Depositors
NCIMB publishes a leaflet containing guidance notes for prospective depositors.