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Budapest Notification No. 100
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure

Notification of the European Patent Organisation (EPO) Relating to an Extension of the List of Kinds of Microorganisms Accepted, for Deposit, and to a Change in the Fees Charged, for the Furnishing of Samples, by the Centraalbureau voor Schimmelcultures (CBS)

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 October 7, 1991, of the notification of the European Patent Organisation (EPO), dated October 1, 1991, stating an extension of the list of kinds of microorganisms accepted, for deposit, and a change in the fees charged, for the furnishing of samples, by the Centraalbureau voor Schimmelcultures (CBS), 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, as amended on September 26, 1980 (see Budapest Notification No. 21 of August 27, 1981). The text of that notification is attached.

The list so extended of the kinds of microorganisms accepted for deposit by the Centraalbureau voor Schimmelcultures (CBS), as well as the fees for the furnishing of samples, will be published in the November 1991 issue of Industrial Property/La Propriété industrielle. The extended list of kinds of microorganisms will take effect as from the date (November 30, 1991) of that publication, while the fees for the furnishing of samples will apply as from the thirtieth day following the date of publication (November 30, 1991) in the said issue of Industrial Property/La Propriété industrielle, that is, as from December 30, 1991.

October 25, 1991


Text of the Notification of the European Patent Organisation (EPO), dated October 1, 1991, Relating to an Extension of the List of Kind of Microorganisms Accepted, for Deposit, and to a Change in the Fees Charged, for the Furnishing of Samples, by the Centraalbureau voor Schimmelcultures (CBS)

NOTIFICATION

1. Pursuant to Rule 3.3 of the Regulations under the Budapest Treaty, I wish to inform you that the assurances furnished in the communication from the European Patent Organisation of 27 July 1981, as published in the September 1981 issue of Industrial Property, to the effect that the CBS complies, and will continue to comply, with the requirements of Article 6(2) of the Budapest Treaty, are extended to include:

- plasmids in pure form or in a host of the kind accepted by CBS
- phages

that can be maintained by routine laboratory techniques without significant modification with appropriately stored either at low temperature in liquid nitrogen or in the lyophilised state.

Strains requiring special cultural conditions can be accepted on request subject to special terms and additional fees.

Annex I lists all the kinds of microorganisms now accepted by the Authority.

2. With reference to Rule 12 of the Budapest Treaty, the CBS will charge the same fees for all accepted kinds of micro-organism.

The schedule of fees is reproduced in Annex II. A change in the fee for furnishing samples is hereby notified in accordance with Rule 12.2(a) of the Regulations under the Budapest Treaty concerning those types of micro-organism accepted hitherto.

Finally, Annex III draws attention to the Authority's requirements under Rule 6.3 of the Regulations under the Budapest Treaty in respect of all accepted kinds of accepted micro-organism.


ANNEX I

KINDS OF MICRO-ORGANISMS WHICH THE CBS ACCEPTS FOR DEPOSIT UNDER THE BUDAPEST TREATY

Fungi; Yeasts; Bacteria; Plasmids in pure form or in a host of the kinds accepted by CBS and phages that can be maintained with routine laboratory techniques without significant modification during appropriate storage at low temperature, in liquid nitrogen or during storage in the lyophilized state. Strains requiring special cultural conditions can be accepted under special conditions and are subject to additional fees (on request).

The following bacteria of pathogenic group I (PG I: World Health Organization (WHO) definition: low individual and community risk) are accepted only when they can be maintained by Rijks Instituut voor Volksgezondheid en Milieuhygiene (RIVM), Centraal Diergeneeskundig Instituut (CDI) or the Royal Institute for Tropical Research:

Bordetella (all species), brucella (all species), Erysipelothrix (all species), Leptospira (all species), Listeria (all species), Mycobacterium paratuberculosis, Pasteurella (all species), Treponema (all species).

The following bacteria of pathogenic group II (PG II WHO definition: severe individual and limited community risk) are accepted only when they can be maintained by RIVM or CDI:

Bartonella (all species), Francisella (all species), Mycobacterium bovis, Mycobacterium tubercolosis, Pseudomonas mallei, Pseudomonas pseudomallei.

The following bacteria are not accepted:

Bacillus anthracis and Yersinia pestis.

In cases of cultures considered to be of special hazard, the CBS should be contacted before sending them.


ANNEX II

FEE SCHEDULE

      Hfl
  1. (a) Storage 2000
    (b) Storage if the right to be notified in furnishing of samples (Rule 11.4(g) Budapest Treaty) is waived 1500
  2. Issuance of viability statement 150
  3. Furnishing of a sample 175
  4. Communication of information under Rule 7.6 of the Budapest Treaty 40
  5. Delivery of attestation under Rule 8.2 of the Budapest Treaty 40

ANNEX III

REQUIREMENTS OF CBS UNDER RULE 6.3 OF THE BUDAPEST TREATY

Form and quantity

The CBS prefers to receive micro-organisms submitted for deposit as lyophilized preparations. Where it is undesirable or impossible to supply lyophilized preparations, active cultures growing in or on a suitable nutrient medium are acceptable. The minimum number of replicates that must be supplied by the depositor when making his deposit is as follows:

Fungi: 12 lyophilized cultures; or 2 agar cultures

Yeasts: 12 lyophilized plus 1 agar culture; or 2 agar cultures

Bacteria: 12 lyophilized plus 1 agar culture; or 3 agar cultures

Plasmids (in hosts): 12 lyophilized plus 1 agar culture; or 3 agar cultures

Plasmids (purified DNA): minimum quantity of 50µg

Phages: 10ml with a titre of at least 109 pfu/ml.

In cases where the depositor is unable to supply lyophilized preparations, the CBS prepares lyophilized cultures at the time of deposit from the material supplied by the depositor at a fee of Hfl 175 for 12 vials. The preparation of a phage lysate with a sufficient high titre can be done at a fee of Hfl 1000. The depositor is required to check the authenticity of a sample of the batches prepared by the CBS, and to inform the CBS of the result. Plasmid stocks are not prepared by the CBS.

Time required for viability testing

The average length of time required for testing viability of the various kinds of micro-organisms accepted by the CBS is given below, but depositors should realise that occasionally viability testing may take longer. This is especially likely if unusual antibiotics or other additives are necessary in the medium.

Fungi, Bacteria, Plasmids in hosts or purified DNA*, Phages: 2 weeks
Yeasts: 1 week

* A "viability test" for plasmids consists of transforming a suitable host with the plasmid. If the host is transformed, the "viability test" is regarded as positive.

Depositor checks and renewal of stocks

The CBS routinely asks the depositor to check the authenticity of the deposited preparations after transfers.

New batches of cultures are prepared whenever it is necessary to renew diminishing stocks.

Whichever method is used for preparing batches of samples for distribution, the CBS always keeps a portion of the original material supplied by the depositor.

Contract

The CBS does not enter into any written contract with the depositor defining the liabilities of either party but, by signing the CBS deposit forms, the depositor surrenders any right to withdraw his deposit during the required storage period and accepts that the micro-organism will be distributed according to the relevant patent requirements.

Import and/or quarantine regulations

Certain micro-organisms are subject to import and/or quarantine regulations. The CBS will advise depositors about these and will make the necessary arrangements for transportation and, if necessary, licenses (fees on request). The CBS should be contacted for precise instructions in this regard, and, in cases of plant pathogens, further information may be obtained from: Plantenziektenkundige Dienst (PD), Geertjesweg 15, Postbus 9102, 6700 NC Wageningen, The Netherlands.

Contact in advance

The CBS should be contacted in advance if deposit of any of the following plant pathogenic bacteria is intended:

Agrobacerium rhizogenes, Corynebacterium flaccumfaciens, C. insidiosum, C. michiganense, C. sepedonicum, Erwinia amylovora, E. stewartii, E. tracheiphila, Pseudomonas caryohpylli, P. solanacearum, P. syringae, pv glycinae, pv persicae, pv pisi, P. woodsii, Xanthomonas ampelina, X. campestris, pv citri, pv corylina, pv oryzae, pv oryzicola, pv phaseolii, pv pruni, pv vesicatoria, X. fragariae, X. populi.

Fee for storage

The fee for storage must be paid.