Pages 100-105

INTERNATIONAL TREATIES

Budapest Treaty

International Microorganism Depositary Authorities

I. In Vitro International, Inc. (IVI)

1. Termination of Status as International Depositary Authority

In an earlier issue (OJ EPO 1991, 416) it was announced that In Vitro International, Inc. (IVI) wished to terminate its status as an international depositary authority. Since 4 June 1991 IVI has not accepted any deposits of microorganisms under the Budapest Treaty.

In a communication dated 25 June 1991 the government of the United States of America informed the Director General of WIPO of the complete withdrawal of its declaration of assurances under Article 7 BT with respect to IVI's status as an international depositary authority under the BT.1

All microorganisms deposited with IVI under the BT up to 3 June1991 were transferred on 20 June 1991 to a substitute authority, the American Type Culture Collection (ATCC)2 in Rockville, Maryland. All mail and other communications addressed to IVI regarding those deposits, including all files and other relevant information, have also been transferred to ATCC. IVI has been requested to notify all its depositors of the discontinuance of its activities and the transfers made.

Pursuant to Article 8(2)(b) and Rule 4.2(c) BT, IVI's status as an international depositary authority under the BT terminated three months after the date of the aforementioned communication, that is, on 25 September 1991.

2. Consequences of the transfer of IVI deposits to ATCC

ATCC can provide samples in accordance with Rule 11 BT on receipt of a request indicating the accession number given initially by IVI (see Rule 7.5 BT).

Applicants whose European patent applications refer to micro-organisms deposited with IVI are invited to file with the EPO a copy of the receipt of transfer issued by ATCC under Rule 7.5 BT.

II. Centraalbureau voor Schimmelcultures (CBS)

A. Extension of the list of kinds of microorganisms accepted

Following notification by the European Patent Organisation on 1 October 1991 under Rule 3.3 BT3, the list of microorganisms accepted by CBS has been extended with effect as from 30 November1991, to include also the following:

• Plasmids in pure form or in a host of the kind accepted by CBS
• 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 on request subject to special terms and additional fees.

With reference to Rule 12 BT, CBS will charge the same fees for all accepted kinds of microorganisms.

The schedule of fees is reproduced under point B. 2. The fee for the furnishing of a sample has been changed with effect as from 30 December 1991.

According to the same notification, attention is drawn to the Authority's requirements under Rule 6.3 BT in respect of all accepted kinds of microorganisms (see point B. 3).

B. Summary of information relating to CBS

All relevant information concerning kinds of microorganisms accepted for deposit by CBS, fees applicable together with other technical information is set out below. This publication replaces the communications published in OJ EPO 1981, 400, 1984, 245 and 1985, 258.

1. List of Microorganisms Accepted for Deposit

• Fungi
• Yeasts
• Bacteria
• Plasmids in pure form or in a host of the kinds accepted by CBS
• 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),

Bucella (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 tuberculosis,

Pseudomonas mallei,

Pseudomona 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.

2. Schedule of Fees

3. Requirements of CBS under Rule 6.3 BT

Form and quantity

The CBS prefers to receive microorganisms 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:

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 NLG 175 for 12 vials. The preparation of a phage lysate with a sufficient high titre can be done at a fee of NLG 1 000. 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 microorganisms 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 DNA4, Phages: 2 weeks

Yeasts: 1 week

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 microorganism will be distributed according to the relevant patent requirements.

Import and/or quarantine regulations

Certain microorganisms 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:

Agrobacterium rhizogenes, Corynebacterium flaccumfaciens, C. insidiosum, C. michiganense, C. sepedonicum, Erwinia amylovora, E. stewartii, E. tracheiphila, Pseudomonas caryophylli, 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.

4. Official language

Dutch. However, CBS also accepts correspondence in English, French or German.

5. Address

Centraalbureau voor Schimmelcultures (CBS)

Oosterstraat 1

Postbus 273

NL - 3740 AG Baarn

Tel: 31-2154 81211

Fax: 31-2154 16142