The " collection of microbial strains held by the Pasteur Institute " was recognized by Interministerial Order on April 30th, 1976 for the purposes of patent procedure as " national collection of cultures of microorganisms ". On August 25th, 1978 an agreement concerning the deposit of microorganisms in application of Rule 28 of the European Patent Convention was signed between the European Patent Organisation (EPO) and the CNCM, Institut Pasteur. Then on August 31st, 1984 the CNCM acquired the status of International Depositary Authority under the Budapest Treaty by virtue of the Communication of France which had been the object of the Budapest Notification n° 39 of June 29th, 1984.

Today the CNCM is an entity saved for the tasks of depositary authority and, in front of (1) increasing complexity of the microorganisms involved, (2) extending international implications, (3) continuous accumulation of files and materials (connected to the very long duration of the storage), (4) permanent obligation of revision according to the evolution of the knowledge, and (5) spreading measures of precaution, important supplementary means are about to be given to it.

The isolation of the deposited materials and the seclusion of any related task secure the conditions of secrecy. The refusal of the CNCM to offer subsidiary remunerated services, like expert evaluation, identification, etc. ensures its moral independence.

Numerous complex internal procedures were elaborated in the course of the years, all these procedures aiming at guaranteeing the neutrality of the CNCM in front of varied situations and multifarious interlocutors.

The CNCM is the second International Depositary Authority in Europe as for the number of deposits.

The CNCM secures the deposit of biological materials according to agreements which resulted from the national and international need of their controlled preservation under a strict secrecy provision. Today most of the microorganisms ensured are deposited with the CNCM under the Budapest Treaty ^(*) on the basis of the relevant communications of France ^(**).

Patent Procedure

As far as patent law is concerned, where the repeatability of an invention involving a microorganism or the use thereof cannot be ensured by means of a written description alone, the said microorganism must be available to any person skilled in the art.

The Budapest Treaty and the Regulations under the Treaty laid down an uniform system, recognized by any Contracting State, of deposit of microorganisms and furnishing of samples.

Where a microorganism has been deposited under the Treaty, as long as no application referring to the deposit of that microorganism or the use thereof has been filed with an Industrial Property Office of a Contracting State, the samples thereof, any related piece of information, including the single fact to know whether the microorganism has, or not, been deposited, are approachable to nobody, except to the depositor and a party authorized by the depositor.

Of this fact and considering the international recognition, the deposit under the Budapest Treaty is often used in other purposes : protection of reference material in production, contracts of collaboration, etc.

For the purposes of the Treaty, " microorganism " means any biological material which may be accepted by an International Depositary Authority.

In its capacity as International Depositary Authority ^(*), the CNCM accepts

• bacteria,
• filamentous fungi and yeasts,
• viruses (including bacteriophages),
• animal cell cultures (including human cell lines).

The CNCM accepts these microorganisms whether they are, or not, genetically modified. The CNCM does not recognize plasmids as " kind of microorganism ", but as part of the properties of an accepted microorganism.

Microorganisms are not accepted where manipulation calls for physical containment levels as P3 or P4 (microorganisms of Group 3 or of Group 4 according to the French Decree n° 94-352 of May 4th, 1994 or the Council Directive 93/88/CEE on the protection of workers from risks related to exposure to biological agents at work); exceptionally a microorganism of Group 3 may be accepted, or a microorganism of Group 2 may be refused, according to the evaluation of the risks as for the manipulation and for the storage of the microorganism in the environment of the CNCM.

Microorganisms are not accepted where their properties are so exceptional that the CNCM is technically not in a position to perform the tasks which are in relation to them and must be performed under the Treaty (microorganisms which cannot undergo the preparation of sub-batches or which cannot undergo a long-term preservation without being by this fact subject to a significant change, for instance)

Microorganisms are not accepted where they are mixtures of undefined and/or unidentifiable components.

Depositors are asked

• to complete the deposit documents, and to provide the microorganism as frozen or freeze-dried material, in form of 12 samples out of a single preparation, each sample containing at least 10⁶ viable units

(except in special cases where lower titres may be accepted).

Depositors are further asked to supply the CNCM with any viable material which is not available at the CNCM ^(*) and which is needed to propagate, to test and/or to store the microorganism. For the same purposes depositors are also asked to furnish any ingredient which is not free or is hard to access.

Deposit Documents

The deposit documents are made of :

The CNCM uses separate forms for

The form is completed by a statement indicating that the depositor has proceeded to all the announcements required by the regulations in force in his country for the handling, use and storage of the microorganism and that he has received any relevant authorization.

By signing the contract, the depositor recognizes that he has acquainted with the conditions of the deposit under the Budapest Treaty, with the requirements of the relevant procedures in use at the CNCM, as well as with the responsibilities in case of incident.

The CNCM provides requesters with copies of the appropriate deposit documents and promptly replies in writing to any question which has been received by mail or by fax. Furthermore the CNCM is always ready, within its competence, to give supplementary information and advice by phone.

The depositors should fill in the documents and give all the information asked for. They should ensure that they meet the requirements as to the form and quantity of the microorganism to be deposited.

signatures. The documents should be signed by both the scientist responsible for the biological material to be deposited and the official acting on behalf of the organization employing the scientist.

The CNCM strongly advises depositors to transmit, IN ADVANCE of the microorganism itself, a facsimile of the completed form so that the CNCM can see whether all necessary information is given and whether it is in a position to accept the microorganism.

The CNCM promptly communicates by fax its agreement, or disagreement, to receive the microorganism, and, if need be, any necessary question, comment or recommendation.

Depositors are strongly advised to inform the CNCM when they plan to send off the microorganism and to provide essential shipping information.

Depositors must comply with any safety requirement necessary for transporting the material, particularly they must 

• comply with the specific requirements for the packaging and for the labelling according to the hazard group of the microorganism and, where appropriate, of the refrigerant (dry ice, liquid nitrogen) ;

• make sure that the package is accompanied by any documentation required by the relevant international and national regulations concerning the transportation and, where appropriate, the export of the material (export permit).

Prevention of Uncontrolled Use.

Certain biological materials which are supposed to be possibly used for warfare or terrorism require special authorizations for the prevention of uncontrolled transportation, handling or storage in France. Where the case arises, depositors are asked to give any indication required by the competent authorities to which the CNCM promptly addresses its demand to obtain the necessary authorization.

For infectious substances from abroad, the CNCM provides depositors with a label to be attached to the parcel. This label ensures smooth transit of the microorganism through the French customs, provided that the packaging and the labelling are in accordance with the relevant regulations and that all the export requirements are complied with.

Original Deposit Documents. The original documents, correctly completed and signed, should be included in the parcel where they have not yet been received by the CNCM.

Language

The official language of the CNCM is French, but any document is available in French and Eng-lish, and correspondence is also either in French or in English.

Registration of the Microorganism

As soon as a microorganism is received in a condition which does not preclude for evident reasons its acceptance, the CNCM registers this microorganism in the exercise book and promptly communicates by fax the registration number to the depositor.

The communication of the registration number does not imply that the CNCM is strictly obliged to accept the microorganism.

The CNCM accepts the microorganism when

1. all the requirements are complied with, and

2. the examination of the content of at least one of the transmitted samples provided confirmation that by no fact the CNCM is precluded from performing the tasks that it must perform under the Treaty in relation to the microorganism.

The receipt referred to in Rule 7.1 of the Treaty testifies to the acceptance of the microorganism. The receipt is issued on the international form BP/4. When the deposit has been accepted, the accession number of the microorganism is identical to the registration number and the date of deposit is the date of registration.

The average time required by the CNCM for testing the various kinds of microorganisms is as follows :

- Bacteria, bacteriophages     30 days

- filamentous fungi, yeasts     30 days

- animal and human cell cultures     60days

- viruses (bacteriophages excluded)    90 days

The notification of the acceptance, or of the refusal, is issued within six months after the date on which the depositor has complied with all the requirements concerning the deposit, except in some cases, where growth of the microorganism is particularly slow, where the known conditions for propagation, tests and/or storage are not satisfactory, where some ingredients are difficult to access, or where irregularities or unexpected facts are noticed and need confirmation.

Once all tests have been performed by the CNCM to be sure that it is in a position to comply with the requirements under the Treaty, the first viability statement referred to in Rule 10.2.a)i) is issued on the international form BP/9. The first viability statement indicating a positive result testifies to the validity of the deposit.

The CNCM prepares its own batches by subculturing original material at the time of deposit and, if need be, at any time during the period of the storage. Samples out of the stored batches prepared by the CNCM are sent to the depositor so that he can test them for all known properties to be preserved under the conditions used by the CNCM for growth and storage.

The duration of the storage of any microorganism deposited under the Treaty is of at least 30 years after the date of deposit and at least five years after the most recent request for a sample.

It is important to know that the deposit cannot be cancelled during this period, either by the depositor or the CNCM, regardless of whether the applications involving the microorganism or the use thereof are abandoned.

The " fee for storage " is a single fee which includes tests and storage for the whole duration of the deposit. It is subject to Value Added Tax (VAT) according to French provisions currently in force and must be paid on receiving the relevant invoice.

- bacteria, phages, filamentous fungi, yeasts freeze-dried    609.80 euros

- all other acceptable cultures case-by-case fee (*)

-bacteria, phages, filamentous fungi, yeasts frozen    701.27 euros

-viruses propagated on embryonated eggs    788.92 euros

-viruses propagated on cell cultures    1 086.96 euros

-cell cultures    1 448.27 euros

In any case

As long as no patent application is in process, samples and information related to the microorganism and the deposit thereof can be given by the CNCM to no one, except

to the depositor (Rule 11.2.i), and

to a party authorized by the depositor (Rule 11.2,ii).

Once an application referring to the deposit of the microorganism or the use thereof has been filed with an Industrial Property Office of a Contracting State for the grant of a patent,

the samples are available to that Office (Rule 11.1), and

where all the conditions are fulfilled or deemed to be fulfilled in accordance with the law governing patent procedure before that Office, the samples are available to public subject to a certification of the request by the said Office (Rule 11.3).

The depositor does not have the right to prevent furnishing of samples to a competent Office or to a party certified by that Office.

Notwithstanding any entitlement of a requester to obtain samples under the Regulations of the Budapest Treaty, the CNCM withhold the samples of hazardous microorganisms until the requester has signed a statement indicating that he has proceeded to all the announcements required by the regulations in force in his country for the handling, use and storage of those microorganisms and that he has received any necessary authorization therefor.

Prevention of Uncontrolled Use.

Certain biological materials supposed to be possibly used for warfare or terrorism require special authorizations for the prevention of uncontrolled transportation in France or outside France. Where the case arises, requesters are asked to give any indication required by the competent authorities to which the CNCM promptly addresses its demand to obtain the necessary authorization.

Where samples must be furnished abroad, requesters are asked to provide an import permit or a declaration indicating that such permit is not required to ensure smooth transit of the microorganism.

Requests from the Depositor

Once the microorganism has been accepted and the receipt has been issued, it is the right of the depositor to obtain samples of his own microorganism whenever he wishes.

His written request must

• clearly indicate the CNCM accession number of the microorganism, and

• be signed by himself or, where the microorganism has been deposited by an organization, the representative of the depositor with the CNCM in connection with the microorganism and its deposit.

The requested samples are promptly sent by the CNCM either

• to the address of the depositor or, according to the request,
• to the address of a third party.

A third party must address his demand, either

• to the depositor
  for a written declaration authorizing the CNCM to furnish the requested sample, or
• to a competent Industrial Property Office
  for a certification that an application referring to the microorganism has been filed with that Office or that the requester has the right to get such sample under the law governing patent procedure before that Office.

The furnishing of information on a particular microorganism is linked to the provisions which govern the furnishing of samples.

No information is given by the CNCM to anyone concerning any deposited microorganism, except

• to the depositor, and
• to a party which is entitled to obtain a sample of that microorganism and subject to the same conditions as those providing this right.

These cases excepted, no authority, no natural person, no legal entity can expect the CNCM to provide information on a particular deposit ; no information, even that concerning the single fact to know whether a microorganism has, or not, been deposited is communicated to no one by the CNCM. The microorganisms deposited under the Treaty are not listed in a catalogue.

The indications which may be provided to an entitled party are restricted and concern :

1. the state of accessibility and the state of viability of the microorganism ;
2. any properties of the microorganism which are or may be dangerous (or are supposed to be dangerous) to health or the environment ;
3. the conditions which the CNCM employs for the cultivation and storage of the microorganism ;
4. any details of the composition of the samples which may be furnished to an entitled party ;
5. any unexpected, technical or scientific fact which had been noticed by the CNCM and notified in writing to the depositor.

All pieces of information are provided by a written communication transmitted by mail or by fax. In any case, a copy of the communication is simultaneously addressed to the depositor.

Where a sample is furnished to an entitled party, such party has a right to obtain :

1. a copy of the receipt referred to in Rule 7 of the Treaty ;
2. a copy of the most recent viability statement referred to in Rule 10 of the Treaty ;
3. a copy of the most recent scientific description and/or taxonomic designation as communicated by the depositor to the CNCM.