|COLLECTION NATIONALE DE CULTURES DE MICROORGANISMES (CNCM)|
25 rue du Docteur Roux
F-75724 PARIS Cedex 15
Tél +33 1 45 68 82 50
Fax +33 1 45 68 82 36
|Executive Head: WAGENER Georges
Scientific Advisors: BUREAU Jean-François - OZDEN Simona
Secretary: GARCONNET Sabine
Technical Assistance: ROUSSEAU Catherine
The CNCM is a collection of microorganisms and cell cultures deposited for purposes requiring a strict secrecy provision.
|1. Main features of the CNCM|
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.
|2. Depositing with the CNCM|
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 (**).
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.
Further Procedures Requiring a Strict Secrecy Provision
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.
(*)Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, done on April 28th, 1977, and amended on September 26th, 1980.
Regulations adopted on April 28th, 1977, and amended on January 20th, 1981.
For more information see Guide to the Deposit of Microorganisms under the Budapest Treaty (WIPO Publication, ISBN 92-805-0195-X) or www.wipo.org
(**)Budapest Communication n° 19, object of Budapest Notification n° 39 of June 29th, 1984
(Industrial Property, July-August 1984, p.264) ;
Budapest Communication n° 48, object of Budapest Notification n° 74 of January 11th, 1989
(Industrial Property, January 1989, p.25) ; et
Budapest Communication n° 100, object of Budapest Notification n° 142 of December 16th, 1995
(Industrial Property, January 1996, p.42)
|3. Kind of Microorganisms accepted|
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
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.
(*) To comply with the French law governing patent procedure, any microorganism (in the classic sense of the term), viable and not contaminated, is accepted, but where that microorganism is not of a " kind " in which extend the insurances of the CNCM by virtue of the Communications of France under the Budapest Treaty, its deposit may fail to be recognized in the other countries.
|4. Guidelines to making a deposit|
Depositors are asked
(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.
(*)The CNCM stores some common bacteria, viruses and cell lines (host cells, reference strains, etc.) which are submitted to no secrecy provision.
The deposit documents are made of :
(1) The deposit form
The CNCM uses separate forms for- bacteria,
- bacteria growing on cell systems,
- filamentous fungi and yeasts,
- viruses, and
- cell cultures.
(2) The Addendum
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.
(3) The Contract
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.
Making a Deposit
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.
Preparing the Deposit
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.
Acceptability of the Microorganism
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.
Transfer of the Biological Material
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
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.
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.
|5. Deposit process|
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.
Acceptance of the Microorganism
The CNCM accepts the microorganism when
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.
Validation of the Deposit
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.
Request for Authenticity Check
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.
|6. Outline of the main steps of the deposit process|
|7. Period of storage and fees for deposit|
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
(*) The fee may include the real cost of the special ingredients which have been indicated by the depositor and which are essential to the CNCM to perform its tasks under the Treaty. If the case arises, the CNCM, promptly after having received the deposit form, notifies the depositor in writing of the fee to be charged.
|8. Furnishing of information on a particular Microorganism|
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 a patent Application is in Process
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.
Health and Safety Requirements
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.
|9. Guidelines to requesting the furnishing of a sample.|
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
The requested samples are promptly sent by the CNCM either
Requests from a Third Party
A third party must address his demand, either
It is assumed that the requester knows who is the depositor or which Industriel Property Offices are competent (i.e., where applications have been filed) to provide certification in respect to the particular microorganism being asked for. The CNCM cannot tell him where to send his request, whatever the case may be.
Certification by an Industrial Property Office
The request must be made on the international form BP/12 (www.wipo.org).
Some Offices may require additional forms to be completed to comply with their own national procedures.
The requester must
The CNCM points out to any requester the requirements to be met to make a valid request and provides copies of the international form BP/12, but it does not provide the additional forms that may be in use by some Industrial Property Offices.
Information of the Depositor.
The CNCM promptly notifies the depositor in writing of any exchange with a third party in connection with his microorganism.
Fee for the Furnishing of a Sample
The fee for the furnishing of a sample amounts to 106.71 euros (plus forwarding costs) to be paid by the person who has signed the request.
|10. Parties entitled to obtain samples of a deposited Microorganism.|
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
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 :
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 :