Pages 269-275

INFORMATION FROM THE EPO

Notice of the European Patent Office dated 18 July 1986 concerning European patent applications and European patents in which reference is made to micro-organisms

I. PURPOSE OF THE NOTICE

1. Where, in disclosing the invention, a European patent application refers to one or more micro-organisms deposited with depositary institutions, applicants are strongly advised to indicate clearly in the application as filed the legal status of the micro-organism deposit.

If this is done the EPO, when examining the application for compliance with Article 83 EPC concerning disclosure of the invention in conjunction, where applicable, with Rule 28(1) and (2) EPC, will not need to communicate with applicants on the matter. Equally important, it will enable the public to determine the procedure for gaining access to the micro-organism.

2. The form entitled "Request for Grant of a European Patent" (EPO Form 1001) includes a section headed "Micro-organisms"1 which must be completed when the patent application refers to a micro-organism deposited in accordance with Rule 28 EPC.

This section of the Request for Grant form contains a box which must be crossed if the invention refers to one or more micro-organisms deposited in accordance with Rule 28 EPC and requires the applicant to indicate where in the technical documents of the European patent application particulars of the depositary institution and the file number of the deposit are given2 or to indicate that such particulars will be furnished at a later date.

Applicants frequently fail to complete this part of the Request for Grant form or do so incorrectly.

The purpose of this notice is to assist applicants with the drafting of their applications and to facilitate completion of the "Micro-organisms" section of the Request for Grant form where the European patent application refers to one or more micro-organisms deposited in accordance with Rule 28 EPC (Chapter II below).

3. Where the European patent application refers to a micro-organism deposited in accordance with Rule 28(1) EPC, the issue of a sample of the micro-organism is governed by Rule 28(3) to (8) which requires submission to the EPO of a request for furnishing of a sample made on the appropriate form. The EPO certifies the request before transmitting it to the depositary institution which is then authorised to issue the sample.

4. Copies of the forms to be used for requesting the furnishing of a sample of a micro-organism deposited in accordance with Rule 28 EPC are available from the EPO.

Another purpose of this Notice is to explain the request form and the sample-issue procedure (Chapter III below).

II. GUIDANCE ON COMPLETING THE "MICRO-ORGANISMS" SECTION OF THE REQUEST FOR GRANT FORM

5. Deposited micro-organisms referred to in a European patent application generally belong to one of the two following categories which will be considered in turn below:

A. Micro-organisms which are not available to the public and which cannot be described sufficiently;

B. Micro-organisms which are available to the public.

In case A, the "Micro-organisms" section of the Request for Grant Form is to be completed, but not in case B.

A. Micro-organisms not available to the public and which cannot be described sufficiently

6. A typical example of a European patent application referring to a micro-organism not available to the public on the date the application is filed and which cannot be described in such a manner as to meet the requirements of Article 83 EPC (Disclosure of the invention) is where the invention relates to a new micro-organism obtained by mutation from known strains available to the public.

7. To meet the requirements of Article 83 in conjunction with Rule 28 EPC a culture of this new micro-organism must have been deposited with a recognised depositary institution not later than the date of filing of the European patent application, in accordance with the legal statute on the basis of which the institution is recognised3.

Two situations arise here:

• either the deposit is made direct in accordance with the Budapest Treaty or, where appropriate, in accordance with the bilateral agreement between the EPO and the institution concerned, in which case the requirements of Rule 28 EPC are automatically met;
• or the deposit was made previously in accordance with a legal statute other than the Budapest Treaty or bilateral agreement (for example, in accordance with a specific national law), in which case, the deposit must be converted to a deposit in accordance with the Budapest Treaty or the bilateral agreement not later than the date on which the European patent application is filed.

The depositary institution and the file number of the culture deposit must be submitted to the EPO within the period applying under Rule 28(2) EPC. Furthermore, in disclosing the invention the application as filed must give such relevant information as is available to the applicant on the characteristics of the micro-organism4.

8. Where a European patent application claims the priority of a previous application in accordance with Articles 87 to 89 EPC, the general conditions covering disclosure of the invention in the previous application apply to the micro-organism5.

In particular, if an invention, in order to be sufficiently disclosed, requires the deposit of a micro-organism culture to supplement the written description, the culture must have been deposited not later than the date of filing of the previous application. The depositary institution and the legal statute under which the micro-organism is deposited must comply with the requirements of the country in which the previous application has been filed.

The previous application must also refer to this deposit in a manner enabling it to be identified.

Where the micro-organism deposit referred to in the European patent application is not the same as the deposit referred to in the previous application, it is up to the applicant, if the EPO considers it necessary to provide evidence that the two micro-organisms themselves are identical.

9. The section relating to micro-organisms in the Request for Grant Form (1001) must be completed where the application refers to that category A of micro-organisms.

10. Rule 28 EPC does not expressly require the depositor to indicate the date of deposit of the micro-organism or to produce the deposit receipt issued by the recognised depositary institution in accordance with Rule 7 of the Budapest Treaty or point 17 of the relevant bilateral agreement as the case may be.

To enable the EPO to ascertain, at the time of substantive examination of the application, whether the micro-organism deposited in accordance with Rule 28(3) EPC is available, the Office must have proof that the requirements laid down in Rule 28(1) and (2) have in fact been complied with.

The EPO accordingly recommends the applicant to furnish upon filing of the European patent application or within the time limit referred to in Rule 28(2) EPC the deposit receipt issued by the international depositary institution or, where appropriate, by the depositary institution recognised in accordance with the bilateral agreement. Unless the deposit receipt or equivalent proof has been furnished by the time examination of the European patent application commences, the examiner will ask for it in the course of examination.

B. Micro-organisms available to the public

11. The second category of micro-organisms to which reference may be made in a European patent application is that of known micro-organisms which are accessible to the public without restriction and typically used as a means for carrying out the invention to which the European patent application relates.

Examples are strains held in the public collections of the recognised depositary institutions within the meaning of Rule 28(9) EPC and available without restriction.

12. The section relating to micro-organisms in the Request for Grant Form (1001) does not apply to this category of deposited micro-organisms.

III. Forms to be used when requesting samples of micro-organisms deposited in accordance with Rule 28 EPC

A. Obligation to file a request using the appropriate form

13. Where a European patent application or patent refers to a micro-organism deposited in accordance with Rule 28(1) and (2) EPC, the public may obtain samples subject to the conditions of Rule 28(3) to (8).

In particular, a sample will be issued only when a request has been made to the EPO which, after certification, transmits the request to the depositary institution (Rule 28(8) EPC and Rule 11(3)(a) of the Budapest Treaty).

Copies of the forms to be used when requesting the furnishing of a sample are available free of charge from the EPO.

14. EPO Form 1140a/1141 must be used where the micro-organism has been deposited under the Budapest Treaty and EPO Form 1140/1141 where the micro-organism has been deposited under a bilateral agreement between the European Patent Organisation and the depositary institution.

B. Procedure to be followed

15. Forms are provided with notes, which it is advisable to read carefully, explaining how they are to be completed and the procedure that is to be followed.

Only one form may be used to request samples of different micro-organisms referred to in one and the same European patent application or patent.

16. EPO Forms 1140a and 1140 are the request forms proper which must be completed and signed by the person making the request in all cases. EPO Form 1140a complies with the requirements of Rule 11.4(d) of the Budapest Treaty in conjunction with Rule 11.3(a) relating to the furnishing of samples to parties legally entitled.

17. EPO Form 1141 contains the wording of the undertakings which the requester must enter into vis-à-vis the applicant for or proprietor of the European patent pursuant to Rule 28(3) EPC. It must be completed and signed in addition to the request proper where:

(i) the European patent application has not been refused or withdrawn and is not deemed to be withdrawn;

(ii) the European patent has not lapsed in all the designated Contracting States.

18. Where the requester of samples of micro-organisms deposited in accordance with Rule 28 EPC appoints a professional representative before the EPO (Article 134 EPC) to deal with the formalities associated with the filing of the request for samples, the following should be noted:

(a) the request forms proper - EPO Forms 1140a or 1140 - may be signed by the professional representative; a specific authorisation or a reference to a general authorisation is required;

(b) EPO Form 1141 containing the wording of the undertakings which the requester must enter into vis-à-vis the applicant for or proprietor of the European patent must be signed by the requester personally; it may not be signed by the professional representative since these undertakings are not entered vis-à-vis the EPO.

19. On receiving a request for the furnishing of samples the EPO checks that the prescribed forms have been correctly completed and signed:

(a) if they have, the EPO certifies the request and transmits it to the depositary institution; a copy is also sent to the applicant for or proprietor of the European patent.

(b) if the request does not fully comply with the requirements, the EPO informs the requester and invites him to remedy matters.

20. The EPO makes no charge for certifying the request. Fees fixed by the depositary institutions for the furnishing of samples must be paid direct to them. The amounts of such fees are published in the Official Journal of the EPO.

C. Application of Rule 28(4) EPC concerning the "expert" option

21. Where a request is made for samples of deposited micro-organisms to be furnished prior to grant of the European patent and provided the application has not been refused or withdrawn or is not deemed to be withdrawn, requesters are advised to check whether the applicant has availed himself of the "expert" option provided for in Rule 28(4) EPC.

If such is the case, until one of the aforementioned events (grant, refusal or withdrawal of the application) takes place, the availability of the culture of the deposited micro-organism may be effected only by the issue of a sample to an expert nominated by the requester. This fact is made known in the published European patent application on a separate form.

22. Under Rule 28(5) EPC, the following may be nominated as an expert: any natural person provided that the requester furnishes evidence, when submitting the request, that the nomination has the approval of the applicant, or an expert recognised by the President of the EPO (cf. the list of recognised experts published in the Official Journal of the EPO6).

23. Where the "expert" option applies, EPO Form 1142 entitled "Request to make a deposited micro-organism available by issuing a sample to an expert" should be used for the purpose of nominating an expert. The form is available on request from the EPO free of charge.

24. In this case, only EPO Form 1142 needs to be signed by the requester whereas "EPO Form 1140" or "EPO Form 1140a" and "EPO Form 1141" (see point 14 above) must be signed by the expert.

25. Where the requester and the recognised expert act through a professional representative before the EPO (Article 134 EPC), a separate representative must be appointed for each one of them. However, "EPO Form 1141" (Undertakings vis-à-vis the applicant for or the proprietor of the European patent) must be signed by the recognised expert personally (see point 18 above).