Biotechnology applications
4.2.5.2 Depositing biological material to supplement the description
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A revised version of this publication entered into force. |
4.2.012If your invention involves the use of or concerns biological material that is not available to the public and cannot be described in your European patent application in such a way that it can be carried out by a skilled person, you must deposit a sample of this biological material with a recognised depositary institution no later than at the date of filing.
The recognised depositary institutions are the international depositary authorities under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. A full list of recognised depositary institutions is published once a year in the EPO's Official Journal.
If the biological material has been deposited by someone else, you must state the depositor's name and address in your application and submit a document satisfying the EPO that the depositor has authorised you to refer to the deposited biological material in your application and has given unreserved and irrevocable consent to the deposited material being made available to the public.
4.2.014Lastly you must state your chosen depositary institution and the accession number of the deposited biological material, as a rule within sixteen months after the date of filing or, if you have claimed priority, after the earliest priority date. If any of these requirements is not satisfied, the biological material in question cannot be considered as having been fully disclosed by way of reference to the deposit. Please refer to the Guidelines for Examination for further details.
4.2.015You should also ensure that you complete the corresponding sections in the EPO's Online Filing or Online Filing 2.0 online filing tools ("Biology" tab), or in EPO Form 1001, sections 35 to 37 ("Biological material") (paper, Web-Form Filing or EPO Contingency Upload Service). These sections are designed to alert the EPO that the application refers to biological material deposited under Rule 31 and to enable it to draw your attention to any deficiencies before the time limits laid down in Rule 31(2) expire.
You are also strongly advised to file the deposit receipt issued by the depositary institution. This document shows the depositor, the chosen depositary institution and the accession number assigned to your deposit (see point 4.2.013). This information enables the EPO to certify any requests for the issuance of a sample (see point 4.2.017) and the examining division to establish whether the application satisfies the requirements of sufficient disclosure (see point 4.2.012). A deposit receipt must be filed for each sample of biological material disclosed in the application and deposited at one of the recognised depositary institutions. The deposit receipt may be filed as long as proceedings before the EPO are pending.
4.2.016From the date of publication of the European patent application (see point 5.3.001), the deposited material is available to anyone on request, but only if the requester makes certain undertakings to the applicant or proprietor regarding restrictions on the transmission and use of the material.
Until the technical preparations for publication of your application are deemed to be completed (see point 5.3.001), you may inform the EPO that, for a certain period, the only way the biological material can be accessed is by the issue of a sample to an independent expert ("expert solution"). Any natural person may be nominated as an expert, provided that they fulfil the requirements and obligations laid down by the President of the EPO. The EPO must receive the information that you wish to choose the "expert solution" no later than about five weeks before the European patent application is published. You can select "expert solution" in the EPO's Online Filing and Online Filing 2.0 online filing tools ("Biology" tab) or in EPO Form 1001 (paper or Web-Form Filing) by ticking the corresponding check box.
The "expert" option is mentioned in the published European patent application.
4.2.017If you are interested in receiving a sample of biological material deposited in someone else's application, you must file a corresponding request with the EPO. Requests for the issue of samples of biological material deposited must be submitted on the requisite forms, which can be downloaded from the EPO website (epo.org). The completed forms must be sent to the EPO, which certifies them and transmits them to the competent depositary institution.