4.1 Biological material; deposit thereof
In accordance with Rule 26(3), "biological material" means any material containing genetic information capable of reproducing itself or being reproduced in a biological system.
Where in relation to an application concerning biological material an applicant states having deposited in accordance with Rule 31(1)(a) the biological material with a depositary institution recognised for the purposes of Rules 31 and Rule 34, the applicant must, if such information is not contained in the application as filed, submit the name of the depositary institution and the accession number of the culture deposit and, where the biological material has been deposited by a person other than the applicant, the name and address of the depositor, within whichever of the following periods is the first to expire:
(i)within a period of sixteen months of the date of filing of the European patent application or the date of priority, this time limit being deemed to have been met if the information is submitted before completion of the technical preparations for publication of the European patent application;
(ii)if a request for early publication of the application according to Art. 93(1)(b) is submitted, up to the date of such submission; or
(iii)if it is communicated that a right to inspection of the files pursuant to Art. 128(2) exists, within one month of such communication.
The above time limit according to Rule 31(2) is excluded from further processing by Rule 135(2). Furthermore, Art. 122 is also not applicable, because a lack of disclosure cannot be remedied by way of re-establishment under Art. 122 (see the notice from the EPO dated 7 July 2010, OJ EPO 2010, 498).
Moreover, when the depositor and applicant are not identical, the same time limit applies for submitting a document satisfying the EPO that the depositor has authorised the applicant to refer to the deposited biological material in the application and has given unreserved and irrevocable consent to the deposited material being made available to the public in accordance with Rule 33(1) and Rule 33(2) or Rule 32(1). The depositor's authorisation for the applicant to refer to the deposit and the consent to the material being made available to the public must have existed as from the filing date of the application in question. For a recommended wording for this declaration, see paragraph 3.5 of the above-mentioned notice from the EPO. For Euro-PCT applications, the document referred to above must be provided to the International Bureau before completion of the technical preparations for international publication (see the notice from the EPO dated 7 July 2010, OJ EPO 2010, 498, points II.7 to II.8).
Note, however, that where the depositor is one of several applicants the document referred to in Rule 31(1)(d) is not required (see the above-mentioned notice).
The depositary institution must be one appearing on the list of depositary institutions recognised for the purposes of Rules 31 to Rule 34, as published in the Official Journal of the EPO. This list includes the depositary institutions, especially the International Depositary Authorities under the Budapest Treaty. An up-to-date list is regularly published in the Official Journal.
The applicant is strongly recommended to file the deposit receipt issued by the depositary institution with the EPO since this document indicates in particular the depositor and shows the information required under Rule 31(1)(a) and (c). This information enables the EPO to certify any requests for the issuance of a sample (see A‑IV, 4.2 and A‑IV, 4.4) and the examining division to establish whether the application satisfies the requirements under Article Art. 83 (see also F‑III, 6.2 and F‑III, 6.3). A deposit receipt must be filed for each sample of biological material disclosed in the application and deposited under the Budapest Treaty for the purposes of Rule 31 EPC. The deposit receipt may be filed as long as proceedings before the EPO are pending.