GL A IV 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.[Rule 26(3); ]
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 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:[Rule 31(1)(c); (d); Rule 31(2); ]
(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; [Rule 31(2)(a); ]
(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[Rule 31(2)(b); ]
(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.[Rule 31(2)(c); ]
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).[Art. 83; ]
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 (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.[Rule 31(1)(d); ]
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). For Euro-PCT applications where the depositor is an applicant, but only in respect of a designated office other than the EPO (e.g. the inventor for the designation of the USA), the document referred to above is required and must be provided to the International Bureau before completion of the technical preparations for international publication (see the above-mentioned Notice from the EPO).
The depositary institution must be one appearing on the list of depositary institutions recognised for the purposes of Rules 31 to 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.[Rule 33(6); ]
The applicant is strongly recommended to file the deposit receipt issued by the depositary institution. 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 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.

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EPC Articles

EPC Implementing Rules

EPO Guidelines - A Formalities Examination

EPO Guidelines - F The European Patent Application

EPO Guide for Applicants, part II Int. - C The EPO as ISA and SISA