6.3 Deposit of biological material 

(i)whether the application as filed gives such relevant information as is available to the applicant on the characteristics of the biological material. The relevant information under this provision concerns the classification of the biological material and significant differences from known biological material. For this purpose, the applicant must, to the extent available, indicate morphological and biochemical characteristics and the proposed taxonomic description. 

The information on the relevant biological material generally known to the skilled person on the date of filing is presumed to be available to the applicant, who must therefore provide it. If necessary, it has to be provided through experiments in accordance with the relevant standard literature.

For characterising bacteria, for example, the relevant standard work would be R.E. Buchanan, N.E. Gibbons: Bergey's Manual of Determinative Bacteriology.

Information also needs to be given on every further specific morphological or physiological characteristic relevant for recognising and propagating the biological material, e.g. suitable media (composition of ingredients), in particular where they are modified.

Abbreviations for biological material or media are often less well known than the applicant assumes and are therefore to be avoided or written in full at least once.

If biological material is deposited that cannot replicate itself but must be replicated in a biological system (e.g. viruses, bacteriophages, plasmids, vectors or free DNA or RNA), the above-mentioned information is also required for that biological system. If, for example, other biological material that cannot be sufficiently described or is not publicly available is required, e.g. host cells or helper viruses, it must also be deposited and characterised accordingly. In addition, the process for producing the biological material within this biological system must be indicated.

In many cases, the above required information will already have been given to the depositary institution (see Rule 6.1(a)(iii) BT and Rule 6.1(b) BT of the Regulation under the Budapest Treaty) and need only be incorporated into the application.

(ii)whether the name of the depositary institution and the deposit's accession number were supplied at the date of filing. If the name of the depositary institution and the deposit's accession number were submitted later, the division must check whether they were filed within the relevant period under Rule 31(2). If so, it must also check whether any reference was supplied on the filing date date of filing enabling the deposit to be linked to the subsequently filed accession number. Normally, the identification reference given by the depositor to the deposit is used in the application documents. The relevant document for filing the data later under Rule 31(1)(c) could be a letter containing the name of the depositary institution, the accession number and the above-mentioned identification reference or, alternatively, the deposit receipt containing all this information (see also G 2/93 and A‑IV, 4.2).

(iii)whether the deposit was made by a person other than the applicant and, if so, whether the depositor's name and address are stated in the application or were supplied within the relevant period under Rule 31(2). In such a case, the division must also check whether the document fulfilling the requirements mentioned in Rule 31(1)(d) was submitted to the EPO within the same time limit (see A‑IV, 4.1 for details of when this document referred to in Rule 31(1)(d) is required).

The division, in addition to the checks referred to under (i) to (iii) above, asks for the deposit receipt issued by the depositary institution (see Rule 7.1 BT of the Regulation under the Budapest Treaty) or equivalent proof of the deposit of biological material if such proof has not already been filed (see (ii) above and A‑IV, 4.2). This is to provide evidence for the indications made by the applicant pursuant to Rule 31(1)(c).

If this deposit receipt has been filed within the relevant time period under Rule 31(2), this document alone is regarded as submission of the information according to Rule 31(1)(c).

In addition, the depositary institution named must be on the list of recognised institutions that is regularly updated and published in the Official Journal of the EPO.

Where a deposit was originally made outside the Budapest Treaty, it must be converted to one under it no later than the date of filing filing date of the European patent application in order to fulfil the requirement of Rule 31(1)(a).

If any of these requirements is not satisfied, the biological material in question cannot be considered as having been disclosed according to Art. 83 by way of reference to the deposit.

Moreover, there are two situations in which the applicant can file information concerning the deposit required under Rule 31(1)(c) and, where applicable, also under Rule 31(1)(d) in a document filed after the accorded filing date date of filing and within the relevant time limit for filing that document but after the expiry of one of the time limits under Rule 31(2)(a) to Rule 31(2)(c). As in the preceding paragraph, the consequence of the information being filed after the relevant time limit under Rule 31(2) is that the biological material is deemed not to have been disclosed according to Art. 83 by way of reference to the deposit. In these situations, the information concerning the deposit is contained in either:

(a)a previously filed application to which reference is made under Rule 40(1)(c), the copy of that application being filed within either the two-month period under Rule 40(3) or that under Rule 55 or

(b)missing parts of the description filed later within the two-month period under Rule 56(2) when the requirements of Rule 56(3) are satisfied, or correct application documents or parts filed later within the two-month period under Rule 56a(3) when the requirements of Rule 56a(4) are satisfied so that the application is not redated.