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Guidelines for Examination

 
 

6.3 Deposit of biological material

If the biological material is not available to the public and if it cannot be described in the application in such a manner as to enable the invention to be carried out by a person skilled in the art, the examiner must check:

(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 to him, indicate morphological and biochemical characteristics and the proposed taxonomic description. 

The information on the biological material in question which is generally known to the skilled person on the date of filing is as a rule presumed to be available to the applicant and must therefore be provided by him. 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.

Against this background, information should then be given on every further specific morphological or physiological characteristic relevant for recognition and propagation of the biological material, e.g. suitable media (composition of ingredients), in particular where the latter are modified.

Abbreviations for biological material or media are often less well known than the applicant assumes and should therefore 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 such biological system. If, for example, other biological material is required, such as host cells or helper viruses, that cannot be sufficiently described or is not available to the public, this material 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) and 6.1(b) Budapest Treaty) and need only be incorporated into the application;

(ii)
whether the name of the depositary institution and the accession number of the deposit were supplied at the date of filing. If the name of the depositary institution and the accession number of the deposit were submitted later, it should be checked whether they were filed within the relevant period under Rule 31(2). If that is the case, it should then further be checked whether on the filing date any reference was supplied which enables the deposit to be related to the later filed accession number. Normally the identification reference which the depositor himself gave to his deposit is used in the application documents. The relevant document for later filing the data pursuant to 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, which contains all these data (see also G 2/93 and A‑IV, 4.2); and
(iii)
whether the deposit was made by a person other than the applicant and, if so, whether the name and the address of the depositor are stated in the application or were supplied within the relevant period under Rule 31(2). In such a case, the examiner 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 examiner, 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 Budapest Treaty) or for equivalent proof of the deposit of a biological material if such proof has not been filed before (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 already been filed within the relevant time period according to Rule 31(2), this document on its own is regarded as submission of the information according to Rule 31(1)(c).

In addition, the depositary institution named must be one of the recognised institutions listed in the Official Journal of the EPO. An up-to-date list is regularly published in the Official Journal.

If any of these requirements is not satisfied, the biological material in question cannot be considered as having been disclosed pursuant 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 which is required under Rule 31(1)(c), and where applicable also under Rule 31(1)(d), in a document filed after the accorded filing date 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 (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 pursuant to Art. 83 by way of reference to the deposit. These situations are those in which the information concerning the deposit is contained in either:

(i)
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
(ii)
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, so that the application is not re-dated.