In general, antibodies can be defined by (but are not limited to):
(a) their own structure (amino acid sequences);
(b) nucleic acid sequences encoding the antibody;
(c) reference to the target antigen;
(d) target antigen and further functional features;
(e) functional and structural features;
(f) the production process;
(g) the hybridoma producing the antibody.
When it comes to define antibodies through a deposited hybridoma cell producing the antibodies, the general requirements for deposited biological materials apply.
The hybridoma must be deposited at a recognized international depositary institution according to the Budapest Treaty, before the filing date of the patent application.
A claim on such subject-matter could read: “An antibody against antigen X as produced by the hybridoma cell deposited at (name of the international depositary institution) on (date of filing said deposit) under accession number Y”.
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 EPO filing division 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 concerns the classification of the biological material and significant differences from known biological material. The applicant must, to the extent available, 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, who must therefore provide it. If necessary, it has to be provided through experiments in accordance with the relevant standard literature. Usually, the above required information will already have been given to the depositary institution (see Rule 6.1(a)(iii) and 6.1(b) 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 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 is checked whether they were filed within the relevant period under Rule 31(2) EPC; 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) EPC. In such a case, the filing division must also check whether the document fulfilling the requirements mentioned in Rule 31(1)(d) EPC was submitted to the EPO within the same time limit. In addition, the depositary institution named must be one of the recognized institutions listed in the Official Journal of the EPO.
Where a deposit was originally not made under the Budapest Treaty, it must be converted to a deposit made within the purview of the Budapest Treaty no later than the date of filing of the European patent application in order to fulfil the requirement of Rule 31(1)(a) EPC.
If any of these requirements is not satisfied, the biological material in question cannot be considered as having been disclosed pursuant to Art. 83 EPC by way of reference to the deposit.