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Deposit of Micro-organisms

5.35 For inventions that require for their performance the use of micro organisms which is not available to the public at the date of filing the application, and which cannot be described in the specification in such a manner as to enable the invention to be performed by a person skilled in the art, the specification shall, in relation to the microorganism itself, be treated as disclosing the invention, if one of the conditions set out in sub-paragraph (2) of the Fourth Schedule to the Patents Rules is satisfied.

5.36 The Patents Act and the Patents Rules does not provide a definition for the term “micro-organism”. This term is also not defined in the Budapest Treaty (the Treaty on the International Recognition of the Deposit of Micro-organisms for the purposes of patent procedure done at Budapest in 1977). For the purposes of Section 114 Patents Act, Rule 20 and the Fourth Schedule of the Patents Rules, Examiners should regard  biological materials that have been successfully accepted for deposit with anyinternational despository authority as defined in the Fourth Schedule of the Patents Rules, as “micro-organisms”.

5.37 Section 114 prescribes that the Rules may require that the applicant or patentee (a) to take such steps as may be prescribed for the purposes of making available to the public samples of the micro-organism; and (b) not to impose or maintain restrictions on the uses to which such samples may be put, except as may be prescribed. A warning is also provided in Section 114(5) that an application for revocation of the patent under Section 80(1)(c) may be made if any of the requirements pertaining to making samples of micro-organisms available in accordance with the Rules ceases to be complied with. Therefore, the applicant or patentee has to be mindful of the requirements relating to availability of the deposited micro-organism during the application of the patent as well as for the duration of the patent, in accordance with Fourth Schedule of the Rules.

5.38 Where a deposit was made, Examiners are to check that the name of the international depository authority, the date when the culture was deposited and the accession number of the deposit are provided in the specification of the application.

5.39 When an application claims priority to an earlier application and the invention relies upon a deposit for sufficiency purposes, the deposit should have been made not later than the date of filing of that earlier application (T 0107/09 Bristol Myers Squibb/CD40CR receptor and ligands thereof). Otherwise, priority cannot be claimed for the subject matter where deposit is required in order for the matter to be sufficiently disclosed.

5.40 In cases where the biological material used in a process is well known and the process can be adequately described by written description, then as long as the process can be performed in a repeatable manner, even if the final product is a new biological material, a deposit may not be required as long as the product can be prepared without undue burden by a skilled person by following the written description.