28A.
| (1) | If the complete specification accompanying an application claims as an invention a microbiological process or a product thereof and requires for the performance of the invention the use of a micro-organism which is not available to the public on the date of lodging the application and which cannot be made or obtained on the basis of the description in the specification, the following provisions shall apply: |
| (a) | Not later than the date of lodging the application, a culture of the microorganism shall be deposited with a depositary institution which has acquired the status of international depositary authority as provided for in the Budapest Treaty on the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure; |
| (b) | subject to subregulation (2), the complete specification shall state the name, or a recognised abbreviation, of the international depositary authority with which the culture was deposited and the accession number given to the deposit by the international depositary authority; and |
| (c) | the complete specification, as lodged, shall give such relevant information as is available to the applicant on the characteristics of the micro-organism. |
| (2) | Where the information specified in subregulation (1)(b) is not contained in the complete specification as lodged, it may be added to the complete specification in accordance with section 50(1)(b) of the Act at any time before the date of publication in terms of section 42 of the Act or before coming open to public inspection in terms of section 43(3) of the Act, whichever is the earlier. |
| (3) | The communication of the information provided for in subregulation (1) shall be considered as constituting the unreserved and irrevocable consent of the applicant to make the deposited culture available to the public in accordance with this regulation from the date contemplated in subregulation (2). |
| (4) | A sample of the deposited culture shall be furnished to any person (hereinafter referred to as the 'requesting party') from the date contemplated in subregulation (2) provided that the requesting party makes a valid request therefor to the international depositary authority with which the culture is deposited. |
| (5) | A request for the furnishing of a sample of the deposited culture shall be valid if it is lodged on Form P23 as set out in Schedule 2 and the Registrar has certified on that form that a patent or patent application referring to the deposit of the culture has been published in terms of section 42 of the Act or has come open to public inspection in terms of section 43(3) of the Act, as the case may be, and that the requesting party is entitled to the furnishing of a sample of the deposited culture. |
| (a) | The Registrar shall not make the certification referred to in subregulation (5) unless the Registrar has received a request on Form P24 as set out in Schedule 2. |
| (b) | The request shall contain an undertaking from the requesting party vis-à-vis the patentee that the requesting party shall not make the deposited culture, or any culture derived therefrom, available to any third party until the patent application has been abandoned or has lapsed, or until the patent ceases to have effect by way of expiration, revocation, voluntary surrender, or lapsing without the possibility of renewal in accordance with section 46 of the Act, as the case may be. |
| (7) | An undertaking given on Form P24 as set out in Schedule 2 in accordance with subregulation (6) shall not prevent the requesting party concerned from depositing with an international depositary authority a derived culture or the culture itself necessary for the purpose of complying with section 32(6) of the Act. |
| (8) | For the purpose of subregulation (6) or (7), a derived culture shall be deemed to be any culture of the micro-organism which exhibits those characteristics of the deposited culture which are essential to the carrying out of the invention described in the complete specification in which reference is made to the deposited culture. |
| (9) | Where the patentee is notified- |
| (a) | by the international depositary authority with which the culture of the microorganism has been deposited that the depositary institution is unable, for any reason, to furnish samples of the culture; or |
| (b) | in writing by a requesting party that the depositary institution with which the culture of the micro-organism has been deposited is unable, for any reason, to satisfy a valid request by the requesting party for the furnishing of a sample of the culture, |
and, if a culture of the micro-organism has not been transferred to or deposited with another international depositary authority from which samples of the culture can be furnished, the patentee shall, within a period of six months from the date on which he was so notified-
| (i) | make a new deposit of a culture of the micro-organism with the international depositary authority with which the original deposit was made; |
| (ii) | furnish to the international depositary authority with which the new deposit is made a statement alleging that the newly deposited culture is the same as that originally deposited; and |
| (iii) | apply to substitute, in the complete specification of the patent, in accordance with section 50(1)(b) of the Act, the accession number given to the new deposit and, where applicable, the name of the international depositary authority with which the new deposit has been made. |
| (10) | Where the patentee has been notified in terms of subregulation (9) by a requesting party, the patentee shall, within two months of complying with subregulation (9)(i) to (iii), inform the requesting party of the accession number of the new deposit and, where applicable, the name of the international depositary authority with which the new deposit has been made. |
| (11) | On compliance with the provisions of subregulations (1) and (2) and, where applicable, subregulation (9), the complete specification shall be deemed fully to describe and ascertain the invention and the manner in which it is to be performed in so far as the relevant micro-organism is concerned. |
