Section 15: Patents relating to micro-biological processes or products

(1) Where an invention concerns a micro-biological process or the product of that process and involves the use of a micro-organism which is not available to the public and which cannot be described in the patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as disclosed if- (a) a culture of the micro-organism has been deposited with a depository institution not later than the date of filing of the application; (b) the application as filed gives such relevant information as is available to the applicant on the characteristics of the microorganism; and (c) the depository institution and the file number of the culture deposit are stated in the application. (2) The information referred to in subsection (1)(b) may be submitted within sixteen months after the date of filing of the application or, if priority is claimed, after the priority date. (3) The deposited culture shall be made available upon request of any person having the right to inspect the files. (4) Where a deposited micro-organism ceases to be available from the institution with which it was deposited because- (a) the micro-organism is no longer viable; or (b) for any other reason the depository institution is unable to supply samples, and if the micro-organism has not been transferred to another depository institution from which it continues to be available, an interruption in availability shall not be taken to have occurred if a new deposit of the microorganism originally deposited is made within three months from the date on which the person who deposited it is notified of the interruption by the depository institution and a copy of the receipt of the deposit issued by the institution is forwarded to the registry within four months from the date of the new deposit stating the number of the application or of the patent. (5) A new deposit shall be accompanied by a statement signed by the person making the deposit indicating that the newly deposited microorganism is the same as that originally deposited. (6) In this section "depositary institution" means a place where biological organisms are stored.