Section 41 of the Patents Act 1990 (Cth) (the Act) sets out the requirements for a patent specification relating to a deposit of a micro-organism made under the International Recognition of the Deposit of Micro-organisms for the Purposes of Patent Procedure (1977) (the Budapest Treaty). This was covered in an earlier article.
Section 42 of the Act sets out what might happen if a deposited micro-organism ceases to be reasonably available. An example of this is if the microorganism which was deposited is no longer viable.
The deposit requirements are set out in Section 6, which require that:
- (a) the micro-organism was, on or before the date of filing of the specification, deposited with a prescribed depositary institution in accordance with the rules relating to micro-organisms; and
- (b) the specification includes, at that date, such relevant information on the characteristics of the micro-organism as is known to the applicant; and
- (c) at all times since the end of the prescribed period, the specification has included:
- (i) the name of a prescribed depositary institution from which samples of the micro-organism are obtainable as provided by the rules relating to micro-organisms; and
- (iii) the file, accession or registration number of the deposit given by the institution; and
- (d) at all times since the date of filing of the specification, samples of the micro-organism have been obtainable from a prescribed depositary institution as provided by those rules.”
If the deposited micro-organism is no longer viable, the requirement of subsection 6(d) of the Act is not satisfied and the Examiner may declare that the specification does not meet the requirements of section 40 of the Act . Under section 40 of the Act, there must be a clear enough and complete enough disclosure of the invention.
The Examiner must notify the applicant if a declaration is made in accordance with the patent regulation 3.29(2). The applicant is entitled to request a patent office hearing to decide the matter.
To rectify the issue, the applicant or patentee must make a new deposit of the same micro-organism within the prescribed period as per the relevant regulations. A copy of the new deposit receipt must also be filed within the relevant prescribed time.
If a new deposit can only be made outside the prescribed period, the applicant or patentee can apply for an extension of time.5
When a new deposit is made, the applicant or patentee must amend the specification to insert the details of the new deposit including the name of the prescribed depositary institution and the file, accession, or registration number of the deposit to meet the deposit requirements.
5 Section 223 of the Act