Inventions Involving the Use, Modification or Cultivation of a Micro-Organism

Date Published

Section 41(2) states that where:

a. an invention involves the use, modification or cultivation of a micro-organism and not the micro-organism per se; and

b. a person skilled in the relevant art could not reasonably expect to be able to perform the invention without first having a sample of the micro-organism; and

c. the micro-organism is not reasonably available to a person skilled in the relevant art in Australia;

then the applicant can satisfy the sec 40(2)(a) requirement if and only if, the deposit requirements specified in sec 6 have been satisfied.

Office practice is to regard a micro-organism as being reasonably available, if the specification discloses a method by which the public can access a sample of the deposit. For example:

  • if the applicant identifies in the specification a commercial source through which a sample of the micro-organism can be obtained;

  • if a sample is freely available from any source, the applicant must name a source from which the public can obtain a sample of the micro-organism; or

  • if a sample of the micro-organism was available, under Rule 11 of the Budapest Treaty, at the filing date of the complete application, the applicant must:

  • identify the published specification (including foreign specifications), which was published before the filing date of the applicant's complete application in which the deposit was used for the purpose of patent procedure;

  • disclose the accession number of the deposit; and

  • name the International Depositary Authority (IDA) from which a sample can be furnished under the Rules of the Treaty. 

Note:  A deposit is regarded as being reasonably available provided the deposit relied on has been made under the Budapest Treaty and the deposit details disclosed in a document published by the filing date of the complete application.

Note: A micro-organism may be taken to be reasonably available, even if it is not reasonably available from an IDA within Australia (sec 41(3)).

Examiners should note that, particularly in literature references, the mere mention of an accession number at a particular depositary may not establish that the deposit is available, as it is common to have private (total limiting), or restrictive (e.g. Budapest Treaty) deposits, as well as freely available (no limitation) deposits in an accredited IDA.

If there is any doubt about the availability, examiners should raise an objection that the invention does not meet the requirements of sec 40(2)(a), as it is not clear if the micro-organism is reasonably available.

If the uncertainty is related to the "reasonably available" aspect of the deposit, examiners should add a note to reiterate Office practice on the meaning of the term "reasonably available" (outlined above).

The procedures for accessing a sample of the deposit are provided in 2.7.6 Release of a Sample.