standard patent applications with an examination request filed on or after 15 April 2013.
innovation patents with an examination request filed on or after 15 April 2013.
innovation patents where the Commissioner had not decided before 15 April 2013 to examine the patent.

For all other standard patent applications/innovation patents, see 2.11.3.15 Biological Inventions and the Budapest Treaty.

Specifications relating to biological material are required to satisfy the requirements of clear enough and complete enough disclosure as for any other technology. However, particular issues can arise with adequately describing the invention in words, or describing it in a manner that it is repeatable.

The Budapest Treaty provides a mechanism whereby the requirements of clear enough and complete enough disclosure of the invention can be met by making a deposit of reproducible biological material with a recognised International Depositary Authority (IDA). Where such a deposit is made, third parties are able to obtain samples of the biological material from the IDA with the approval of the Commissioner. In this way the invention is made available to the public, even though a written description may be inadequate to describe the invention in words and/or in a repeatable manner.

In order for an applicant to rely on the Budapest Treaty mechanism to provide a clear enough and complete enough disclosure of the invention, the following criteria must be satisfied:

A sample of the biological material must have been filed with an IDA on or before the filing date of the complete specification;
The specification must include the characteristics of the biological material;
The specification must include the name of the IDA and its deposit number by the OPI date; and
The deposit must have been made with the IDA under the provisions of the Budapest Treaty, such that samples are available under the Rules of that Treaty.

In general, an applicant is not required to use the Budapest Treaty deposit mechanism. However, if:

the invention relates to the use, modification or cultivation of a specific micro-organism;
performance of the invention requires having a sample of that micro-organism; and
that micro-organism is not reasonably available to a person in Australia (even if the micro-organism itself is not located in Australia);

the applicant must rely upon the Budapest Treaty deposit mechanism in order to provide a description of the micro-organism (sec 41(2)).

Note: The Budapest Treaty relates to the deposit of micro-organisms, however the reference to 'micro-organism' is not intended to limit its application only to micro-organisms per se. Rather, it relates to a wide range of biological materials, including bacteria and other procaryotes, fungi (including yeast and mushrooms), algae, protozoa, eucaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, seeds and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes.

A full discussion of the particular issues associated with biological inventions, and the Budapest Treaty, is provided in 2.7 Micro-Organisms and Other Life Forms.