Section 41 of the Patents Act 1990 (Cth) (the Act) sets out specific requirements that a patent specification should meet where the specification relies on a deposit under the Budapest Treaty on the International Recognition of the Deposit of Micro- organisms for the Purposes of Patent Procedure (1977) (the Budapest Treaty) for the purposes of patenting micro-organisms1 in Australia.
Where a micro-organism is the invention, a specification is deemed to sufficiently disclose the invention2 if the micro-organism is deposited with a prescribed epositary institution3 in compliance with the provisions of the Act, the Patent Regulations 1991 (the Regulations),5 and the Budapest Treaty. 6
On the other hand, in the case of a complete specification:
- where the invention involves the use, modification, or cultivation of a micro-organism, i.e., the micro-organism is not the invention in itself;7
- a person skilled in the relevant art in the patent area could not reasonably be expected to perform the invention without having a sample of the micro-organism before starting to perform the invention;8 and
- the micro-organism is not reasonably available to a person skilled in the relevant art in the patent area;
the specification is deemed to sufficiently describe the invention, 9 insofar as the specification requires a description of the micro-organism, provided the deposit requirements are met with respect to the micro-organism.10
Broadly speaking, to satisfy the deposit requirements:
- a sample of the micro-organism must have been deposited with the prescribed depositary institution on or before the filing date of the specification in accordance with the rules relating to micro-organisms;
- the specification must at the filing date include:
- relevant information on the characteristics of the micro-organism known to the applicant; and
- identifying information with respect to the prescribed depositary institution and the deposited sample.11
The patent applicant may choose whichever prescribed depositary institution they prefer, provided the prescribed depositary institution will accept the relevant micro-organism for deposit purposes.
It should be noted that it is not necessary for the prescribed depositary institution to be in Australia, i.e., the patent area, for the micro-organism to be considered reasonably available.12
1 The term “micro-organism” is not defined in the Act or the Budapest Treaty. Fortunately, however, the Patent Manual of Practice and Procedure of IP Australia at 2.7.1 sets out that the Australian Patent Office broadly interprets the term “… to include any biological materials accepted for deposit with a prescribed depositary institution, for the purposes of the Budapest Treaty, in accordance with the rules relating to micro-organisms. Examples of micro-organisms include bacteria and other procaryotes, fungi including yeast, 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.”
2 Sections 40(1) and 40(2)(a) of the Act deal with provisional specifications and complete specifications, respectively.
3 A prescribed depositary institution should be understood to mean an international depositary authority (IDA) as defined in the Budapest Treaty or any depositary institution as provided in the Act. There are presently two IDAs in Australia, namely the Lady Mary Fairfax Cell Bank Australia (CBA) for animal cell cultures, human cell cultures, and hybridomas, and the National Measurement Institute (NMI) for bacteria (non-pathogenic), fungi (non-pathogenic), and yeast (non-pathogenic).
4 Section 6 of the Act
5 Regulation 1.5 of the Regulations
6 Sections 41(1A) and 41(1) of the Act with respect to provisional specifications and complete specifications, respectively
7 Section 41(2)(a) of the Act
8 Section 41(2)(b) of the Act
9 Section 40(2)(a) of the Act
10 Sections 6 and 41(2) of the Act
11 Section 6 of the Act
12 Section 41(3) of the Act