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What to consider before applying
Before you apply for a patent, you'll need to consider if it's the right protection for you.
What can I patent?
You can patent:
- Isolated or genetically modified microorganisms
- Products made by microorganisms
- New processes involving microorganisms
- Transgenic plants and animals
- Mutant plants and animals.
You can't patent:
- Genes isolated from any natural organism
- Human beings
- The biological processes for the generation of humans.
What to include in your application
You'll need to include a detailed description of the invention in your application so that it can be distinguished from others, and so that someone else is able to repeat your work.
You can use text, drawings and sequence listings to fully describe your invention.
For a new microorganism such as a bacterium or fungus, you'll need to describe all known features.
This might include:
- The taxonomic description
- Morphological characteristics such as shape, size, stainability and motility
- Colony characteristics such as colour, shape, size, swarming and any distinguishing features in appearance such as shininess
- Metabolic characteristics such as substrate requirements, products, by-products and isozyme characteristics
- Genetic characterisation of any known genes relevant to the use or characterisation of the organism or the inventive concept.
You'll need to deposit a sample of the microorganism to an International Depositary Authority.
For new products of microorganisms, such as a new antibiotic or enzyme, you should characterise it by its chemical structure in your application.
Where the structure isn't known, you can define the product in terms of the organism which produces it and/or by the physical or chemical characteristics that are known. You must be able to provide sufficient information to distinguish it from other known compounds.
You might do this by providing:
- Ultraviolet or infrared absorption spectra
- Nuclear magnetic resonance spectra
- Elemental analysis
- Molecular weight
- Melting point
- Solubility characteristics
- High-performance liquid chromatography analysis.
You should consider making a deposit to an International Depositary Authority to help distinguish the product.
If you want to patent a process that makes use of a microorganism, such as fermentation, you'll need to fully describe:
- The source of the particular microorganism used for the process
- The nutrient and culture conditions required by the microorganism for the process.
If your invention relates to transgenic plants or animals, you'll need to describe:
- The characteristics of the gene introduced into the organism, preferably including the complete sequence of the gene
- The best method of transformation, regeneration and selection of the transformed materials, such as protoplast, pollen or embryo
- The parent strains or the source of the host material.
If you want to patent a mutant plant or animal, you'll need to describe:
- The parent strains -- these must be readily available to the public
- The method of mutagenesis -- such as by chemical or UV radiation
- The mutant produced -- we recommend making a deposit to an International Depositary Authority
- The method of selecting or obtaining the mutant organisms.
Why you should deposit a specimen of your invention
You'll need to describe the invention as part of your application. This can be challenging in the case of biological inventions. We suggest that you deposit a specimen of your invention, then refer to it in your written specification. This can make it much easier for us to assess the application.
Under the Budapest Treaty, you can deposit microorganisms and other biological material inventions at an International Depositary Authority on or before the filing date of the provisional or standard application in Australia. This will incur a fee determined by the Authority.
You can deposit material such as:
- Cells — including bacteria, fungi, plant and animal cell lines and plant spores
- Seeds that can be dried to a low moisture content and stored at -20°C or lower
- Genetic vectors such as plasmids or bacteriophage vectors or viruses containing a gene or DNA fragments
- Organisms or systems used to produce a protein from a gene, including:
- bacterial, yeast, viral, plant or animal cell cultures
- yeast, algae, protozoa, eukaryotic cells, cell lines, hybridomas, viruses, plant tissue cells, spores, and hosts containing materials such as vectors, cell organelles, plasmids, DNA, RNA, genes and chromosomes
- purified nucleic acids
- deposits of materials not readily classifiable as microorganisms, such as 'naked' DNA, RNA, or plasmids.
In Australia, there are two International Depositary Authorities that accept patent deposits.
CellBank Australia accepts deposits of:
- Animal cell lines
- Human cell lines.
The National Measurement Institute accepts deposits of:
- Bacteria (including actinomycetes)
- Yeasts and fungi — other than known human and animal pathogens, with a hazard categorisation no greater than World Health Organization Classification Risk Group 2
- Some nucleic acid preparations and phases under certain conditions.
These deposits must be preserved by freezing or freeze-drying, without significant change to their properties.
The National Measurement Institute won't accept:
- Microorganisms that require special attention to handling and preparation for storage
- Animal, plant, algal and protozoal cultures
- Viral, rickettsial and chlamydial agents
- Seeds — these deposits can be made at other International Depositary Authorities.
Overseas deposits
If you need to deposit a specimen outside Australia, the World Intellectual Property Organization has a directory of International Depositary Authorities across the globe.
Applying to patent a living organism involves some complex steps.
If you'd like specific advice suited to your situation, we'd suggest that you engage an IP attorney for assistance.
