Patents can be granted for inventions relating to:
- products of micro-organisms
- processes involving micro-organisms
- transgenic plants or animals.
In your patent application for a new micro-organism or related invention, you must include enough detail to enable the invention to be repeated.
Genes isolated from any organism are not eligible for patent protection.
The following information is intended to be a guide only. An intellectual property (IP) professional will be able to provide more detailed advice.
If you have invented a micro-organism (such as a bacterium or fungus), its known features should be disclosed in your application. These features may 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.
- depositing a sample of the micro-organism under the Budapest Treaty provisions.
Products of micro-organisms (such as a new antibiotic or enzyme) are best characterised by their chemical structure.
As this is not always known, the product may be defined in terms of the organism which produces it and/or by the physical or chemical characteristics that are known and are sufficient to distinguish it from other known compounds.
Such information may be:
- ultraviolet (UV) or infrared (IR) absorption spectra
- nuclear magnetic resonance (NMR) spectra
- elemental analysis
- molecular weight
- melting point
- solubility characteristics
- high-performance liquid chromatography (HPLC) analysis.
In all the above cases a deposit made under the Budapest Treaty may assist in fully describing the invention.
When the invention lies in a process that makes use of a micro-organism (such as fermentation), the description of the invention should include:
- the source of the particular micro-organism used for the process
- the nutrient and culture conditions required by the micro-organism for the process.
If applying for a patent relating to transgenic plants or animals you will 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.
Mutant plants or animals
If applying for a patent relating to mutant plants or animals you will 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 method of selecting or obtaining the mutant organisms
- the mutant produced (a deposit made under the Budapest Treaty may assist in this regard).
Innovation patents for micro-organisms
An innovation patent may be obtained for:
- micro-organisms (bacteria, protozoans, bacteroids, viroids, bacteriophages and viruses), as these are not considered to be either plants or animals
- processes that use a plant or animal, or part thereof, but that do not produce a plant or animal
- microbiological processes or products of such processes, for instance:
- industrial processes involving the use of micro-organisms (such as microbial bleaching and leaching of ores using micro-organisms)
- the use of enzymes derived from micro-organisms for the preparation of cheeses or detergents (for example, those comprising protease)
- the use of yeast, fungi or moulds for the preparation of useful products (penicillin, enzymes, fermented meats or industrial alcohol) and the products produced by such use
- the use of viruses in the preparation of vaccines.
In the case of innovation patent applications involving micro-organisms, each application must comply with the requirements for full description and repeatability. These requirements can be met by depositing a sample of the micro-organism under the Budapest Treaty provisions.
An innovation patent cannot be obtained for plants and animals and the biological processes for the generation of plants or animals. In particular this includes:
- genetically modified whole plants, plants produced by cross-breeding of one strain with another strain or selection of a plant from a range of plants (note that the definition of a plant includes fungi, yeast, moulds and algae)
- genetically modified whole animals (including human beings), animals produced by cross-breeding of one strain with another strain or selection of an animal from a range of animals
- seeds of plants, plant tissue cultures or any matter that could give rise to a plant
- animal embryo or foetus, zygote or any matter or group of cells that could give rise to an animal.
The Budapest Treaty allows an applicant to deposit a sample of a micro-organism in order to meet the requirements for repeatability and full description of biological materials.
Making a deposit
Deposit must be made at an International Depositary Authority (IDA) on or before the filing date of the patent application.
Materials that may be deposited under the Budapest Treaty include:
- cells (including bacteria, fungi, 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 micro-organisms, such as 'naked' DNA, RNA, or plasmids, subject to the qualification given below.
International Depositary Authorities
There are approximately 30 IDAs worldwide. There are two in Australia:
The CBA accepts deposits for animal and human cell lines.
The NMI accepts deposits of bacteria (including actinomycetes), yeasts and fungi, other than known human and animal pathogens, with a hazard categorisation no greater than WHO Classification Risk Group 2. These must be preserved without significant change to their properties with the preservation techniques in use.
The NMI will also accept nucleic acid preparations and phases under certain conditions, but will not accept:
- micro-organisms that require special attention to handling and preparation for storage
- animal, plant, algal and protozoal cultures
- viral, rickettsial and chlamydial agents
- seeds (seed deposits can be made at other IDAs).
We can provide a list of IDAs in other countries on request. They are also listed in the World Intellectual Property Organization's Guide to the Deposit of Micro-organisms under the Budapest Treaty.