FOR IP PROFESSIONALS

Patents for micro-organisms

Patent claims to inventions relating to micro-organisms may be directed to the micro-organism itself, its products or processes involving it.

The specific details required in a description of a new micro-organism or related invention will vary depending on the particular invention and must include information enabling the repeatability of the invention.

The following is intended only as a guide to the sort of information needed. An IP Professional will be able to provide more detailed advice.

Processes involving micro-organisms, cell lines, hybridomas and other biological materials

When the invention lies in a process, such as fermentation that makes use of a micro-organism, the description of the invention should provide details including the source of the particular organism used for the process as well as its required nutrient and culture conditions.

New micro-organisms, cell lines, hybridomas and other biological materials

If the invention is a micro-organism, such as a bacterium or fungus or a new cell line, as much as is known of its features should be described. This may include:

  • the taxonomic description
  • morphological characteristics such as shape, size, stainability, motility and so on
  • colony characteristics, for example, colour, shape, size, swarming and any distinguishing features in appearance such as shininess
  • metabolic characteristics including substrate requirements, products or by-products, isozyme characteristics and so on
  • genetic characterisation of any known genes relevant to the use or characterisation of the organism or the inventive concept. The characterisation may be at the level of gene sequence, function or restriction pattern
  • depositing a sample of the micro-organism under the Budapest Treaty provisions. 

Products of micro-organisms, cell lines, hybridomas, etc.

A microbial product, such as a new antibiotic or enzyme, is best characterised by its chemical structure or frequence. 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 that are sufficient to distinguish it from other known compounds.

Such information may be UV or IR absorption spectra, NMR spectra, elemental analysis, molecular weight, melting point, solubility characteristics and HPLC analysis.

In all the above cases a deposit made under the Budapest Treaty may assist in fully describing the invention.

Transgenic plants and animals

The characteristics of the gene introduced into the organisms must be described (preferably including the complete sequence of the gene) as well as the best method of transformation, regeneration and selection of the transformed materials, e.g. protoplast, pollen or embryo.

The parent strains or the source of the host material must also be fully described and readily available to the public.

Mutant plants and animals

The parent strains must be fully described and readily available to the public. The method of mutagenesis (e.g. chemical or UV radiation) and the method of selecting or obtaining the mutant organisms must be disclosed.
Finally, there must be a full written description of the mutant produced. A deposit made under the Budapest Treaty may assist in this regard.

Innovation patent applications

It is not possible to obtain an innovation patent for certain inventions.

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.

Subject matter for an innovation patent

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:
    • preparation of cheese, wine-making, brewing and 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) 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 as detailed above. These requirements can be met by depositing a sample of the micro-organism under the Budapest Treaty provisions.

Get professional advice

For specific assistance and advice contact an IP professional.

Last Updated: 03/4/2014

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Doctor of Philosophy in Chemistry

Policy Officer -  International Policy & Cooperation
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