FOR IP PROFESSIONALS

Patents for biological inventions

Patents are not available for gene sequences, DNA, RNA or nucleic acid sequences that replicate the genetic information that exists in any human's or in any other organism's DNA blueprint or genome. This is regardless of whether the genetic material was isolated or man made.

A standard patent can be obtained for isolated bacteria, cell lines, hybridomas, some related biological materials and their use, and genetically manipulated organisms. Examples of patentable inventions include:

  • isolated bacteria and other prokaryotes, fungi (including yeast), algae, protozoa, plasmids, viruses, prions
  • cell lines, cell organelles, hybridomas
  • genetic vectors and expression systems
  • apparatus or processes for enzymology or microbiology
  • compositions of micro-organisms or enzymes
  • propagating, preserving or maintaining micro-organisms
  • mutagenesis or genetic engineering
  • fermentation or enzyme using processes to synthesise a desired compound or composition
  • measuring or testing processes involving enzymes or micro-organisms
  • processes using enzymes or micro-organisms to liberate, separate, purify or clean
  • the use of micro-organisms to produce food or beverages.

Patents for genetic modification or manipulation

A standard patent can also be obtained for inventions involving:

  • genotypically or phenotypically modified living organisms, for example, genetically modified bacteria, plants and non-human organisms (patenting of plant varieties is described in Plant Breeder's Rights)
  • isolated polypeptides and proteins.

Examples of patentable inventions include:

  • synthetic DNA or nucleic acid sequences only where the genetic information does not exist in any human's or in any other organism's DNA blueprint or genome.
  • an isolated protein expressed by a gene
  • vectors (such as plasmids or bacteriophage vectors or viruses) containing a transgene
  • methods of transformation using a gene
  • host cells carrying a transgene
  • higher plants or animals carrying a transgene
  • organisms for expression of a protein from a transgene
  • general recombinant DNA methods such as PCR and expression systems.

Patents for DNA or gene sequences

Human beings and the biological processes for their generation are not patentable.

Patents are not available for gene sequences, DNA, RNA or nucleic acid sequences that replicate the genetic information that exists in any human's or in any other organism's DNA blueprint or genome. This is regardless of whether the genetic material was isolated or man made.

Although standard patents can be obtained for biological material such as micro-organisms, peptides and organelles, this material is only patentable if it has been isolated from its natural environment, or has been synthetically or recombinantly produced.

Patent specifications must also describe a specific use for a biological material. For example, although patents are not provided for genes, if the specification discloses a specific use for the gene, such as its use in the diagnosis or treatment of a specific disease, or its use in a specific enzymatic reaction or industrial process, then patent protection is available for methods of using the gene.

Standard patents as they apply to biological inventions

The usual requirements for a standard patent must also be met. There are also specific description requirements for micro-biological inventions: 

  • involves the intervention of a technologist to produce something that differs in some way from the natural source material. A patent cannot be granted for biological materials in their natural environment. For example, a biologically pure culture of a naturally occurring micro-organism or the isolation and cultivation of a naturally occurring micro-organism would satisfy the requirement for technical intervention.
  • is new in the sense of not previously being publicly available. A patent cannot be granted for subject matter that has previously been made publicly available.
  • is inventive when compared to the prior art.
  • has been fully described in the sense that sufficient information is provided to allow someone to make the product or perform the process.
  • has a demonstrated use. A patent cannot be granted for a mere discovery. The use to which the invention is to be put (for example: for the treatment of diseases such as cancer or multiple sclerosis) must also be fully described. There must be an actual use for an invention rather than speculation as to future uses.

Last Updated: 11/2/2016

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