Can I patent biological materials?
Many types of biological materials can be patented, but only if they've been:
- Isolated from their natural environment, or
- Have been synthetically or recombinantly produced.
You can also patent methods and processes that use or test biological material.
Examples of patentable biological inventions
A patent can cover a broad range of biological inventions, including:
- Isolated bacteria and other prokaryotes, fungi (including yeast), algae, protozoa, plasmids, viruses, prions
- Cell lines, organoids, hybridomas
- Genetic vectors and expression systems
- Isolated proteins, polypeptides, cell organelles
- 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.
You can't patent human beings and the biological processes for their generation.
Can I patent genetic modification or manipulation?
You can patent genetically or phenotypically modified biological inventions. This includes genetically engineered:
- Non-human organisms.
Examples of patentable genetically or phenotypically modified biological inventions
A patent can cover a broad range of genetically or phenotypically modified biological inventions, including:
- Synthetic DNA or nucleic acid sequences only where the genetic information doesn't exist in the DNA blueprint or genome of any human or other organism
- 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.
Can I patent DNA or gene sequences?
No, you can't. Patents aren't available for gene sequences, DNA, RNA or nucleic acid sequences that replicate the genetic information that exists in the DNA blueprint or genome of any human or other organism. This is regardless of whether the genetic material was isolated or man-made.
Note that patent specifications must also describe a specific use for a biological material. For example, although patents aren't provided for genes, if the specification discloses a specific use for the gene such as its use in a specific enzymatic reaction or industrial process, then patent protection is available for methods of using the gene.
In addition to the general requirements for patents, there are patent requirements specific to biological inventions.
The biological invention must:
- Have a demonstrated use. A patent can't be granted for a mere discovery or for speculation about future uses. You have to fully describe how the invention will be put to use, such as a treatment for multiple sclerosis.
- Have resulted from the intervention of a technologist. It must produce something that differs in some way from the natural source material as a patent can't be granted for biological materials in their natural environment. For example, a biologically pure culture of a naturally occurring micro-organism would be patentable, and so would the isolation and cultivation of a naturally occurring micro-organism. This is because both have resulted from technical intervention.
- Be new in the sense of not previously being publicly available. A patent can't be granted for subject matter that's previously been publicly disclosed.
- Be fully described. Someone else could make the product or perform the process by replicating your description.