In New Zealand, genetically modified organisms (GMOs) are currently regulated under the Hazardous Substances and New Organisms Act 1996 (the HSNO Act). The Gene Technology Bill progressing through parliament aims to modernise New Zealand’s approach to regulating GMOs.
The Select Committee has published its report on the Gene Technology Bill, recommending that the Bill be passed and all proposed amendments be accepted. The Bill will next have a second reading in the House of Representatives, a vote, a debate by the Committee of the whole House, a third reading of the bill in its final form, a final vote, and (assuming the votes are in favour) the Bill will become law when it receives Royal assent.
The Bill has spurred discussion about the role of GMOs in science, industry and commerce. One question raised is whether organisms (genetically modified or not) can be the subject of patent protection.
Subject matter captured by patent claims must be new
To be valid, a claim in a patent must be novel, i.e. new. This generally means that a patent cannot validly claim anything in a form that exists in nature. This includes naturally-occurring microorganisms, plants, and animals.
However, some jurisdictions will allow claims to an “isolated” microorganism or a “biologically pure culture” of a microorganism, as such forms do not ordinarily exist in nature. Many jurisdictions will allow claims to organisms that have been modified by humans, including GMOs.
Patentability of organisms varies by jurisdiction
The patentability of organisms varies by jurisdiction, as summarised in the table below. In some cases, different rules are applied to microorganisms, plants, and animals.
|
Jurisdiction |
Patentability (assuming novelty) |
||
|
Microorganisms |
Plants |
Animals (excluding humans) |
|
|
New Zealand |
✓ Isolated ✓ Modified (including GMO) |
✗ Plant variety at the lowest taxonomic rank (but may be protected using Plant Variety Rights instead) ✓ Higher taxonomic rank |
✓ |
|
Australia |
✓ Isolated ✓ Modified (including GMO) |
✓ Plant varieties may also be protected using Plant Breeder’s Rights — dual protection is possible |
✓ |
|
Europe |
✓ Isolated ✓ Modified (including GMO) |
✗ Obtained exclusively by essentially biological processes (e.g. breeding, selection) ✓ Modified by technical means (including GMO) |
✗ Obtained exclusively by essentially biological processes (e.g. breeding, selection) ✓ Modified by technical means (including GMO) |
|
United States |
✗ Isolated ✓ Modified and having markedly different characteristics from naturally occurring microorganisms (including GMO) |
✓ Modified and having markedly different characteristics from naturally occurring plants (including GMO) Plants may also be protected by plant patents or plant variety protections. Plant patents can protect asexually reproduced plant varieties (other than tuber propagated plants or plants found in an uncultivated state) Plant variety protection can protect seeds, tubers, and asexually reproduced plants |
✗ Obtained by traditional breeding or selection ✓ Modified and having markedly different characteristics from naturally occurring animals (including GMO) |
Other forms of protection may be possible
Even if an organism itself isn’t patentable, it may be possible to patent the use of the organism for a particular purpose, or a new composition comprising the organism. For example, it may be possible to patent:
- a method that uses the organism (for example, a method of medical treatment, a method of killing pests, etc)
- a method of producing or culturing the organism
- a method of producing a useful substance using the organism
- a composition (for example, an agricultural composition or a pharmaceutical composition) comprising the organism and an acceptable excipient.
If the Gene Technology Bill becomes law, we can expect a modernised approach to the regulation of GMOs. With innovation comes the need for robust intellectual property protection, and it’s reassuring to know that New Zealand’s patent system is well-equipped to support these advancements.
If you’d like to explore how patent protection can support your innovation, feel free to reach out to our experts.
