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.
Requirements relating to sequence listings
From 1 July 2022 all new patent applications which include nucleotide and/or amino acid sequence listings must include the sequence listing in the WIPO Standard ST.26 file format.
This applies to Australian national patent applications as well as international Patent Cooperation Treaty applications.
Check out our frequently asked questions for details on how to use to the new file format.
1. What applications need to contain an ST.26-compliant XML sequence listing?
All applications filed on or after 1 July 2022 disclosing amino acid and nucleotide sequences must contain an ST.26 compliant XML sequence listing.
2. Do divisional applications need to comply with WIPO ST.26?
Yes. All divisional applications filed on or after 1 July 2022 must provide an ST.26 compliant XML sequence listing.
3. Do national phase entries need to comply with WIPO ST.26?
National phase applications having an international filing date on or after 1 July 2022 will need to comply with WIPO ST.26.
4. Does IP Australia perform ST.26 compliance checking?
We perform ST.26 validation of the sequence listing accompanying all applications filed from 1 July 2022 using the WIPO sequence validation tool.
For national applications, a formalities notice will be issued when a sequence listing fails validation. Other issues associated with the sequence listing may also be raised during examination. (For additional information on formalities processing see Questions 13 and 14 below).
In the case of international applications, the applicant will be advised of non-compliance via a notification in Box VII of the International Search Opinion (ISO) or earlier where the non-compliance would prohibit a meaning search being performed.
5. Will I receive a copy of the compliance report?
For national applications we won't provide a copy of the compliance report with the formalities notice.
In the case of international applications, we'll forward a copy of the compliance report to the applicant together with the International Search Report (ISR)/International Search Opinion(ISO).
6. The sequence listing filed with my application has failed formalities validation. How do I correct this?
For national applications, the applicant will be provided a period of two months for the date of issue of the formalities notice to prepare and file a ST.26 compliant sequence listing. The sequence listing can be submitted in the normal manner via online services
For international applications, as compliance will be assessed at International Searching Authority (ISA) stage the applicant will have the opportunity to correct the sequence listing through normal Patent Cooperation Treaty processes i.e. by way of Article 34 Amendment etc. Where correction is sought by way of amendment applicants will need to provide an explanation of the changes and ensure that no new matter has been added. (See question 10 below regarding preparation and submission of ST.26 Compliant listings).
7. How do I resubmit an amended sequence listing?
For international applications any corrections to the sequence listing must be furnished as a complete sequence listing with an accompanying letter explaining the changes. The amended sequence can then be submitted using ePCT.
For national applications, applicants will need to prepare a corrected sequence listing ensuring that it meets the requirements of WIPO standard ST.26 without adding subject matter.
Applicants will then need to submit the corrected listing via online services. When submitting the corrected listing it's also recommended that applicants provide an explanation of the changes or otherwise indicate that that the content of the resubmitted sequence is in the accepted format and that no new matter has been added.
8. Can WIPO ST.26 compliant sequence listings be prepared from WIPO ST.25 sequence listings without adding new information?
ST.25 compliant sequence listings may be converted to ST.26 compliant sequence listings without introducing new matter. Recommendations for the transformation of a sequence listing from ST.25 to ST.26 are given in Annex VII of the WIPO Standard ST.26.
For additional information requiring added or omitted subject matter concerns in the conversion of ST.25 to St.26 listings please refer to questions 15 and 16 below.
9. How can I prepare WIPO ST.26 compliant sequence listings?
ST. 26 compliant listings can be prepared using WIPO’s Sequence Suite.
10. Do I need to provide a translation of the ST.26 sequence listing if it was originally filed in a language other than English?
A translation of any “free text” descriptors isn't required at filing. Please note however, that a translation of specific free text field within the listing may be requested during examination if deemed necessary.
11. How do I deal with large listings in WIPO Sequence?
The WIPO Sequence suite may experience difficulties importing large sequence listings. In such cases it's recommended to follow the work around provided by WIPO.
12. What if my sequence listing file size exceeds the maximum file size allowed by IP Australia’s online services?
Where applicants have listings exceeding the 40 MB size limit, they should consider splitting the file into manageable parts to enable the listing to be uploaded. When splitting the file, it's also advisable to provide an indication in the file name as to the order of the files.
In such cases it's also recommended that the applicant provide a copy of the complete listing as filed on physical media to IP Australia.
13. When is an application containing a sequence listing considered to meet formalities requirements?
In order to meet formalities requirements an application must substantially comply with the requirements specified in the Formalities Requirements Determination 2022.
Applications containing an ST.26 listing are passed through the WIPO sequence validation tool to determine if they are a valid ST.26 listing. A listing is taken to substantially comply with the formalities requirements when the validator tool indicates that the listing is valid.
14. My application has passed formalities - what's next?
Applicants should note that while a listing may be indicated as valid by the validator tool and therefore comply with formalities requirements, this doesn't mean the listing is free of errors.
Listings that are considered valid may have one or more errors (e.g. the listing contains invalid nucleotide symbols at particular positions, the sequence length is not equal to the number of residues found in the sequence, the omission of mandatory sequence total quantity element, etc.) These errors may have impacts at a later stage of prosecution e.g. during examination.
15. What should I do to prevent matter being omitted due to conversion to ST.26?
We're aware that there's the potential for matter to be inadvertently omitted during the conversion process.
There are several options open to applicants to ensure that matter as originally disclosed in the parent application is preserved in the divisional application:
- Incorporating by reference the matter disclosed in the parent in its entirety. Such a cross reference would effectively allow any material in the parent including material from the sequence listing to be inserted into the divisional application by way of an amendment if required
- Including the original ST.25 listing of the parent application in some form in the divisional specification e.g. inclusion of the original ST.25 listing in the body of the specification by way of an annexure.
16. I'm concerned that subject matter has been added as a result of the conversion to ST.26.
The inclusion of additional matter is permissible in a divisional application. Consequently, if new matter is inadvertently introduced through the conversion process, this wouldn't appear to have an adverse impact on a divisional application, provided that the original matter is not omitted.