ST.26: The New Sequence Listing Standard – Part III
This article is the final in our short series that focuses on understanding the differences between ST.25 and ST.26 sequence standards. Our previous articles on this topic can be found here.
Below, we continue our discussions on how sequence annotations under the ST.26 format is especially informative. We also present our thoughts on the relevance of understanding these differences between the ST.25 and ST.26 standards, when looking to file a divisional application in Australia or overseas.
ST.26 Sequence Annotations
Whilst sequence annotations were also present under the ST.25 standard, the annotations were only with respect to the feature keys alone. The ST.26 standard offers an improvement to this by allowing annotation of sequences with respect to both feature keys as well as qualifiers.
Given that the ST.26 format seeks to offer more information on sequence data, it also requires that more information is provided from the outset. Thus, in addition to identifying the sequences as either DNA, RNA or as amino acids, it is now also essential to enter the molecule type qualifier to further describe the molecule. For example, one must specify whether an RNA sequence is “genomic RNA”, “mRNA”, “tRNA”, “rRNA”, “viral cRNA”, “transcribed RNA”, “unassigned RNA” or “other RNA”. The same requirement also applies to DNA as well as for amino acids. Specifically, one must identify if the DNA is for example, “genomic DNA”, “unassigned DNA” or “other DNA” and if the amino acid sequence is a modified or an unmodified amino acid sequence.
Situations whereby it would be appropriate to select “other RNA”, or “other DNA” would normally be when the sequence is not one that is naturally occurring. In such cases, the “organism” qualifier should be set to “synthetic construct” and the molecule type qualifier should be set to “other RNA” or “other DNA”.
Along similar lines, whilst not mandatory, Applicants are encouraged to include as much sequence annotation as possible, particularly if there are variants to a primary generic sequence. The addition of this further information can be included as a “note” qualifier in the “source” feature to specify that the variant sequences are related to the primary generic sequence. By including the variant sequences and annotating these, this ensures better compliance with the WIPO Standards, in that the full scope of the invention, as it relates to biological sequences is disclosed as accurately and as complete as possible.
Note qualifiers are also especially useful as this is what allows ST.26 sequences to include branched sequences, nucleotide analogs, D-amino acids, amongst other types of sequence variations.
Why Understanding These Differences Matter
The ST.26 sequence standard has been introduced in recent years and is undergoing constant refinement, as demonstrated by the latest WIPO update effective 1 July 2024 (as discussed in our previous articles). Thus, the ST.25 sequence remains relevant to patent applications filed prior to 1 July 2022. However, divisional applications filed after 1 July 2022 fall under the considerations of national law. This means that whether or not ST.25 sequences need to be converted to a ST.26 sequence depends on the practices of the individual patent offices.
For at least the Patent Offices in Europe, the US, Japan, Korea, Argentina, and Australia, Applicants of divisional applications filed on or after 1 July 2022 are required to convert their ST.25 sequences to ST.26 format.
For others, such as the Patent Offices in the UK, Brazil, Chile and Mexico, ST.25 sequences remain to be accepted on divisional applications, where the parent application was filed prior to 1 July 2022.
In Australia, procedurally, ST26 sequences are validated by the Patent Office via the WIPO Sequence validation tool. Should validation fail, a formalities notice will be issued during examination. The Applicant will then have 2 months from receipt of the formalities notice to prepare and file a replacement ST.26 sequence listing that is compliant with the requirements of WIPO standard ST.26 and which do not contain added subject matter.
It is important to note that passing the formalities requirements does not necessarily mean that the sequence submitted is free from errors that may have been introduced by the Applicant themselves, or even through the conversion process itself, which could affect examination. For this reason, it is highly recommended that Applicants carefully review their ST.26 sequence listings to ensure that no new matter is introduced as a result of the conversion process.
The inclusion of further matter is nevertheless permissible in an Australian divisional application, provided that the original matter is not omitted from the divisional application.
Our Advice
In light of the above considerations, we recommend Applicants considering filing a divisional application internationally for their biotechnological invention engage in conversation with their patent attorneys as early as possible. This is of particular importance as the process of converting ST.25 sequences to ST.26 compliant format and the process associated with verifying the successful conversion may take some time.
If you have any questions in relation to any of the above, please do not hesitate to contact our team who will be more than happy to assist.
