WIPO ST.26 Breakdown – Part VIII
As mentioned in the last post, this post is going to focus on sequences with D-amino acids. As you are not aware, all sequences with D-amino acids are required to be included in a Sequence Listing (unless fewer than 4 amino acids in length). This is a drastic change from ST.25 which did not require these sequences. This means that, going forward, if a Sequence Listing was submitted in a parent application under ST.25, it will be necessary to review the application for any discloses with D-amino acids that will need to be added and included in the Sequence Listing for submission under ST.26.
In addition, since each D-amino acid is considered a modified residue, the ST.26 listing will need to include a feature/qualifier for each D-amino acid position with the full name of the D-amino acid residue as shown below.
<INSDFeature>
<INSDFeature_key>SITE</INSDFeature_key>
<INSDFeature_location>9</INSDFeature_location>
<INSDFeature_quals>
<INSDQualifier>
<INSDQualifier_name>note</INSDQualifer>
<INSDQualifier_value>D-Arginine</INSDQualifer_value>
<INSDQualifier>
<INSDFeature_quals>
</INSDFeature>
As you can tell, depending on the sequence, defining each D-amino acid position will add significant time and room for error, especially considering that these sequences were not even required previously.
The overall impact of this new requirement to include D-amino acids will be seen in the overall increase in the number of sequences in Sequence Listings, as well as the increased number of features/qualifiers. The burden will be on the applicant to ensure these sequences are both included and annotated properly.
Any questions, please reach out to me!