The EPO's practice in relation to applying sequence listing Standard ST.26 to divisional applications filed on or after 1 July 2022 is clarified below and supplementary information is provided on the communication under Rule 71(3) EPC for applications filed before 1 July 2022.
Yes. Under the EPC legal framework a divisional application is an independent application subject to the procedural requirements applicable on the date of its submission. Therefore, any divisional application submitted on or after 1 July 2022 which discloses nucleotide or amino acid sequences (four or more amino acids or ten or more nucleotides) must include a sequence listing complying with WIPO Standard ST.26. The sequence listing can be filed after the filing date, in which case it does not form part of the disclosure of the application.
The EPO's practice for divisional applications allows the benefits of the new standard to materialise sooner. The practice followed by the EPO is similar to that in the USA, Japan, Germany, France, Denmark and Norway.
For more details, see OJ EPO 2021, A97.
Yes. The sequence listing from the parent application can be submitted in PDF format on the filing date as part of the disclosure of the divisional application.
You can also file the application by reference to a previously filed application, under Rule 40(1)(c) EPC. In that case, the full description of the parent application is used as the description of the subsequent application. If the description of the previously filed application contained a sequence listing on its date of filing, then that sequence listing forms part of the subsequent application.
An additional page fee may be due in both of the above scenarios (Rule 38(2) EPC and Article 2(1), item 1a, RFees). You will also have to subsequently submit a sequence listing in ST.26 format. A late furnishing fee (Rule 30(3) EPC) will have to be paid to cover the additional administrative burden for the EPO unless the ST.26 sequence listing is filed before the issuing of an invitation under Rule 30(3) EPC.
Yes, a standard-compliant sequence listing can be submitted after the date of filing. It will not form part of the disclosure of the application and instead is used only for search purposes. As a consequence, no added subject‑matter issues (Article 76 EPC) can arise from such a sequence listing.
As an applicant, it is recommended that you use the WIPO Sequence software tool to create sequence listings compliant with WIPO Standard ST.26. This standard has been supplemented by two guidance documents, Annexes VI and VII, the latter of which deals specifically with the transformation of a sequence listing from ST.25 to ST.26. Annex VII also contains guidance on how to avoid adding subject‑matter during transformation.
Annex VII to WIPO Standard ST.26 provides guidance on how to transform an ST.25 sequence listing into an ST.26 sequence listing without adding or deleting subject-matter. It is highly recommended that you follow this guidance. In particular, the teaching in the description accompanying the ST.25 sequence listing must be checked very carefully to avoid added subject-matter.
Scenario 8 in Annex VII to WIPO Standard ST.26 lists the ST.25 feature keys that are not available in ST.26 and describes how to represent such ST.25 feature data in ST.26 format without introducing added or deleted subject‑matter.
In WIPO Standard ST.26, the feature key "source" is mandatory for every sequence, in addition to the qualifiers "organism" and "mol_type" (paragraph 75 of WIPO Standard ST.26).
The value of the "mol_type" qualifier has to be selected from a list of predetermined terms as defined in Annex I of the standard (section 6, qualifier mol_type 6.39; section 8, qualifier mol_type 8.1).
Annex VII to WIPO Standard ST.26 provides guidance on how to transform an ST.25 sequence listing into an ST.26 sequence listing without adding or deleting subject-matter. It is strongly recommended that you ensure that the transformation has been accurate before proceeding to the filing step. If in doubt as to whether the conversion to ST.26 format has been successful or is complete, the content from the earlier sequence listing (priority/divisional) could be repeated in the main body of the later application. You must therefore check the transformation very carefully and, if you have doubts about its quality, consider inserting specific points in the description of the application.
If you have activated the Mailbox, a sequence listing forming part of the description in TXT format or XML format will be included as a ZIP file in the communication under Rule 71(3) EPC. If you have not activated the Mailbox, a link (URL address) to download the sequence listing from the European Patent Register in TXT or XML format will be included in the communication under Rule 71(3) EPC. In the Register, sequence listings in ST.26 XML format will be displayed as Sequence listing in ST.26 (.XML) in the list of document types in the All documents view. The document type identifier for sequence listings in ST.25 TXT format will be Sequence listing.
For more details, see OJ EPO 2021, A97, points 37 and 41, and information on the European Patent Register.
The implementation of the proposed functionality to link to the sequence listing in its original TXT format in the communication under Rule 71(3) EPC will be available from 2 November 2022. Until then, the EPO will continue to convert sequence listings filed in TXT format into PDF format. The sequence listing in PDF format will be included in the communication under Rule 71(3) EPC when notified to the Mailbox. For postal notification, the EPO will continue to print the sequence listing in PDF format or, if the sequence listing contains 400 or more pages, provide it on a data carrier as part of the communication under Rule 71(3) EPC.
From 2 November 2022, sequences listings that form part of the description will be published in the original format received (TXT or XML format) in both the A- and the B-publication. Sequence listings in the original filing format will be made available on the EPO publication server by including them in the ZIP file containing the relevant publication documents.