On July 1, 2022, a new sequence listing format, World Intellectual Property Organization (WIPO) Standard ST.26, will replace the current ST.25 standard in the WIPO and in the national patent offices of all WIPO member states.[1],[2] There is no transition period between the standards, and thus, all applications with a filing date of July 1, 2022, or after must comply with the new ST.26 format.
Key Differences between ST.25 vs. ST.26
Feature | ST.25 | ST.26 |
File format | TXT | XML |
Sequences with <10 nucleotides or <4 amino acids | Permitted | Prohibited |
Listing of:
– linear portions of branched sequences |
Not required | Required |
Sequence type identifiers | DNA, RNA, PRT only | DNA, RNA, PRT, and mol_type qualifier (e.g., mRNA, tRNA) |
Letter for Uracil | U | T |
Amino Acid Abbreviations | Three-letter | One-letter |
“X” and “n” variables | Requires definition in feature key | Assumes default value (n is T, A, G, C; X is any natural amino acid), no definition required |
“Mixed mode” sequences (nucleotide sequences with amino acid translation below) | Permitted | Prohibited |
Application Information | All priority information, all applicants, all inventors may be listed | Only the earliest priority application, one applicant, and one inventor may be listed |
Creating an ST.26 Sequence Listing
WIPO has developed a desktop tool, WIPO Sequence, to support authoring, validation, and generation of ST.26-compliant sequence listings.[3] ST.25 sequence listings, .RAW files, and FASTA files may be imported into the WIPO Sequence software for creating an ST.26 sequence listing.
Implementation of ST.26 at the USPTO[4]
All applications with a filing date or international filing date before July 1, 2022 MUST file sequence listings in ST.25 format.
All applications with a filing date or international filing date on or after July 1, 2022 MUST file sequence listings in ST.26 format.
Filing an ST.26 Sequence Listing at the USPTO
The USPTO’s EFS-Web filing system does NOT support uploading of ST.26 sequence listings (i.e., XML files). ST.26 sequence listings may ONLY be uploaded and filed via the USPTO’s new Patent Center filing system, or on a read-only optical disc.
If an applicant erroneously files an ST.25 sequence listing in an application that requires an ST.26 sequence listing, the USPTO will issue a Notice to Comply with the Sequence Rules, which provides the applicant with a deadline for correction. The ST.25 sequence listing may be used to provide support for the submission of the ST.26 sequence listing.[5]
Implementation of ST.26 in International (PCT) Applications
PCT applications filed on or after July 1, 2022, will only accept ST.26 sequence listings as part of the description.
Any PCT application filed on or after July 1, 2022, with an ST.25 sequence listing will NOT treat the sequence listing as part of the description. The ST.25 sequence listing may NOT be converted to ST.26 format after filing as a “formal correction.” Any ST.26 sequence listing provided subsequent to filing may serve for search purposes only under Rule 13ter. An ST.26 sequence listing may be filed as an amendment under Article 34, provided that basis for the sequence listing is found in the application as filed.
Implementation of ST.26 in Other Regional/National Offices
While all regional and national offices will transition from ST.25 to ST.26 on July 1, 2022, each regional/national office sets its own rules for implementation of the ST.26 standard for divisional applications. The general guidelines for the European Patent Office (EPO), Japan Patent Office (JPO), and Korean Intellectual Property Office (KIPO) are summarized below:
Additional Resources
The USPTO has launched a new Sequence Listing Resource Center to assist applicants and patent practitioners during the ST.26 transition.
The WIPO Sequence Suite provides the latest news, software updates for WIPO Sequence, and information regarding training sessions.
[1] See “STANDARD ST.26,” version 1.5, World Intellectual Property Organization Handbook on Industrial Property Information and Documentation, November 2021.
[2] See “FAQ: Implementation of WIPO ST.26,” World Intellectual Property Organization, accessed at https://www.wipo.int/standards/en/sequence/faq.html.
[3] Available at https://www.wipo.int/standards/en/sequence/index.html.
[4] See Section f. “Applicability,” 87 Fed. Reg. 30806, May 20, 2022.
[5] See id.
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