July 1, 2022
Biotechnology Practice Area
Are You Ready for WIPO Standard ST.26?
If you file patent applications that disclose DNA, RNA or amino acid sequences, you may have already heard about the new WIPO Standard ST.26. ST.26 replaces the former standard, WIPO Standard ST.25 and lays out the requirements for presenting nucleotide and/or amino acid sequences in patent applications. The new Standard applies to international applications filed on or after July 1, 2022. As of the same date, Members States also apply the new Standard to national and regional patent applications.
ST.26 seeks to harmonize sequence listing practices across all patent offices, reflect advances in biotechnology and meet international sequence database requirements. For example, ST.25 (last updated in 2009) fails to capture some of the growing sequence types present today, such as branched sequences, D-amino acids and nucleotide analogs. In addition, ST.25 is not compliant with current public sequence database requirements, meaning that ST.25 data can be lost during transfer to sequence databases. Further, with ST.26 being structured data, patent Offices and applicants alike will benefit from automated validation and improved searching capabilities.
The most apparent difference between ST.25 and ST.26 is the file format. Compared to TXT or PDF under ST.25, ST.26 requires sequence listings to be provided in XML. Sample of ST.26 sequence listing.
For those concerned that sequence data may not be easily readable amid the XML tags, the WIPO Sequence software (additional information below) allows you to import XML sequence listings and view sequences and related information in a more user-friendly way. Additionally, WIPO plans to incorporate a sequence listing reader in PATENTSCOPE which will display sequence listings in published applications in a human-readable format.
Other notable changes involve the requirement to include additional sequence types mentioned above—specifically, D-amino acids, linear portions of branched sequences and nucleotide analogs. Further, ST.26 prohibits the inclusion of small sequences (<10 specifically defined nucleotides or < 4 specifically defined amino acids). Under ST.26, amino acids are now represented by a single capital letter rather than three-letter codes, and uracil in RNA is represented by “t” rather than “u”. For a more detailed explanation of the changes, refer to ST.26 webinars linked below under Resources.
WIPO, in close collaboration with national and regional patent offices, developed and released WIPO Sequence, a free desktop software that helps you generate standard-compliant sequence listings and validate them against ST.26 requirements. WIPO Sequence will also help you transform ST.25 into ST.26 and inform you where additional information is required under ST.26. While WIPO Sequence is intuitive, if you need additional help, a crash course webinar on how to use the software is linked below. Also, sign up for the mailing list to receive notifications of WIPO Sequence software updates. If you have any questions regarding drafting your sequence listings using WIPO Sequence, there is both a user manual published on the WIPO website as well as the knowledge base of WIPO Sequence and ST.26.
We recommend filing PCT applications using ePCT. ePCT allows you to prepare and file PCT application with 79 participating receiving Offices (including RO/IB) with real-time validation features to help prevent errors. Starting July 1, 2022, ePCT will only permit sequence listings to be uploaded as XML files, in accordance with ST.26.
For the receiving Offices that require filing via Office-specific filing systems (e.g., RO/CA, RO/IL and RO/US), you may still use ePCT to prepare the request form (Form PCT/RO/101) and benefit from the validation features. You will then download the application package from ePCT and upload it to the receiving Office filing system.
To the extent that your receiving Office does not accept ePCT for the filing of international applications, you should use the filing software provided by your receiving Office of choice which should enable you to file sequence listings in accordance with ST.26.
As indicated above, ST.26 enters into force in respect of all patent applications (national, regional and PCT) having a filing date on or after July 1, 2022. Any PCT application filed on or before June 30, 2022 should continue to comply with ST.25 through national/regional phase. Be extra careful as ST.26 applies to applications based on the filing date and not the priority date!
Any priority application filed on or before June 30, 2022 should also continue to comply with ST.25. If you are concerned about inadvertently introducing new matter under ST.26 when claiming priority to applications filed under ST.25, ST.26 Annex VII provides recommendations on how to transform ST.25 sequence listings into ST.26 without introducing new matter.
Start with an introductory webinar on ST.26 and explore additional trainings and resources below!