On 1 July 2022 a new standard for patent applications which include biological sequence listings will come into effect. This change is being adopted by all WIPO contracting states. It will apply to all new patent applications filed here at the IPO. This includes new divisional applications and new international PCT (Patent Cooperation Treaty) applications.
The new standard is WIPO ST.26 The full description and definition of WIPO ST.26 is available on the WIPO website. In summary it applies to all patent applications which include sequence listings of:
- any nucleic acid sequences (DNA, RNA) having ten or more fully defined residues and
- any peptide (including cyclic peptides) sequences having four or more fully defined residues
The new standard specifies biological sequence listing must be in electronic XML format. Applicants can use new software, WIPO Sequence, to compile their sequence listings. This will generate XML files compliant with WIPO ST.26 WIPO Sequence is available to download from the WIPO website.
Filing international PCT (Patent Cooperation Treaty) applications containing biological sequence listings
From 1 July 2022 all new international PCT (Patent Cooperation Treaty) applications which include biological sequence listings must include the sequence listing in the ST.26 file format. The International Search Authority will examine the sequence listings.
Filing UK national patent applications containing biological sequence listings
For UK national applications, EOLF and online web-filing services will accept the ST.26 XML files from 1 July 2022. XML sequence files generated using WIPO Sequence software will be compliant with WIPO ST.26
Your application will have a preliminary examination. The examination will identify if your application refers to or includes a biological sequence listing. It will also confirm compliance with WIPO ST.26
If your application includes a biological sequence or sequence listing but it does not comply with WIPO ST.26, you will have 15 months from the filing date to provide a compliant sequence listing. If you only put the sequence listing in the description or as a drawing, this will not comply with WIPO ST.26.
If your application mentions a biological sequence or sequence listing but you do not include it when you file your application, you will have two months to file it. We will treat this as a missing part of the application. The filing date of your application will be reset to the date on which the sequence is received.
Filing amended biological sequence listings
If you amend your biological sequence listing, you must include a declaration it does not add matter to your original filing. This includes amendments to overcome objections in the preliminary examination report.
Filing divisional patent applications containing biological sequence listings
For new divisional patent applications filed on or after 1 July 2022, the sequence listing should be supplied in the format required for the parent application. For a parent application filed on or after 1 July 2022, this must be ST.26. This is a change compared to our original plan. This change was made in response to feedback from our stakeholders and further consideration of what is required under UK law.
Additionally, the biological sequence listings must not add matter beyond the parent application. You must include a declaration that the sequence listing does not add matter.
Preparing for the changes
All patent applicants and attorneys are advised to prepare for the changes early. If this applies to you, we strongly encourage you to familiarise yourself with using WIPO Sequence ahead of 1 July 2022.
If you currently file, or plan to file, this type of patent at the IPO, we’d value your feedback via this survey.
https://www.gov.uk/government/publications/changes-for-patent-applications-with-biological-sequence-listings
Content Reproduced verbatim from the Website of the United Kingdom Intellectual Property Office (UKIPO) as permitted under their Terms of Use.