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2.29.9 Requirements for Amino Acid and Nucleotide Sequences on Compact Disc or Other Electronic Means

Date Published

Requirements for Amino Acid and Nucleotide Sequences for applications filed on or after 1 July 2022

The supplied sequences must be in a format which complies with the WIPO ST.26 standard (Patent Formalities Determination (sec 16)).

The sequence listing can be filed in the appropriate format via e-Services. Examiners should also note that it is possible for sequence listing and identifying data to be provided to the Office on physical media such as a CD, DVD etc (see CD Requirements). In such cases the files contained on the CD or physical media will need to be in the format approved by the Commissioner, i.e WIPO ST.26 compliant. 

ST.26 Requirements

WIPO ST.26 standard requires the listing to be provided in a particular XML format.

To help patent applicants and filers comply with WIPO Standard ST.26, WIPO has made available the WIPO Sequence tool.  XML sequence files generated using WIPO Sequence software will be compliant with WIPO ST.26. Users of WIPO Sequence are encouraged to join the WIPO subscription list, where details regarding all upcoming releases and other important announcements will be provided. Users can subscribe by completing this online form.

ST.26 Compliance Check

The Office will conduct compliance checking of all sequence listings accompanying applications filed on or after 1 July 2021. Compliance checking will be performed using the WIPO Sequence tool.

Where it is determined that the sequence listing does not comply with the ST.26 Standard a formalities notice will be issued.  Applicants will then be afforded a period of two (2) months from the date of issue of the formalities notice to prepare and file a ST.26 compliant sequence listing.

The corrected sequence listing can be submitted in the normal manner via e-services. When submitting the corrected listing it is also recommended that applicants provide an explanation of the changes or otherwise indicate that that the content of the resubmitted sequence is in the accepted format and that no new matter has been added.

​​​​​​​Requirements for Amino Acid and Nucleotide Sequences for applications filed before 1 July 2022  

Applicants may file an amino acid or nucleotide sequence on a compact disc (CD) or other electronic means. The supplied sequences must be in a format approved by the Commissioner, i.e. the sequences must comply with the standard provided for in Annex C of the Administrative Instructions under the PCT.  The software known as PatentIn conforms to the format specified in the Annex and is available at:

http://www.uspto.gov/patents/resources/tools/checker/patentinrel.jsp

For national applications, examiners should note that a computer readable form of a sequence listing on CD is instead of any written sequence listing in the application, rather than in addition to the sequence listing as required for applications filed under the PCT. (Paragraphs 39 and 40 of Annex C of the Administrative Instructions do not apply.) The sequence listing and identifying data can be provided to the Office on CD as a general text file generated by PatentIn, or as a text file identical to that generated by PatentIn.

Note: The provision of sequences in electronic form is optional. Applicants may therefore choose to supply such sequences in printed form. Examiners cannot request that applicants supply sequences in electronic form.

Note: The relevant provisions are:

>•  Formalities Determination (sec 16)
•  Schedule 3 (clause 12).

See 2.29 Formalities and Forms for further information.


CD Requirements

The entire printable copy of the sequence listing and identifying data should be contained within one text file on a single standard (ISO9660) CD-ROM or CD-R in an uncompressed format. If the text file is too large for a single CD, then multiple CDs may be filed. Each CD should contain one text file only.

CDs will be subject to a formality check at the time of filing by COG. This will check for viruses, determine if there is a text file on the disc and whether it can be opened. However, it should be noted that the content of the CD will not be checked in any way and the onus is on the applicant to ensure that all the desired sequences are actually on the CD. Where a CD is supplied, but does not comply with the requirements, e.g. the information is unreadable or the CD has a virus associated with it, the applicant will be issued with a formalities notice and asked to supply a substitute CD.

Any amendment to the CD must be made by submitting a substitute CD. Any correction or amendment of the CD is subject to the normal provisions of the Act, including that the amendment must be allowable under sec 102.


Note: The CD must be submitted as part of the application. If a CD is submitted later, it must be accompanied by a request under sec 104 and will be subject to the normal provisions for amendments.

Amended Reasons

Amended Reason Date Amended

Proposed amendments reflect changes to the MPP concerning the implementation of the ST.26 standard which come into effect on 1 July 2022.

Please note that I have:

- amended the suggested first sentence under the heading "Requirements for Amino Acid and Nucleotide Sequences for applications filed on or after 1 July 2022" as the sentence suggested appeared to contain a typographical error.

- set up the hyperlinks so the hyperlinked pages open in a new window as I thought this would be more convenient for examiners.

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