On July 1, 2022, the new WIPO standard ST.26 for sequence protocols entered into force.
It will be implemented by the patent offices of countries and organizations that are members of WIPO worldwide. As a result, the previous standard ST.25 will no longer apply to patent applications filed on or after July 1, 2022. All applications filed on or after that date that disclose amino acid and nucleotide sequences must include an ST.26 XML-compliant sequence listing
How will applicants be assisted in creating the ST.26 standard sequence listing?
To enable applicants to create a sequence listing that complies with the ST.26 standard, WIPO has made available a desktop program called "WIPO Sequence" (download link). Although it is theoretically possible to create a corresponding format-compliant XML document with an ordinary text editor, this can only be strongly discouraged due to the syntactic and content complexity of the standard and the sequence data.
How is the new WIPO standard ST.26 validated by the patent offices?
The patent offices use a service provided by WIPO, the "WIPO Sequence Validator", to validate the submitted sequence listings.
Applicants who create their sequence listing because of the "WIPO Sequence Program" and have it checked as valid can therefore assume that the file also satisfies the formal requirements of the patent offices worldwide. All offices use practically the same WIPO service for validity checks.
What are the advantages of the new WIPO standard ST.26?
From the applicant's perspective, the introduction of ST.26 is to be welcomed. First, it standardizes the practice of patent offices in validating sequence listings. The new standard also allows for greater diversity of sequence information related to non-standard sequence features, which have become more important recently. The main advantage, however, may be that "WIPO Sequence" greatly simplifies the creation and validation of complex sequence protocols, which may include hundreds of sequences. There is a "bulk edit function" and also the import of sequences in FASTA format is possible. This helps to avoid copy-and-paste errors.
Can problems occur when filing according to WIPO standard ST.26?
However, difficulties may arise with divisional applications filed on or after July 1, 2022, which are based on a parent application filed before July 1, 2022 (and for which ST.25 accordingly continues to apply). In this case, the European Patent Office requires a conversion of the ST.25 stem sequence protocol to an ST.26 protocol. When converting ST.25 to ST.26 sequence protocols, it cannot be ruled out at this stage that this will (have to) result in the inclusion of information in the ST.26 sequence protocol that is not contained in the ST.25 protocol of the parent application. The Biotechnology Committee of the epi has expressed concerns regarding this practice of the EPO (link).
Our attorneys are happy to assist you with sequence listing or other issues in the context of biotechnology inventions. This notice is for general informational purposes only and should not be used as a substitute for legal advice regarding your particular circumstances. Kindly note that the law may change since the date of publication of an article, and there may be circumstances to consider in your particular case that this generalized article did not address.
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Author: Dr. Thorsten Barnickel