Sequence Listings in Patent Applications: USPTO Adopts Updated WIPO Standard | Morgan Lewis

The US Patent and Trademark Office (USPTO) finalized the adoption of version 1.7 of the World Intellectual Property Organization (WIPO) Standard ST.26, effective July 1, 2024. This standard, integral for disclosing and submitting amino acid and nucleotide sequence listings within patent applications, ensures greater consistency in technical terminology and enhances the descriptions of such sequences.

Initially incorporated by reference in 2022, WIPO Standard ST.26 mandates the submission of sequence listings in an eXtensible Markup Language (XML) format. This requirement not only streamlines the filing process across multiple jurisdictions but also facilitates improved data preservation, accessibility, and organization.

BACKGROUND AND OVERVIEW

On December 8, 2023, WIPO adopted a new version (version 1.7) of WIPO Standard ST.26 to introduce modifications aimed at ensuring consistency and clarity of technical terminology across related documents. Revisions to WIPO Standard ST.26 under version 1.7 affect the main body and Annex VI. The changes to the main body improve the consistency of technical terminology. For example, in paragraph 3(f), all instances of “3′-monophosphate” were changed to “5′-monophosphate” to be consistent with paragraph 3(g) and standard nucleotide naming conventions.

In addition, updated Annex VI provides two new illustrative examples (Examples 7(a)-7 and 7(a)-8 in Annex VI) that demonstrate how sequences with inverted nucleotides should be included in a sequence listing. In particular, those examples illustrate how to properly represent a DNA molecule in the sequence listing by including two sequences (i.e., two SEQ ID NOs) within the sequence listing when the directionality of the DNA sequence changes within the strand.

The adoption of version 1.7 is classified as a procedural update. The update does not impose additional requirements or applicant fees and, as such, does not require a notice-and-comment period typically mandated under the Administrative Procedure Act. This adoption aligns with precedents that exempt procedural modifications from extensive regulatory reviews.

IMPLICATIONS FOR PATENT APPLICANTS

The USPTO’s integration of WIPO Standard ST.26 version 1.7 reflects ongoing efforts to harmonize the technical aspects of patent documentation globally. While the changes are only procedural, they play a critical role in maintaining the integrity and consistency of patent applications involving detailed biological sequences.

With the enforcement of the updated standard, applicants are encouraged to review their sequence listings for compliance with the newly adopted terminology and formatting guidelines. While the changes are predominantly ministerial and do not impose additional substantive requirements on filers, adherence to these updated guidelines is important for ensuring that a patent applicant doesn’t get bogged down with the time and expense of resubmitting sequence listings to comply with the new rules.

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