Proposed rulemaking to implement WIPO Standard ST.26September 7, 2021

Patent applications containing nucleic acid or protein sequences will be required to submit a sequence listing in compliance with the new WIPO Standard ST.26 beginning on January 1, 2022. With the implementation of the new standard coming soon, the USPTO has issued a notice of proposed rulemaking to revise the rules of practice for submitting sequence data.

The notice addresses a number of outstanding questions in regard to how the new standard will be implemented at the USPTO.

Continuing Patent Applications

According to the proposed rules, any application that has a filing date on or after January 1, 2022 would be required to contain a sequence listing in accordance with Standard ST.26. The USPTO is proposing that this would include applications that claim priority to applications with filing dates before January 1, 2022. In other words, if a prior application to which priority is claimed contained a sequence listing in the previous Standard ST.25 format, the applicant would be required to convert that sequence listing to Standard ST.26 format for inclusion in the new application.

New Software

The WIPO Sequence software would replace the current USPTO PatentIn software for preparation and validation of sequence listings. One frequently mentioned concern with the new XML format is that it can be more difficult for humans to review and check for errors. However, WIPO Sequence can also generate a “human-readable” version of the sequence listing to facilitate review. WIPO is also developing a sequence listing validation tool, known as WIPO Sequence Validator, that will be synchronized with the validation function in the WIPO Sequence software. The notice states that the USPTO is integrating the same WIPO Sequence Validator into its internal systems, thereby providing a greater level of confidence that a sequence listing complies with the USPTO rules and will be accepted.

The full text of the notice is available at the Federal Register. A general overview of the new sequence listing standard was previously published in the December 2020 MVS Briefs.

Brian D. Keppler, Ph.D. is a registered Patent Agent in the MVS Biotechnology & Chemical Practice Group. To learn more, visit our MVS website, or contact Brian directly via email.