USPTO Issues Final Rule Adopting WIPO Standard ST.26 for Sequence Listing Submissions | Practical Law

USPTO Issues Final Rule Adopting WIPO Standard ST.26 for Sequence Listing Submissions | Practical Law

The US Patent and Trademark Office (USPTO) has issued a final rule adopting World Intellectual Property Organization (WIPO) standard ST.26 and making other changes to the rules for disclosing and submitting amino acid and nucleotide sequence listings with patent applications. The changes apply to applications filed on or after July 1, 2022.

USPTO Issues Final Rule Adopting WIPO Standard ST.26 for Sequence Listing Submissions

by Practical Law Intellectual Property & Technology
Published on 20 May 2022 • USA (National/Federal)
The US Patent and Trademark Office (USPTO) has issued a final rule adopting World Intellectual Property Organization (WIPO) standard ST.26 and making other changes to the rules for disclosing and submitting amino acid and nucleotide sequence listings with patent applications. The changes apply to applications filed on or after July 1, 2022.
On May 20, 2022, the USPTO issued a final rule adopting World Intellectual Property Organization (WIPO) standard ST.26 and making other changes to the rules for disclosing and submitting amino acid and nucleotide sequence listings with patent applications (87 Fed. Reg. 30806 (May 20, 2022)).
Key features of the new system include:
  • A requirement for a single sequence listing submission in XML format filed electronically or on an optical disc.
  • Broader and clearer definitions of covered sequences, including modified sequences.
  • Standardized identifiers for sequence units in International Nucleotide Sequence Database Collaboration (INSDC) format, which is compatible with the GenBank database.
  • Elimination of the option to include non-covered sequences within a sequence listing submission.
  • Uniformity among all WIPO members, simplifying the submission process.
Applicants can find additional information at the WIPO ST.26 FAQ page and use WIPO Sequence software to prepare and validate sequence disclosures.
The USPTO believes the new requirements will:
  • Result in better preservation, accessibility, and searching of sequence data.
  • Enhance public database content.
  • Because of the single sequence listing requirement, eliminate the potential for differences between multiple sequence listing submissions.
The new sequence listing requirements:
  • Apply to patent applications filed on or after July 1, 2022.
  • Will be codified in 37 C.F.R. §§ 1.831 to 1.839, which incorporate ST.26 by reference.
In addition to ensuring that new original patent applications comply with the new standards, patent counsel must ensure to make the necessary revisions when filing continuing applications based on applications filed under the old rules.