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Brand New requirements for patent applications with biological sequence listing

December 20, 2021

By Renu Bala and Johny Soloman Raj

A new standard for patent applications that incorporate biological sequence listings will take effect on July 1, 2022. All WIPO contracting states have adopted this standard and from that particular date all new patent applications filed at the IPO will be subject to this rule. This will be including new divisional applications as well as international PCT (Patent Cooperation Treaty). Applicants can now compile their sequence listings using WIPO sequence, a new software which will be available on the WIPO website.

The new standard is WIPO ST. 26 which has come to address the issues with the existing format which are not meeting the requirements of the international; Nucleotide Sequence Database Collaboration (NSDC), which could lead to data loss from public databases. The ST.25 rules are also a little hazy, resulting in varying interpretations and enforcement between patent offices. Furthermore, the current ST.25 standard fails to account for a growing number of modified nucleotides and amino acid residues.

Under this ST.26, if a biological sequence or sequence listing is included in an application but does not comply with WIPO ST.26, the applicant has 15 months from the date of filing to furnish a complying sequence listing. Furthermore, if a biological sequence or sequence listing is mentioned in an application but is not included when it is first filed, the applicant is given two months to file the sequence. The application’s filing date will be reset to the day the sequence is received.

There are other changes as well which are summarized below.

  • To address data loss associated with INSDC format compatibility and make data exchange both human- and machine-readable .xml file types (rather than.txt) are required.
  • Sequences containing fewer than ten specifically defined nucleotides or fewer than four specifically defined amino acids (excluding ‘n’ or ‘x’) are no longer permitted.
  • D-amino acids, branched sequences, and nucleotide analogues are now required.
  • Additional annotation options for sequences are now available.
  • The definition of sequence identifiers has been refined (e.g. mRNA, tRNA).
  • The organism name options have been updated (for example, “artificial construct” has been changed to “synthetic construct”).
  • The letter “t” now stands for uracil in RNA and thymine in DNA.
  • Three-letter codes for amino acids are favored over single-letter ones.
  • It is no longer necessary to define the variables “n” and “X.”
  • The format of the feature location has changed.
  • Mixed-mode sequences are no longer allowed.
  • Only the most recent priority information (rather than all of it) can be included.
  • There are a few more simple changes to the language requirements

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