Everything to Know about the New WIPO Sequence Listing Standard – ST.26

 The inclusion of a sequence listing is crucial in patent applications that disclose nucleotide or amino acid sequences, as it helps examiners understand the invention and compare it to prior art. All DNA and protein sequences must be incorporated into the patent specifications according to the guidelines established by patent and trademark offices (PTOs). To ease comprehension, these sequences must have a defined structure. Sequence listing is the process of taking raw sequences and inserting them into the necessary format as per the rules of the patent office.


A sequence listing identifies the gene or protein and provides the entire sequence using "SEQ ID NO." (for example, SEQ ID NO: 1). If a patent application discloses nucleotide and/or amino acid sequences, a sequence listing that complies with the WIPO's criteria must be submitted to the concerned intellectual property office (IPO). The primary goal of a sequence listing is to make sequence data searchable by intellectual property offices and the public. For instance, some patent offices, including the EPO and USPTO, provide sequence data through publicly available databases like EMBL and NCBI. Therefore, a standard international format helps ensure seamless transfer and searching of data between and on such databases.


Sequence listings solve a critical problem that inventors and patent offices often face. They offer a systematic way to compile all biological sequence information provided in a patent application into one document, facilitating the recording and transmission of biological sequence data from patent applications to searchable databases used by public and national patent offices. Therefore, including a sequence listing that satisfies the standard requirements outlined by international organizations is crucial, regardless of whether the invention was created synthetically, organically, or artificially.


Before the new sequence listing standard ST.26, all sequence listings in patent applications had to comply with the WIPO's ST.25 sequence listing standard. The new ST.26 standard aims to harmonize the way nucleotide and amino acid sequence listings are submitted in patent applications worldwide, improving the accuracy and benchmark of nucleotide and amino acid sequences provided in international applications. In accordance with the requirements, the applicant can create a single sequence listing application that will be accepted by all receiving offices. It also facilitates sequence searching and eases the exchange of sequence data in electronic form, benefiting applicants, the general public, and examiners. Failure to meet the sequence listing standards can lead to the rejection of a patent application.


Benefits of ST.26 Sequence Listing Standard


The new ST.26 standard brings a number of benefits to patent applicants, patent offices, and the public. Some of the key benefits are:


Compatibility: The new standard is designed to be compatible with the latest technology and software used by patent offices and applicants, ensuring hassle-free transfer and searching of data between and on various databases.


Accuracy: The ST.26 standard makes it easier to ensure the accuracy of the sequence listing, with clear rules and guidance for how the data should be presented and organized.


Harmonization: The new standard aims to harmonize the way sequence listings are presented across different patent offices, simplifying the process for applicants who file in multiple jurisdictions.


Efficiency: The ST.26 standard streamlines the process of preparing and submitting a sequence listing, reducing the time and resources required to comply with the guidelines.


Accessibility: With a standardized format, the ST.26 standard makes it easier for the public and examiners to search and access sequence information in patent applications.


Future-Proofing: The ST.26 standard is designed to be adaptable and flexible, able to accommodate future developments in the field of biotechnology and the changing needs of patent offices and applicants.


Shortcomings of ST.25 Sequence Listing Standard


While the ST.25 standard served as a useful guideline for patent applicants and offices for many years, there were several shortcomings that needed to be addressed. Some of the main issues with the ST.25 standard were:


Limited Compatibility: The ST.25 standard was not always compatible with the latest software and technology used by patent offices and applicants, making it difficult to transfer and search for data between different databases.


Inconsistent Presentation: The ST.25 standard allowed for some flexibility in how the data was presented, leading to inconsistencies in the way sequence listings were formatted and organized.


Lack of Harmonization: The ST.25 standard was not universally adopted by all patent offices, leading to differences in how sequence listings were accepted and reviewed across different jurisdictions.


Complexity: The ST.25 standard was complex and difficult to understand for some applicants, leading to errors and inconsistencies in the way the data was presented.


What’s New in ST.26 Sequence Listing Standard?

The ST.26 standard has brought about several noteworthy changes to the sequence listing requirements. Here are some of the key updates:


  • XML format is now required for sharing sequence listings, replacing TXT or PDF used in ST.25. This allows for better sequence representation, automates data verification, and simplifies IPO procedures.
  • General information only requires a single applicant and inventor name, and changes to this information are formal rather than substantive.
  • Priority information now only needs the oldest priority, and multiple invention titles can be submitted in various languages.
  • Sequences must be designated as DNA, RNA, or AA, along with a mandatory qualification for accurate identification.
  • Unlike ST.25, which only required L-amino acids, ST.26 mandates the inclusion of D-amino acids, nucleotides, branched sequences, and analogs.
  • A single sequence listing can be adopted globally, with language translations as necessary.
  • The standard specifies the required sequence disclosures, allowable sequences, and representation formats.
  • Small sequences are no longer allowed under ST.26.
Putting ST.26 Standard into Practice with WIPO Sequence Listing Software

The WIPO Sequence Suite is an XML file editing tool that adheres to the ST.26 standard and is recommended for creating sequence listings under the new rules. The software was developed in partnership with patent offices globally and can import various file types, including ST.25 and ST.26 sequence listings, multi-sequence format files, and more. The software features an easy-to-use interface and allows users to add feature keys and qualifiers to sequences by selecting from drop-down options. It also enables users to validate and verify project data and create human-readable project data for review. In addition, the software can save unique applicant and inventor details, record unique organism names, and facilitate the translation of free text qualifier values. Overall, the WIPO Sequence Suite makes it simpler for applicants to construct and validate ST.26-compliant sequence listings.

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