Starting from July 1, 2022, the Korean Intellectual Property Office (the “KIPO”) has amended (i) the Enforcement Rules and Notification of the Patent Act and (ii) the Notification on the Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in accordance with the World Intellectual Property Office’s (the “WIPO”) new ST.26 standard for nucleotide and amino acid sequence listing (the “ST.26 (XML)”). 

The ST.26 has been introduced to address some of the shortcomings of the previous ST.25 (TXT) WIPO standard.  For example, the ST.25 did not require a common format or structure so intellectual property offices worldwide interpreted and enforced their rules regarding sequence listings differently, creating difficulties in exchanging or entering data for patent applications in each country.  In particular, as the ST.25 was not compliant with internationally recognized nucleotide sequence database requirements, it was sometimes difficult to identify the sequence information despite the disclosure of sequence listings following the ST.25 standard.

As a result, at the fifth session of the Committee on WIPO Standards (the “CWS”) held in 2017, the Member States of the WIPO agreed to adopt the Recommended Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings using XML for all national, regional and international-level patent applications containing sequence listings.  Accordingly, the KIPO has also adopted the ST.26 (XML) system.

1.   Features of ST.26

The ST.26 requires sequence listings to be provided in a specific electronic file type and presentation format so that they are compatible with major international sequence database requirements.  Specifically, the ST26 has the following features compared to the ST.25: 

• XML file type
• Includes additional sequence types, specifically, D-amino acids, linear portions of branched sequences and nucleotide analogs
• Feature keys must be used, along with associated qualifiers
• Prohibits the inclusion of small sequences (<10 specifically defined nucleotides or < 4 specifically defined amino acids) in the e-file

2.   Changes to Patent Applications Containing Sequence Listing

With the entry into force of this amendment, any patent or utility model application requiring an attached sequence listing must include the submission of an e-file of the sequence list prepared (i) in accordance with the WIPO Standard ST.26 or (ii) using WIPO Sequence, a free desktop software developed and released by the WIPO .  A sequence listing so submitted has the same effect as described in the “Description of the Invention” of the specification.  However, for the prohibited small sequences listed above, only the sequence identification number assigned to the sequence is included in the e-file of the sequence listing, while specific sequence information is intentionally omitted, and the specific details of the sequence should be disclosed in the description ([Sequence List] column) or drawings.

If the sequence listing e-file in XML format is not submitted with the application, or if a submitted listing does not comply with the ST.26, it is subject to a correction order by the KIPO.  As the electronic file of sequence listing is deemed to have been described in the “Description of Invention” of the specification, the amendment to the electronic file of sequence listing may be made only to the extent that no new matters are added as is the case with other amendments of the specification.

3.   Applicability of New Standard

The new standard applies to all patent/utility model applications with a nucleotide or amino acid sequence having a filing date on or after July 1, 2022.  Specifically, the new standard applies to:

• Patent/utility model applications filed on or after July 1, 2022.
• Applications claiming priority following the Paris Convention that are filed on or after July 1, 2022 (not based on the priority date).
• PCT applications filed on or after July 1, 2022 and their national phase applications (based on the PCT application date, not the entry date of the national phase).
• Divisional applications, converted applications, split-off applications, or applications filed by a legitimate right-holder after filing by an illegitimate applicant, whose parent or original application was filed on or after July 1, 2022 (not based on the filing date of the follow-on application): for example, in case of a divisional application filed after July 1, 2022 whose parent application was filed before July 1, 2022, a sequence listing may be submitted in the ST.25 format.

Under the ST.26, the sequence listing must be submitted electronically in XML format (i.e., not on paper).  Since the new format is intended to include more details regarding the sequence compared to the old format, if the electronic sequence listing file prepared under the existing standard is amended to the file prepared under ST.26, an issue of new matter may arise unless those additional details are sufficiently supported by the originally filed specification.  Further, with respect to patent applications claiming priority, the applicability of this new standard to a patent application is determined based on the filing date of the application, not the priority date.  Thus, we would recommend paying extra attention to the format of the sequence listing to make sure that the right format is filed. 

As the WIPO member states have uniformly applied the new ST.26 standard to disclose the sequence listing, we expect that the sequence information for genetic sector patents filed in different countries will be more accurately identified in the future.