In order to improve the accuracy and quality of sequence listings, make sequence listings easier to disseminate, facilitate retrieval, and facilitate data exchange between different databases and import into computer databases, the World Intellectual Property Organization (WIPO) established a Standard ST.26 to replace ST.25 standard.

For domestic, regional or PCT international patent applications containing nucleotide or amino acid sequence listings, WIPO Member States were originally scheduled to uniformly transition from WIPO ST.25 to WIPO ST.26 from January 1, 2022 , but due to the impact of the COVID-19 new crown epidemic, the implementation will be postponed to July 1, 2022, and July 1, 2022 will be the "Explosion Day", that is, the date when all patent offices uniformly implement the WIPO Standard ST.26. Based on the fact that the sequence listing flaws may affect the approval of the patent application and the rights and interests of applicants, and EPO has proposed a more detailed explanation on the handling of sequence listing flaws, the introduction of this article is as follows:

In order to comply with the WIPO Standard ST.26, the EPO issued the Director-General's Decision on Sequence Listing Submission (hereinafter referred to as the Measures for Submitting Sequence Listings) on December 9, 2021, with a total of 6 articles, and further explanations on the Sequence Listing submission method (hereinafter referred to as the “Measures”) were provided, a total of 42 points, the handling process for further explanations on the sequence listing flaws in the European patent approval and examination procedure as follows:

1. European patent application

Article 6(1) of the Measures for Submitting Sequence Listings stipulates that this Measures for Submitting Sequence Listings will take effect on July 1, 2022, and Article 1(1) of the Measures for Submitting Sequence Listings stipulates that European patent applications such as disclosure of nucleotide or amino groups For acid sequences, the description shall contain a sequence listing in XML file format conforming to the WIPO Standard ST.26. In addition, in accordance with Article 1(2) of the Measures for Submitting Sequence Listings, the sequence listing submitted on the filing date will be disclosed or announced together with the patent application or the granted patent.

Articles 2 and 3 of the Measures for Submitting Sequence Listings stipulate different aspects of sequence listing defects and countermeasures, which are explained as follows:

(1) Article 2 of the method for submitting sequence listings: Failure to submit a sequence listing that conforms to the WIPO Standard ST.26.

Article 2(1) of the Measures for Submitting Sequence Listings stipulates that if the applicant fails to submit a sequence listing that complies with the WIPO Standard ST.26, EPO will require the applicant to comply with the regulations within 2 months in accordance with the provisions of EPC Rule 30(3). Sequence listing and payment of supplementary fees, and the period cannot be extended. In addition, based on the provisions of Article 2(2) of the Measures for Submitting Sequence Listings, if the sequence listing is supplemented after the filing date, it must be declared that the supplementary sequence listing does not involve content beyond the application.

Finally, the above-mentioned supplementary sequence listing and payment of supplementary fees are two separate acts. Therefore, if any of the acts is delayed, it is necessary to request further processing separately. In addition, in accordance with the provisions of EPC Rule 30(2), the sequence listing supplemented after the filing date is for search purposes only, does not constitute a part of the description, and cannot be used to determine the scope of disclosure at the time of filing, nor will it be related to the patent application or approval. The patent is published or announced together.

From the above it can be seen that the notification of EPC Rule 30(3) is issued by the receiving department, not the examiner, so it is recommended to make good use of the free software, that is WIPO Sequence Suite produced by WIPO, to make the sequence list, and indeed use its built-in check and confirmation function, to check sequence listings for formal errors that do not conform to WIPO Standard ST.26 to reduce the risk of deriving EPC Rule 30(3) notifications. In addition, the sequence listing supplemented after the filing date is only for search and does not constitute a part of the description, so the scope of disclosure at the time of filing is still determined based on the documents submitted on the filing date.

(2) Article 3 of the Measures for Submitting Sequence Listings: The file is unreadable, incomplete or infected by a virus

Article 3(1) of the Measures for Submitting Sequence Listings stipulates that if the file is unreadable or incomplete, the unreadable or incomplete part shall be regarded as uncommitted; where the file is infected with a virus or contains other harmful software programs, the file shall be regarded as unreadable under Article 3(2) of the Measures for Submitting Sequence Listings; and the sequence listing submission method Article 3(2) it is stipulated in the Article 3(2) of the Measures for Submitting Sequence Listings that where the circumstances indicated in Articles 3(1) and 3(2) of the Measures for Submitting Sequence Listings are found, the applicant shall be notified immediately, and shall be dealt with in accordance with the Article 2 of the Measures for Submitting Sequence Listings.

In addition, Article 1(4) of the Measures for Submitting Sequence Listings stipulates that if the sequence listing is also submitted in a file format acceptable to other application documents, the search will still only refer to the sequence listing that complies with the WIPO Standard ST.26. In accordance with Article 1(1) of the Measures for Submitting Sequence Listings in the Point 6 of Supplementary Measures, only the sequence listing in a single XML file format is accepted, and the sequence listing in the paper, PDF or TXT file format is not allowed. Therefore, if the applicant submits the sequence listings other than the XML file format at the time of application for multiple protection, if the XML file has the above-mentioned problems, it may still be necessary to supplement the sequence listing in the XML file format.

2. Divisional case

The division case is also a European patent application case, and the above-mentioned provisions are also applicable. In point 16 of the method description, the division case specifically points out that the sequence listing is a part of the description. Therefore, in division cases submitted after July 1, 2022, the sequence listing is the list should still conform to WIPO Standard ST.26. In addition, point 17 of the approach note states that if a sequence listing is required to be part of the specification, it must be filed with other documents on the filing date of the division, unless the sequence listing is by reference pursuant to EPC Rule 40(1)(c) If the sequence listing of the cited earlier application does not conform to the WIPO Standard ST.26, the EPO will require a subsequent sequence listing that conforms to the WIPO Standard ST.26. Therefore, three aspects are derived, which are described as follows:

(1) Where the parent case has already submitted the sequence listing which does not conform to the WIPO Standard ST.26: the applicant must submit a sequence that conforms to the WIPO Standard ST.26 when submitting the divisional case, otherwise, it will be required to supplement.

(2) Where the parent case has submitted a sequence listing which has complied with the WIPO Standard ST.26, and the applicant has not submitted a sequence listing when filing a divisional case and has not cited the sequence listing of the parent case in accordance with the provisions of EPC Rule 40(1)(c): the online application tool and point 38.3 of the EPO Form 1001 application form have pre-checked the applicant's request to add the sequence listing of the parent case to the division case for the division case, and indicate that this sequence listing is only for retrieval, not form part of the description of the division.

(3) Where the parent case has submitted a sequence listing which has complied with the WIPO Standard ST.26, and the applicant submits the sequence listing along with the divisional case or cites the sequence listing of the parent case in accordance with the provisions of EPC Rule 40(1)(c): the sequence listing filed on the filing date of the division or citing the parent case under EPC Rule 40(1)(c) will form part of the division specification and the EPO will no longer adds the sequence listing of the parent case to the division case under Point 38.3 of the EPO Form 1001.

Due to that WIPO Standard ST.26 expressly prohibits the inclusion of less than 10 specially defined nucleotide sequences and less than 4 specially defined amino acid sequences in the sequence listing, and adds a new requirement for the types of targets that should be included, that is, D-amino acids, branched chain sequences and nucleotide analogues are required to be included in the sequence listings. Therefore, a sequence listing that conforms to WIPO Standard ST.26 may contain a different number of sequences than the parent case to which WIPO Standard ST.26 applies. However, it should be reminded that the number of sequences contained in the supplemented sequence listing should not be increased or decreased compared with the description at the time of application, and the original sequence numbers cannot be changed. The above-mentioned too short nucleotide sequence or amino acid sequence will have form errors that can be detected by WIPO Sequence Suite, so it is recommended to make good use of the skipped sequence (intentionally skipped) in Article 3(d) of the WIPO Standard ST.26. sequence) to represent the original sequence that should be excluded according to the WIPO Standard ST.26 to reduce the risk of deriving EPC Rule 30(3) notifications. Regarding the parts of D-amino acids, branched chain sequences and nucleotide isoforms, it is recommended that the description of the parent case at the time of the application list the sequences with reference to the WIPO Standard ST.26 in advance, so as to avoid to the risk of derivative modifications out of scope when the sequence listing complying with the WIPO Standard ST.26 is prepared for the division case.

In conclusion, point 7 of the Measures points out that sequence information that meets the length threshold set by the WIPO Standard ST.26, regardless of whether the protection of these sequences is requested or not, should be submitted as a sequence listing. Therefore, when submitting a divisional case, it is recommended to submit the sequence information that meets the WIPO Standard ST.26 to avoid the dilemma of the lack of a sequence listing in the split case.

From Tai E International Patent & Law Office

June 2022