PCT international applications:

Article 4 of the Measures for Submitting Sequence Listings stipulates that if a PCT international application discloses a nucleotide or amino acid sequence, when the EPO acts as the International Searching Authority (ISA) and the Supplementary International Searching Authority (SISA) or the International Preliminary Examining Authority (IPEA), and if it cannot obtain the sequence listing that complies with the WIPO ST.26 standard, it will require the applicant, in accordance with the provisions of PCT Rule 13ter.1(a), to supplement and pay the supplementary fee within one month from the date of notification, which is not extendable.

The descriptions of the PCT international phase and national phase are as follows:

1.  International stage:

Points 21 to 26 in the description of the Measures point out that when an applicant makes a supplementary sequence listing in accordance with PCT Rule 13ter.1(a), that the supplementary sequence listing does not contain the content beyond the PCT international application should also be declared. In addition, this supplementary sequence listing will be used for only search and will not form part of the PCT international application.

If the applicant fails to submit a sequence listing that complies with the WIPO Standard ST.26 or pay the supplementary fee within the time limit, the EPO will deal with it according to its different roles as follows:

(1) EPO as ISA:

It will not repeatedly issue notifications, and in accordance with PCT Rule 13ter.1(d), when there is no sequence listings, ISA will only need to search for the portion that can be meaningfully searched, and describe the specific request in the international search report item cannot be searched , or explains that the international search report has not been produced under PCT Article 17 2(a). However, before the international search, even if the applicant overdue the supplementary sequence listing and pay the supplementary fee, will it will be still considered that the supplementary sequence listing has been received within the time limit.

Further, if the supplemented sequence listing is found to exceed the content of the PCT international application, the ISA will mark it in the international search report, and deal with it by the condition that the above-mentioned sequence listing that is not supplemented in accordance with the WIPO Standard ST.26.

In the end, if the above-mentioned files are unreadable, incomplete or infected with viruses in the supplementary listings, the applicant will be required to provide replacement files within one month from the date of notification in accordance with PCT Rule 13ter.1(a), for example, if the applicant has previously notified the applicant to make up, the time limit for the post-fill shall still be based on the previously notified period, and the period will not be extended.

(2) EPO as IPEA:

Where the international search report shows that one or all of the above-mentioned cases are not searched, IPEA will not notify the applicant to submit the sequence listing, and based on the provisions of PCT Rule 66.1(e), the international preliminary examination will only be carried out for the part where meaningful examination can be performed, and in accordance with the provisions of PCT Rule 66.2(a)(vii) and PCT Rule 70.12 (iv), notify the applicant in writing and record it in the international search report.

(3) EPO as SISA:

If SISA receives the documents described in PCT Rule 45bis.4(e)(i) to (iv), and finds that there is a lack of sequence listings that comply with WIPO ST.26 standards, it will be required in accordance with the provisions of PCT Rule 13ter.1(a). The applicant shall make a supplementary supplement, and the applicant shall be required to pay the supplementary fee in accordance with PCT Rule 13ter.1(c) within one month from the date of notification, which cannot be extended. SISA will conduct a supplementary international search in accordance with PCT Rule 45bis.5(a) only upon receipt of a sequence listing in compliance with WIPO ST.26.

Above all, even if priority is claimed in the PCT international application, a sequence listing that conforms to the WIPO Standard ST.26 can still be re-prepared, and only the newly added part cannot enjoy the benefit of priority, and there is no problem of modification beyond the scope, therefore, refer to WIPO Standard ST.26, and use the free software WIPO Sequence Suite produced by WIPO to produce sequence listings, which should effectively reduce the risk of non-compliance with WIPO Standard ST.26.

2. National stage:

Point 27 in the description of the Measures reiterates whether the PCT international patent application entering the national phase is applicable to the WIPO Standard ST.26 shall be based on the "international filing date" of the PCT international patent application, therefore, the PCT international filing date is earlier than July 1, 2022. However, international patent applications that entered the national phase after July 1, 2022 will continue to apply the WIPO Standard ST.25.

Article 5 of the Measures for Submitting Sequence Listings stipulates that a sequence listing conforming to the WIPO Standard ST.26 is required to be submitted in accordance with the provisions of EPC Rule 1(3) to 1(5), Rule 2 and Rule 3, and Points 28 to 34 of the Measures Statement are further explained as follows:

If a PCT international patent application includes a sequence listing that conforms to the WIPO Standard ST.26 in accordance with the provisions of PCT Rule 5.2, and the sequence listing has been supplemented in accordance with PCT Rule 13ter 1(a) or provided by other ways for EPO, the applicant will not need to submit the sequence listing repeatedly during the national phase, the exceptions are explained as follows:

Where the PCT international application is not disclosed in the official language of the EPO, the applicant must submit a translation of the published text within 31 months from the international filing date or priority date. Although it is unnecessary for the controlled vocabulary in the sequence listing to be translated, the free text in Articles 85 to 88 of the WIPO Standard ST.26 and the qualifiers for nucleotides in Part 6 of Annex 1 nucleotide sequences) and the qualifiers for amino acid sequences in Part 8 of Annex 1 are language-dependent fields, and the version written in official language of the EPO still needs to be provided; wherein, if the sequence listing provides two language versions at the same time, at least one of them must be in English. Therefore, if any version of the sequence listing is in English or other official language of the EPO, the applicant does not need to submit a translation, otherwise the applicant should still submit a translation of the sequence listing.

Second, if the 31-month period of the international filing date or priority date set by EPC Rule 159(1) has passed, and the EPO has not obtained a sequence listing that meets the WIPO Standard ST.26, the EPO will comply with EPC Rule 163(3) Article 5 of the Measures for Submitting Sequence Listings requires that the sequence listing conforming to the WIPO Standard ST.26 be supplemented, and based on EPC Rule 30 (3) and Article 2 of the Measures for Submitting Sequence Listings, the applicant is required to supplement the sequence listing within 2 months. The specified sequence listing and the payment of the supplementary fee, and the time limit cannot be extended, and according to the provisions of EPC Rule 30 (2), the sequence listing that is supplemented after the filing date is only for search.

In conclusion, where the supplementary list still does not comply with the WIPO Standard ST.26, or where the supplementary fee is not paid immediately, the application will not be accepted, and the applicant shall request for further processing in accordance with the provisions of EPC Article 121 and Rule 135 and pay the fee.

Conclusion:

Due to EPO’ strict determination on the modification beyond the scope, for the patent application converting the standard from WIPO ST.25 to the WIPO ST.26, it is recommended to pre-assess whether the sequence listing complies with the WIPO Standard ST.26 under the condition without modification beyond the scope. For example, when the patent specification still meets the conditions that can be realized, delete sequences that are relatively unimportant and do not have much content, and then file an application to reduce the scope of the patent application due to the revision of the sequence listing or risk of not being accepted for not meeting WIPO Standard ST.26. In addition, it should be noted that Point 7 of the Measures points out that in accordance with Decision J 0008/11 of the Board of Appeal of the EPO (Board of Appeal) in 2013 on sequence listings, for example, the sequence is prior art and is publicly available with the database accession number obtained and recorded in the description, such sequences do not need to be included in the sequence listing, even those being recorded in the claimed item, constituting the essential technical features of the invention, or being necessary to be searched. Therefore, when applying for a patent in Europe, the applicant may consider making good use of the database registration number to reduce the production cost of the sequence listing and the risk of mistakes, in order to avoid unnecessary supplementary procedures. However, if it is expected to apply for multiple countries, based on the said decision was made in accordance with the provisions of Article 3(iii) of WIPO ST.23 and the legislative intent of the EPC, so it is unclear whether other Member States will consider similarly.

From Tai E International Patent & Law Office

June 2022