ST.26 Sequence listings: a one-year celebration?

The WIPO Standard ST.26 for Sequence listings recently celebrated its one year anniversary of coming into force on the big bang date of 1 July 2022. The EPO determined its implementation in a strict manner insofar that for divisional patent applications and end of priority patent application filings the new standard had to be used filed as from 1 July 2022 and conversions of sequence listings prepared the WIPO ST.25 standard were forced to be made[1].

What are the issues and worries?

Annex VII of the WIPO Standard ST.26 explains situations in which subject-matter could be deemed to have been added or even lost when making a conversion of a sequence listing from the ST.25 to the ST.26 format. This involves many legal risks and creates a huge effort and extra costs for applicants, their representatives and paralegals.

An epi position paper was prepared and replied to by the EPO in the summer of 2022. This was commented on in blogs such as in IP Kat (see 1/08/2022 and 9/08/2022).

The fact that there are issues arising from the implementation of the new standard, especially relating to possible added or lost subject-matter issues resulting from the conversion form the WIPO ST.25 Standard to the new WIPO Standard ST.26 is acknowledged in the WIPO ST26 itself in many instances (see for instance on page 03.26.vi of the ST26 Version June 2023):

“The guidance provided in this document is directed to the preparation of a sequence listing for provision on the filing date of a patent application. Preparation of a sequence listing for provision subsequent to the filing date of a patent application must take into account whether the information provided could be considered by an IPO to add subject matter to the original disclosure. Therefore, it is possible that the guidance provided in this document may not be applicable to a sequence listing provided subsequent to the filing date of a patent application.”

Per definition, in the last year practically all divisional filings with a sequence listing as well as practically all filings claiming priority from applications with a sequence listing, required the filing of a “subsequent” ST.26 format sequence listing.

This leads to the situation where a priority is filed with a sequence listing using the ST.25 format and a follow-up application has to be filed with a sequence listing in the ST.26 format, potentially comprising additional or lost information which may lead to an objection as to lack of priority under Art. 87 EPC.

A similar situation exists in case of a divisional application that needs to be filed with an ST.26 sequence listing, while the parent application was filed with an ST.25 sequence listing and thus may lead to added matter objections under Art. 123(2)/76 EPC.

In both cases a conversion needs to be made from an ST.25 sequence listing to an ST. 26 sequence listing and this conversion, particularly before the EPO, holds risks of adding or losing subject matter. The WIPO ST26 is aware of that risk as it points out to the added matter problem in Annex VI Examples: 3(c)-2, 3(g)-2, 3(k)-2, 7(a)-1, 7(a)-6, 27-1, 27-2, 27-3, 36-3, 89-1, 89-2, 93-3, 94-1, 95(a)-1 and in the twenty Scenarios of Annex VII.  While the ST26 WIPO standard thus provides some sort of guidance, it cannot and is not able to resolve some issues that are inborn in the ST26 itself.

Practitioners at epi are concerned that the current required conversion for divisionals of an ST.25 sequence listing to an ST.26 sequence listing will lead to lost material and/or added material in Sequence listings which  may only submerge after grants during oppositions (added-matter issues). The legal risks for the future are very high. The EPO has different standards for unallowable amendments than other jurisdictions which contributes to the EPO practitioners’ request on this point. They are the users of the EPO filing system and of its mandatory platform, and thus they see the responsibility to resolve the issues with the EPO. Some issues are related to EPO practice such as the divisional application page fees and added matter issues.

Another important problem associated with the implementation of the new ST.26 format pertains to a significant increase of costs related with filing sequence listings in the new format (additional page fees incurred for the pages of an ST.25 sequence listing that are reproduced as pages of the description of a divisional application to maintain the subject matter of its parent application).

Epi strongly requested that the EPO would adopt the same practice for EP applications for divisional applications as the UK Patent Office applies and alternatively as the CA Patent Office applies. Up till now the EPO is not willing to do so.

Solutions offered in the FAQs of the EPO

The EPO has in the meanwhile published its FAQs relating to WIPO Standard ST.26 for divisionals on their website . These FAQs also illustrate the extra burden and problems applicants are faced with in case of divisionals with ST.26 sequence listings at the EPO.

Further questions were raised by epi and they eventually filed a complaint was in January 2023 with the EPO Ombuds Office to resolve the problems and to be heard. The procedure is confidential. Discussions are still going back and forth with the EPO. One of the main causes of the questions is the horrible ST.26 format created by WIPO. No one understands why it was actually needed. Nevertheless, the EPO has decided not to show leniency like to the UK[2] and Canadian Patent Office have done in the sense that for divisionals they allow to use an ST.25 sequence listings in case the parent application has an ST.25 format sequence listing.

Solutions offered by WIPO

WIPO continues to work on their software and recently introduced a new version. EPO level is given on WIPO Sequence Suite. A new software version of the program WIPO sequence 2.3.0 was released on 8 May 2023.

Developments in sight

Recently, a new Decision of the President  and Notice of the EPO was published in the Official Journal May 2023 (epo.org) which clarifies that Sequence listings filed as from 1 July 2023 for European patent applications to which WIPO Standard ST.26 applies MUST comply with version 1.5 or 1.6 of that standard. It is important for the sequence listing software to updated on the computers of those generating them regularly.

We hope that by questioning the EPO, epi practitioners and applicants can collaborate with the EPO to resolve the issues so that it becomes clearer what the options are and that procedures can become more lenient for users of the patent system. Epi practitioners are lobbying for a more lenient treatment, longer time limits, less extra fees and also possibilities for corrections pre- and post-grant of any possible errors occurring due to this imposed conversion regime.

Requests are being made to waive the requirements for additional page fees that are specifically incurred for the pages of an ST.25 sequence listing that are reproduced as pages of the description of a divisional application to maintain the subject-matter of its parent application.

Practitioners at epi request Rule 30(3) EPC to be discussed and amended and would like to waive the late furnishing fee under Rule 30(3) EPC for providing ST.26 sequence listings for search purposes only on cases where a pre-existing ST.25 listing is submitted to the EPO. This would offset the cost of completing the onerous conversion requirements from ST.25 to ST.26. In view of the raised complexity of the sequence listing standard, the time limit of Rule 30(3) EPC may be extended to three months, or be made extendible upon request.

Also it is necessary to further amend the Guidelines for Examination and the FAQs on sequence listings and devote enough attention to this matter and for instance go into details about page fees, when and how an automatic conversion of an ST25 sequence listing into description pages is done, when and how the page fees are communicated. Also, the FAQs could go into certified copies of the parent application.

Also, it is necessary to waive the requirement for applicants/representatives to file a declaration that the sequence listing does not add subject matter. This is because this requirement will be impossible to satisfy in some cases. The requirements of ST.26, with the additional information over and above ST.25, may make it impossible for a patent attorney to actually declare that the new sequence listing does not add new matter. This would place applicants and representatives in an impossible position in which they would be pressured to declare something that they know is not true. Also declarations of this kind are unprecedented in any other procedural matter before the EPO.

We are of the opinion that the ST.26 sequence listing software was still in a test phase when it was launched and applicants cannot be punished for not being able to use a software that has not been thoroughly tested. Already for this reason only ST.25 sequence listings should be allowed also for divisional applications where the parent application contained such a format of sequence listing (or later corrections should be possible).

Further it is being requested that at least the EPO should make an official notification or statement that ST.26 Sequence listings can be corrected at any time before and after grant if an applicant or patentee realizes or is informed that a correction is needed. Epi practitioners, think it is only fair and reasonable to ask this.

In a whole it is clear that further developments and clarifications of how to handle specific sequence listing problems is needed and quick help for such problems should be able to be offered by the EPO in our opinion.

If you have any questions, we would be happy to help. Feel free to reach out to our European Patent Attorneys via email on info@dcp-ip.com.