The European Patent Office (EPO) has issued a response to epi's letter voicing concerns over implementation of the new sequence listing format, ST.26, for patent applications (IPKat). The EPO's full response has been published by epi and can be read here.
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In order to avoid added matter, the EPO advice is as follows:
"The applicant may choose to file a sequence listing in PDF on the filing date, or to file the divisional application by reference to the description of the parent application, and thus to file the ST.26 sequence listing only for search purposes under Rule 30(3) EPC. This prevents added subject matter issues from arising but an additional fee may fall due, reflecting the additional burden on the side of the EPO."
A sequence listing filed after the filing date does not form part of the description of a patent application, and may require payment of a late furnishing fee. epi raised concerns about the late furnishing fee and the excess page fees that will be due if a very long ST.25 sequence listing is added to the description.
The EPO response goes on to explain that its reason for requiring ST.26 for all new applications, including divisionals, is that it will allow the "benefits of the new standard to materialize sooner while reducing the necessary IT support for the old standard as far as possible".
The EPO therefore seems content with shifting the costs associated with ST.25 to ST.26 transition to EPO users.
Further reading
EPO under fire for its approach to ST.26 sequence listings (1 Aug 2022)
Reviewed by Rose Hughes
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Tuesday, August 09, 2022
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It is nothing new that the EPO shifts thé burden to the users.
ReplyDeleteJust remember that users have to check the electronic file to see if there are new documents in the opposition or the appeal file.
Especially in appeal there can be short time changes to the venue or the time.
Two R decisions made it clear that the parties do not have a duty to check the electronic file…..
"Under the EPC legal framework a divisional application is an independent application, subject to the procedural requirements applicable on the date of its submission."
ReplyDeleteSo, as far as the requirements of Article 76 EPC are concerned, it seems that the EPO simply intends to stick its head in the sand and ignore its users...
What relief to know that our worries about ST.26 sequence listings adding new matter can now be forgotten. All that we need to do is either pay the EPO lots more money, or to adopt a strategy that will permanently decrease the useful information content of our EP application (and its potential offspring). Don't we all feel so silly now for not having thought of those solutions beforehand!
ReplyDeleteOn a less sarcastic note, I see that the EPO is still effectively raising their middle finger in the direction of the whole life sciences section of the European patent profession (and essentially the whole life sciences industry).
This really ought to illustrate to the EP profession quite how little respect or consideration the EPO has for their views. Whether this prompts the (representative organisations of) the EPO's users to adopt a more robust and pro-active approach to countering the EPO's more outrageous proposals remains to be seen.
Even if it does, it may now be too late for even the strongest and most coordinated of protests to have any significant impact upon the EPO. After all, the EPO has both a substantial income stream and diplomatic immunity for any "official" decisions (no matter how unreasonable / unlawful) relating to the running of the Office. As long as those remain in place, and the flow of funds ensures that the AC remains a case study in regulatory capture, why should the EPO's management care one jot about what any pesky patent professionals or applicants think?
If I were to file a divisional referring to the earlier application under Rule 40(2) with its ST.25 sequence listing and the next day file the ST.26 sequence listing, no issues of added subject matter arise and no fees are payable. Is there an issue here?
ReplyDeleteThe costs of conversion aside, I guess that there is no issue ... unless, of course, you would like the content of the divisional application as filed to also comprise subject matter that may only be disclosed (in the sense of Art 123(2) EPC) in the claims of the parent application as originally filed.
DeleteWhilst the EPO's comments are welcome, it appears that neither of the proposed solutions to prevent added matter issues from arising are satisfactory:
ReplyDelete(1) filing a sequence listing in PDF will incur excess pages fees. At EUR 15 per page, these fees will be extremely large for sequences listings with hundreds of sequences (which are not uncommon).
(2) filing the divisional application by reference to the description of the parent application may risk losing subject-matter. It is typical practice to add the claims of the parent application as embodiments at the end of the description to avoid any potential loss of subject-matter. This doesn't seem to be possible if filing by reference if the applicant wishes to pursue different claims (although I am happy to be corrected on this point!).
It seems, therefore, that the burden is still very much on the applicant to adequately convert the ST.25 sequence listing, which can often be very onerous. I would welcome any other potential solutions!
I see several comments about added matter issues but, in my practice in this field, I see a more "under the radar" insufficiency risk that already looms in several patent applications containing DNA/protein sequence information, Too often attorneys/inventors have not double-checked sequences across tables, figures, ST.25 files, and/or cited Genbank/Uniprot/other database accession numbers that are inconsistent/incomplete/incorrect and that can make difficult, if not impossible, to reproduce key elements of the claimed invention (plasmid constructions, cloning process, validation experiments, etc.).
ReplyDeleteIn my opinion, the original sin should be found at standard defining institution (WIPO) which has not established a sequence deposit system similar to those available at NCBI or EBI, with an embargo system until patent publication, and sequence data format/indexing similar to scientific standard, providing the patent community with a ST.25 global database.
I would also highlight the job made at Lens.org in indexing ST.25 sequence information and assigning an http address to each listed sequence (as a DOI code for an article) in a FASTA format. The Lens.org system is indeed incomplete but IP5/WIPO should have been honest and endorse this initiative to at least minimise the evident, present problems in performing a patentability analysis involving ST.25 biological sequence information (and future, hardly avoidable ones for ST.26 ones)