Report of the Committee on Biotechnological Inventions
De Clercq (BE), Chair
Below is a summary of discussion points since our last report in epi information. The following topics were discussed during our last meeting of 22 September 2022 and afterwards.
1. ST26 standard for Sequence listings
We refer to the discussion in our last report in which we gave and overview of the new ST.26 WIPO Standard for Sequence Listings which came into force on the big bang date of 1 July 2022On the legal side a decision of the President (https://www.epo.org/law-practice/legal-texts/official-journal/2021/12/a96.html) and Notice of the EPO (https://www.epo.org/law-practice/legal-texts/official-journal/2021/12/a97.html) were published on 9 December 2021. and the problems created by the conversion of an ST.25 format sequence listing to an ST.26 format sequence listing. This is currently required for (1) divisional EP applications filed as from 1 July 2022 when the parent application was filed before 1 July 2022 with an ST.25 format sequence listing and (2) end of priority applications filed as from 1 July 2022 (both EP or PCT) when the earlier application was filed before 1 July 2022 with an ST.25 format sequence listing. Annex VII of the WIPO Standard ST.26 explains situations in which subject-matter could be deemed to have been added when making a conversion of a sequence listing from the ST.25 to the new ST.26 format. This involves many risks and creates a huge extra effort and costs for applicants.
A position paper on this matter was prepared by our ad-hoc group and passed on by epi to the EPO on 21 June 2022 (this was also published on the EPI website and in epi information 2-2022). The EPO replied on 28 July 2022 (see also discussion in our last report in epi information 2-2022). The committee finds this reply unsatisfactorily. It is also commented on in IP Kat blog posts of 1/08/2022 and 9/08/2022.
The EPO has in the meanwhile published FAQs relating to WIPO Standard ST.26 for divisionals as well as relating to sequence listings in the communication under R. 71(3) EPC. These FAQs do not clarify the questions and do not offer solutions for the problems of practitioners. Matters will have to be put much more clearly. For example as to which page fees would have to be paid when including the ST.25 sequence form the parental application in a divisional application and in which cases this needs to be done. The EPO clearly warns for added matter issues in relation to filing an ST.26 sequence listing for (i) divisional applications where an ST.25 sequence listing was present in the parent application or (ii) for end of priority applications where an ST.25 sequence listing was present in the priority document. 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.
We also prepared comments to parts of the new (still confidential) draft EPC GLs (A-IV, 5, 5.3-5.4) relating to sequence listings that appear unclear and discussed at the SACEPO WP GLs meeting. The EPO promised to look into it by the next revision.
The UK Patent Office has already indicated on 28 February 2022 in an update of their Guidelines for examination that they will allow transitional measures. We refer to the discussion in our last report. We strongly continue to request that the EPO would adopt the same practice as the UK Patent Office for EP applications.
Further communications/training webinars by the EPO may be very useful and needed to further inform patent attorneys and patent administrators (paralegals) dealing with the matter and allow questions to be addressed. Up till now only FAQs are available on the EPO website (FAQs) and further information at WIPO level is given on WIPO Sequence Suite. A new software version of the program WIPO sequence 2.2.0 became available on 13 October 2022 ( see WIPO Sequence Suite).
Our concerns regarding the lack of reactivity from the EPO on sequence listings problems and questions will be raised with the EPO Ombuds Office Service.
2. Plant patenting
We refer to our earlier discussion on plant patenting in our last report. At the SACEPO WP GLs meeting of 11 October 2022, we reiterated our concerns about amongst others the need for plant disclaimers for which we held there is no legal basis. We regret at this moment no changes are being considered in the GLs. We are eager to discuss these matters in upcoming meetings with the EPO. We would like our comments to be heard and hope the EPO takes the necessary time to listen to our comments. We also look forward to any Technical Board of Appeal cases on this topic. The committee is also following up the developments on national level in the EPC members states.
We also raised the following comment on patentability of plants during the CPL56 meeting on 15 November 2022 wherein we were presented with report CA/PL 20/22:
EPI thanks the EPO for its detailed report on plant and animal patenting. The EPO has implemented a disclaimer solution in the GLs for examination. EPI would like to understand where the basis is in R. 28 (2) for a disclaimer requirement as mentioned in item 15 of the report. The fact that only 1 patent was granted with a disclaimer as mentioned in item 16, may reflect the unwillingness or resistance to incorporate a disclaimer because applicants might perceive such a disclaimer is not needed and/or has no legal basis. EPI believes that G3/19 may not have brought legal certainty and stability as mentioned in item 27 of the report. The disclaimer would appear to introduce legal uncertainty for applicants, because the scope of what is disclaimed, and how national courts or the UPC will interpret the coverage of the remainder of the claim remain to be seen, particularly in light of various definitions of “essentially biological processes” or “exclusively obtained by essentially biological processes”.
We refer to our earlier discussion on antibodies in our last report in epi information 2-2022. With respect to antibodies, we informed the EPO at the SACEPO WP GLs meeting of 11 October 2022 that we think the new EPC GLs (G-II, 5.6) unfortunately still do not address some of our concerns on the inventive step requirements for antibodies. We would like that the Guidelines are not stricter than the Case Law on antibodies. We also request that individual Examiners would not insist to include framework region sequences in the claims in addition to CDR sequences when the surprising effect does not involve the binding affinity (this is not what the Case Law reflects). The GLs need to be very carefully drafted and reflect the Case Law as they are also being referred to in national Court cases. We would like our comments to be heard and hope the EPO takes the necessary time to listen to our comments. We would like to see a process wherein there is more interaction with the epi practitioners when draft GLs are made (also in the other Biotech areas). We deem it important that the EPO may wish to be continuously updated by practitioners in the field of antibody inventions as antibody patenting should receive prime importance. We look forward to additional meetings with the EPO on antibodies.
4. Process of drafting GLs in Biotech
An example of the impact of the GLs is the manner in which G 3/19 was embodied in the GLs. Another example is that in a recent French court decision on SPCs, the French court used the EPO GLs to determine whether there was an independent inventive step and specifically used the part of the GLs on antibodies. This shows that the content of the GLs may have an effect in litigation, which is very dangerous, particularly if the GLs are not in line with the case law.
5. Further meetings
We look forward to a new date also for discussing Biotech Issues with DG1 of the EPO and with other EPO circles, as in general we think this is of prime importance to obtain strong IP protection in the Biotech sector. We would also like to hold a further committee meeting before the next council meeting.