Report of the Committee on Biotechnological Inventions
A. De Clercq (BE), Chair
Below is a summary of discussion points since our last report in epi information issue 4-2021. A meeting was held also between a delegation of our committee and DG1 relating to biotech topics on 31 March 2022. This biotech session was very interactive and interesting.
1. ST26 standard for Sequence listings
An ad-hoc group of the Biotech Committee is following the developments regarding the new ST.26 WIPO Standard for Sequence Listings which will come 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.Future publications will follow on this topic.. We had several meetings and prepared our position in advance of further discussions with the EPO. A discussion took place on this topic during our meeting with DG1 on 31 March 2022. We have flagged several times and are further trying to clarify possible added matter and priority issues relating to conversions of ST.25 format sequence listings to ST.26 format sequence listings and ways to avoid these type of problems. Conversion of an ST.25 format sequence listings to an ST.26 format sequence listing is necessary 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 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. We are of the strong opinion that the EPO should consider the requests of the users to introduce transitional measures to allow that at least divisional applications can be filed with an ST.25 format sequence listing if the parental case was filed with an ST.25 format sequence listing. We refer to the position paper prepared by our committee and published seperately in this edition. In their recent May 2022 newsletter WIPO also acknowledged the risk of adding matter when going from an ST 25 to an ST26 sequence listing.
The UK Patent Office has already indicated on 28 February 2022 in an update of their Guidelines for examination that they will allow such transitional measures. The UK mentions that for new divisional patent applications filed on or after 1 July 2022, the sequence listing should be supplied in the format required for the parent application. For a parent application filed on or after 1 July 2022, this must be ST.26. For a parent application filed before 1 July 2022 this should be ST.25. This is a change compared to the original plan of the UK and this change was made in response to feedback from their stakeholders. We strongly continue to request that the EPO would adopt the same practice as the UK Patent Office for EP applications.
A new software version of the program WIPO sequence 2.0.0 became available on 16 May 2022 and can be found on WIPO Sequence Suite.
Epi stressed at the meeting with DG1 that further training webinars by the EPO may be very useful and needed to further inform patent attorneys and paralegal assistants dealing with the matter and allow questions to be addressed. Also further communications/statements from the EPO on this matter were requested to inform the public on how to avoid adding matter for conversions of sequence listings.
2. Plant patenting
We commented on the current version of the GLs on plants (see parts F-IV, 4.12 and G-II,5.4) both at the meeting with DG1 on 31 March 2022 and via our comments as prepared for the SACEPO meeting on Guidelines of 19 May 2022.
We mainly informed about the need for plant disclaimers for which we held there is no legal basis. The EPO confirmed they are not needed for genetically modified transformed plants and gene edited plants (created by CRISPR technology), provided the latter can be distinguished from natural variation and also are not needed for offspring and propagatable parts of said plants. Epi explained that the boundaries are not clear in terms of single or multiple nucleotide exchanges. The EPO explained that it is up to the applicant to show that it does not relate to a plant produced by an essentially biological process and mentioned they had not yet encountered any case gene-edited plants which could not have been obtained by natural variation.
EPO will quite automatically raise an objection as it is an exception to patentability. EPO explained they consider what kind of exchanges are known for the plant in question and depending on the plant make an objection or not. We are of the opinion that the EPO should only raise an objection when the objection is reasoned. EPO requested Epi to raise further questions relating to specific cases if needed.
A further question concerning adaptation of the description to conform with the allowable claims was discussed in relation to plant patents. In particular, it was questioned whether a description containing passages relating to crossing and selecting with plants obtained by technical means needed to be deleted or explicitly marked. The EPO confirmed such passages do not need to be deleted as the guidelines explain that progeny plants of such technically obtained plants are also covered by the claims. On the other hand, passages relating to natural variation equivalents of technically obtained plants would need to be deleted or marked.
With respect to antibodies we informed the EPO at the meeting on 31 March 2022 and via our comments as prepared for the SACEPO meeting on Guidelines of 19 May 2022 that the 2022 GLs (G-II, 5.6) address some of our comments on the inventive step requirements for antibodies but they are still perceived to be too strict. Inventive step of antibodies does not have to rely anymore only on an unexpected effect. Some changes have been included. Also a further clarification has been incorporated regarding the definition of antibodies as to the amount of necessary CDRs. At the level of alternative antibodies, we see no change yet from the EPO. A further discussion will be needed on this topic and also on the topic of general platform technologies applicable to a multitude of antibodies. The discussion on inventive step of antibodies is also much related to the plausibility discussion as in pending G2/21. On the basis of our detailed comments provided at the SACEPO meeting, we assume the EPO will keep on updating the section on antibodies in the next versions of the Guidelines. We deem it important that the EPO may wish to be continuously updated by practitioners in the field also regarding the commercial importance of antibody inventions. Antibody patenting should receive prime importance.
4. Deposits of Biological Material
Case T 32/17 (relating to EP2311654) was discussed during the meeting with DG1 on 31 March 2022 relating to an antibody produced by a deposited hybridoma. The EPO would look more closely into this case in the future. They confirmed that hybridomas can be used to define an antibody as mentioned in the GLs. In most cases antibodies were identified by their sequence nowadays. The overlap with the principles of G1/92 were also briefly discussed. We assume we will learn more about this matter in the future.