Report of the Committee on Biotechnological Inventions

De Clercq (BE), ChairDe Clercq (BE), Chair

Below is a summary of discussion points since our last report in epi information issue 2-2022. An online committee meeting was held on 22 September 2022. We will report in more detail on that meeting in a future issue.

1. ST26 standard for Sequence listings

A position paper setting out epi's concerns on the implementation of the new ST.26 WIPO Standard for Sequence Listings which came into force on 1 July 2022On the legal side a decision of the President ( and Notice of the EPO ( were published on 9 December 2021.Future publications will follow on this topic. was passed to the EPO and published on the EPI website and in epi information 2-2022. The EPO replied on 28 July 2022. This reply was also published on the EPI website. The committee finds this reply unsatisfactory. It has also been commented on in IP Kat blog posts of 1 August 2022 and 9 August 2022.

epi will keep on stressing to the EPO that it would like its concerns to be considered, both in relation to added matter in case of EP divisional applications when the parent EP application has an ST.25 Sequence Listing, and in relation to loss of priority right if the priority application has an ST.25 Sequence Listing to be considered (see also discussion in our last report in epi information 2-2022). We do not think these concerns should for example be avoided by having to file an ST. 26 Sequence Listing for search purposes only. We think the added matter problems need to be explained clearly to practitioners and applicants. At the upcoming SACEPO GLs meeting on 11 October 2022 we intend to pose further questions about this matter to 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. These comments will also be discussed at the upcoming SACEPO WP GLs meeting. An additional member from the epi Biotech Committee will attend that meeting.

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. 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.

Further communications/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 from the ST.25 to the ST.26 format Sequence Listing.

2. Plant patenting

We refer to our earlier discussion on plant patenting in our last report in epi information 2-2022.

In preparation of the next 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 at the SACEPO WP GLs meeting of 11 October 2022 or in a separate meeting on this topic with the EPO. We would like our comments to be heard and hope the EPO takes the necessary time to listen to our comments.

3. Antibodies

We refer to our earlier discussion on antibodies in our last report in epi information 2-2022.

With respect to antibodies we will inform the EPO again via our comments as prepared for the SACEPO WP GLs meeting on Guidelines of 11 October 2022 on the new (still confidential) draft EPC GLs (G-II, 5.6) which unfortunately still do not address some of our concerns on the inventive step requirements for antibodies. We would like the Guidelines not to be more strict than the Case Law on antibodies. We also request that individual Examiners would not insist on including 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, since they also may be 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 also seeks to be continuously updated by practitioners in the field regarding the commercial importance of antibody inventions. Antibody patenting should receive prime importance.

4. TCR

We wonder whether a section on T cell receptors (TCRs) could be introduced into the GLs in the future.

We also look forward to a new date 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.