Report of the Committee on Biotechnological Inventions
Below is a summary of the points our committee has been handling in 2023.
1. Chair of the Biotech Committee (BC)
A new Chair and Secretary of the epi Biotech Committee has been elected on 19th of July. Simon Wright (GB) and Brigitte Taravella (FR). The EPO has been informed of that change on August 4, 2023. Ann De Clercq (BE) will remain as BE member and she has been elected as liaison person with the Presidium.
2. ST.26 Sequence listings
As a follow-up of the complaint with the EPO Ombuds Office of January 16, 2023 highlighting our concerns regarding the lack of reactivity from the EPO on sequence listings problems and questions raised by epi, the EPO sent an answer beginning in May just after the last meeting April meeting with the DG1.
Furthermore, on June 30, 2023 the EPO sent responses to epi’s technical questions. The BC agreed to ask the EPO to make those response public accessible in the EPO’s FAQ. On August 29, 2023 EPO answered that it supports the idea of making those technical comments publicly available. They would, however, prefer publishing them on their own website and EPO is currently working on an improved version which can be also added in any publication epi would initiate on this topic such as the epi Information.
It has to be highlighted that technical issues remain with the systems for which we need EPO input. Some BC members suggested to formulate a reply to request clarifications about what is acceptable or not regarding any automatic sequences’ translations from ST.25 to ST.26. The Box-declaration on form 1001 for divisional application is also a concern. Some BC members are of the opinion that the declaration of non-added matter is considered as unfair. Such declaration should not be needed at all as soon as it will not part of the specification. It has been decided that it’s up to the new chair and the new secretary to decide to formulate (or not) a reply after the summer break.
On September 28, epi received a letter from the EPO in response to concerns raised by epi regarding the potential conversion errors from an ST.25 to an ST.26 sequence listing and the associated risks of added or lost subject matter. The EPO promised to change its practice soon and to implement further safeguards and steps in the transitional regime for divisional patent applications with sequence listings.
And finally, during the SACEPO Working Party on Guidelines of October 10, the EPO shared the news that it will discontinue its practice of raising page fees for ST.25 sequence listings in a PDF format filed as part of a divisional application as a safeguard in order to avoid added-matter issues. A corresponding notice should be published in the Official Journal of November 2023.
3. Draft amendments for the 2024 EPC and PCT Guidelines
epi has the possibility to comment on the draft of the new Guidelines proposed by the EPO following the SACEPO WP GL meeting of October 10. The epi/EPPC organised an in person meeting on August 24 and 25 to discuss those guidelines amendments. Simon Wright (new BC’s chair) and De Clercq (former BC’s chair) attended the meeting for sharing the first input on behalf of the BC. Our final and assembled comments have been passed to Anette Hegner by 1st September and concern mainly comments on ST.26 sequence listings, plant disclaimers and antibody patenting parts.
Our comments to amend R. 30 EPC to be more lenient on sequence listings have also been passed on to the EPPC subcommittee in preparation of the SACEPO meeting WPR on October 30.
Looking at the amendments proposed by the EPO on the GLs, epi biotech committee still has concerns on the GLs drafting process and the impact it has on quality. There seems to be no real dialogue or listening in the SACEPO meetings on GLs. We suggest keeping on addressing at any possible level at the EPO about this matter and would like to ask for an improvement of the process of the GLs drafting.
It could be that the EPO does not see the need to discuss the GLs with the users since it is considered an internal document. In addition, our comments are sometimes simply disregarded. This creates frustration in the user community and in the BC, at least about the section dedicated to amendment of the description. About sequence listing, things are moving into the right direction ’see above).
4. Biotech Committee meeting of July 19, 2023
The main topics of the meeting were to follow-up to points to be discussed with DG1 in the meeting of April 25, 2023, to discuss the status of our complaint to the EPO Ombuds Office and to elect the new Chair and Secretary of the epi BC.
5. Further special Biotech Committee meetings with the EPO
As a reminder, a formal letter was sent on March 29, 2023 by the Biotech Committee to the EPO to request to organise further meetings regarding antibodies and ST.26 sequence listings. Based on the summer e-mail exchanges with the EPO, the BC agreed to decide in the next future if such meeting is needed or to wait for the next meeting with the DG1 to be organised in 2024.BC will continue on email exchange with the EPO about Biotech issues.
6. New elected Biotech Committee
Following the last validation election of the BC during the Ljubljana Council C96, the inaugural BC meeting took place on 6 December 2023 by Videoconference to perform the election of the new Chair and Secretary, to discuss about the location of the 2024 in person BC and the way to organise BC’s agenda for the future. Simon Wright and Brigitte Taravella were re-elected as Chair and Secretary of the Committee. Another meeting will be planned for 2024 only by Videoconference to respect the established 2024 BC’s budget. Finally, we anticipate organising a new meeting with DG1 in Q2/2024.
