Report of the Committee on Biotechnological Inventions

S. Wright (GB), ChairS. Wright (GB), Chair and B. Taravella (FR), Secretary

1. New Chair and Secretary of the Biotech Committee (BC)

A new Chair and Secretary of the epi Biotech Committee were elected on 19th of July, namelky 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 in early May, just after the last meeting April meeting with the DG1. On June 30, 2023 the EPO sent a response to the epi’s technical questions. The BC asked the EPO to make this response public by 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 journal. Significant technical issues still remain with the systems, for which we need EPO input. Some BC members suggested we formulate a reply to request clarification about what is acceptable, or not, regarding automatic translations from ST.25 to ST.26. The Box-declaration on Form 1001 for divisional application is also a concern. Some BC members feel that the declaration of non-added matter is considered as unfair. Such declaration should not be needed if the sequence will not be part of the specification.

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 the Guidelines amendments.

Simon Wright (new BC chair) and Ann de Clercq (former BC chair) attended the meeting 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 on amending 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 19.

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 this matter, at every possible level at the EPO.

We wonder if the EPO does not see the need to discuss the GLs extensively 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.

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 BC.

5. Further special Biotech Committee meetings with the EPO

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 near 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. Next Biotech Committee

The next BC has not yet been planned. It should be scheduled for January or February 2024 after the autumn council meeting. Only one in-person meeting is scheduled for 2024, to keep to the established 2024 BC budget.