Report of the Committee on Biotechnological Inventions for epi information

De Clercq (BE), Chair

Below is a summary of discussion points since our last report.

1. ST.26 Sequence listings complaint to EPO Ombuds Office

We filed a complaint with the EPO Ombuds Office on January 16, 2023 to highlight our concerns regarding the lack of reactivity from the EPO on sequence listings problems and questions raised by epi. We launched our full submission as prepared by the epi Biotech Committee to the EPO Ombuds Office on March 1, 2023 and our annexes on March 7, 2023. The procedure is confidential. On March 31, Ann De Clercq (chair) and Simon Wright (secretary) had a short meeting to discuss the further steps of the complaint handling process. A web meeting to discuss the “technical case” aspects of the complaint was held on April 19, 2023 with from epi side: Ann De Clercq (BE), Simon Wright (GB), Jan Desomer (BE), Benjamin Quest (DE) and Katerina Hartvichova (CZ). On April 21^st, we received a request for the opportunity to test the next version of the WIPO ST.26 software tool. A further follow-up meeting was held with Ann De Clercq on May 8, 2023 to touch base on the further steps of the process. In follow up of this meeting we received an overview of the discussions and an indication that the case would be closed soon.

Regarding ST.26 Sequence listings, we also wish to point attention to a new Decision of the President and Notice of the EPO dated 24 April 2023 which have recently been published in the Official Journal May 2023 (epo.org) which clarifies that Sequence listings filed as from 1 July 2023 for European patent applications to which WIPO Standard ST.26 applies must comply with version 1.5 or 1.6 of that standard.

2. Committee meeting on April 24, 2023

The main topics of the meeting were to prepare for the points to be discussed with DG1 in the meeting to be held on 25^th April, 2023 and to discuss the status of our complaint to the EPO Ombuds Office.

3. DG1 meeting on April 25, 2023

The concept of the meeting was very much appreciated by epi this time, the EPO let us present first all our questions and points and they replied to them. So this time, there was time to discuss a few matters in some detail. This format was agreed on for points 1 to 3 as depicted below. Only for the points 4 and 5, the EPO would give their own presentation first, as that seemed easier for them.

The following topics were on the agenda for the Breakouts session from Biotech for the DG1 meeting of April 25, 2023

1 ST.26 sequence listings:

Added matter and/or priority issues for divisional applications and filings having a ST25 SL in the priority applications
Necessity to declare on filing that the ST26 SL does not go beyond the scope of the original filing (divisional applications)
No official way to handle technical problems
Time limits and late furnishing fees
Other issues

2 Plants and animals and disclaimer practice on plants
3 Antibodies
4 Process of drafting Guidelines in Biotech
5 Colour documents acceptance and handling at the EPO

The meeting took place as a hybrid meeting in the Isar Building. Due to the late notice from the EPO of the format of the meeting, only 5 members, along with one of epi’s Legal Advisors, were able to attend in person. For the Biotech/Pharma breakout session, we were represented from the epi Biotech Committee live by Ann De Clercq (BE), Vasiliki (Vicky) Kosti (GR) and Hans-Rainer Jaënichen (DE, associate member) and Heike Vogelsang-Wenke (DE as our liaison from Presidium) and also by Martin Wilming (CH) as Chair of the EPPC Pharma subcommittee. Several other epi Biotech committee members attended virtually.

A more detailed report on the Biotech/Pharma breakout session of this DG1 meeting will be provided later but the highlights were as follows:

There was a lot of discussion about ST.26 sequence listings and about the above-mentioned subtopics. As promised by epi at the meeting, we sent a written-out version of our comments on ST.26 sequence listings to the EPO to forward our examples which were highlighted during the meeting (our comments were sent to the EPO on April 28, 2023).

There was also a lot of discussion on antibodies. Some of the topics of interest we discussed about antibodies were structural requirements application (required CDRs and the framework region) and novel monoclonal antibodies against a known target and the application of G2/21: How the “derivable” test is applied by the EPO? A detailed report of this discussion will be made still.

There was no time to discuss points 4 and 5 of the agenda during the Breakout session on Biotech/Pharma as listed above and the EPO promised to send their presentations. We have requested to also still receive their presentation on the process of drafting Guidelines in Biotech.

We have requested the EPO when further special meetings on ST.26 sequence listings and antibodies can take place.

It was very useful to meet at least some of the EPO attendees in person again and we hope this will encourage the EPO to allow more face-to-face meetings.

4. Updated comments to the 2023 EPC GLs

The biotech aspects of the 2023 EPC and PCT GLs were discussed during a zoom Biotech committee meeting on March 17, 2023. Our assembled comments were passed to Anette Hegner on March 22, 2023. We were represented by Simon Wright at the epi preparatory meeting on March 27, 2023. Our comments were taken up in the submission as filed by epi in the framework of the User Consultation.

We further updated the biotech aspects of the 2023 EPC GLs in view of what was discussed at our committee meeting on April 24, 2023 and in view of the discussion with DG1 on April 25, 2023. We forwarded the last updated version to Anette Hegner on April 29, 2023 and posted it on the forum.

The Biotech committee was not represented at the SACEPO WP GLs meeting on May 4, 2023 as already 3 epi members have been appointed by the President. Anette Hegner requested a special meeting for GLs on Biotech at the SACEPO meeting. Unfortunately it looks like this has not been allowed by the EPO.

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. It was promised that the EPO would review this further after the DG1 meeting. We look forward to the EPO’s reply.

We understand matters relating to plants may be political, nevertheless we think epi has a right to be heard as well. We mainly have questions about the need for plant disclaimers for which we held there is no legal basis according to epi. We deem it appropriate to have regular discussions with the EPO regarding its practice in this field.

For antibodies we really need discussions so that the quality of what is entered in the GLs is guaranteed and so that the GLs do not contradict the case law. We are also concerned about individual examiners’ objections which are not in line even with 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 attention.

6. Process of drafting GLs in Biotech

Epi biotech committee still has concerns on the GLs drafting process and the impact it has on quality and on citation of GLs parts in court cases. There seems to be no real dialogue possible in the SACEPO meetings on GLs. The role the Guidelines can play is not assessed when determining quality. We hope the EPO picks this up. We suggest to keep 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 often disregarded. This creates frustration in the user community. 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 EPC 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.

7. Next committee meeting

A committee meeting by zoom has been scheduled for 19 July 2023 to discuss the following matter:

Chairship and Secretaryship of the Committee for the remaining term till next council meeting
Outstanding reply from the EPO to our comments of 28 April 2023 and missing reply on special meetings on ST.26 Sequence Listings and antibodies.
Draft minutes of the DG1 Biotech/Pharma session meeting
Associate Membership requests for the Biotech Committee
Complaint before the EPO Ombuds Office
Slides form the EPO regarding the process of adapting the GLs in Biotech
ST.26 Sequence listings developments
AOB

We will also schedule a further (live or hybrid or zoom) committee meeting shortly after the summer and before the autumn council meeting.