Report of the Biotechnological Committee
Below is an update of activities in our Biotechnology Committee (BC) since the last Q1_2025 report:
1. Education and training
After the success of the 1st epi’s podcast dedicated to NGT plants, the Chair and the Secretary of the BC gave a one-hour webinar on 20 November 2024 on Biotech and Life Science legal matters, addressing various issues relating to the protection of biotechnology innovations. Some subjects deserve to be addressed in greater detail at other, more specific, seminars later.
A new webinar was scheduled on May 28, 2025 to explore and discuss in detail the EPO’s practice on patenting antibodies, dealing with novelty, and, in particular, inventive step/obviousness and sufficiency. Our expert speakers Niklas Mattsson and Hans-Rainer Jaenichen discussed the EPO Guidelines, case law and practice in this niche area, while Simon Wright acted as Moderator.
2. SEQ Listing and WIPO Standard ST.26
During the DG1 meeting which took place on 29 November 2024 in the Hague with the EPO we were agreed about the following action to be taken on the WIPO Standard ST.26:
- EPO to share with WIPO all the various issues met by users in using the ST.26 software and to push WIPO to improve the tool in the near future.
- EPO should improve the support for applicants form the official resources of the EPO is rather thin (partially misleading FAQs, no link to other resources for support, no specific email address or whatsoever).
- epi will appreciate if EPO share as soon as possible a version for testing the new version of ST.26 expected in 2025.
Since that meeting, epi has been reached-out in view of a survey on WIPO Standard ST.26 that the International Bureau launched to investigate the impact of the WIPO ST.26 minimum length requirement on applicants and sequence searchers.
On the initiative of the Sequence Listing Task Force of the Committee on WIPO Standards (CWS), the International Bureau has launched a specific survey. epi’s President, Peter Thomsen, kindly requested that the BC submits the feedback on behalf of epi and informs him about the input provided. The survey was open for feedback until 31 March 2025.
Furthermore, John Gray (Chair, epi Online Communications Committee) attended WIPO PCT WG meeting 18-20 Feb. The BC has also connected with Emma Francis (IP Data Expert & WIPO Sequence Product Owner, Standards Section, International Classifications & Standards Division) of WIPO. A meeting took place on 26 February with epi’s experts on sequence listing and ST.26.
As reported in the March 14, 2025 BC meeting in Krakow, there have been positive developments since the DG1 meeting regarding sequence listings. The committee noted that WIPO is receptive to user feedback but needs more input to drive changes to the ST.26 tool. Benjamin has been tasked with drafting an epi position paper to support members in responding to the WIPO survey, with particular focus on issues with large sequence listings. The committee has also called for volunteers to test updated versions of the software.
3. EPO’s Approach to Antibody Patents
During the November 2024 DG1 meeting, epi’s Biotech Committee raised significant concerns about the EPO’s overly systematic approach to evaluating inventive step in antibody patents. In response, EPO/DG1 agreed to remind Examiners that their approach should be flexible rather than rigid, emphasizing case-by-case evaluation based on available information and supporting evidence.
Following this meeting, Tamaris Bucher, a new associate member of the BC, published a comprehensive three-part series in epi Information addressing the barriers facing antibody inventions at the EPO. These articles argued that EPO Guidelines create an artificial barrier for antibody inventions, subjecting them to stricter standards than low molecular weight compounds without solid foundation in case law. Bucher highlighted how the “surprising technical effect” exception is misinterpreted from original case law and challenged the misconception that antibody engineering represents merely routine work. The articles concluded that the unpredictability of structure-function relationships in antibodies should be more broadly recognized to align treatment with other chemical inventions.
At the March 14, 2025 BC meeting in Krakow, members expressed growing concern about the EPO’s approach, leading to the formation of a dedicated working group to draft proposals for revising the EPO Guidelines. The BC collaborated with EPPC for the public consultation ending April 7, 2025, specifically requesting complete removal of Guidelines section G.II.6.2. To strengthen their position, the BC engaged with EFPIA and Business Europe to broaden industry support for this initiative.
On May 8, 2025, Brigitte Carion-Taravella advocated the BC’s position at the SACEPO WP meeting, but the outcome fell short of expectations. The EPO continues to characterize the issue as purely technical requiring a specific meeting with epi’s Biotech Committee while showing resistance to policy adjustments. The EPO frames user concerns as “ misunderstandings“ despite established practices and claims that modifying guidelines wouldn’t alter existing practices.
The immediate priority now is scheduling a technical meeting with the EPO as soon as possible to influence potential changes in the 2026 Guidelines, with draft versions expected by the end of July 2025. The BC remains committed to pursuing constructive dialogue on this important matter and will continue to monitor developments closely.
5. NGT plants Regulation update
The Polish Presidency’s proposal on NGT Plants Regulation is currently under consideration by Member States, with discussions expected to advance to the EU Parliament if approved. The proposal primarily focuses on transparency requirements regarding patents and applications for plants entering the market, though concerns have been raised about “ equitable conditions“ and potential reduction in plant variety choices.
During the Board Committee meeting of March 14, 2025, the Position Paper was thoroughly discussed, with Jan Desomer (DE) questioning the relevance of access/transparency issues to patents, while epi’s President Peter Thomsen (CH) advocated for immediate action during the current Polish Presidency, which is considered more favorable to the epi position. The importance of proposing constructive alternatives was emphasized, leading to the formation of a dedicated working group to review the position paper on this topic.
The epi’s position paper on EU NGT plant regulation has now been finalized and published on the epi website. President Peter Thomsen has confirmed the paper is ready for distribution with the following implementation plan: publication on the epi website, inclusion in the epi newsletter with appropriate links, and utilization by each Board Committee member for engagement with national government contacts of EU member states.
Despite the Regulation proposal currently being in the trilogue phase, which limits opportunities for external influence, the organization has decided to proceed with the planned communication strategy to maximize potential impact.
6. New associate member
Tamaris Bucher (CH) is a new Associate member of the Biotech Committee.
