Report of the Biotechnological Committee

Below is a summary of the activity of the Biotechnology Committee (BC) in 2025:

1. Executive Summary

Throughout 2025, the epi Biotechnology Committee engaged intensively with the European Patent Office (EPO), WIPO, the European Commission, and industry stakeholders to address key policy areas in biotechnology patenting. The Committee’s primary focus remained on:

Reforming antibody patentability practices and the problematic Guidelines section G‑II, 6.2.
Addressing issues with WIPO Standard ST.26 sequence listings.
Monitoring and influencing EU plant‑related regulatory developments, including NGT plants.
Expanding training and educational outreach within epi.

This report consolidates all activities from January to December 2025.

2. Patentability of Antibodies – Year in Review

2.1 Early‑year developments (Q1 2025)

The BC reiterated concerns raised during late‑2024 meetings with DG1 that the EPO applied a too systematic, rigid approach to inventive step for antibodies.
EPO indicated examiners would be reminded to conduct case‑by‑case assessments. BC noted that internal EPO practices seemed to rely on unwritten standards and requested disclosure of any such internal guidance. Several articles by Tamaris Bucher published in epi Information further criticized the misleading interpretation of “surprising technical effect” case law and highlighted the unpredictability of antibody structure–function relationships.

The Committee recognized the need for systemic reform and prepared to escalate concerns through public consultation and coordinated stakeholder action.

2.2 Q2 2025 – Consolidation of analysis and external engagement

March 2025: At the Krakow BC meeting, a dedicated working group was formed to draft formal proposals for Guideline changes.
The BC collaborated with EPPC, EFPIA, and BusinessEurope in the run‑up to the EPO Guidelines consultation (deadline 7 April 2025).
The BC’s proposal: complete deletion of Guidelines section G‑II, 6.2 due to its legal and scientific deficiencies.
Despite these coordinated efforts, EPO maintained resistance, asserting that concerns reflected “misunderstandings,” and indicated that a technical meeting would be necessary for deeper discussion

2.3 Q3 2025 – Escalation & structured dialogue with EPO

The year’s turning point came with a series of exchanges: April 2025 – BC submits major comments to SACEPO WPG. The BC highlighted:

The unlawful presumption of non‑inventiveness for antibodies.
Misuse of case law (over‑reliance on T 187/04, T 605/14; neglect of T 67/11, T 1171/18).
Internal inconsistencies regarding sequence requirements.
Lack of scientific accuracy in evaluating antibody development complexity.

May 8, 2025 – SACEPO WPG meeting. BC presented its concerns, leading EPO to agree to a dedicated technical meeting.

July 24, 2025 – Dedicated EPO–BC meeting. EPO acknowledged:

Work in progress to eliminate negative presumptions from Guidelines.
The need to review examination practices, which were stricter than Guidelines.
Shared 14 foundational decisions shaping their practice.

A follow‑up meeting was scheduled for October.

2.4 Year‑end developments (October–December 2025)

October 13, 2025 – Bilateral BC/DG1 meeting. The BC completed an in‑depth assessment of 15 EPO decisions, concluding they do not support the draft 2026 Guidelines’ restrictive approach. Key conclusions:

No case law supports a presumption that antibodies to known antigens lack inventive step.
No legal basis for limiting assessment to four sub‑tests.
Many cited cases involve in‑vitro mouse antibodies, not therapeutics.

BC recommended comprehensive revision of the 2026 Guidelines.

October 14, 2025 – SACEPO WPG meeting (The Hague). BC emphasized issues with the terminology (“surprising/unexpected”) and with antibody‑specific conditional structures.
EPO and BC agreed that amendments are needed, though not full deletion of section G‑II, 6.2.

Planned 2026–2027 actions

Spring 2026: In‑depth case‑law meeting (already scheduled on 26 May 2026).
Target: inclusion in 2027 Guidelines.

3. SEQ Listings & WIPO ST.26

Sequence listing issues were a continuous topic throughout 2025, starting with the November 2024 DG1 meeting and continuing through Q1, Q2, and year‑end.

3.1 Q1–Q2 2025 – Early activities

Key issues identified:

ST.26 software difficulties and insufficient EPO support (FAQ gaps, no help desk).
epi requested early access to the 2025 ST.26 tool update.
BC coordinated epi’s contribution to the WIPO survey (feedback until 31 March 2025).

The BC also engaged with WIPO experts, including Emma Francis, and participated in the PCT Working Group. A position paper was assigned (Benjamin) focusing on issues with large sequence listings.

3.2 Q3–Q4 2025 Developments

EPO announced a new Presidential Decision effective 1 January 2026, mandating XML/ST.26 and clarifying accepted filing channels.
BC raised concerns:

Burdensome correction procedure (added‑matter declarations + fees).
Inconsistency between EPO and UK IPO practice for divisionals.
Need for flexibility for short sequences.

The BC confirmed willingness to assist EPO in shaping implementation.

4. Plant‑Related Patent Developments (NGT & EPC Practice)

4.1 Q1–Q2 2025 – EU NGT regulation work

The BC became actively involved in developing epi’s response to the NGT Plants Regulation:

Reviewed the Position Paper extensively in March 2025.
Raised concerns about the draft’s assumptions (“equitable conditions”, impact on breeder choices).
Finalized the epi Position Paper and launched a communication strategy targeted at national authorities.

4.2 October 2025 – EPC‑related plant discussions with DG1

BC raised major concerns:

EU expert draft report suggesting “no patents = fewer worries for farmers”.
Very low grant rate + high refusals in plant cases due to strict EPO positions.
Criticism of “conceivable natural process” disclaimers considered speculative and discriminatory.

BC proposed the use of disclaimers for essentially biological processes as a compromise solution to avoid outright bans.

5. WIPO – Genetic Resources / Traditional Knowledge

Introduced in the October 2025 BC–DG1 meeting:

Principle: disclose source of genetic material without impact on validity.
BC expressed willingness to join future discussions once EPO–WIPO internal deliberations progress.

6. Education, Training & Outreach

2025 saw robust educational activity:

20 November 2024 webinar on biotech & life‑science legal matters, with more specialized sessions planned.
28 May 2025 webinar on antibody patentability, with speakers Mattsson, Jaenichen, and Wright (moderator).
BC contributed to podcasts, articles, and WIPO engagement to raise awareness of biotech patenting challenges.

7. Committee Composition & Meetings

New Members: Tamaris Bucher (CH) joined as Associate Member (Q2 2025).

Key Committee Meetings in 2025

March 13–14 (Krakow): BC + EPPC; divisional applications, G2/24, exam quality.
May–July: multiple meetings with EPO on antibody issues.
October 13–14 (The Hague): major DG1 and SACEPO sessions.

8. Conclusions and Outlook for 2026

In 2025, the BC significantly strengthened its influence over biotechnology‑related examination practice at the EPO. Notably:

Antibody patentability reform is on track for multi‑stage revision through 2026–2027.
ST.26 implementation remains a top‑priority technical topic.
Plant‑related patentability will remain volatile due to political and EPC‑practice pressures.

The BC will continue to lead expert‑level dialogue with the EPO and WIPO and will expand training and stakeholder engagement in 2026.