Report of the Biotechnological Committee

Below is a summary of the activity of the Biotechnology Committee (BC) since the last report:

1. EPO - Antibody Patentability (Guidelines Section G-II, 6.2) - Update and Next Steps

As reported in C100, the BC completed in October 2025 an in-depth assessment of 15 EPO decisions and presented its findings to DG1 and SACEPO WPG, concluding that the case law does not support the restrictive framework in the draft EPO Guidelines for antibody inventive step assessment.

Key updates since C101:

The EPO and BC agreed that amendments to the Guidelines are needed, though not full deletion of section G-II, 6.2. A significant development regarding the EPO Guidelines for antibody-based inventions is effective in 2026. While the textual changes may appear subtle at first glance, the philosophical shift is substantial and worth noting:
- Previous approach (“Not inventive except if…”): The EPO Guidelines were framed with a negative premise - starting from the position that an antibody directed to a known antigen per se is not inventive, and then listing exceptions where inventiveness could be recognised. This created a presumption against patentability that applicants had to overcome.
- New 2026 approach (“Inventive when…”): The revised wording adopts a more positive framing. Instead of presuming non-inventiveness with carve-outs, the Guidelines now approach antibody claims from a positive standpoint - acknowledging that such antibodies can be inventive, with the assessment focusing on the specific technical contribution and unexpected properties.
The joint EPPC and BC meeting held in Barcelona (13-14 April 2026) included productive discussions on antibody patenting. Key themes included the need to challenge the “routine methods” mindset embedded in current EPO practice, the importance of assessing inventive step based on the actual claim and facts of each case, and the relevance of UPC case law which does not incorporate the EPO’s reasoning on routine methods and structural non-obviousness.
An in-depth case-law meeting has taken place 26 May 2026, at which the BC’s detailed analysis of the foundational decisions has been discussed with the EPO.
The target is inclusion of revised provisions in the 2027 Guidelines.

2. Sequence Listings & WIPO ST.26 - Implementation of New Presidential Decision

The new Presidential Decision on sequence listings entered into force on 1 January 2026, superseding the December 9, 2021 decision and mandating XML/ST.26 format. The BC continues to monitor implementation and has flagged ongoing concerns:

Burdensome correction procedure requiring added-matter declarations and late furnishing fees, unlike corrections to other parts of the application (e.g., drawings)
Inconsistency between EPO and UK IPO practice for divisionals
Need for flexibility for short sequences, with discussions ongoing regarding optional presentation either in the description or sequence listing

New developments (April 2026):

WIPO is working on allowing shorter sequences to be included in sequence listings in the next version of the PCT, with release expected in spring or mid-2027.
Updated seqPUS/WINDOWS software to support Windows 11 is in development and is slowly moving toward production level, with release also expected around 2027.
The BC maintains active contacts with WIPO - including the US patent attorney leading the sequence listings work - to receive advance warning of any regulatory changes.

The BC confirmed its willingness to assist the EPO in shaping implementation and to participate in further discussions. The BC stresses that no additional burden should be placed on users.

3. Plant-Related Patent Developments (NGT Regulation & Patent Safeguards)

The EU NGT Plants Regulation was formally adopted on 8 April 2026, broadly maintaining the Commission’s two‑tier structure (Category 1 and Category 2 NGT plants) and introducing a set of patent‑related safeguards. These include a voluntary Code of Conduct, enhanced transparency obligations on patent and licensing information, the creation of an NGT Plant Patent Expert Group, and mandatory impact assessments with explicit legislative triggers if access barriers, market concentration, or negative effects on breeders and farmers are identified.

epi Engagement - Key Actions:

Following the 2026 April BC meeting, epi leadership took immediate steps to assess and influence the NGT Plant Patent Expert Group nomination process, which provides no direct European‑level user representation and relies exclusively on Member State nominations (with one expert each from the EPO and CPVO). epi’s strategy focuses on:

Mapping Member State nomination procedures and timelines
Engaging high‑level EPO contacts to confirm EPO participation and potential nominees
Positioning suitable epi members for nomination via national channels

Status: Investigation ongoing (as of 20 April 2026), led by epi leadership and Legal Advisors.

BC View:

The Expert Group and mandatory Commission reviews represent critical leverage points for addressing restrictive EPO practice and potential patent‑related barriers to innovation. The BC will monitor developments closely and coordinate with epi leadership to ensure timely and effective engagement.

4. WIPO – Genetic Resources / Traditional Knowledge

No significant new developments since C101. The principle remains that the applicant should name the source of genetic material in a patent application, but this should have no influence on patent validity. Further progress is contingent on EPO-WIPO internal deliberations. The BC remains willing to engage in future discussions once these deliberations progress.

5. Education, Training & Outreach

The BC continues its educational outreach activities. In 2025, the BC organised webinars, including the 28 May 2025 webinar on antibody patentability (speakers: Mattsson and Jaenichen; moderator: Wright), and contributed to podcasts and articles to raise awareness of biotech patenting challenges. Further specialised training sessions are planned for 2026.

6. BC Meetings and Upcoming Events

A joint EPPC and BC meeting was held on 13-14 April 2026 in Barcelona, with productive discussions on antibody patenting, NGT regulation, and sequence listings.
The in-depth case-law meeting with EPO on antibody inventions is scheduled for 26 May 2026 in Munich.

7. Outlook for 2026

Antibody patentability reform remains on track for multi-stage revision through 2026-2027, with the May 2026 EPO meeting as the next key milestone.
ST.26 implementation remains a top-priority technical topic. WIPO confirms no plans for ST.27; focus is on short sequence inclusion and software updates expected in 2027.
Plant-related patentability will remain a key area of focus due to the implementation of the NGT Regulation, Patent Expert Group activities, and ongoing EPC-practice pressures.