Report of the Biotechnological Committee
Below is an update of activities in our Biotechnology Committee (BC) since the last Q2_2025 report:
1. EPO – SACEPO WPG and meeting with Patent law (Dir. 5.3.1) and DG1
In April 2025, significant comments were submitted by the BC to the SACEPO Working Party Guidelines addressing section G II-6.2 of the EPO Guidelines on antibody patentability. These comments highlighted fundamental concerns about the current examination approach for antibody-related patent applications.
In summary, epi / BC’s comments were as follows:
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The current Guidelines establish a problematic legal frameworks by automatically presuming antibody inventions lack inventive step unless proven otherwise. This approach directly contradicts Article 56 of the European Patent Convention and creates an unfair distinction between antibodies and other technologies. The Guidelines’ interpretation seems to reply on misunderstood case law, particularly decisions T 187/04 and T 605/14, while overlooking crucial decisions (T 67/11 and T 1171/18) that acknowledge the inherently unpredictable nature of antibody development.
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A significant technical assessment issue arises from the Guidelines’ paradoxical requirements. Examiners are instructed to consider unpredictability in overall antibody architecture while simultaneously ignoring amino acid sequence analysis. They must require framework sequences in claims yet dismiss their relevance in inventiveness assessments. This creates an inconsistent and technically unsound examination process.
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The Guidelines demonstrate also a fundamental misunderstanding of new antibody development. The process for obtaining antibodies requires complex optimization for therapeutic use, considering numerous critical parameters including specificity, stability, immunogenicity, and solubility. Furthermore, the high unpredictability in structure-function relationships makes this field particularly challenging.
The proposed solution focusses on structural reform, including the complete removal of section G.II.6.2 and elimination of the prima facie non-inventiveness assumption. The EPO’s approach should implement consistent structural similarity principles across all technical fields, specifically in chemistry of large polymers, focusing on specific sequence information in claims and properly evaluating structure-function relationships.
The BC was able to participate in the SACEPO meeting on May 8, 2025, to share these comments. However, during the meeting, discussions on the antibody section of the examination Guidelines were relatively brief. At the request of the EPO, it was agreed to organize a dedicated meeting specifically focused on these expert technical issues to allow for more detailed exchanges directly with the examiners.
The dedicated meeting took place on July 24, 2025, with both EPO legal representatives and examiners responsible for examining antibody inventions. The EPO immediately indicated that modifications to the antibody patentability section were already underway, primarily focused on reworking the text to remove the negative presumptions about antibody non-inventiveness (which were contrary and inconsistent with the rest of the guidelines on invention patentability).
Discussions also addressed the very strict position adopted by the EPO during examination of inventions, which goes well beyond what is stated in the guidelines. EPO will initiate a review of examination practices. EPO also shared 14 fundamental decisions that according to the EPO, currently shape its practices.
Looking forward, another exchange on this subject is scheduled for October 13, 2025. Before then, a working group is expected to conduct a detailed examination of the 14 decisions shared by the EPO, which seem to represent the basic jurisprudence for inventive step assessment of antibody inventions.
The ultimate goal is to create a more balanced and technically sound approach to antibody patent examination at the EPO, one that recognizes the unique challenges and complexities of this field while maintaining the fundamental principles of patent law. Change of EPO practices is essential for fostering innovation in the crucial field of biological therapeutics while ensuring proper patent protection for genuine inventions.
2. Education and training
The Chair, Simon Wright (GB) and two members of the epi’s BC, Niklas Mattsson (SE) and Hans-Rainer Jaenichen (DE) gave an epi webinar on 28 May 2025 on Patentability of Antibodies matter by addressing various issues relating to the protection of antibody innovations.
3. BC meeting
epi’s EPPC and BC will hold their next in-person joint meeting on October 14, 2025, in Munich. Prior to this, on October 13, they will meet with the EPO to address several key topics: the handling of divisional applications, recent Enlarged Board of Appeal decisions (G1/24 on claim interpretation and G1/25), and the overall quality of EPO examinations. This EPO meeting will also provide an opportunity to continue in a new specific meeting our ongoing discussions regarding the assessment of inventiveness for antibody-related patents.
