Human Definitions versus Biological Reality (T 630/24)

Key Takeaways

• EPO's gold standard demands strict basis for any claim amendment.
• Genus disclosure cannot be broadened to phylogenetic clusters without explicit support.
• Board held clusters IV/XIVa extend beyond original Clostridium genus disclosure.
• Drafting precise taxonomic language can avoid added‑matter rejections.

Pulse Analysis

The European Patent Office’s “gold standard” for added matter under Article 123(2) EPC requires that any amendment be directly and unambiguously derivable from the original filing. In practice, this creates a high bar for biotech inventions where scientific nomenclature evolves rapidly. Applicants accustomed to more permissive jurisdictions often stumble when a claim attempts to replace a taxonomic genus with a broader phylogenetic grouping, because the original disclosure may not provide a clear bridge between the two concepts.

In T 630/24, the University of Tokyo sought to protect a pharmaceutical composition that stimulates regulatory T‑cells using bacteria from *Clostridium* clusters IV and XIVa. While the original application described bacteria belonging to the *Clostridium* genus, the appellant argued that the clusters, defined phylogenetically, encompassed the same active agents. The Board of Appeal rejected this view, reasoning that the clusters are broader than the genus and include other genera, thus extending the claim beyond the disclosed subject‑matter. The decision reinforces that, under European practice, a phylogenetic classification cannot replace a taxonomic genus without explicit support in the filing.

For innovators in cell therapy, microbiome therapeutics, and related fields, the case serves as a cautionary tale. Drafting strategies must anticipate future reclassifications by explicitly linking phylogenetic descriptors to the underlying genus or species, or by including alternative taxonomic definitions in the original specification. Failure to do so can lead to costly refusals and delayed market entry. By aligning claim language with the EPO’s strict added‑matter standards, applicants can safeguard their inventions against the shifting sands of biological taxonomy while preserving robust protection across key markets.