Paris Central Division clarifies limits for urgency, added matter, and proof of software infringement

Paris Central Division clarifies limits for urgency, added matter, and proof of software infringement at PI stage – not every conceivable combination of disclosed features is disclosed

Guardant Health v Sophia Genetics – Paris Central Division, 23 January 2026, UPC_CFI_808/2025

Introduction

In a wide-ranging order refusing provisional measures concerning three liquid biopsy and bioinformatics patents, the Paris Central Division addressed four issues of general relevance for UPC practice: (i) what constitutes an “unreasonable delay” under Rule 211.4 RoP in technically complex multi-patent cases; (ii) the added-matter standard in view of a  “reservoir” of features; (iii) the consequences of multiple unprompted selections from lists in the parent disclosure; and (iv) the level of proof required to show software-based infringement with a “sufficient degree of certainty” under Rule 211.2 RoP.

No unreasonable delay: three months acceptable in complex multi-patent case

Under Rule 211.4 RoP, the Court must consider whether there has been any “unreasonable delay” in seeking provisional measures. Following Mammut v Ortovox (UPC_CoA_182/2024), the relevant period runs from the moment the applicant had — or should have had — sufficient knowledge of the infringing acts and supporting evidence to file a PI application with a reasonable prospect of success.

Sophia Genetics argued that Guardant Health should have acted much earlier, pointing to webinars, marketing materials and industry visibility dating back to 2024 and early 2025. The Court rejected this broad approach. It distinguished between:

• general awareness of a competitor’s activity, and
• sufficiently specific technical knowledge enabling a substantiated infringement analysis.

The Court accepted 27 May 2025 — the date of a first detailed letter based on concrete product information — as the starting point. Earlier webinars and public-facing materials did not, in the Court’s view, necessarily provide the technical detail required for a reliable infringement assessment in such a complex technological field.

From that starting point, Guardant filed its PI application on 29 August 2025. The Court held that a three-month period was not unreasonable, given:

• the involvement of several patents,
• the complex and sophisticated sequencing technology, and
• the need to obtain and analyse non-public technical documentation.

Added matter: no “reservoir” of features

The Court then examined validity with a “sufficient degree of certainty” under Rule 211.2 RoP and found that two patents (EP’073 and EP’066) were more likely than not invalid for added matter.

For EP’073, the claimed method combined features that were individually disclosed in different parts of the PCT application (e.g. cfDNA, ≤100 ng input, non-unique barcodes, enzymatic ligation). However, the Court found no clear disclosure of this specific combination in the earlier application, nor any pointer guiding the skilled person to assemble these elements together.

The Court expressly criticised the applicant for relying essentially on the EPO Opposition Division’s reasoning without demonstrating why the skilled person would have been led to the claimed combination. The approach was characterised as an ex post facto reconstruction from scattered fragments.

The reasoning for EP’066 was even more explicit. Claim 1 required:

• detection of four specific cancers, and
• sequencing a panel comprising one or more loci from each of 25 named genes.

The parent application disclosed broader lists (including five cancers and flexible gene panels), but the Court saw no clear pointer to the exact selection embodied in the granted claim. The invention as claimed was therefore the result of several unprompted selections from lists, which the Court held could not be directly and unambiguously derived.

The headnote captures the essence: from such selections without clear indication in the earlier application, the claimed invention cannot be regarded as originally disclosed.

Software infringement: press releases are not enough

For the third patent (EP’986), validity was not the decisive issue. Instead, the application failed on infringement.

Guardant Health alleged that Sophia Genetics’ SOPHiA DDM platform implemented a database-driven method for identifying effective therapies based on longitudinal genomic data and treatment outcomes. However, the evidence relied primarily on:

• a joint press release describing a collaboration, and
• high-level public materials and webinar statements.

No technical insight into actual data processing

The Court held that such material was too general and aspirational to establish how the accused software actually processed data. In particular, it was not sufficiently shown that:

• a database as claimed was in fact implemented,
• it contained the specific categories of data required by the claim, and
• it was used to identify effective therapeutic interventions in the claimed manner.

The Court stressed that additional in-depth technical investigations or documentation on the operation of the accused software would have been necessary. Reliance “mainly on a press release” was insufficient for both direct and indirect infringement.

Takeaways

• A three-month preparation period may be acceptable where multiple patents and complex technology require substantial technical analysis before filing a PI.
• The Paris Central Division did not allow to assemble claims from scattered passages of a parent application without a clear pointer. The “reservoir” approach is expressly rejected.
• Selections from lists are critical: Multiple unprompted selections (e.g. specific diseases and specific gene panels) strongly support a finding of added matter.
• High-level marketing materials or press releases are insufficient to show infringement with the necessary degree of certainty. Detailed insight into actual system operation is essential.

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