Guardant Health v Sophia Genetics (CFI, 23 January 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

By an order of 23 January 2026 (UPC_CFI_808/2025), the Paris Local Division dismissed Guardant Health’s application for provisional measures against four Sophia Genetics companies concerning the « MSK-ACCESS powered with SOPHiA DDM » liquid biopsy test. Of the three patents still in issue, two (EP 3 591 073 and EP 3 443 066) were held more likely than not to be invalid for added matter, and infringement of the third (EP 3 766 986) was not shown. Guardant Health was ordered to pay EUR 400,000 in interim costs.

The order is useful on three points: three months to prepare the application is not an unreasonable delay, the PCT application cannot serve as a reservoir of fragments to be combined, and a disputed press release is not enough to prove infringement.

Facts and procedure

On 29 August 2025 Guardant Health applied for provisional measures on the basis of four patents relating to cell-free DNA analysis: EP 3 470 533, EP 3 591 073 (detection of rare mutations), EP 3 443 066 (early detection of cancer) and EP 3 766 986 (a computer-implemented method using a database of serial testing data). Sophia Genetics filed its objection on 27 October 2025. In its reply of 10 November 2025 Guardant Health withdrew its request based on EP 3 470 533. The oral hearing took place on 12 December 2025, and the preliminary opinion of an EPO Board of Appeal of 15 December 2025 was admitted by order of 18 December 2025. The value of the dispute, which was not contested, is EUR 6 million.

The applicable law

Provisional measures are governed by Art. 62 UPCA and Rules 206 and 211. The applicant must satisfy the court with a sufficient degree of certainty that the patent is valid and infringed (Rule 211.2), and the court takes any unreasonable delay into account (Rule 211.4). Added matter is assessed under Art. 123(2) EPC: all the elements must be directly and unambiguously derivable from the application as filed.

Question

Has Guardant Health shown, with a sufficient degree of certainty, that its patents are valid and infringed, and was its application brought without unreasonable delay?

Decision

A period of three months up to the application of 29 August 2025 was reasonable (paragraph 36). For EP 3 591 073, the PCT application cannot be used as a reservoir of scattered fragments to be combined (paragraph 77), compliance with Art. 123 EPC was not shown with sufficient certainty (paragraph 86), and infringement was not established either (paragraph 88). Claim 1 of EP 3 443 066 results from selections made without any clear indication in the earlier application and is not directly and unambiguously derivable from it (paragraph 113): the patent is more likely than not to be invalid (paragraph 114).

For EP 3 766 986, the alleged infringement concerned only the SOPHiA DDM software platform. How it processes information was not sufficiently proven, the applicant relying mainly on a press release (paragraphs 144 and 145). Refining clinical trial design is not the same as identifying effective therapeutic interventions (paragraph 146). Neither direct nor indirect infringement was shown (paragraphs 148 and 149). The court dismissed all the requests without examining the subsidiary ones (paragraphs 150 and 151) and set interim costs at EUR 400,000 rather than the EUR 600,000 ceiling, given the summary nature of the proceedings and the late withdrawal of one patent (paragraphs 152 to 156).

Key points for practice

• Three months to prepare an application for provisional measures based on several patents is not an unreasonable delay under Rule 211.4 (paragraph 36).
• On added matter, combining elements scattered across the PCT application without any clear pointer leads to likely invalidity (paragraphs 77 and 113).
• The burden of proving infringement lies with the applicant. A disputed press release does not establish how software works (paragraphs 145 and 148).
• Practical point: a patentee targeting a software platform should gather direct technical evidence of the data processing before applying, rather than relying on the defendant’s marketing material.

Provisions applied

Agreement on a Unified Patent Court

Arts 32(1)(a), 33(1)(b), 62, 69 and 73(2)(a)

Rules of Procedure

Rules 33, 206, 211.1(d), 211.2, 211.4, 220.1(c), 224.1(b) and 336

European Patent Convention

Arts 52 to 57, 64, 69, 76(1) and 123(2)

Case law cited

Mammut Sports Group v Ortovox, Court of Appeal, 25 September 2024, Expert e-Commerce v Seoul Viosys, Court of Appeal, 2 October 2025, Meril v Edwards, Court of Appeal, 25 November 2025, orders UPC_CoA_335/2023 and UPC_CoA_1/2024

Prepared by Dhenne Avocats from the official decision, consulted on 10 October 2026. The database is updated every week, on Friday. Only the official text is authoritative.