A three-month preparation period for a complex provisional measures application is not an unreasonable delay under R. 211.4 RoP, considering the technical complexity and multiple patents involved
The Court held that “delay” runs from when the applicant has, or should have, enough facts and evidence to file with a reasonable prospect of success (R. 206.2 and 211.4 RoP).
Here, that point was the first detailed infringement letter of 27 May 2025, when Guardant Health had obtained key technical documents on the accused test and started substantive analysis, not earlier public webinars or high-level marketing.
Given four patents and sophisticated liquid biopsy technology, three months to investigate, assemble evidence and draft a front‑loaded application was considered objectively reasonable and not an “unreasonable delay” barring provisional relief.
A patent is likely invalid for added matter (Art. 123(2) EPC) if claims combine scattered features from the original application without a clear pointer, creating a new invention
For EP 3591073 B1, the Court applied the EPC added‑matter standard: the claim must be directly and unambiguously derivable, using common general knowledge, from the application as filed.
The granted claim was built by combining elements from embodiment 78 (collapsing reads into consensus sequences), dependent embodiments (e.g. ≤100 ng cfDNA), and separate description passages (cell‑free DNA from body fluid, non‑unique barcodes, enzymatic ligation).
The Court found no “pointer” in the PCT application to this specific combination, and stressed that the description cannot be treated as a “reservoir” of features to assemble a new claim. On this basis, EP’073 was more likely than not invalid for added matter.
Making specific selections from lists in a parent application (e.g., four out of five cancers) without a clear basis constitutes added matter, rendering the patent likely invalid
For EP 3443066 B1, the Court focused on how claim 1 specified: (i) exactly four cancer types (colorectal, ovarian, lung, pancreatic), while the parent application described a broader list including a fifth cancer; and (ii) a panel comprising loci from each of 25 named genes, whereas the earlier disclosure only taught that one or more loci from that gene list could be included.
These are multiple selections from lists in the parent without any explicit or implicit teaching to select that precise subset and combination.
The Court held that such a selection created subject‑matter not directly and unambiguously derivable from the original filing, so the patent was more likely than not invalid for added matter.
Infringement is not proven with sufficient certainty (R. 211.2 RoP) if the applicant relies only on vague evidence like a press release, without providing detailed technical proof
Under R. 211.2 RoP, the Court may require “reasonable evidence” showing with a sufficient degree of certainty that the patent is infringed or that infringement is imminent.
For EP 3766986 B1, the Applicant primarily relied on a joint press release about a partnership and high‑level references to using data to gain “insights into efficacy of therapies,” plus webinar statements about longitudinal variant tracking.
The Court found this material aspirational, non‑technical and silent on whether a database matching serial cfDNA data, therapies and efficacy was implemented as claimed.
Without technical documentation, system descriptions or similar in‑depth evidence on how the SOPHiA DDM platform actually operated, the burden of proof for direct or indirect infringement (Arts. 25–26 UPCA) was not met.
Division
Paris Local Division
UPC number
UPC_CFI_808/2025
Type of proceedings
Application for provisional measures
Parties
Applicant: Guardant Health, Inc.
vs.
Defendants: Sophia Genetics SA, Sophia Genetics SAS, Sophia Genetics SRL, Sophia Genetics GmbH
Patent(s)
EP 3470533 B1 (withdrawn during the procedure)
EP 3591073 B1
EP 3443066 B1
EP 3766986 B1
Jurisdictions
UPC
Body of legislation / Rules
Art. 25, 26, 32, 33, 73 UPCA
R. 211.1(d), 211.2, 211.4, 220.1(c), 224.1(b), 336 RoP
Art. 69, 123(2) EPC
