In brief
- The UPC Court of Appeal has dismissed Guardant's appeal against the rejection of its application for provisional measures against Sophia Genetics, holding that Guardant did not act with the required urgency when it made its application.
- The Court found that a patent holder need not assert all infringed patents in a single application but, once aware that a document evidences infringement of one patent, it must not turn a blind eye to the fact that the same document may evidence infringement of others. Unreasonably delaying an application to await information on all patents can be fatal to urgency. Here, a three-month delay was unreasonable, leading to rejection of the application.
- The UPC's order also addresses international jurisdiction over non-Contracting Member State defendants, claim construction, added matter, and cost allocation.
Background
Guardant Health, Inc. is the proprietor of European Patent 3 443 066 with unitary effect (the Patent), covering a method for detecting colorectal, ovarian, lung or pancreatic cancer using deep sequencing of circulating cell-free DNA.
On 27 May 2025, Guardant sent a warning letter to Sophia Genetics SA concerning alleged infringement of certain UK patents by Sophia's "MSK-ACCESS powered with SOPHIA DDM" liquid biopsy test, and began UK litigation on 14 July 2025.
On 29 August 2025, Guardant applied for provisional measures before the Paris Local Division against four Sophia Genetics group companies for alleged infringement of the Patent and other patents; one further patent claim was later withdrawn.
The Paris Local Division rejected the application (finding the Patent more likely than not invalid for added matter) and ordered Guardant to pay an interim costs award of EUR 400,000.
Guardant appealed in respect of the Patent and costs; Sophia cross-appealed.
Urgency: the decisive issue
The Court of Appeal's key determination concerned whether Guardant had acted with sufficient urgency in making its application. The Court of Appeal found that Guardant had not made its application for a provisional injunction with sufficient urgency under Rule 211.4 Rules of Procedure, making infringement and necessity irrelevant. Whilst a patent holder need not assert all infringed patents in one application, and filing separate applications weeks apart is compatible with procedural efficiency, delaying an application until information on all patents is available may itself constitute unreasonable delay.
It is the applicant's burden to show it acted without unreasonable delay. Guardant's own 27 May 2025 warning letter (concerning other patents) relied on a User Manual that also disclosed the Patent's features, meaning Guardant knew or should have known of the alleged infringement well before that date; the court assumed the relevant technical details were known by 1 May 2025.
A diligent patent holder using the same public information could have established infringement by all four Sophia companies within two weeks, meaning Guardant should have had the requisite knowledge by 15 May 2025 at the latest. Since all information relied upon by Guardant was publicly available, no substantial investigative measures were required.
Guardant's application was not filed until 29 August 2025 - a delay of more than three months not adequately explained by technical analysis, expert consultation, or awaiting a response to the warning letter.
There is no legislative deadline for filing a PI application: the court will apply a case-by-case assessment of all circumstances of the matter. In this case, the Court of Appeal indicated that Guardant had not submitted sufficient evidence to conclude it had acted with the required urgency, indicating that if a patent holder's behaviour shows that the enforcement of their rights is not urgent, provisional legal protection is not required.
International jurisdiction over Swiss and Spanish acts
Sophia contested jurisdiction over alleged infringing acts taking place in Spain and Switzerland. The Court of Appeal held that jurisdiction over the three defendants domiciled in Contracting Member State arose from that domicile under Article 4 in conjunction with Article 71b(1) of the Brussels Recast Regulation, regardless of where the infringing acts occurred.
As for the Swiss-domiciled company, jurisdiction over its acts flowed from Article 8(1) of Brussels Recast Regulation, using the French subsidiary as anchor defendant, and applying the CJEU's Solvay v Honeywell case law on the risk of irreconcilable judgments.
Claim construction
The Court of Appeal construed claim 1 of the Patent broadly: it does not require identification of the specific cancer type; instead, detection of just one of the four listed cancers suffices, and the test need not distinguish those cancers from other cancer types mentioned elsewhere in the description.
The required sequencing depth of at least 50,000 reads per base applied to all loci in the 25-gene panel, and "consensus sequence" under feature 1.7 covered both the "collapsing" method and probabilistic functions.
Added matter
Reversing the Paris Local Division's decision, the Court of Appeal rejected the added matter complaint, finding all features of claim 1 directly and unambiguously disclosed as filed.
Key takeaways
- Infringement analysis should be conducted across the whole of a patent portfolio as soon as possible, considering all the obtained information and documentation. The Court of Appeal here treated the patent holder's constructive knowledge broadly: once a document (here, Sophia's User Manual) discloses features relevant to more than one patent, urgency is assessed from the date that document was available, not from when the holder chose to consider it in relation to additional infringements or has obtained additional supporting documents.
- A delay of just three months can be detrimental to a Patent holder's application for provisional measures, even when there is no negative determination in relation to validity.
- Filing separate provisional injunction applications for different patents days or weeks apart remains procedurally acceptable, but there is no equivalent tolerance for delay caused by waiting to build a combined case. Parties should treat urgency clocks as running per patent, per defendant, from the earliest point infringement could reasonably have been identified from public information.