Advanced Cell Diagnostics v Molecular Instruments (CFI, 18 November 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 18 November 2025, given in infringement action UPC_CFI_187/2024 and counterclaim UPC_CFI_507/2024, the Hague Local Division held Advanced Cell Diagnostics’ EP 1 910 572 and EP 2 500 439 (multiplex in situ hybridisation) valid, but found no infringement by Molecular Instruments’ HCR products. Both claims were dismissed and each party bears the costs of the proceedings it lost.

The decision upholds validity although the UK High Court had held the patents invalid for obviousness on 23 April 2024 (paragraph 14). It also shows a strict reading of a term such as « non-overlapping », which decides the infringement question here.

Facts and procedure

The patents concern the detection of nucleic acids in individual cells using capture probes, label probes and branched DNA amplifiers, notably in a cruciform arrangement. After two purchases of HCR products delivered to a university hospital in Heidelberg (paragraph 10), the claimant sued on 22 April 2024 (paragraph 11). At the interim conference of 2 July 2025, the value of each action was set at EUR 5,000,000 and the parties agreed on the product description and common general knowledge adopted in the United Kingdom (paragraph 12). The oral hearing took place on 2 October 2025.

The applicable law

Claim construction follows Art. 69 EPC and the principles set by the Court of Appeal in NanoString v 10x Genomics (paragraph 29). Inventive step is assessed under the test of the Central Division in Sanofi v Amgen (paragraph 49), and added matter under the gold standard restated by the Court of Appeal on 2 October 2025. The admissibility of a late equivalence argument is examined in light of the OrthoApnea order (paragraph 104). Costs fall under Art. 69 UPCA.

Question

Are the patents novel, inventive, sufficient and free of added matter, and do the HCR probes, which overlap by one to four nucleotides, meet the « non-overlapping » feature, literally or by equivalence?

Decision

On construction, the T section of the capture probe must hybridise directly to the label probe (paragraph 33), « non-overlapping » allows no overlap at all (paragraphs 38 and 39) and « simultaneously » means in the same hybridisation step (paragraph 44).

On validity, Collins does not destroy novelty, its in situ and cruciform options being merely theoretical, and if anything teaches away (paragraphs 55 to 60). Neither Urdea, whose conditions are too harsh for in situ use, nor Kenny renders the invention obvious (paragraphs 64 to 76). Insufficiency was not substantiated (paragraphs 77 and 78) and the added matter attacks failed (paragraphs 83 to 92). Both patents are valid as granted or amended (paragraph 93).

On infringement, the HCR probes overlap by one to four nucleotides (paragraphs 99 and 100), so there is no literal infringement (paragraph 101). The equivalence argument was admissible (paragraph 107) but failed, given legal certainty, the limited inventive contribution and the overlap’s own function (paragraph 108). The ceiling for recoverable costs was set at EUR 800,000, or EUR 400,000 per action (paragraph 111).

Key points for practice

• A numerical or negative claim limitation (« non-overlapping ») is read strictly and may be enough to rule out literal infringement (paragraphs 38 and 101).
• Equivalence fails where the variant has a function of its own and the inventive contribution is limited, legal certainty favouring third parties (paragraph 108).
• The division upheld inventive step despite the contrary judgment given in the parallel UK proceedings (paragraphs 14 and 59 to 76).
• Practical point: a late equivalence argument may be admitted (paragraph 107), but it must be substantiated on each of the criteria applied by the division.

Provisions applied

Agreement on a Unified Patent Court

Art. 33(1)(a) and 69

Rules of Procedure

Rules 13, 19, 190 and 263

European Patent Convention

Art. 69

Regulation (EU) No 1215/2012

Art. 7(2)

Case law cited

OrthoApnea, Court of Appeal, 21 November 2024, Sanofi-Aventis Deutschland v Amgen, Munich Central Division, 16 July 2024, Expert e-Commerce v Seoul Viosys, Court of Appeal, 2 October 2025, NanoString Technologies v 10x Genomics, Court of Appeal, 26 February 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.