GXD-Bio v Myriad International (CFI, UPC_CFI_437/2024, 19 December 2025)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 19 December 2025, given in infringement action UPC_CFI_437/2024 and counterclaim for revocation UPC_CFI_681/2024, the Munich Local Division revoked GXD-Bio’s patent EP 3 346 403 for Austria, Belgium, France, Germany, Italy, Luxembourg and the Netherlands, dismissed the application to amend and dismissed GXD-Bio’s action against Myriad International and eight other companies. The patent, which stems from a chain of divisionals, claims a method for quantifying gene expression in formalin-fixed paraffin-embedded (FFPE) breast cancer tissue, normalised to OAZ1 as the sole reference gene. The decision applies the direct and unambiguous disclosure test to each earlier application in the chain and is of interest to holders of divisional portfolios in the life sciences.

Facts and procedure

The patent, granted on 17 June 2020, derives from a divisional application filed on 5 October 2017, linked through EP 2 455 878 and EP 2 115 158 to international application WO 2008/078969, GXD-Bio acquired it by an assignment in May 2024. It targeted the EndoPredict test, which normalises eight target genes to the mean of three reference genes (CALM2, OAZ1 and RPL37A). The preliminary objection was rejected on 14 February 2025 and security of EUR 112,000 was ordered on 27 February 2025. GXD-Bio defended the patent as granted and on three auxiliary requests. The hearing took place on 18 November 2025.

The applicable law

The counterclaim falls under Article 65(2) UPCA and Article 138(1)(c) EPC. For a divisional, the division asks what the skilled person, using common general knowledge, derives directly and unambiguously from each earlier application as filed, including the original PCT application. Implicit disclosure counts only if it clearly follows from what is explicitly stated (paragraphs 100 to 102). Claims are construed under Article 69 EPC and its Protocol (paragraph 66).

Question

Does claim 1, directed to a method limited to FFPE breast cancer tissue and normalised to OAZ1 alone, have a direct and unambiguous basis in the original application, and does the EndoPredict test, which normalises to three genes, fall within it?

Decision

The division held that feature 3 requires normalisation to the expression level of OAZ1 alone: « comprising » does not allow a further reference gene, since step 2 names only OAZ1 and step 3 refers to « that » gene (paragraphs 84 to 97). On validity, the original application does not disclose a method limited to FFPE breast cancer tissue, its object being universal reference genes and Example 7 mentioning such samples only among sixty FFPE samples (paragraphs 109 to 119). Nor does it disclose OAZ1 as the sole reference gene, OAZ1 being one of thirteen novel reference genes without being selected in the claims or any example (paragraphs 120 to 134). The dependent claims and all three auxiliary requests suffer from the same defect (paragraphs 135 and 138), the other grounds were not examined (paragraph 136). Infringement failed in any event: the test normalises to the mean of three genes, the mathematical argument raised late at the hearing was disregarded under Rule 9.2 and indirect infringement was not substantiated (paragraphs 140 to 145). GXD-Bio bears the costs. The value in dispute was set at EUR 1,000,000 for the action and EUR 1,500,000 for the counterclaim.

Key points for practice

• For a patent from a chain of divisionals, added matter is assessed against each earlier application, back to the original PCT application (paragraph 102).
• An example mentioning one type of sample among others does not support limiting the claim to that type of sample (paragraphs 114 to 119).
• « Comprising » cannot widen a step defined by reference to a single element (paragraph 86).
• Practical point: before suing, a proprietor should check that the limitations in a late divisional find explicit support in the original application, as auxiliary requests built on the same combination fall with the main request.

Provisions applied

Agreement on a Unified Patent Court

Art. 65(2), Art. 69(1) and Art. 73(1)

Rules of Procedure

Rules 9.2, 19, 118.8 and 220.1(a)

European Patent Convention

Art. 69 and Art. 138(1)(c)

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, Insulet v EOFlow, Court of Appeal, 30 April 2025 (UPC_CoA_768/2024), Alexion v Amgen, Court of Appeal, 19 June 2025, OTEC Präzisionsfinish v STEROS GPA Innovative, Court of Appeal, 7 November 2025, expert e-Commerce v Seoul Viosys, Court of Appeal, 2 October 2025, Abbott Diabetes Care v Sibio, Court of Appeal, 14 February 2025

Related decisions

• GXD-Bio v Myriad Genetics, 14 February 2025, order rejecting the preliminary objection.

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.