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UPC CFI 681/2024

Nov 8, 2024·EP3346403 +1 more: DATA PROCESSING, ANALYSIS METHOD OF GENE EXPRESSION DATA TO IDENTIFY ENDOGENOUS REFERENCE GENES

Parent infringement case:UPC CFI 437/2024

Case details
Status
Case Closed
Action
Counterclaim for revocation
Category
Counter Claim for Revocation
Parties
Respondents
Reps: Hölder (Hoffmann Eitle)
Division
Munich LD
Judges
Technology
Biotech · Genomics · Biotechnology
Language
English
First decided
Dec 19, 2025
Claims
At issueall
Maintainedall
Not infringedall
Notes: Infringement action dismissed (no infringement of EP 3 346 403 three-step normalization method) and counterclaim for revocation also dismissed, patent maintained.
Decisions
  • 2025-12-19
    Not infringedRevocation meritsCounterclaim for revocation

    The Munich Local Division dismissed both the infringement action (UPC_CFI_437/2024) brought by GXD-Bio Corporation and the counterclaim for revocation (UPC_CFI_681/2024) brought by the Myriad defendants, concerning EP 3 346 403 (a patent on data processing/gene expression analysis for identifying endogenous reference genes). The Court found no infringement because the accused products (Myriad test kits) did not use the claimed three-step normalization method — the products used a single-step average normalization that differed from the patented calculation method. The counterclaim for revocation was also dismissed, so the patent was maintained. Each party bears its own costs, with costs capped at EUR 600,000 total.

    Legal issues:Direct and indirect patent infringementClaim construction of normalization methodTimeliness of evidence under R. 9.2 RoPCounterclaim for revocationPatent amendment auxiliary requests
Documents
Document titleDatePublic
Order2026-01-21Not public
Order2026-01-21Not public
Receipt2026-01-19Not public
Cover sheet2026-01-19Not public
Exhibit document Applicant2026-01-19Not public
Application document Applicant2026-01-19Not public
Decision2025-12-19Public
action.phaseChange.caseClose2025-12-19Not public
action.issueDecision.decision2025-12-19Not public
Decision2025-12-19Not public
action.summons.oralHearing2025-09-24Not public
Order2025-09-24Not public
Receipt2025-06-30Not public
Request to reject new facts and arguments as late filed2025-06-27Not public
Receipt2025-06-02Not public
Rejoin-Amend-Patent-Defence2025-05-30Not public
HE33a2025-05-30Not public
HE332025-05-30Not public
HE33d2025-05-30Not public
HE33e2025-05-30Not public
HE33c2025-05-30Not public
250530 Rejoinder on Application to amend and request to admit addtional evidence.pdf2025-05-30Not public
HE33b2025-05-30Not public
Rejoinder on Application to amend and request to admit addtional evidence2025-05-30Not public
HE332025-05-30Not public
HE33B2025-05-30Not public
HE33a2025-05-30Not public
HE33c2025-05-30Not public
HE33e2025-05-30Not public
HE33d2025-05-30Not public
Reply-Amend-Patent-Defence2025-04-30Not public
Acknowledgement-of-lodging2025-04-30Not public
VB572025-04-30Not public
VB582025-04-30Not public
VB642025-04-30Not public
Reply to Defense to Application to amend the patent2025-04-30Not public
VB622025-04-30Not public
VB562025-04-30Not public
VB602025-04-30Not public
VB552025-04-30Not public
VB612025-04-30Not public
VB592025-04-30Not public
VB632025-04-30Not public
VB592025-04-30Not public
VB572025-04-30Not public
VB562025-04-30Not public
VB612025-04-30Not public
Rejoinder to Reply to Defense to Counterclaim for Revocation2025-04-30Not public
VB642025-04-30Not public
VB622025-04-30Not public
VB602025-04-30Not public
VB582025-04-30Not public
VB552025-04-30Not public
VB632025-04-30Not public
VB592025-04-30Not public
VB592025-04-30Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-04-03Not public
Rejoinder2025-04-03Not public
Acknowledgement-of-lodging2025-03-31Not public
Rejoinder2025-03-31Not public
Acknowledgement-of-lodging2025-03-31Not public
HE 272025-03-31Not public
HE 262025-03-31Not public
HE 282025-03-31Not public
HE 322025-03-31Not public
HE 312025-03-31Not public
HE 25a2025-03-31Not public
HE 26g2025-03-31Not public
HE 26h2025-03-31Not public
HE 26c2025-03-31Not public
HE 302025-03-31Not public
HE 26e2025-03-31Not public
HE 26f2025-03-31Not public
HE 26d2025-03-31Not public
Rejoinder2025-03-31Not public
HE 292025-03-31Not public
Panel-Appointment2025-03-25Not public
Hearing-Dates2025-02-27Not public
Date oral hearing2025-02-27Public
Hearing-Dates2025-02-27Not public
Acknowledgement-of-lodging2025-01-31Not public
Formal-checks_Notification-of-positive-outcome2025-01-31Not public
Formal-checks_Notification-of-positive-outcome2025-01-29Not public
Acknowledgement-of-lodging2025-01-29Not public
Exhibit VB372025-01-29Not public
Exhibit VB472025-01-29Not public
Exhibit VB382025-01-29Not public
Exhibit VB522025-01-29Not public
Application to amend the patent2025-01-29Not public
Exhibit VB402025-01-29Not public
Exhibit VB362025-01-29Not public
Exhibit VB542025-01-29Not public
Exhibit VB462025-01-29Not public
Exhibit VB352025-01-29Not public
Exhibit VB422025-01-29Not public
Exhibit VB532025-01-29Not public
Exhibit VB442025-01-29Not public
Exhibit VB432025-01-29Not public
Exhibit VB452025-01-29Not public
Exhibit VB412025-01-29Not public
Exhibit VB512025-01-29Not public
Exhibit VB392025-01-29Not public
Exhibit VB342025-01-29Not public
Exhibit VB502025-01-29Not public
Exhibit VB492025-01-29Not public
Exhibit VB482025-01-29Not public
Exhibit VB342025-01-29Not public
Defense to Counterclaim for revocation2025-01-29Not public
Exhibit VB362025-01-29Not public
Exhibit VB522025-01-29Not public
Exhibit VB372025-01-29Not public
Exhibit VB472025-01-29Not public
Exhibit VB392025-01-29Not public
Exhibit VB422025-01-29Not public
Exhibit VB492025-01-29Not public
Exhibit VB402025-01-29Not public
Exhibit VB412025-01-29Not public
Exhibit VB532025-01-29Not public
Exhibit VB482025-01-29Not public
Exhibit VB352025-01-29Not public
Exhibit VB502025-01-29Not public
Exhibit VB382025-01-29Not public
Exhibit VB512025-01-29Not public
Exhibit VB542025-01-29Not public
Exhibit VB442025-01-29Not public
Exhibit VB462025-01-29Not public
Exhibit VB432025-01-29Not public
Exhibit VB452025-01-29Not public
Notification Of Service2024-11-19Not public
Proof of Service - Access to case2024-11-19Not public
Acknowledgement of access to case2024-11-19Not public
communicationCheck2024-11-19Not public
Document from EPO2024-11-19Not public
Letter-for-Service2024-11-15Not public
Panel-Appointment2024-11-15Not public
EPO-Request-for-case-pending2024-11-15Not public
Acknowledgement-of-lodging2024-11-15Not public
Formal-checks_Notification-of-positive-outcome2024-11-15Not public
HE 7b - Vandesompele et al2024-11-08Not public
HE 15 - Dropping the OAZ1 Reference Gene from the EndoPredict Algorithm2024-11-08Not public
HE 17 - Paik et al2024-11-08Not public
HE 7 - Declaration Prof Vandesompele2024-11-08Not public
HE 13 - Tramm et al2024-11-08Not public
HE 24 - Sestak et al2024-11-08Not public
HE 9 - Klein et al2024-11-08Not public
HE 6 - Vandesompele et al2024-11-08Not public
HE 21 - Emails2024-11-08Not public
HE 25 - AGO Guidelines2024-11-08Not public
HE 12 - Kwon et al2024-11-08Not public
HE 5 - Prio KR 10-2006-01348832024-11-08Not public
HE 7a - CV Prof. Vandesompele2024-11-08Not public
HE 4 - WO 2008078969 A12024-11-08Not public
HE 5a - Translation (EN)2024-11-08Not public
241108 Revocation Counterclaim_sig2024-11-08Not public
HE 19 -Sinn et al2024-11-08Not public
HE 11 - Applicants submission of December 20 20182024-11-08Not public
HE 8 - Feature breakdown of claim 12024-11-08Not public
HE 23 - Andre et al2024-11-08Not public
HE 20 - Mullins et al2024-11-08Not public
HE 16 - De Jonge et al2024-11-08Not public
HE 14 - Smith et al2024-11-08Not public
HE 10 - WitnessStatement_2411082024-11-08Not public
HE 22 - Email 26.09.20242024-11-08Not public
HE 18 - Genexpressionstest Wikipedia2024-11-08Not public
HE 3 - EP17194976NWA12024-11-08Not public
Plain-English summary

GXD-Bio Corporation sued multiple Myriad Genetics entities for infringement of EP 3 346 403 B1 (a method for identifying endogenous reference genes using gene expression data) by Myriad's test kits used in breast cancer diagnosis. The Munich Local Division dismissed the infringement action because the accused products use a single-step average normalization rather than the patent's sequential three-step method; simultaneously, the patent was revoked on the Myriad counterclaim for seven UPCA territories, and the amendment application was also dismissed.

Accepted arguments
What the court agreed with — by party.

  • Myriad's test kits do not perform the patented three-step normalization method of claim 1 of EP 3 346 403

    RespondentLegal basis: Art. 25 UPCA; claim construction; direct infringement

    Note: Court accepted that the accused products use a single-step average normalization across three reference genes, which differs from the patent's required sequential normalization against each individual reference gene; the method therefore does not embody the technical teaching.

  • Late-filed argument that the calculation is mathematically equivalent to the patented method must be disregarded

    RespondentLegal basis: R. 9.2 RoP

    Note: Claimant's novel mathematical-equivalence argument raised for the first time at oral hearing was excluded as late-filed; defendants had no opportunity to respond.

  • Revocation counterclaim: EP 3 346 403 lacks validity

    RespondentLegal basis: Art. 65 UPCA

    Note: Patent was revoked in full for all seven requested territories (AT, BE, FR, DE, IT, LU, NL); the excerpt's outcome summary confirms revocation although detailed grounds are not in the visible excerpt.

Rejected arguments
What the court did not agree with — and why.

  • Accused test kits directly infringe claim 1 because the average normalization is mathematically identical to successive per-gene normalization

    ClaimantLegal basis: Art. 25 UPCA; claim construction

    Reason: Mathematical identity of results does not equate to use of the claimed method; the actual configuration (single-step average) is decisive, and the patented method requires further steps not performed by the accused product.

  • Indirect infringement: the test kit is suitable and intended for the patented method using OAZ1 alone as reference gene

    ClaimantLegal basis: Art. 26 UPCA; indirect infringement

    Reason: Claimant did not argue that the test kit, despite its materials and reagents, is suitable and intended for normalization against OAZ1 alone; indirect infringement therefore ruled out.

  • Genes CALM2 and RPL37A can serve as further reference genes under the patent's multi-reference-gene reading

    ClaimantLegal basis: Claim construction; Art. 25 UPCA

    Reason: The patent itself identifies CALM2 and RPL37A as candidate reference genes rejected for insufficient expression stability; using them as reference genes falls outside the claim's scope.

Key legal principles
Doctrines and rules cited in the reasoning.
Mathematical identity of results does not establish infringement; actual method configuration is decisiveLate-filed arguments at oral hearing excluded under R. 9.2 RoPIndirect infringement requires showing the product is suitable and intended for the patented useClaim scope limited by the patent's own description disclosing insufficiently stable reference genes as non-qualifying

Browse other cases on this principle.

Claim construction notes

Claim 1 of EP 3 346 403 requires a three-step normalization method in which the expression level of a target gene is normalized against each reference gene individually (sequentially). The court held this excludes a single-step average normalization using the mean of three reference gene expression levels, even if the numerical result is mathematically the same. Reference genes CALM2 and RPL37A were identified in the description as 'candidate' genes not selected as 'guide genes' due to insufficient expression stability, placing them outside the claim's scope.