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UPC CFI 535/2025

Jun 19, 2025·EP2401365 · REENGINEERING MRNA PRIMARY STRUCTURE FOR ENHANCED PROTEIN PRODUCTION

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Case details
Status
Case Closed (Patent revoked)
Action
Counterclaim for revocation
Category
Counterclaim for revocation
Parties
Claimants
Representatives
Respondents
Representatives
Division
Munich LD
Judges
Technology
  • Chemistry
    Biotechnology
Language
English
First decided
Jul 7, 2026
How this compares
The court's record for this kind of case, counted in first-instance rulings. A figure in brackets is the number of rulings a rate rests on.
Patent revokedMedian days to first decision
All UPC37% (34/91)124
Munich LDLockedLocked
Judge Daniel VossLockedLocked
Judge András KupeczLockedLocked
Judge Georg WernerLockedLocked
Judge Martin SchmidtLockedLocked

At the UPC: BioNTech Group (21 cases)·Promosome LLC (15 cases)

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Related cases
All proceedings on this patent

This dispute contains 11 other proceedings

UPC CoA 146/2026·UPC CoA 147/2026·UPC CFI 2819/2026·UPC CFI 2822/2026·UPC CFI 846/2024 and 6 more

2 other defendants litigating the same or a related patent

UPC CoA 148/2026·UPC CFI 485/2025

Start a free trial to see how each one ended.

More cases: Munich LD·2025

Decisions
  • 2026-07-07
    Counterclaim for revocationPublic

    Summary: The Local Division Munich revoked European patent EP 2 401 365 in its entirety with effect to Germany, France and Sweden, finding claim 1 as granted lacks novelty over prior art D1 (WO 91/01374) and D2 (Matsuda et al. 2006), and all 25 auxiliary requests invalid. The infringement action brought by Promosome LLC against BioNTech/Pfizer was dismissed both because the patent is invalid and because the claimant failed to sufficiently substantiate that the attacked Comirnaty embodiments practised the claimed method of mutating actual secondary initiation codons.

    Show the legal issues (7)
    • Standing to sue — whether Promosome LLC holds an exclusive licence under Art. 47(2) UPCA sufficient to bring infringement proceedings
    • Temporal jurisdiction — whether the UPC has competence over acts of infringement committed before 1 June 2023 (Art. 28 VCLT / Art. 32 UPCA)
    • Claim construction — whether 'secondary initiation codon' in claim 1 requires an actual (functional) codon at which protein synthesis initiates, or merely a putative/potential codon
    • Lack of novelty of claim 1 over D2 (Matsuda et al. 2006, RNA) and D1 (WO 91/01374) — enabling disclosure of prior art for novelty
    • Infringement — whether Comirnaty mRNA vaccines practise the claimed method of mutating actual secondary initiation codons versus codon optimisation
    • Validity of 25 auxiliary requests — lack of novelty (AR1, AR3, AR5), added matter (AR2), lack of inventive step (AR1, AR3, AR4), partial-problem approach for AR4 combining secondary-initiation-codon mutation and miRNA-binding-site mutation
    • Admissibility of late-filed evidence (exhibits VB37, VB38) and Rule 36 RoP further written pleadings
Documents
Show all 212 documents
Document titleDatePublic
Decision2026-09-28Public
Communication2026-08-25Not public
Receipt2026-08-05Not public
Cover sheet2026-08-05Not public
Application document Applicant2026-08-05Not public
Decision2026-07-07Public
Case closed2026-07-07Not public
Decision2026-07-07Not public
Decision2026-07-07Not public
Decision2026-07-07Not public
Accepted arguments
What the court agreed with — by party.

  • Promosome LLC is an exclusive licensee with standing to sue under Art. 47(2) UPCA: the licence agreements (VB4a/VB4b) transfer all rights of commercial exploitation while barring the patent proprietor from granting rights to any other party in the same field, which is sufficient for exclusivity even if geographically or otherwise limited

    ClaimantLegal basis: Art. 47(2) UPCA

  • The UPC has competence to hear infringement acts occurring before 1 June 2023, including Comirnaty Original/Omicron BA.1 (attacked embodiment 2b); the UPCA imposes no temporal limitation on the Court's exclusive competence under Art. 32(1)(a) UPCA

    ClaimantLegal basis: Art. 32 UPCA; Art. 28 VCLT; UPC_CoA_30/2024 (Fives/Reel); UPC_CoA_156/2025 (XSYS/ESKO)

  • Claim 1 requires mutation of one or more actual secondary initiation codons (at which protein synthesis actually initiates) and a causal link between mutation and the claimed functional effects (feature group 1.3); putative/potential codons are insufficient

    RespondentLegal basis: Art. 69 EPC; Protocol on Interpretation of Art. 69 EPC

  • D2 (Matsuda et al. 2006) discloses all features of claim 1: the bicistronic TYMV system provides a coding sequence for p69 (protein of interest) with primary initiation codon AUG69, a downstream secondary initiation codon AUG206 within the coding sequence, mutation of AUG206 to ACG increasing p69 expression 2.5-fold without altering amino acid sequence; D2 thus anticipates claim 1

    RespondentLegal basis: Art. 54 EPC

  • D1 (WO 91/01374) also discloses all features of claim 1 in an enabling manner: it teaches preventing undesired internal translation initiation by altering internal initiator codons without changing amino acid sequence, thereby maximising yield of useful polypeptides

    RespondentLegal basis: Art. 54 EPC

  • Claimant failed to sufficiently substantiate infringement: the evidence (VB6a, VB34) cannot establish that actual secondary initiation codons were mutated and caused the claimed effects, because (i) the difference between Test B (vaccine) and Test C (deoptimised tozinameran) also reflects a significant difference in CAI/codon optimisation, and (ii) functional internal start sites are admittedly rare

    RespondentLegal basis: Art. 25 UPCA; burden of proof on claimant

  • AR4 combines two independent methods (secondary-initiation-codon mutation + miRNA-binding-site mutation) that are a mere aggregation/juxtaposition without functional interdependency; applying the partial-problem approach, each method is independently obvious from prior art (D9/D10 for miRNA features, D1/D2 for secondary initiation codon features), so AR4 lacks inventive step

    RespondentLegal basis: Art. 56 EPC; UPC_CoA_71/2025 (VMR Products/NJOY)

  • AR2 introduces added matter: requiring mutation of at least one of each of seven specific non-canonical codons (ACG, GUG, UUG, CUG, AUA, AUC, AUU) as a combined requirement is not directly and unambiguously disclosed in the application as filed

    RespondentLegal basis: Art. 123(2) EPC; Art. 138(1)(c) EPC
Rejected arguments
What the court did not agree with — and why.

  • D1 (WO 91/01374) does not provide an enabling disclosure because its preferred embodiment (59 kDa IL-2-toxin contaminant) is merely asserted but not experimentally demonstrated, and the underlying scientific explanation is not credible

    ClaimantLegal basis: Art. 54 EPC (enabling prior art disclosure requirement)

  • D2 does not disclose a secondary initiation codon within the meaning of claim 1 because AUG206 is the primary initiation codon of a second protein in a bicistronic construct, not a secondary initiation codon of the protein of interest

    ClaimantLegal basis: Claim construction — Art. 69 EPC

  • Feature group 1.3 (mutation results in decrease in initiation / reduction in ribosomal diversion / increased expression efficiency) is merely a technical limitation / stated purpose that does not add a limiting method step, so that mutating any putative secondary initiation codon suffices for infringement

    ClaimantLegal basis: Claim construction — Art. 69 EPC

  • The experimental evidence (VB6a, VB34) showing increased spike protein expression in vaccine vs. re-introduced-secondary-codons construct (Test B vs. Test C) is sufficient to demonstrate that actual secondary initiation codons were mutated resulting in the claimed effects

    ClaimantLegal basis: Burden of proof / infringement substantiation

  • The Defendants' preliminary objection that the UPC lacks jurisdiction over acts committed only before 1 June 2023 (Comirnaty Original/Omicron BA.1) should be upheld under Art. 28 VCLT

    RespondentLegal basis: Art. 28 VCLT; Art. 32 UPCA