UPC CFI 535/2025

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

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

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

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

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

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

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

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

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

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

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

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

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