Promosome v BioNTech (CFI, UPC_CFI_846/2024, 7 July 2026)

Dhenne Avocats · 10 October 2026

Our analysis

Summary

In a decision of 7 July 2026, given in the joined proceedings UPC_CFI_846/2024, UPC_CFI_485/2025 and UPC_CFI_535/2025, the Munich Local Division revoked in its entirety, for Germany, France and Sweden, EP 2 401 365 (re-engineering the primary structure of mRNA), of which Promosome is exclusive licensee, dismissed the application to amend and dismissed the infringement action against BioNTech and Pfizer’s Comirnaty vaccines. Claim 1 lacks novelty over D2 and D1, none of the 25 auxiliary requests is valid, and infringement was not shown in any event: mutating merely putative secondary initiation codons in the course of codon optimisation does not prove that actual ones were mutated. The decision is of practical interest on jurisdiction over past acts, limited exclusive licences, the requirement of an enabling prior disclosure and the aggregation of independent methods.

Facts and procedure

Promosome, exclusive licensee of The Scripps Research Institute, the proprietor, sued five BioNTech and four Pfizer group companies on 30 December 2024 over products directly obtained by the patented process, for Germany, France and Sweden (paragraphs 1 to 13). The defendants raised a preliminary objection for products sold before 1 June 2023 and counterclaimed for revocation. The patent was defended as granted and in 25 auxiliary requests (paragraphs 11, 16 and 17).

The applicable law

The Division applied Articles 32, 47 and 25(c) UPCA, Articles 54 and 56 EPC and the inventive step approach laid down by the Court of Appeal in Amgen v Sanofi and Meril v Edwards (paragraph 197).

Question

Does the UPC have jurisdiction over acts completed before its entry into force. Does a licensee whose exclusivity is limited have standing. What is the scope of claim 1 and is it novel?

Decision

The preliminary objection was dismissed: the UPCA places no temporal limit on the UPC’s jurisdiction, with no distinction between acts completed before 1 June 2023 and continuing acts (paragraphs 54 to 62). Promosome has standing, since an exclusive licence may be limited by field and coupled with a reservation in favour of the proprietor (paragraphs 63 to 76). Claim 1 requires mutation of actual secondary initiation codons, causally linked to increased expression (paragraphs 125 to 138). It lacks novelty over D2 (paragraphs 141 to 158) and over D1: prior art is novelty-destroying only if the skilled person can reproduce it without undue burden, but neither a correct scientific explanation nor experimental results are required, and the party disputing reproducibility must substantiate its doubts (paragraphs 172 to 186). As the claim sets were closed, dependent claims were not examined separately (paragraph 188). The 25 auxiliary requests, admissible despite their number, fail: lack of inventive step over D1 and D3, added matter for request 2 and, for request 4, a mere juxtaposition of two methods without functional interaction, the synergy data presented at the hearing being late (paragraphs 191 to 250). On infringement, Article 25(c) UPCA requires no intent, but Promosome had to show the mutation of actual codons causing the claimed effects. Its tests, comparing constructs that also differ in their degree of codon optimisation, do not show this (paragraphs 259 to 280). Exhibits VB37 and VB38, filed after the rejoinder, were disregarded, Rule 36 allowing only a limited response to new arguments (paragraphs 282 to 291). Each losing side bears the other’s costs, within the agreed flat cap of EUR 750,000 per group of defendants, for a case worth over EUR 50 million (paragraphs 294 and 295).

Key points for practice

• The UPC has jurisdiction over products made and sold only before 1 June 2023 (paragraphs 61 and 62).
• Prior art describing concrete, reproducible steps destroys novelty even if the scientific explanation it offers is disputed (paragraphs 174 to 179).
• Combining two methods presented in the patent as independent is not inventive where each is known and no combined effect emerges from the application (paragraphs 239 to 244).
• Practical point: where the defendant relies on routine optimisation producing the same effect, the patentee must isolate, through single-variable tests, the effect of the claimed feature itself (paragraphs 264 to 276).

Provisions applied

Agreement on a Unified Patent Court

Arts 2(g), 3, 25(c), 32(1)(a) and (e), 47(2) and (3), 69(1) and 76(1)

Rules of Procedure

Rules 9.1, 13.1(f), 19.1(a), 19.7, 23, 24(g), 30, 36, 118.5, 118.8, 150.2, 352.1 and 354.2

European Patent Convention

Art. 54, Art. 56, Art. 54, Art. 56, Art. 69, Art. 83, Art. 83, Art. 84, Art. 123

Regulation (EU) No 1215/2012

Arts 24(4), 26, 71a(2)(a) and 71b(1)

Case law cited

NanoString v 10x Genomics, Court of Appeal, 26 February 2024, VusionGroup v Hanshow, Court of Appeal, 13 May 2024, Mammut v Ortovox, Court of Appeal, 25 September 2024, NJOY v Juul, Paris Central Division, 5 November 2024, Fives v Reel, Court of Appeal, 16 January 2025, Insulet v EOFlow, Court of Appeal, 30 April 2025, XSYS v ESKO, Court of Appeal, 2 June 2025, Knaus Tabbert v Yellow Sphere, Court of Appeal, 17 June 2025, Brita v Aquashield, Munich Local Division, 22 August 2025, Baussmann v Raimund Beck, Munich Central Division, 20 November 2025, GXD Bio v Myriad, Munich Local Division, 19 December 2025, TCL v Corning, Munich Central Division, 24 February 2026, Kodak v Fujifilm, Court of Appeal, 2 June 2026, Amgen v Sanofi, Court of Appeal, 25 November 2025, Meril v Edwards, Court of Appeal, 25 November 2025, Abbott v Sibio, Court of Appeal, 14 February 2025, expert e-Commerce v Seoul Viosys, Court of Appeal, 2 October 2025, VMR Products v NJOY, Court of Appeal, 29 December 2025, Hefei v Grundfos, Court of Appeal, 27 May 2026, OTEC v STEROS, Court of Appeal, 24 July 2025, Heraeus v Vibrantz, Munich Local Division, 10 October 2025, Pari Pharma v Philips, Milan Central Division, 27 November 2025, Fujifilm v Kodak, Düsseldorf Local Division, 28 January 2025, EPO Enlarged Board of Appeal, G 2/88, G 6/88, G 3/14 and G 2/21

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.