Promosome LLC v. BioNTech SE et al.

This order was issued by Judge-Rapporteur András Kupecz of the Local Division Munich of the Unified Patent Court on 3 April 2025 in case UPC_CFI_846/2024, a patent infringement action brought by Promosome LLC (Claimant) against BioNTech SE, BioNTech Manufacturing GmbH, BioNTech Manufacturing Marburg GmbH, BioNTech Innovative Manufacturing Services GmbH, BioNTech Europe GmbH, Pfizer Manufacturing Belgium NV, Pfizer SAS, Pfizer AB, and Pfizer, Inc. (Defendants) concerning European patent EP 2 401 365.

The Defendants filed applications on 7 March 2025 (Application Nos. 11376/2025 and 11372/2025) requesting the Court to order Promosome to produce the detailed materials and methods of all experiments and the raw data underlying the qPCR experiments set out in an expert report submitted as Exhibit VB 6 in the infringement proceedings. The expert report concerned experiments measuring the effect of mutating codons within specific polynucleotide sequences on the expression of the SARS-CoV-2 Spike protein and on the stability of mRNA constructs. The Defendants argued that access to this underlying data was necessary to assess the accuracy, reliability, and relevance of the test results and to defend against the Claimant's infringement assertions. They also requested severe periodic penalty payments under Article 82(4) UPCA for non-compliance.

Promosome opposed the request, arguing it was inadmissible and disproportionate because it did not aim to grant Defendants access to the means to meet their burden of proof. Promosome contended that the Defendants, as well-known pharmaceutical companies, would first need to dispute infringement and substantiate their non-infringement defence with their own tests and experiments. Promosome further argued that the Defendants had failed to properly specify the evidence to be provided.

The Court applied the principles established by the Court of Appeal in Guangdong OPPO and Orope/Panasonic (UPC_CoA_298, 299 and 300/2024) and adopted by the Local Division Mannheim in Dish/Aylo. It noted that while Rule 190 RoP is available to defendants seeking to produce counter-evidence in support of a defence, an order to produce evidence presupposes that there is a fact relevant to the substantiation of claims or defences requiring proof, and the applicant must specify which fact it wishes to prove by which means of evidence and for what reason. The applicant must also have presented reasonably available and plausible evidence in support of its claims or defences.

The Court found that the Defendants had not yet disputed infringement and had not presented any reasonably available evidence in support of their defences. It held that the Defendants should be able to set out why the action should fail, including any challenge to the facts relied upon by the Claimant, and that it had not been argued or shown that this was impossible without the requested evidence. The Court also found it doubtful whether the requested evidence had been sufficiently specified under Rule 190.1 RoP, as the Defendants had not explained which concrete means of evidence they sought and for what specific reason. The Court further held that there is no general rule arising from the front-loaded nature of UPC proceedings requiring all data and findings used by a party to be submitted at this stage, and that a party is generally free to determine the subject-matter of and supporting evidence for its case under Article 43 UPCA.

For the sake of completeness, the Court noted that it could, at any later stage in the proceedings, on request or of its own motion, order a party to produce evidence under Rules 190 and 172.2 RoP or to answer questions or provide clarifications under Rule 9.1 RoP. The Court ultimately rejected the Defendants' requests to produce evidence as inadmissible or, in any event, unfounded, and consequently also rejected the dependent request for penalty payments.