GlaxoSmithKline Biologicals SA v. C.P. Pharmaceuticals International C.V. and Others

This case management order was issued by the Hague Local Division of the Unified Patent Court in three consolidated proceedings (UPC_CFI_620/2025, UPC_CFI_1509/2025, and UPC_CFI_1511/2025). The Claimant is GlaxoSmithKline Biologicals SA (GSK), proprietor of European Patent No. EP2590626. The Defendants comprise 30 entities, including C.P. Pharmaceuticals International C.V., numerous Pfizer entities across Europe and globally, and four BioNTech entities (collectively referred to as 'PBNT'). The proceedings concern the allegedly infringing Comirnaty products (COVID-19 vaccines). The panel consisted of presiding judge Edger Brinkman, legally qualified judge Stefan Schilling, technically qualified judge Martin Schmidt, and judge-rapporteur Margot Kokke.

The order addresses several case management issues arising after the interim conference (IC) held on 17 June 2026, in preparation for the oral hearing (OH) scheduled for 3 September 2026. The key disputes concerned:

1. **Admission of Exhibit PBNT C73**: PBNT filed a reasoned request to admit this exhibit, which was permitted, along with GSK's response of 15 July 2026.

2. **Admission of the Cayman 2024 Report (Exhibit PBNT C84)**: PBNT sought to admit this report, commissioned by GSK prior to the already-admitted Cayman 2025 Report. GSK objected, arguing PBNT could have filed it earlier since a non-confidential version was produced in US proceedings on 24 October 2025. PBNT countered that the report was designated as highly confidential.

3. **Post-IC Submissions**: PBNT submitted a 24-page document on 24 June 2026 providing an overview of exhibits and relief sought, but did not comply with the request for a comprehensive overview of claims. PBNT also filed a communication on 8 July 2026 that did not limit its invalidity attacks as instructed during the IC.

4. **GSK's R.36 RoP Application**: GSK sought to admit the '2021 BNT Website' (Annex I), which contained a statement about the allegedly infringing Comirnaty products. PBNT objected on grounds of late filing, arguing the website had been publicly available since 2021.

The Court reasoned as follows:

- **On the Cayman 2024 Report**: While the threshold for admitting new documents after written submissions is high in UPC proceedings, the Court found special circumstances justifying admission. The report was commissioned by GSK (and therefore familiar to it), is part of parallel proceedings with disclosure obligations, uses identical methodology to the already-admitted Cayman 2025 Report, and contains limited new information (a single pKa value concerning the ionisable cationic lipid ALC-0315). PBNT was given the benefit of the doubt regarding timing.

- **On the 2021 BNT Website**: The Court found GSK could not have submitted this exhibit earlier, particularly given that PBNT itself only recently became aware of the statement during a US deposition. The exhibit was admitted as potentially relevant.

- **On PBNT's Invalidity Attacks**: The Court clarified that PBNT could only rely on three inventive step attacks at the OH: WO 748, WO 152, and Martinon in combination with common general knowledge only. PBNT was ordered to limit attacks against each retained auxiliary request (AR) to a maximum of one or two, contrary to its broader interpretation of the IC Order.

- **On GSK's Auxiliary Requests**: The Court clarified that GSK would only rely on the ten ARs previously communicated.

The final order admitted exhibits PBNT C73, PBNT C84, and GSK's Annex I into the proceedings; ordered PBNT to submit a consolidated overview of exhibits by 25 August 2026; clarified the scope of inventive step attacks and ARs; and ordered PBNT to submit a new response to the IC Order at G in line with the Court's instructions.