Short Summary
This is a case management order from the Unified Patent Court's The Hague Local Division in patent infringement proceedings brought by GlaxoSmithKline Biologicals SA (GSK) against multiple Pfizer and BioNTech entities (collectively PBNT) concerning European Patent EP2590626, which relates to Comirnaty COVID-19 vaccine products. The order addresses procedural matters arising after the interim conference, including the admission of late-filed exhibits, clarification of the scope of invalidity attacks and auxiliary requests to be relied upon at the upcoming oral hearing, and the rejection of certain unsolicited submissions.
Detailed Summary
This case management order was issued by Judge-Rapporteur Margot Kokke of the Unified Patent Court's The Hague Local Division on 21 August 2026, in proceedings (UPC_CFI_620/2025, UPC_CFI_1509/2025, and UPC_CFI_1511/2025) brought by GlaxoSmithKline Biologicals SA (GSK) against numerous defendants including C.P. Pharmaceuticals International C.V., various Pfizer entities (Defendants 1-26), and BioNTech entities (Defendants 27-30), collectively referred to as PBNT. The patent at issue is EP2590626, owned by GSK, and the proceedings concern the allegedly infringing Comirnaty COVID-19 vaccine products.
The order addresses several procedural matters that arose after the interim conference held on 17 June 2026, ahead of the oral hearing scheduled for 3 September 2026. First, the Court admitted exhibit PBNT C73 into the proceedings along with GSK's response of 15 July 2026. Second, regarding exhibit PBNT C84 (the Cayman 2024 Report), the Court addressed PBNT's Rule 9.1/Rule 36 RoP application. While the Rule 36 portion requesting further written pleadings was rejected as not permitted, the Court admitted the Cayman 2024 Report itself into the proceedings. The Court noted that although the threshold for admitting new documents after written submissions is high given UPC's accelerated and front-loaded nature, special circumstances justified admission: the report was commissioned by GSK prior to the already-admitted Cayman 2025 Report, the test and setup were identical, and the new information was limited to a single pKa value concerning the ionisable cationic lipid ALC-0315. PBNT was given the benefit of the doubt regarding whether it could have submitted the report earlier, given the dispute over its confidentiality status in parallel US proceedings.
Third, the Court addressed PBNT's post-IC submissions of 24 June 2026. While PBNT complied with providing an overview of exhibits and relief sought, the Court noted it did not comply with the request for a comprehensive overview of claims. The Court clarified that any amendments to claims in the submitted overview were not taken into account, as they bypassed Rule 263 RoP requirements, though the guidance from the Court of Appeal's 2 June 2026 decision in Kodak v Fujifilm could be discussed during the oral hearing. Fourth, the Court clarified that PBNT would rely on only five specific invalidity attacks at the oral hearing: lack of novelty over WO 748 and WO 799, and lack of inventive step over WO 748, WO 152, and Martinon, each combined with common general knowledge. Fifth, the Court confirmed that GSK would rely only on the ten auxiliary requests it communicated on 1 July 2026. Sixth, the Court rejected PBNT's 8 July 2026 communication for failing to limit its attacks against each auxiliary request to one or two as instructed, ordering PBNT to submit a new response.
Finally, regarding GSK's Rule 36 RoP application filed on 24 July 2026 seeking to admit the 2021 BNT Website (Annex I), the Court found the Rule 36 portion inadmissible as filed after the written procedure closed, but admitted the exhibit itself under Rule 9.1 RoP as potentially relevant. The Court accepted GSK's explanation that it only became aware of the website content when produced by US counsel on or after 2 July 2026, rejecting PBNT's argument that the publicly archived website should have been discovered earlier, particularly since PBNT itself acknowledged only recently becoming aware of the statement during a US deposition. The Court ordered that the parties could comment on this exhibit during the oral hearing, but rejected any material submissions already made as unsolicited.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before The Hague Local Division. Understanding the court's reasoning in GlaxoSmithKline Biologicals SA vs C.P. Pharmaceuticals International C.V. et al. (Pfizer and BioNTech entities) is valuable context for structuring arguments or assessing risk in similar proceedings.
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