UPC_CFI_620/2025; UPC_CFI_1509/2025; UPC_CFI_1511/2025 – GSK v Pfizer

Expert Commentary

Streamlining by the JR Facts Before the oral hearing, the JR deals with solicited and unsolicited issues which arose after the interim conference. The JR 1. The JR states, among other things, that, given the accelerated and front-loaded nature of the UPC proceedings, the threshold for new documents after all written submissions have been exchanged is high. It is then explained in detail why, in this case because of special circumstances, the document is allowed, making clear that the other party knows (and has already studied) the document. 2. Apart from the above, I understand from the JR that a request for a further exchange of pleadings before the end of the written proceedings, or a request to produce a further document, should not already include the substantive pleading or document. The Court must decide the request first. 3. The JR stresses that only the 5 best invalidity attacks and 10 auxiliary requests will be considered during the oral hearing. 4. The JR states that the defendants did not comply with her request to indicate one or two invalidity attacks in respect of each auxiliary request and therefore orders them (again) to do so. Comment The JR again does a good job. She wants to make sure that the one-day oral hearing focuses in an organized fashion on the real issues, and is understandably frustrated that, despite her efforts during the interim conference, the parties did not fully comply with her initial effort. The problem for parties is that they do not like making tough decisions as to what their best arguments are. (Probably because they have all experienced winning a case with an argument they did not think was their best!) However, this is the UPC and tough decisions are demanded. Experienced representatives who have already been confronted in their national courts with this type of proceeding (such as the accelerated proceedings in the Netherlands, with which the JR is of course very familiar) know how to make them. For the objective observer, the interesting thing is that the quality of the judgments after such efficient UPC proceedings is certainly not inferior to that of US or UK proceedings, where you spend weeks in court at far greater cost.

Full Decision Text

Unified Patent Court Court of First Instance The Hague Local Division UPC_CFI_620/2025 UPC_CFI_1509/2025 UPC_CFI_1511/2025 Order of the Court of First Instance of the Unified Patent Court delivered on 21/08/2026 **CLAIMANT** GlaxoSmithKline Biologicals SA, Rue de l’Institut 89, 1330 Rixensart, Belgium, “GSK” Represented by Carlos Andres van Staveren, Tjibbe Douma, Nicole Jadeja, Emilia Zalewska and others (Bird & Bird) **DEFENDANTS** 1. C.P. Pharmaceuticals International C.V., Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, the Netherlands 2. Pfizer Export B.V., Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, the Netherlands 3. Pfizer B.V., Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, the Netherlands 4. Pfizer Manufacturing Belgium N.V., Rijksweg 12, 2870 Puurs-Sint-Amands, Belgium 5. Pfizer Service Company B.V./S.r.l., Hoge Wei 10, 1930 Zaventem, Belgium 6. Pfizer S.A./N.V., Boulevard de la Plaine 17, 1050 Brussels, Belgium 7. Pfizer Luxembourg SARL, Rond-Point du Kirchberg 51, Avenue J.F. Kennedy, L-1855 Luxembourg, Luxembourg 8. Pfizer Inc., 66 Hudson Boulevard East, New York, 10001-2192, the United States of America 9. Pfizer Corporation Austria Gesellschaft m.b.H, Floridsdorfer Hauptstraße 1, 1210 Vienna, Austria 10. Pfizer ApS, Lautrupvang 8, 2750 Ballerup, Denmark 11. Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland 12. Pfizer S.A.S., 23-25 avenue du Docteur Lannelongue, 75014 Paris, France 13. Pfizer Pharma GmbH, Friedrichstraße 110, 10117 Berlin, Germany 14. Pfizer S.r.l., Via Isonzo 71, 04100 Latina LT, Italy 15. Laboratórios Pfizer, Lda., Lagoas Park – Building 10, 2740 271 Porto Salvo, Portugal 16. Pfizer Romania S.R.L., Șoseaua București-Ploiești 172-176 (Willbrook Platinum Business and Convention Center), 013697 Bucharest, Romania 17. Pfizer AB, Solnavägen 3H, 113 63 Stockholm, Sweden 18. Pfizer, spol. s.r.o., Stroupežnického 3191/17, 150 00 Prague 5, Czech Republic 19. Pfizer Hellas A.E., Mesoghion Ave 243, Neo Psychiko 154 51, Athens, Greece 20. Pfizer, S.L., Avenida de Europa, 20-B, Parque empresarial, La Moraleja, 28108 Alcobendas Madrid, Spain 21. Pfizer Croatia d.o.o., Slavonska avenija 6, 10 000 Zagreb, Croatia 22. Pfizer Gyógyszerkereskedelmi Kft., Alkotás utca 53, H-1123 Budapest, Hungary 23. Pfizer Polska Sp. z.o.o., ul. Żwirki i Wigury 16b, Warsaw 02-092, Poland 24. Pfizer Trading Polska Sp. z.o.o., ul. Żwirki i Wigury 16b, Warsaw 02-092, Poland 25. Pfizer AG, Schärenmoosstrasse 99, 8052 Zurich, Switzerland 26. Pfizer AS, Drammensveien 288, 0283 Oslo, Norway 27. BioNTech SE, An der Goldgrube 12, 55131 Mainz, Germany 28. BioNTech Europe GmbH, An der Goldgrube 12, 55131 Mainz, Germany 29. BioNTech Manufacturing GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany 30. BioNTech Manufacturing Marburg GmbH, Emil-von-Behring-Straße 76, 35041 Marburg, Germany Defendants 1-26, collectively also “Pfizer”, are represented by Christian Dekoninck, Geert Theuws, Pauline Springorum, Thomas Witte, Simon Cohen, Ed Vickers and others (Winston Taylor) Defendants 27-30, together also “BioNTech” are represented by Tess Waldron, Penny Gilbert, Joel Coles, Peter FitzPatrick, Daniel Brown, Gabriella Simon and Abraham Darby-Zaier and others (Powell Gilbert) Defendants 1-30 are collectively referred to as “defendants” or as “PBNT”. Cooperative counsel for PBNT include Theo Blomme and Christine Kanz (Hoyng Rokh Monegier) and Georg Schnappauf and Sebastian Höpfner (Zwicker Schnappauf & Partner) **PATENT AT ISSUE** Patent no. EP 2 590 626 Proprietor/s: GlaxoSmithKline Biologicals SA **THE PANEL / DECIDING JUDGE** The composition of the panel is as follows: Edger Brinkman, presiding judge Stefan Schilling, legally qualified judge Martin Schmidt, technically qualified judge Margot Kokke, judge-rapporteur This order is issued by the judge-rapporteur (“JR”). **LANGUAGE OF PROCEEDINGS:** English **POINTS AT ISSUE / GROUNDS** 1. Some submissions (both solicited and unsolicited) submitted and issues that consequently arose after the interim conference (IC), which was held on 17 June 2026, need to be clarified and/or decided before the upcoming oral hearing (OH), which is scheduled for 3 September 2026. Exhibit PBNT C73 2. Pursuant to m.n. 9 and the order at J. of the R.105.5 RoP order (the “IC Order”), PBNT filed a reasoned request to admit exhibit PBNT C73 into the proceedings. This will be permitted. GSK was provided the opportunity to respond to this exhibit materially. To the extent that its submission of 15 July 2026 concerns PBNT C73, it is also admitted. Exhibit PBNT 84 – R.9.1 / R.36 application PBNT 3. By R.9 / R.36 RoP application received on 8 June 2026, PBNT requested the Court to admit a new Exhibit PBNT (C)84 (the “Cayman 2024 Report”) into the proceedings: On the basis that it was not open to PBNT to rely on the Cayman 2024 Report at an earlier stage and it is of direct relevance to the issue of infringement in these proceedings, PBNT request that the Court exercise its discretion to admit into these proceedings: (a) the Cayman 2024 Report; and (b) the accompanying submissions set out in this document; The Cayman 2024 Report was commissioned by GSK prior to a report referred to as the “Cayman 2025 Report” that is part of the proceedings already (as exhibit BB52). 4. The part of the request relating to Rule 36 RoP was addressed during the IC. Pursuant to Rule 36 RoP, if a party submits a reasoned request before the date on which the judge-rapporteur intends to close the written procedure, the judge-rapporteur may permit the exchange of further written pleadings within a specified timeframe. As the application was filed shortly before the written procedure closed and is reasoned, it is admissible. However, rather than requesting permission to submit further written pleadings, these were submitted together with and as part of the reasons for the request. During the IC, this submission was therefore rejected as not permitted; the same applies to GSK’s response. 5. Regarding the admission of the Cayman 2024 Report (part R.9.1 of the application) into the proceedings, the document seems to be relevant. GSK disputes PBNT’s assertion that it was not possible for PBNT to file this report at an earlier stage of the proceedings, given that it was only made available to PBNT in the parallel English proceedings between PBNT and GSK concerning the same patent. GSK asserts that the report was made available to PBNT in the US proceedings nearly a year ago. PBNT counters that the report was qualified as highly confidential in the US proceedings. 6. As set out in the IC Order at m.n. 10 and K, the parties were invited to clarify their positions regarding the confidentiality status of the Cayman 2024 Report. Declarations from both parties’ US representatives indicate that GSK produced a non-confidential version of the Cayman 2024 Report in the US proceedings on 24 October 2025. However, the parties disagree on whether this overrules the highly confidential designation under which the report was produced by GSK on 9 June 2025 and by Cayman on 24 September 2025 in the same proceedings. It is therefore not possible to reach an obvious conclusion on whether PBNT could have submitted the report at an earlier stage without further evidentiary proceedings, which are not possible at this stage of the proceedings, shortly before the oral hearing. PBNT is given the benefit of the doubt. 7. Given the accelerated and front-loaded nature of UPC proceedings, the threshold for admitting new documents after all written submissions have been filed is high, as this could affect the fairness of the trial and the speed of the proceedings. Notwithstanding the foregoing, the relevant result of the Cayman 2024 Report will be admitted into the proceedings because of the following special circumstances. The report was commissioned by GSK and is therefore familiar to it. It is also part of parallel proceedings in jurisdictions where there is an obligation to disclose such information. The test used and the report's setup are identical to those of the Cayman 2025 Report, which has already been commented on extensively in these proceedings. In view of what is already known from the Cayman 2025 Report, the new information disclosed in the Cayman 2024 Report is limited: it relates to a single pKa value concerning the ionisable cationic lipid of the allegedly infringing Comirnaty products (ALC-0315). Furthermore, the parties are familiar with each other's arguments regarding the Cayman 2024 Report, as this was set out in the unsolicited and unauthorised submissions filed with the IC (and dismissed). Consequently, commenting on the Cayman 2024 Report in the context of the Cayman 2025 Report during the OH (in two rounds) is deemed sufficient to meet the requirements of a fair trial. No additional written submissions concerning the Cayman 2024 Report are deemed necessary. In the particular circumstances of this case, therefore, the late-filed exhibit PTBNT (C)84 will be admitted into the proceedings. post-IC submissions 8. On 24 June 2026, PBNT submitted a 24-page document to the Court, providing the requested comprehensive overview of exhibits and relief sought, as well as a list of the five validity attacks on which they intend to rely at the OH, pursuant to the IC Order at C. and E. PBNT is herewith (see below at 2.) requested to submit a complete overview of admitted exhibits as a separate document, updated to include only the exhibits admitted above (C73 and C84). 9. The Court notes that PBNT did not comply with the request to submit a comprehensive overview of its claims as submitted to the Court during the (written phase of the) proceedings. During the IC, this request was explained to be made to facilitate the drafting by the Court, given that the relief sought tends to be amended during proceedings. This was not an invitation from the JR to amend the claims during the interim phase while bypassing R.263 RoP. While unconditional limitations of claim are always permitted, they are subject to an application for leave (R.263.1 and 263.3 RoP). Amending a claim also requires such an application. Leave to amend is subject to the conditions set out in that rule. The fact that the envisaged amendment is said to be prompted by the CoA’s decision of 2 June 2026 (in Kodak v Fujifilm) does not change this. Therefore, any amendments in the submitted overview of the relief sought, are not taken into account. That being said, the guidance provided by the CoA can be discussed during the OH. 10. GSK pointed out that the limitation to five invalidity attacks in PBNT’s submission of 24 June 2026, is unclear, also in view of the relevant paragraphs of the submissions referred to. The Court understands an inventive step attack to consist of a realistic starting point in the prior art combined with one other document or with common general knowledge (CGK), as the case may be. The combination of the same realistic starting point with another prior art document constitutes a new attack. PBNT has subsequently clarified that it will rely on the following five attacks: 1. Lack of novelty over WO 748; 2. Lack of novelty over WO 799; 3. Lack of inventive step over WO 748 (combined with CGK); 4. Lack of inventive step over WO 152 (combined with CGK); and 5. Lack of inventive step over Martinon (combined with CGK). It is thus clear that only these attacks, or in any case some of these attacks, will be relied on during the OH. These are presumably considered by PBNT to be the most promising. Insofar as PBNT indicated parts of its submissions to be relevant that go beyond this, this does not need to be considered. 11. In accordance with the IC Order at F, on 1 July 2026, GSK submitted a list of ten auxiliary requests (“ARs”) on which it intends to rely during the OH. Clearly, only these ARs will be relied on during the OH, if any. 12. Pursuant to the IC Order at G, PBNT filed a further communication to the Court on 8 July 2026. Contrary to the instructions provided during the IC to focus the attacks against each retained AR to a maximum of one or two in order to focus pleadings during the one-day oral hearing on the most promising attack, PBNT did not limit its attacks against the ARs. Instead, PBNT communicated its intention to rely on all the invalidity attacks listed above for the main claim, as well as some additional attacks for the ARs. PBNT’s interpretation of the IC Order at G does not align with the intended (and communicated) purpose of focusing of the case. It seems to rely on a literal interpretation of the word ‘additional’ taken out of context; the IC Order merely confirms of what was discussed at the IC and must be interpreted in that context. PBNT can only rely on one (maximum two) attacks for each AR during the OH. It was urged to rely as much as possible on the same prior art as relied on for the claims as granted. What was submitted is not acceptable. PBNT is ordered to submit a new response to the IC Order at G. Annex I - R.36 RoP application GSK 13. GSK’s application under R.36 RoP application, requesting a further exchange of written pleadings and filed on 24 July 2026, is not admissible. This is because it was filed after the IC, and therefore after the written procedure was closed, which goes against the requirements of R.36 RoP. A further written exchange is not permitted. However, as with PBNT’s R.36 RoP application discussed above, this application also concerns a request to admit a new exhibit into the proceedings pursuant to R.9.1 RoP. This rule is not limited to the written procedure. The exhibit that GSK wishes to submits, concerns sections of the website of the BioNTech website as it appeared in 2021 (the “2021 BNT Website”, Annex I to the application). Regarding the allegedly infringing Comirnaty products, the following is stated: 14. GSK asserts that this statement does not align with the position taken by PBNT in these proceedings. This document therefore appears to be relevant for the proceedings. GSK indicated that it only became aware of the 2021 BNT Website when it was produced by its US counsel on or after 2 July 2026 in the US proceedings. PBNT objects to the document on the grounds that it was filed late, arguing that the 2021 BNT Website has been publicly available since 2021 (through archives) so GSK should have been aware of it and submitted it earlier. However, the Court does not find this argument convincing, particularly given that PBNT also argue that they only became aware of the existence of the statement on the 2021 BNT website recently, when it was marked by GSK as an exhibit during a deposition in the US proceedings. The Court finds that GSK could not have submitted the exhibit earlier. Like exhibit PBNT C84, exhibit Annex I, the 2021 BNT Website, is also permitted into the proceedings as potentially relevant. The parties can comment on the exhibit during the OH. Any material submission made already are rejected as unsolicited. **ORDER** The Court, having heard the parties, 1. Admits the following documents into the proceedings: a. exhibit PBNT C73 and GSK’s response thereto of 15 July 2026 are admitted into the proceedings; b. exhibit PBNT C84 and c. GSK’s exhibit Annex I; 2. Orders PBNT to submit a new consolidated overview of Exhibits as a separate document (see 8 above) on or before Tuesday 25 August 2026; 3. Clarifies that the three inventive step attacks relied on by PBNT at the OH in these proceedings are WO 748, WO 152 and Martinon in combination with common general knowledge only (see 10 above); 4. Clarifies that GSK will only rely on the ten ARs communicated (see 11 above); 5. Orders PBNT to submit a new response to the IC Order at G in line with 12 above.

Key Holdings

• The threshold for new documents after written submissions is high in UPC proceedings due to their accelerated and front-loaded nature.
• Requests for further pleadings or documents should not include the substantive content; the Court must decide the request first.
• The Court may limit the number of invalidity attacks and auxiliary requests considered during the oral hearing to ensure focus.
• Parties are expected to make tough decisions about their best arguments and comply with the Judge-Rapporteur's requests for streamlining.

Tags

• Case Management
• Procedural Efficiency
• Oral Hearing
• Evidence
• Invalidity Attacks
• Auxiliary Requests
• Judge-Rapporteur

Related Cases

• UPC_CFI_620/2025; UPC_CFI_1509/2-025; UPC_CFI1511/2025 – GSK v Pfizer
• UPC_CFI_620/2025; UPC_CFI_1509/2025; UPC_CFI_1511/2025 – GSK v Pfizer