UPC_CFI_616/2025; UPC_CFI_1439/2025 – GSK v Moderna

Expert Commentary

Revocation JR order after oral argument Facts 1. GSK started an infringement action against 15 Moderna companies on the basis of EP 2 590 626. 2. Moderna filed a counterclaim for revocation. 3. On 12 June 2026, the JR had refused new technical reports as late-filed, for having been filed with the latest submissions in the revocation proceedings while they pertained to the infringement case. 4. The decision of the JR was confirmed by the panel in review proceedings. 5. The oral hearing took place on 1 September 2026. 6. On 3 September 2026, the Presiding Judge informed the parties that the Court intended to (partly) revoke the order of refusal by the JR and asked the parties to comment by 7 September 2026. 7. GSK requests the order to be (partly) revoked. 8. Moderna states that this is procedurally impossible but, should the new technical reports be admitted, it demands extra explanations from GSK, after which it should be able to respond. The Court 1. Referring to R. 335 RoP, the Court (partly) revokes the order of the JR stating that during the oral hearing the importance of the new ATEM reports for the infringement question became clear. Fairness requires their admittance into the case and that the opposing party be given the right to comment on them. 2. The Court considers R. 114. RoP to not be applicable; but if applicable the Court considers the case an exceptional case in the sense of R. 114 RoP. 3. The Court gives GSK until 16 September 2026 to give a no more than 600-word long explanation. Moderna thereafter has a week to respond with a maximum of 900 words. Comment 1. R. 335 RoP does give the Court the possibility to vary or revoke an order, including in my opinion after such order has been confirmed in review proceedings. Later in the proceedings, circumstances may change and R. 335 RoP is intended to give the Court maximum flexibility to manage the case in such a way that it can deliver the most appropriate decision. 2. I do think that R. 114 RoP (which in exceptional circumstances gives the Court the possibility to adjourn the case and call for further evidence) is in fact the appropriate rule in this situation, because the evidence which the Court wants to have is not presently in the proceedings because it was refused and I cannot see how the refused reports can be qualified as anything other than “evidence”. 3. I commented last week on late-filed facts and arguments and the tension between the front-loaded character of UPC proceedings and the fact that the question of infringement and validity is a question of law (see Unfiltered week 37). The above case illustrates this even more clearly. Not only the JR, but also the Court during panel review, had explicitly not allowed the late-filed evidence and arguments. That these were late could hardly be disputed as they had to do with the infringement case but were filed with the last submissions in the revocation proceedings (instead of the claimant asking for a further round of written submissions - R. 36 RoP -). 4. In this case, I assume that Moderna has argued that the Court has to make its decision on the basis of the facts as they were established in the proceedings at the time of oral argument. The Court has to decide the legal question of infringement on the basis of the facts on record. The burden of proof of the infringement allegations is on GSK and if the Court cannot find infringement on the basis of the evidence filed by GSK in due course, the Court should in principle dismiss the case. 5. This is different from a situation where all the relevant facts of the case have been submitted but the claimant, on the basis of these facts, comes up with (too) late new arguments why there is infringement. In that case, the Court can and should still come to the correct answer to the legal question of infringement (but, as indicated in my comment last week, should avoid a surprise decision, i.e. one based on reasons undiscussed by the parties). 6. If a claimant has not provided all the facts (evidence) for an infringement finding, I do not think that it is “unfair” to dismiss the case, even though it may be seen as unsatisfactory because there may well be infringement while the Court would reach a non-infringement verdict. 7. The Rules give the Court a way out in exceptional cases, with the possibility to allow a party to bring further evidence even after the oral hearing to avoid an incorrect result. It is for the Court of Appeal to determine what “exceptional” means but I think that at least a party should have argued that it is willing to bring such additional relevant evidence, which here was clearly the case. However, if one could have brought that evidence earlier (which is also the case here), can one bring this under “exceptional circumstances” in the front-loaded UPC proceedings, also having regard to R. 36 RoP (which one failed to use)? It is certainly unsatisfactory for a Court to have to give a decision on the basis of incomplete facts but it is a principle that it is up to the parties to bring the facts to the table and if a party does not do so then you may lose where you may have won. These are the rules of the game!

Full Decision Text

1 The Hague - Local Division UPC_CFI_616/2025 UPC_CFI_1439/2025 Order of the Court of First Instance of the Unified Patent Court delivered on 11/09/2026 CLAIMANT/DEFENDANT IN THE COUNTERCLAIM 1) GlaxoSmithKline Biologicals SA (Claimant) - Rue de l'Institut 89 - 1330 - Rixensart - BE Represented by Tjibbe Douma, Carlos van Staveren, Nicole Jadeja and Emilia Zalewska of Bird & Bird LLP DEFENDANTS/COUNTERCLAIMANTS 1) Moderna Netherlands B.V. Claude Debussylaan 7 - 1082 MC - Amsterdam - NL 2) Moderna Biotech Spain, S.L. C/Julián Camarillo 31 - 28037 - Madrid - ES 3) Moderna Biotech UK Limited 54 Portland Place - W1B 1DY - London - GB 4) Moderna Biotech Distributor UK Ltd MYO, 123 Victoria Street - SW1E 6DE - London - GB 2 5) Moderna Switzerland GmbH (Defendant) - Peter Merian-Weg 10 - 4052 - Basel - CH 6) Moderna Poland SP. Z.O.O. Rondo Ignacego Daszynskiego 1 - 00-843 - Warsaw - PL 7) Moderna, Inc. 325 Binney Street - MA 02142 - Cambridge - US 8) ModernaTX, Inc. 325 Binney Street - MA 02142 - Cambridge - US 9) Moderna Belgium S.R.L. Avenue Marnix 23 - 1000 - Brussels - BE 10) Moderna France SASU 19 Rue Cognacq-Jay - 75007 - Paris - FR 11) Moderna Germany GmbH Brienner Strasse 45 a-d c/o Design Offices, Campus Köningsplatz - 80333 - Munich - DE 12) Moderna Italy S.R.L. Via Vittorio Veneto 54/B - CAP 00187 - Rome - IT 3 13) Moderna Portugal Unipessoal LDA Rua Joâo Chagas, 10-B Direito - 1500-493 - Lisbon - PT 14) Moderna Sweden AB c/o Scandinavian Trust AB, Birder Jarlsgatan 12 - 114 34 - Stockholm - SE 15) Moderna Norway A/S c/o CSC (Norway) AS, Wergelandsveien 7 - 0167 - Oslo – NO Defendants 1-15 are represented by Gertjan Kuipers, Andreas von Falck, Lukas Sievers, Floris Patijn and others of Hogan Lovells Cadwalader PATENT AT ISSUE EP2590626 B1 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 panel. Language of the proceedings: English Subject matter of the proceedings: Infringement action, counterclaim for revocation and application to amend the patent. SUMMARY OF FACTS AND GROUNDS 1. The claimant, GSK, initiated infringement proceedings against the defendants, collectively: Moderna. Moderna filed a counterclaim for revocation as part of their defence. During the interim conference (IC), held on 12 June 2026, the judge-rapporteur (JR) dismissed exhibits BB140A-E and the parts of the second expert declaration by Forrest relating thereto, including exhibit BB137B.11. Exhibits BB140A-E and BB137B.11 are collectively referred to as the New ATEM reports. These exhibits were considered late-filed, as they pertain to the issue of 4 infringement yet were only submitted with GSK’s final written submission regarding the counterclaim. The rejection was confirmed in the R.105.5 RoP order of 12 June 2026 (in the operative part at I.). The New ATEM reports were generated by the research company ATEM and contain Cryo-TEM data with stained/dyed RNA of the accused products. 2. ATEM reports with cryo-TEM images of the attacked products submitted by GSK as exhibit BB74(A-G) and supplemented by Moderna with the ATEM document titled ‘Method notes, LNP Classification, Precision & Accuracy’ (exhibit HL75), are part of the file (collectively: the First ATEM Reports). These reports describe and depict images of the attacked products without dyed RNA and include inter alia the following image of attacked product Spikevax: 3. The oral hearing (OH) in the infringement proceedings and the counterclaim for revocation took place on 1 September 2026. During the OH, the defendants not only maintained their position that the cryo-TEM images shown in Figure 3 of the publication referred to as “Brader”, are not indicative for the accused products, but furthermore (inter alia) disputed that an aqueous core is present in the accused products and that RNA is present in that aqueous core. 4. After the OH, on 3 September 2026, the presiding judge sent the following communication to the parties via CMS: 5 The panel is contemplating to revoke the order of the JR regarding the admissibility of the stained/dyed Cryo-TEM images of the attack product in view of the arguments made and positions taken by the respective parties during the OH (R.335 RoP). Pursuant to R.337 RoP parties are here- with given the opportunity to comment ultimately on Monday 7 September 2026 (maximum 600 words). 5. Both parties responded on 7 September 2026. GSK requests the reports to be admitted. Moderna consider the proposed admissions of the New ATEM reports procedurally impermis- sible and improper. Alternatively, Moderna submits that it could agree to the admission of the New ATEM reports into the proceedings subject to the following two conditions: (1) GSK should fully and clearly explain how and where the claimed structural features of a liposome, as well as the position of SM-102, are shown in the Cryo-TEM images. (2) Moderna should be given the opportunity to respond thereto. This material was not a sub- ject of the oral hearing. Thus, giving Moderna the opportunity to at least respond in writing is necessary to safeguard its right to be heard (Art. 76(2) UPCA; Art. 6 EHRC, Art. 47, 41(2) CFR). GROUNDS 6. The panel makes use of its case management powers and revokes the R.105.5 order of the JR dated 12 June 2026 according to R. 335 RoP insofar as it concerns the rejection of the New ATEM reports into the proceedings. 7. While the rejecting order was appropriate at the time of its issuance because the evidence provided was not made within the briefs relating to the infringement action, the discussion at the oral hearing requires a new assessment of this order. During the oral hearing it became more apparent that the exact location of the mRNA within the particles, the presence of water and the nature of the aqueous core was at the centre of the infringement discussion. Hence, the new ATEM Reports containing Cryo-TEM data with stained/dyed RNA of the accused prod- ucts have matured to be of significance to the assessment of infringement. Fairness requires their admittance to the case. And fairness also requires that the opposing party is given a chance to comment on them (see below). 8. In addition, admitting this – already provided – evidence is suitable to promote fact-finding and to serve the interest of justice. Furthermore, the evidence in question is limited and very specific. It consists of the New ATEM reports containing Cryo-TEM images of the attacked products with stained/dyed RNA. As this evidence was previously submitted to the proceedings but rejected as late-filed (see 1 above) the parties are already familiar with it. The evidence is readily available and straightforward to re-admit. It relates to the defendants’ own products whose exact specifications and design should be known to them in any case. 9. Admitting this evidence is therefore appropriate and proportionate, as well as necessary for a proper assessment of the proceedings. It will assist the Court, including in the event of an appeal, where such new evidence may not be permitted. 10. Moderna’s procedural objection is dismissed. The panel finds a procedural basis for admitting further evidence in its case management powers according to R. 334 RoP in combination with R.335 RoP. R.331.3 RoP, when read with R.335 RoP, creates the possibility to revoke or vary an 6 earlier case management order. In this case, this would mean overturning the JR's decision not to admit the evidence in question, as confirmed in the R.105.5 order of 12 June 2026 at I. This can be done at any stage of the proceedings, also in the oral phase. 11. To safeguard the right to be heard, GSK is given the opportunity to submit a concise written explanation alongside the uploading of the New ATEM reports only, as set out below. Re- submission of the original, unrevised, second declaration of Forrest is not permitted. Moderna can respond to this submission in writing, as set out below. Given the limited scope of the additional evidence and the fact that it was previously submitted but rejected, such response is considered sufficient to meet the requirements of Art. 76(2) UPCA. 12. The target date for the issuing of the decision (R.118.6 RoP), as communicated at the OH, remains unaffected. 13. In view of the above, the panel does not consider the revocation of the JR decision to fall within the scope of R.114 RoP. However, should R.114 RoP be nonetheless considered to apply, the panel finds that the specific circumstances of this case constitute an exceptional case (the evidence is already available, it will not lead to any (noticeable) delay and hence no need for adjournment of the case). ORDER For all these reasons and after having heard the parties, the Court I. Revokes the R.105.5 order of the JR dated 12 June 2026 insofar as it concerns the rejection of the New ATEM reports into the proceedings; II. Orders GSK to resubmit the dismissed exhibits BB140A-E and exhibit BB137B.11 into the proceedings, together with a concise explanation of no more than 600 words, by 16 September 2026; III. Allows Moderna to respond to the aforementioned submission within one week of the exhibits being uploaded to the CMS, with a submission of no more than 900 words. Brinkman Schilling Schmidt Kokke On behalf of the deputy registrarSwinkels Nikki 2026-09-11 16:06:18 +0200Kokke Margot Elsa 2026-09-11 15:43:55 +0200Brinkman Edger Frank Digitally signed by Brinkman Edger Frank Date: 2026.09.11 12:49:35 +02'00'Digital signiert von STEFAN SCHILLING DN: cn=STEFAN SCHILLING, c=DE, email=stefan.schilling@unifiedpatentcourt.org Datum: 2026.09.11 13:45:19 +02'00' STEFAN SCHILLINGMartin SCHMIDT Signature numérique de Martin SCHMIDT Date : 2026.09.11 14:49:45 +02'00' 7

Key Holdings

• Under Rule 335 RoP, the Court has the flexibility to vary or (partly) revoke an order of the Judge-Rapporteur even after the oral hearing and after the order had previously been confirmed in panel review proceedings.
• Late-filed technical reports initially refused by the Judge-Rapporteur may be admitted post-hearing if their relevance to the infringement question becomes clear during oral argument and fairness warrants their inclusion.
• When admitting late-filed evidence post-hearing, procedural fairness requires affording the producing party an opportunity to submit an explanation and the opposing party an adequate opportunity to respond.

Tags

• Revocation JR order after oral argument
• Late-filed evidence
• Case management

Related Rules

• Rule 3 – Power of staff of the Registry and a sub-registry to perform functions of the Registry
• Rule 1 – Application of the Rules and general principles of interpretation
• Rule 3 – Power of staff of the Registry and a sub-registry to perform functions of the Registry

Related Cases

• UPC_CFI_616/2025; UPC_CFI_1439/2025 – GSK v Moderna
• UPC_CFI_616/2025; UPC_CFI_1439/2025 – GSK v Moderna
• UPC_CFI_616/2025; UPC_CFI_1439/2025 – GSK v Moderna