UPC_CFI_619/2025; UPC_CFI_1526/2025; UPC_CFI_2033/2025 – GSK v Moderna

Court
Local Division The Hague
Date
Outcome
Partially Granted
Sector
Pharma/Bio
Decision Type
PROCEDURAL

Expert Commentary

Housekeeping by JR Facts 1. These are infringement proceedings against 15 Moderna companies regarding EP 4 066 856 and EP 4 226 941. 2. Parties have made several applications. The judge-rapporteur (JR) issues a decision regarding these applications in this order. The JR 1. Amendment of Claim GSK sought to include Moderna's newest vaccine, which is the latest update of Moderna's Spikevax vaccine. The JR allowed the amendment, noting that the requested injunction was formulated in general terms. Consequently, an amendment was actually not necessary. 2. The number of auxiliary requests The JR was not convinced that 51 auxiliary requests (27 against one patent and 24 against the other) is a reasonable amount. The requests were not presented in an objection-related manner, and no tabular overview was provided. A final decision on this matter will be made during the interim conference. 3. Late filed submission and arguments Moderna’s objections and request for a stay of proceedings were dismissed. Comment 1. This is how a court should handle proceedings in the UPC. The JR engaged in active case management from day one, exactly as intended. When Divisions become too busy, active case management is no longer possible – as seen in certain German Divisions – meaning that speed and, ultimately, quality will suffer. During its last meeting, the Administrative Committee made clear that the solution is not simply adding more judges to busy Divisions. A shift in the attitude of users and their representatives should be brought about instead. Users and representatives should file cases in less busy Divisions. If users and representatives do not, they must accept that they will not receive the "royal UPC treatment": they may wait well over 12 months for an oral argument, and a decision could take significantly longer than 12 to 14 months. Users have already seen recent examples from Vienna (where one can also file in German), Paris and The Hague: high-quality judgments delivered within 14 months. 2. The JR's lessons for representatives: a. Formulate your request for an injunction in a general way (as well). This allows for the inclusion of updated products introduced by the defendant during the proceedings, assuming that an at least similar infringement reasoning applies. b. Do not object to new submissions, arguments, or exhibits that are triggered by and serve as a response to the Statement of Defence, and for which there was no reason to bring them earlier in the Statement of Claim. The UPC is a front-loaded system. However, you are still able to answer arguments included in the defence. The defendant can, after all, react to these arguments in their Rejoinder. c. If you file auxiliary requests, then include them in a tabled overview. In addition, substantiate each auxiliary request (i.e. which invalidity arguments each auxiliary request addresses and why it should succeed). I would like to add that it was never the intention of the drafters of the Rules that 51 auxiliary requests would be considered a reasonable number. The argument that there are numerous invalidity attacks is unconvincing. You should do your homework before you take your patent into litigation: have an experienced litigator and patent attorney look for potential extension of subject matter problems and perform a thorough prior art search. If needed, limit the patent in central limitation proceedings. d. UPC proceedings are not the place to conduct prosecution or repair mistakes (such as the extension of subject matter) made during the initial filing. The Drafting Committee generally envisioned about five auxiliary requests. The JR is entirely correct: one cannot expect a decision within 12 to 14 months if a Court must handle an excessive number of auxiliary requests.

Full Decision Text

1 The Hague - Local Division UPC CFI 619/2025 UPC CFI 1526/2025 UPC CFI 2033/2025 Order of the Court of First Instance of the Unified Patent Court delivered on 24/02/2026 regarding R.263 and R.9 RoP CLAIMANT 1) GlaxoSmithKline Biologicals SA - Rue de l'Institut 89 - 1330 - Rixensart – BE, “claimant” or “GSK” Represented by Tjibbe Douma and others DEFENDANTS 1) Moderna Netherlands B.V. (Defendant) - Claude Debussylaan 7 - 1082 MC - Amsterdam - NL 2) Moderna Biotech Spain, S.L. (Defendant) - C/Julián Camarillo 31 - 28037 - Madrid - ES 3) Moderna Biotech UK Limited (Defendant) - 54 Portland Place - W1B 1DY - London - GB 2 4) Moderna Biotech Distributor UK Ltd (Defendant) - MYO, 123 Victoria Street - SW1E 6DE - London - GB 5) Moderna Switzerland GmbH (Defendant) - Peter Merian-Weg 10 - 4052 - Basel - CH 6) Moderna Poland SP. Z.O.O. (Defendant) - Rondo Ignacego Daszynskiego 1 - 00-843 - Warsaw - PL 7) Moderna, Inc. (Defendant) - 325 Binney Street - MA 02142 - Cambridge - US 8) ModernaTX, Inc. (Defendant) - 325 Binney Street - MA 02142 - Cambridge - US 9) Moderna Belgium S.R.L. (Defendant) - Avenue Marnix 23 - 1000 - Brussels - BE 10) Moderna France SASU (Defendant) - 19 Rue Cognacq-Jay - 75007 - Paris - FR 11) Moderna Germany GmbH (Defendant) - Brienner Strasse 45 a-d c/o Design Offices, Campus Köningsplatz - 80333 - Munich - DE 3 12) Moderna Italy S.R.L. (Defendant) - Via Vittorio Veneto 54/B - CAP 00187 - Rome - IT 13) Moderna Portugal Unipessoal LDA (Defendant) - Rua Joâo Chagas, 10-B Direito - 1500-493 - Lisbon - PT 14) Moderna Sweden AB (Defendant) - c/o Scandinavian Trust AB, Birder Jarlsgatan 12 - 114 34 - Stockholm - SE 15) Moderna Norway A/S (Defendant) - C/o CSC (Norway) AS, Wergelandsveien 7 - 0167 - Oslo – NO Defendants 1-15, collectively “defendants” or “Moderna”, are represented by Gertjan Kuipers and others PATENT AT ISSUE Patent no. Proprietor/s EP4066856 EP4226941 GlaxoSmithKline Biologicals SA GlaxoSmithKline Biologicals SA DECIDING JUDGE: the judge rapporteur (“JR”) LANGUAGE OF PROCEEDINGS: English POINTS AT ISSUE 1. In this procedural order several applications of the parties are addressed, as set out below. R.263 application to amend the claim 2. Together with its reply/defence to the counterclaim submitted on 12 January 2026, (the “Reply”), GSK submitted an application to amend its claim in infringement action UPC CFI 619/2025, to include Moderna’s new product mNEXSPIKE in the definition of ‘Spikevax Infringing Products’, allegedly the latest upgrade of Spikevax. It asserts in support 4 that mNEXSPIKE is a product with the same lipid composition as the other two allegedly infringing products, so the infringement discussion is not materially affected and defendants are not unreasonably hindered by its inclusion. GSK also points out that this updated product already falls within the requested relief, which is requested for ‘A liposome (…) such as the Infringing Products (the Spikevax Infringing Products and mRESVIA Infringing Products individually and jointly), and/or further versions or variants thereof” The R.263 application is merely made for completeness and clarity. GSK also points out that the EMA only recently adopted a positive opinion recommending the grant of a marketing authorization for mNEXSPIKE on 11 December 2025. Therefore, there was no indication for GSK that should have prompted the inclusion of mNEXSPIKE in the statement of claim (“SoC”) dated 4 July 2025. The addition of mNEXSPIKE could not have been made with reasonable diligence at an earlier stage (Rule 263(2)a RoP). 3. Moderna opposes the amendment regarding the introduction of a new product, asserting that the amendment could have been made with reasonable diligence at an earlier stage as the FDA had already approved mNEXSPIKE in the US on 30 May 2025, which was reported on publicly, so that GSK knew, or should have known. Defendants also argue that it is unreasonably hindered in its defence because, inter alia, GSK devoted 15 pages of its reply to this new product and Moderna would be deprived of one written round in its response thereto. Number of ARs R.30.1 RoP 4. With its Reply GSK filed two conditional applications to amend the patent pursuant to R. 30.1 RoP, one for each patent. In counterclaim action UPC CFI 1526/2025 regarding EP4226941 (“EP941”) GSK uploaded 27 proposed conditional amendments as Auxiliary Requests (“ARs”)1- 27. Regarding EP4066856 (“EP856”) GSK uploaded 24 proposed conditional amendments as ARs1-24 in counterclaim action UPC CFI 2033/2025. Both applications to amend are also included in the Reply. In paragraphs 889-892 (for EP856) and 1149-1152 (for EP941) of the Reply, GSK addressed why it deems the number of ARs reasonable in view of the circumstances of the case, pointing at the complexity of the case, in particular the numerous invalidity attacks submitted by Moderna, the importance of the patent, underlined by the fact that the highest possible value in dispute possible has been selected (by both claimant and defendants in the counterclaim actions) and the principle of fairness. GSK also points out that the 24 ARs for EP856 the number of unique amendments is rather low, ten, and a considerable amount of the ARs are subject to parallel proceedings before the EPO and are thus needed in order to prevent conflicting outcomes. The same applies to the ARs for EP941, according to GSK. 5. Moderna replied, firstly pointing out that the total number of ARs for both patents is potentially much higher because combination of ARs with other ARs, other requests and other subject matter is asserted by GSK in its application to amend. According to Moderna the ARs relate to twenty new amendment features (ten for each patent). Moderna also challenges inter alia the allegedly unstructured and non-convergent nature of the ARs. Moderna submits that GSK should be directed to (a) elect a single, genuinely convergent line of amendments tied to the pleaded objections (b) confine themselves to ARs that are properly substantiated with a clear, objection- specific rationale (c) limit the number of ARs to 10 and (d) eschew any further reshuffling or recombination beyond a fixed, notified set. 5 R.9 application to dismiss late-flied submissions and arguments 6. On 27 January 2026, Moderna filed a R.9 application, objecting to several of GSK’s allegedly late-flied submissions and arguments in its Reply. In short Moderna requests the court to order GSK to remove: - the Cryo-TEM images of the attacked products (Exhibits BB69A-G) from the proceedings - the expert opinion of Prof. Forrest including annexes (see Exhibit BB62A-B), in the alternative, to remove those sections of and annexes to the expert opinion of Prof. Forrest which are based on or relate to the Cryo-TEM images - any new explanations of why the facts relied on in the SoC would constitute an infringement. - its extensive new sections on claim construction or at least those parts which are not strictly in response to Moderna’s claim construction (p. 34 to 53 of GSK’s Reply). In the alternative Moderna requests the court to disregard the mentioned sections and exhibits as it asserts these were not submitted within the time limit for filing them of R.13.1(m) and (n) RoP. 7. GSK asks the court to dismiss Moderna’s application and to allow GSK’s submissions in the Reply to stay in the proceedings, awarding costs for the application to GSK, alternatively to defer a decision on the application to the main action. With reference to the RoP and to case law of the UPC it points out that it is permitted to further substantiate arguments already made in its SoC, especially in response to arguments raised by the other party in its defence. It asserts that all arguments objected to are admissible because they are a direct response to Moderna’s incorrect claim construction and Moderna’s strategy to ‘plead ignorance’ in the statement of defence. The submissions are also in line with the fundamental right to be heard. Granting any of Moderna’s requests would violate this right. 8. On 11 February 2026, Moderna submitted another pleading titled ‘Inquiry about decision on application pursuant to R.9 RoP to dismiss late-filed submissions and arguments’, requesting the court to issue a decision on the R.9 application and to stay all procedural deadlines until that decision has been rendered. GSK uploaded a request to be allowed to respond to the ‘request to stay’. GROUNDS R.263 application to amend the claim 9. The R.263 application is admissible and leave to change the claim accordingly shall be granted. As clarified by the CoA, inter alia on 14 February 2025 in UPC CoA 328/2024 (Abbott/Sibio), there is no need for a limitation of an injunction to specific infringing products. In the present case, GSK, in the SoC, requested general injunctive relief to prohibit infringement of claim 1 and several other claims, whereby the specific products Spikevax and Resvia are mentioned as examples, but where the requested relief is not limited thereto: “A liposome (…) such as the Infringing Products (the Spikevax Infringing Products and mRESVIA Infringing Products individually and jointly), and/or further versions or variants thereof,” [emphasis added] This means that relief against other products, in particular new versions or variants that fall within the scope of protection of the claims, already fall within the request from the start of the proceedings. There was thus no need to amend the claim to include the new allegedly infringing product mNEXSPIKE. 6 10. Also, in case defendants’ reasoning is followed, and the adding of a new product is considered a change of claim or amendment of the case, the court finds the amendment admissible as it meets the requirements of R.263.2 RoP. The court is satisfied that the request could not have been made with reasonable diligence at an earlier stage in the proceedings, as the EMA only gave a positive opinion for the marketing of mNEXSPIKE for the territory relevant for these proceedings in December 2025. The fact that an FDA approval (for the US) had been granted for the product just before the filing of SoC does not imply that GSK should have known that it would become available for the European market (shortly). The court is also satisfied that defendants are not unreasonably hindered in the conduct of its action by the addition. Defendants did not dispute in its reply to the application that the new product is a newer version of the products already specifically mentioned in the SoC with the same or a similar relevant composition. Number of ARs R.30.1 RoP 11. Regarding the number of ARs, the court firstly points out that the number of conditional ARs submitted with the R.30.1 application to amend, is understood to be twenty four for EP856 and twenty seven for EP941. The admissibility of any further possible combinations is subject to approval pursuant to a R.30.2 RoP request. 12. The court is at this point not convinced that the fifty one proposed conditional ARs (concerning at least twenty new features), are reasonable in the circumstances of the case. GSK’s assertion that this is triggered by the great number of validity attacks, is not shared by the court. It is questionable whether, in proceedings before the UPC that aim to render speedy decisions within fourteen months, it is feasible to address so many ARs. Furthermore, although GSK did indicate the order in which the court should address the ARs in case the patent as granted is deemed invalid, the 51 ARs are not presented in an objection-related way. No tabular overview of the ARs is presented. 13. The possible limitation of the ARs (and of the inventive step attacks) is a topic that will be discussed during the IC. To assist the court and the other parties, GSK is ordered to submit a comprehensive tabular overview of its ARs for each patent, clearly indicating which (combination of) features is introduced with each AR and indicating in one column which invalidity attack(s) is(are) addressed. Such overview must be submitted within one week from today. Moderna’s requests to dismiss the ARs en bloc (Moderna’s 21 January 2026 submission at 1.1) or to limit the number to ten is dismissed. R.9 application to dismiss late-flied submissions and arguments 14. The further arguments and further evidence submitted by GSK in its Reply and objected to by Moderna, are permitted. In the circumstances of the present case these are considered a response to positions taken by Moderna in the statement of defence/counterclaim concerning non-infringement and claim-construction. The further arguments/submissions objected to, including the Cryo-TEM images in support of infringement, mostly further expand on arguments GSK already made in the SoC. The front-loaded character of the proceedings does not require a claimant to anticipate every defence/argument of defendants in its SoC, if this is even possible. To disallow the arguments/evidence objected to would in the present case interfere with GSK’s right to be heard. Moreover, Moderna has sufficient opportunity to respond, both in one more written round and during the oral hearing. 7 15. The R.9 application to admit allegedly late-filed submissions and arguments, is thus dismissed. Defendants’ subsequent request to decide thereon is herewith addressed. The requested stay of all deadlines until a decision on Moderna’s R.9 application is taken, is dismissed. In view of the latter decision, there is no need for GSK to respond to the request to stay. ORDER The court having heard the parties, 1. grants GSK’s R.263 application for leave to amend the claim; 2. dismisses Moderna’s R.9 application; 3. orders GSK to submit, within one week from today, a tabular overview of its ARs for each patent as set out in 13 above; 4. cost decisions are referred to the main proceedings.

Key Holdings

  • Active case management by the Judge-Rapporteur is crucial for the UPC's efficiency and speed.
  • Parties should consider filing cases in less busy divisions to ensure timely decisions.
  • Injunction requests should be formulated generally to cover updated products.
  • Excessive auxiliary requests (e.g., 51) are discouraged and can hinder the UPC's goal of timely decisions; they should be substantiated and presented in a tabular overview.
  • UPC proceedings are not for patent prosecution or repairing mistakes made during initial filing.

Tags

  • Case Management
  • Auxiliary Requests
  • Patent Amendment
  • Injunction
  • Procedural Efficiency
  • Pharmaceuticals
  • Vaccines

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