UPC_CFI_468/2024; 687/2024 – GSK v Pfizer Group

Expert Commentary

Bifurcation Background On 5 August 2024, GSK filed an infringement action against Pfizer. On 14 August 2024, the patent was granted. On 14 August 2024, some defendants filed a revocation action at the Milan Central Division. On 14 November 2024, the other defendants filed a counterclaim for revocation. On 13 January 2025, the claimant filed a defence against the counterclaim for revocation and an application to amend the patent. On 13 January 2025, the claimant also filed its defence in Milan and a request to amend the patent. The Order 1. The Local Division invited the parties to comment on an early decision regarding bifurcation (see R. 37.2 RoP). 2. Both parties supported bifurcation. The claimant wanted to proceed with the infringement case, while the defendant requested a stay ("high likelihood that the patent is invalid") and a two-month extension for their rejoinder to the defence to the counterclaim for revocation. The Decision 1. The Local Division decided on bifurcation and sent the case, including the request to amend the patent, to Milan. 2. The Court continued with the infringement case.. 3. The filed auxiliary requests remained subject to the infringement proceedings.. 4. The claimant's request to limit the case to the granted version of the patent was rejected. 5. The term for filing the rejoinder to the reply was extended by one month.. Comment 1. This decision makes sense as it avoids delays and duplication of work. However, it is regrettable that the Milan Central Division (which is certainly not overloaded with cases) has scheduled the oral argument for 10 November 2025 which is 14 months after the start of the revocation proceedings! Now that LD Düsseldorf has sent the counterclaim to Milan and continues with the infringement proceedings, it is hoped that this date will be changed to an earlier one. That is what R. 40(b) RoP requires ("The JR shall accelerate proceedings"). A hearing should be possible much earlier, allowing for a decision in August, which would enable LD Düsseldorf to hold an oral hearing in early September, knowing the outcome of the revocation proceedings, and to reach a decision about 14 months after the start of litigation. 2. Note that the infringement proceedings began before the grant of the patent. This is permissible as long as the text to be granted is known. An infringement action can be initiated as long as the statement of claim clarifies whether a Unitary Patent will be sought or for which countries the EP will be validated so that the defendant knows exactly what they are defending against. 3. The decision that the defendant must also defend against the auxiliary requests is practical. If Milan decides to maintain the patent based on one of the auxiliary requests, the infringement proceedings will not be delayed, as the infringement question regarding such auxiliary requests will have already been discussed. To clarify, I note: • Auxiliary requests are not dependent claims. If the claimant has also invoked dependent claims, the defendant must defend against those as well. • All such claims are granted independent claims, and no auxiliary request in revocation proceedings is necessary to defend their validity and if claimant does not specifically invokes their invalidity they will (should) not be revoked.. • The result may be that only some claims survive, but since they were already part of the granted patent, no auxiliary request is necessary. • An auxiliary request pertains to a new claim that was not in the granted patent and is based (partly) on the description and/or drawings. • Again, it is essential to realize that we are at the UPC, not the European Patent Office.

Full Decision Text

1 Düsseldorf Local Division UPC_CFI_468/2024 UPC_CFI_687/2024 Procedural Order of the Court of First Instance of the Unified Patent Court issued on 4 March 2025 concerning EP 4 183 412 CLAIMANT: GlaxoSmithKline Biologicals SA, Rue de l’Institut 89, 1330 Rixensart, Belgium, Represented by: Attorney at law Oliver Jan Jüngst, Attorney at law Luca Brons, Bird & Bird LLP, Carl-Theodor-Straße 6, 40213 Düsseldorf, Germany, Participating: Patent Attorney Dr. Daniela Kinkeldey, Patent Attorney Dr. Anna Schadel, Bird & Bird LLP, Maximiliansplatz 22, 80333 Munich, Germany, Electronic address for service: oliver.jan.juengst@twobirds.com DEFENDANTS: 1. Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Ixelles, Belgium, 2. Pfizer Manufacturing Belgium NV, Rijksweg 12, 2870 Puurs, Belgium, 3. Pfizer Pharma GmbH, Friedrichstraße 110, 10117 Berlin, Germany, 4. Pfizer Corporation Austria GmbH, Floridsdorfer Hauptstraße 1, 1210 Wien, Austria, 5. Pfizer SA, Boulevard de la Plaine 17, 1050 Ixelles, Belgium, 6. Pfizer Aps, Lautrupvang 8, 2750 Ballerup, Denmark, 7. Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland, 8. Pfizer SAS, 23-25 Avenue du Docteur Lannelongue, 75014 Paris, France, 9. Pfizer S.r.l., Via Isonzo 71, 04100 Latina, Italy, 10. Pfizer B.V., Rivium Westlaan 142, 2909 LD Capelle aan den Ijssel, The Netherlands, 11. Laboratórios Pfizer, Lda., Lagoas Park, Edificio 10, 2740-244 Porto Salvo, Portugal, 2 12. Pfizer AB, Solnavägen 3H, 113 63 Stockholm, Sweden, 13. Pfizer Luxembourg S.a.r.l., Rond-point du Kirchberg 51, Avenue J.F. Kennedy, I 1855 Luxembourg, 14. Pfizer Service Company S.r.l., Hoge Wei 10, 1930 Zaventem, Belgium, All represented by: Patent Attorney Gareth Williams, Marks & Clerk LLP, 15 Fetter Lane, London, EC4A 1BW, United Kingdom, Attorney at law Dr. Claudia Milbradt, Attorney at law Dr. Tobias J. Hessel, Clifford Chance Partnerschaft mbB, Königsallee 59, 40215 Düsseldorf, Germany, Electronic address for service: MCL-RSV@marks-clerk.com PATENT AT ISSUE: European patent n° EP 4 183 412 B1 PANEL/DIVISION: Panel of the Local Division in Düsseldorf DECIDING JUDGES: This decision was issued by Presiding Judge Thomas, legally qualified judge Dr Schumacher acting as judge-rapporteur and legally qualified judge Postiglione. LANGUAGE OF THE PROCEEDINGS: English SUBJECT OF THE PROCEEDINGS: Patent infringement action – R. 37 RoP; Art. 33(3) UPCA (bifurcation) and R. 9.3(a) (extension of a time period) SUMMARY OF THE FACTS: On 5 August 2024, the Claimant filed a patent infringement action against the Defendants in respect of EP 4 183 412 (patent in suit). The mention of the publication of the grant of the patent in suit was published on 14 August 2024. On the same day, 14 August 2024, Defendants 1., 2., 3., 5., 10., 14. and two other Pfizer entities filed a revocation action with the Milan Central Division. Defendants 4., 6., 7., 8., 9., 11., 12. and 13. filed a counterclaim for revocation on 14 November 2024. Together with its Reply to the counterclaim for revocation dated 13 January 2025, the Claimant filed an application to amend the patent in suit. On the same day, the Claimant filed its Defence to the revocation action and a further application 3 to amend the patent with the Milan Central Division. The Defendants request a two-month extension of the time periods for filing the Rejoinder to the Defence to the counterclaim and the Defence to the application to amend the patent. By Preliminary Order of 14 February 2025, the judge-rapporteur has informed the Parties that the Panel intends to take an earlier decision under R. 37.2 RoP on how to proceed with the counterclaim for revocation. The Parties were invited to submit observations. The Claimant and the Defendants agree that the Counterclaim for revocation should be referred to the Central Division. However, they disagree on whether to proceed with the infringement proceedings in the event of a referral. The Claimant seeks to proceed and requests the Court to set a timely date for the oral hearing, even if the oral hearing then takes place before the oral hearing on the Counterclaim for revocation in Milan. The Defendants request a stay of the proceedings pending a final decision in the revocation action. They base their request primarily on the alleged high likelihood of invalidity of the patent in suit. Apart from that, they argue that the validity issue should be addressed first anyway. The judge-rapporteur has also informed the Parties that the Panel considers an extension of one month for the filing of the Rejoinder to be sufficient. While the Defendants maintain their request for a two-month extension, the Claimant opposes any extension of the deadline. By Procedural Order dated 19 February 2025, the Central Division has set a date for the oral hearing in the revocation proceedings for 10 November 2025. GROUNDS FOR THE DECISION: I. Pursuant to R. 37.2 RoP, the Local Division takes an earlier decision on the question of how to proceed with regard to Art. 33(3) UPCA before the end of the written procedure. 1. If a counterclaim for revocation has been brought in the case of an infringement action, Art. 33(3) UPCA states that the local or regional division concerned shall, after having heard the parties, have the discretion either to: (a) proceed with both the action for infringement and with the counterclaim for revocation and request the President of the Court of First Instance to allocate from the Pool of Judges in accordance with Art. 18(3) a technically qualified judge with qualifications and experience in the field of technology concerned; (b) refer the counterclaim for revocation to the central division and stay or proceed with the action for infringement; or (c) with the agreement of the parties, refer the case to the central division. 2. In the present case, the Local Division exercises its discretion to refer the counterclaim for revocation to the Central Division and to proceed with the infringement action (Art. 33(3)(b) UPCA). 4 While in general there are advantages in having the infringement action and the counterclaim for revocation being heard together by the same panel, the circumstances of this case call for a different decision. The Parties have unanimously requested a referral of the Counterclaim for revocation to the Central Division. Unanimous requests by all parties will be granted unless strong counterarguments require a different decision (UPC_CFI 14/2023 (LD Munich), Order of 2 February 2024 - Amgen v Sanofi). The Panel does not see any such strong counterarguments. On the contrary, a referral of the Counterclaim for revocation seems to be appropriate, particularly for reasons of efficiency. In the exercise of discretion, procedural efficiency is of particular importance (cf Preamble 4 RoP; see also UPC_CFI_410/2023 (LD Mannheim), Order of 10 July 2024 - MED-EL v Advanced Bionics). The Revocation action and the Counterclaim for revocation are essentially based on the same prior art documents and other grounds for invalidity such as added matter, lack of technical contribution and lack of sufficiency. The Defendants themselves state that the Counterclaim for revocation (only) updates and amends the grounds in the Statement for revocation because since the filing of the Revocation action the B-specification of the patent in suit has been published and the UK Patent Courts handed down a judgement by which two further related patents were held to be invalid and not infringed. The Central Division is therefore already familiar with the subject matter of the counterclaim for revocation. For the avoidance of doubt, it should be noted that the panel refers the counterclaim for revocation filed by all counterclaimants to the Central Division (Defendants 4., 6. to 9., 11. to 13.). 3. The Local Division further exercises its discretion to proceed with the infringement action pursuant to Art. 33(3)(b) UPCA, R. 37.4 RoP. Where the panel decides to proceed in accordance with Art. 33(3)(b) UPCA, it may stay the infringement proceedings pending a final decision in the revocation proceedings and shall stay the infringement proceedings where there is a high likelihood that the relevant claims of the patent will be held to be invalid on any ground by the final decision in the revocation proceedings, R. 37.4 RoP. The Panel is of the opinion that a stay of the proceedings would not be appropriate at this stage. The question of whether there is a high likelihood of invalidity requires a detailed examination, taking into account the entire content of the file. For this reason, given the stage of the proceedings, it does not appear effective to deal with the issue of invalidity at this point in time. However, the Panel reserves the right to reconsider the possibility of staying the infringement proceedings at a later stage (cf UPC_CFI 14/2023 (LD Munich), Order of 2 February 2024 - Sanofi v Amgen). 4. To avoid any doubt, it is clarified that the Application to amend the patent is referred together with the Counterclaim for revocation. II. R. 9.3(a) RoP authorises the Court to extend time periods. However, this possibility should only be used with caution and only in justified exceptional cases (UPC_CFI_363/2023 (LD Düsseldorf), Order of 20 January 2024 - Seoul Viosys Co., Ltd. v expert e-Commerce GmbH, expert klein GmbH). 5 This is such an exceptional case. However, the Panel considers an extension of the time period by one month to be sufficient. Given that the bifurcation decision was taken only relatively shortly before the expiry of the time period for lodging the Rejoinder, it appears appropriate to grant the Defendants an extension by one month. The Panel has also taken into account that the deadlines for filing the Reply to the defence and the Defence to the patent amendment application in the revocation proceedings have been extended and will now also expire on 13 April 2025. The Panel also had to consider that the bifurcation decision does not mean that the auxiliary requests no longer have any significance for the infringement proceedings. The auxiliary requests are also indirectly relevant to the infringement proceedings and require the Defendants to address them. As far as the Defence to the counterclaim and the Defence to the application to amend the patent are concerned, the Panel no longer needs to decide on the request for an extension of time periods. Once the referral has been realised, this decision will be taken by the Central Division. III. The Defendants' proposal to limit their pleadings to the granted version of the patent is rejected. Such an order would be incompatible with the time limit regime laid down in the Rules of Procedure. The proper conduct of the oral proceedings would also be put at risk. However, the granted extension of the time limit for filing the Rejoinder will allow the Defendants to address all issues relating to the infringement, including the auxiliary requests. ORDER: I. The Düsseldorf Local Division refers the counterclaim for revocation to the Milan Central Division and proceeds with the infringement action (Art. 33(3)(b) UPCA). II. The time period for the Defendants’ Rejoinder to the reply to the statement of defence is extended until 13 April 2025. DETAILS OF THE ORDER: App_4496/2025 related to the main proceeding ACT_45141/2024 and CC_60908/2024 UPC-Number: UPC_CFI_468/2024 and UPC_CFI_687/2024 Subject of the Proceedings: Patent infringement action and Counterclaim for revocation 6 Issued in Düsseldorf on 4 March 2025 NAMES AND SIGNATURES Presiding Judge Thomas Legally Qualified Judge Dr Schumacher Legally Qualified Judge Postiglione

Key Holdings

• The Local Division decided to bifurcate the case, sending the revocation counterclaim and patent amendment request to the Central Division (Milan) while retaining the infringement proceedings.
• Infringement proceedings can commence before patent grant, provided the granted text is known and the statement of claim specifies the patent's scope.
• Defendants must defend against auxiliary requests in infringement proceedings, even if the validity of these requests is simultaneously being assessed in revocation proceedings.
• The Court extended the deadline for the rejoinder to the reply by one month.

Tags

• Auxiliary Requests
• Bifurcation
• Counterclaim
• Infringement
• Patent Validity

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