Local Division Munich UPC_CFI_148/2024 - UPC_CFI_503/2024

Procedural Order

of the Court of First Instance of the Unified Patent Court Local Division Munich issued on 27 June 2025

CLAIMANTS

Sanofi SA as successor of Sanofi Mature IP Sanofi Winthrop Industrie Sanofi Winthrop Industrie as successor of Sanofi-Aventis France

(not a party in UPC_CFI 145/2024)

Sanofi-Aventis GmbH Sanofi Belgium Sanofi-Aventis Deutschland GmbH Sanofi S.r.l. Sanofi B.V. Sanofi - Produtos Farmaceuticos Lda Sanofi AB Sanofi A/S

represented by:

Frédéric Chevallier (McDermott Will & Emery).

DEFENDANTS -UPC_CFI_148/2024 - UPC_CFI_503/2024

Zentiva France Zentiva Pharma GmbH Zentiva, k.s.

represented by:

Dr. Anja Lunze (Taylor Wessing)

Dr. Elisabeth Greiner (df-mp).

UPC_CFI_148/2024 - UPC_CFI_503/2024

PATENT AT ISSUE

European patent n° 2 493 466

PANEL/DIVISION

Panel 1 of the Local Division Munich

DECIDING JUDGE/S

This order has been issued by Presiding Judge Dr. Matthias Zigann acting as judge-rapporteur, the legally qualified judges Alima Zana and Tobias Pichlmaier and the technically qualified Judge Carola Wagner.

LANGUAGE OF THE PROCEEDINGS

English

SUBJECT-MATTER OF THE PROCEEDINGS

R 333 Application against the order dated 8 May 2025 (ORD_10069/2025)

PROCEDURAL HISTORY

The judge-rapporteur made a decision on 8 May 2025 (ORD_10069/2025) regarding the management of the subsequent proceedings, which was as follows:

The judge-rapporteur informs the parties that the preliminary objections will be dealt with in the main proceedings. The judge-rapporteur puts the remaining pending requests to the panel for decision following the main oral hearing. The defendants are invited to file the rejoinder to the reply to the defence (Rule 29 (d) RoP) within two months from today. The claimants are invited to file a brief according to Rule 29 (2) RoP within one month following the filing of the rejoinder to the reply to the defence. The written procedure will be closed on 8 August 2025. The date for the Interim Conference scheduled for 17 July 2025 is confirmed. The IC will primarily focus on the outcome of the appeal proceedings at the BoA of the EPO. Another (the main) Interim Conference is set for 12 September 2025, 10.00 a.m., via videoconference. The dates for the oral hearing scheduled for 14-17 October 2025 are confirmed. The parties are summoned to the above-mentioned hearings and interim conferences.

Zentiva lodged an application pursuant to R. 333 RoP on 22 May 2025 (App_24524/2025). The Sub-Registry completed the formal checks on 3 June 2025.

APPLICATIONS BY THE PARTIES

Zentiva requests the panel to:

A. reviews and sets aside Order 4. of the Procedural Order with regard to the infringement proceedings;

B. reviews and amends Order 5. of the Procedural Order to the effect that the written procedure in the infringement proceedings will be closed on July 8, 2025 and the written procedure in the counterclaim for revocation will be closed on August 8, 2025; C. issues an order clarifying which, if any, of the Claimants formal requests, facts and arguments have been effectively introduced into the proceedings under R. 12, 13 et seqq., 263, 36 or 9.1 RoP; and

in the alternative, if the panel does not rule in accordance with any of the requests A., B. and/or C., then Defendants request that the panel:

D. grant leave to appeal its order.

Zentiva argues that if order 4 should be understood to open a possibility for Sanofi to further argue infringement it must be set aside. Further there should be two dates for the closure of the written proceedings. Finally, Zentiva identified a dilemma to file a brief in two months' time not knowing exactly which facts and formal pleadings, in particular regarding damages, will be admitted and which not.

Sanofi requests the panel to:

Dismiss the Defendants' present application for review by the panel;
Confirm the Order of 8 May 2025;
Be granted leave to appeal should the Order of 8 May 2025 be amended.

ARGUMENTS BY THE PARTIES

Zentiva argues:

Item A:

Defendants kindly request that the panel of the LD Munich (a) reviews and sets aside Order 4. of the Procedural Order as it relates to the infringement proceedings and (b) amends Order 5. of the Procedural Order to specify that the written procedure will be closed for the

infringement proceedings on 08 July 2025 and for the revocation proceedings (R.333.1, R.333.2 RoP) on August 8, 2025. 20 Otherwise, if it is indeed intended that Claimants be allowed to further reply on the infringement proceedings in their final submission on 8 August 2025, then Defendants will need sufficient time to respond as it is the concept of the Rules of Procedure that the respective defendant party has the last word. Therefore, the schedule must be altered already now, as it is foreseeable that the deadlines cannot be met due to case management.

Currently, it is unclear whether Order 4. of the Procedural Order allows the Claimants only to file a rejoinder under R. 12.3(c), 29(e) RoP (i.e. in the counterclaim proceedings only) or additionally also as a reply to Defendants rejoinder in the infringement proceedings. Order 4. of the Procedural Order cites R. 29(2) RoP. However, to Defendants' understanding, R. 29 (2) RoP does not exist.

In the event that Order 4. of the Procedural Order should indeed intend to allow Claimants to also file a reply to Defendants rejoinder in the infringement proceedings, it is unjustified. R. 29 RoP does not provide legal basis for this since the exchange of submissions under R. 29 RoP concludes with the respective rejoinder of each Party, i.e., for the Claimants it applies to their rejoinder in the counterclaim. See R. 29(e) RoP. Pursuant to R. 36 sentence 1 RoP and R. 12.5 RoP, further submissions can only be allowed by the Judge Rapporteur under the condition, that Claimants apply for the granting of a further submission in written form. Since the RoP contain this specific provision on additional written submissions, the granting of further submissions is not covered by the general case management under R. 9.1 RoP.

Item B:

The written procedure can be closed under R. 35, 36 sentence 2 RoP. Based on how the RoP set up the written submissions, the RoP always require that the respective defendant has the last word. See Rule 12 RoP, Rule 13 et seq. RoP. Therefore, in the present proceedings, the Defendants must have the last word in the infringement proceeding and the Claimants must have the last word in the counterclaim. However, since it is currently unclear what the Claimants are entitled to comment on in their next submission, there is no legal basis for Order 5. of the Procedural Order in the infringement proceedings.

Item C:

The Judge Rapporteur announced that the decision on the admissibility and effectiveness of amendments/additions of arguments and formal requests provided by the Claimants will be made at a later stage of the main proceedings. So long as those issues are undecided, however, it is completely unclear what subject matter the Defendants should address in their rejoinder by 8 July 2025. A clarification is therefore urgently required in several respects.

With their submissions on formal aspects that were intended to rectify the deficiencies of their formal requests, Claimants widely introduced new facts and arguments with regard to their alleged material claims. Furthermore, Claimants have filed four formal requests so far: the Statement of Claim, dated 14 May 2024; the first amendment dated 13 December 2024;

the second amendment dated 29 January 2025; and the third amendment dated 20 March 2025. Since Claimants argue that each of their amended formal requests had already been part of their previous formal requestsand therefore each of their later amendments had already been part of their original Statement of Claim, it is unclear which of Claimants' formal requests should actually be part of infringement proceedings.

Furthermore, it is currently unclear which of those requests will be accepted or dismissed. Nevertheless, Defendants only have the remaining rejoinder due on 8 July before closure of the written procedure. Defendants therefore find themselves in a position where they will be forced to comment on each and every one of Claimants formal submissions, out of precaution, regardless of whether or not they are admissible and/or effectively introduced into the main proceedings. This will lead to a reversal of the burden of proof to the detriment of the Defendants, who already suffer from the delaying tactics of the Claimants.

In detail:

Defendants find themselves in a conflict with regard to the distribution of the burden of proof. The burden of presentation and proof lies with the Claimants in relation to the assertion of their material claims. With regard to the rejoinder, R. 29(d) and (c) RoP, the Defendants are required to limit their rejoinder to the matters raised in Claimants reply to Defendants' Statement of defence. The rejoinder may only address new facts, arguments, and formal requests, if Claimants have effectively introduced their new facts, arguments and formal requests into the infringement proceedings.

In the present case, Defendants are obliged to address all of Claimants' formal requests, facts and arguments in their rejoinder, regardless of whether they are admissible and/or effectively admitted. Otherwise Defendants would risk to be precluded.

If, however, the LD Munich should come to the conclusion that Claimants have not yet effectively introduced their new facts and arguments into the proceedings Defendants will have effectively introduced those new facts and arguments into the main proceedings on behalf of Claimants, in order to avoid preclusion of Defendants' right to counter them. By that, the burden of proof will be turned upside down -- Defendants will have been compelled to contribute to the substantiation of Defendants' claims and will also be hindered from appealing therefrom.

It is particularly unclear to the Defendants whether or not they will have to comment on the possible amount of damages in the rejoinder without risk of preclusion from doing so at a later stage or in appeal. The Judge Rapporteur already announced that he does not intend to rule on the amount of (interim) damages in the current proceedings, but that this will be the subject of separate proceedings. However, since the Claimants have not yet withdrawn the respective formal requests from all respective submissions, the Defendants would be obliged to address the issue of the amount of damages already as a matter of precaution. 33 This is particularly relevant given that the Claimants did not effectively introduce their requests or new arguments for damages into the infringement proceedings, cf. supra. Defendants disagree with p. 57 of Procedural Order that interim damages can be estimated based on all information presented in the proceedings irrespective of the time of filing. R.

119 RoP does grant the court discretion. However, discretion does not mean that the principle of party disposition, the provisions on preclusion and the rules on front-loading may be undermined or rendered ineffective and it does not release Claimants from their obligation to submit facts at the earliest possible stage in the proceedings. Such comprehensive discretion would provide Claimants with an unfair advantage over Defendants. Since Claimants are precluded from submitting factual arguments on the possible amount of damages, these factual arguments cannot be the subject of a discretionary decision by the court.

As a further example for the dilemma, Defendants remind that they requested in their submission dated 12 February 2025 para 3 (also referred to in Defendants' submission dated 9 April 2025 para 3) regarding under A. II., cf. p. 22 of Procedural Order:

the dismissal and disregard of the facts, evidence, arguments and requests filed by Claimants in violation of R. 263 RoP in the Claimants' Statement of Claim dated May 14, 2024, the Claimants' Reply to the Statement of Defence dated November 1, 2024, and the Claimants' Comments dated January 29, 2025.

In this formal request, Defendants did not explicitly refer to Claimants' last submission dated 20March 2025, as Claimants had unequivocally stated that those amendments had already been included in their previous submissions. Since the Judge Rapporteur has now announced that he intends to interpret Claimants' requests 'generously,' Defendants clarify that, according to Claimants' own statement, Claimants' latest requests are covered by their previous requests.

Hence, the responsive request of Defendants (cited in previous paragraph) also covers and responds to Claimants' most recent requests of 20 March 2025.

As regards standing to sue, this is now being handled within the Preliminary Objection (see p. 57 of the order of May 8) although Defendants addressed that issue in their original Statement of Defence and not in their Preliminary Objection. In their Preliminary Objection dated 2 July 2024, Defendants only addressed standing to sue with regard to the inadmissability of references submitted in the wrong language by Claimants, to support their alleged standing to sue. Claimants' lack of the right to sue under Art. 47 UPCA was attacked in the Statement of Defence dated 2 September 2024. Defendants therefore had not yet had any chance to reply to Claimants' late and false arguments brought forward in their reply dated 1 November 2025. Based on the order dated 7 January 2025, the oral hearing of 15 January 2024 only dealt with the Preliminary Objection, as did the subsequent submissions by the parties.

Hence, it is improper for the Judge Rapporteur to dismiss Defendants' arguments as not convincing without waiting for and considering Defendants' rejoinder. Insofar as Defendants of parallel cases should have addressed standing to sue in their Preliminary Objection, this does not have effect for the present proceedings against the present Defendants.

Furthermore, Defendants do not have access to nor knowledge of the court file of those parallel cases.

Item D:

In any case, a leave to appeal is necessary particularly because of the obvious discrepancies between the LD Munich's case management, on the one hand and, on the other hand, the Regulatory framework of the RoP and UPCA with regard to the front-loaded proceeding, the order of submissions in the written proceedings, the unambiguous requirements for amendments of formal requests and for introducing new facts, arguments into the proceedings and the principles of fair trial and right to be heard.

These discrepancies must be resolved and require clarification by the Court of Appeal.

Therefore, in the further alternative, Defendants kindly request that the panel of the LD Munich grant a leave to appeal (R.220 RoP)

Sanofi argues:

Sanofi agrees with all items 1 to 9 in the Order of 8 May 2025, and notably with item 4 concerning the lodging by Sanofi of the Rejoinder to the Reply provided under Rule 29(e) RoP, and with item 5 concerning the closure of the written procedure on 8 August 2025 after such Rejoinder to the Reply will have been lodged.

Sanofi does not even understand Zentiva's comments in this respect, and notably their request for a dual closure of the written procedure on two separate dates.

More generally, Sanofi does not understand either the content and objective of Zentiva's present and isolated application. What Sanofi understands is that:

Zentiva has been free riding on Sanofi's rights for years, probably expecting a revocation of the patent in suit by the Technical Board of Appeal which instead upheld the validity of EP 466 as granted by decision of 3 June 2025, notwithstanding a dozen of opponents and more than a hundred prior art documents, all irrelevant;
Zentiva has been obviously desperate to make this case look complicated, alleging meritless arguments after meritless arguments, notably focusing on footnotes in the Statement of claim, in order to avoid discussing the merits of the case;
Zentiva has already gone as far as voluntarily breaching the fundamental and underlying principle of confidentiality of correspondence between lawyers, (i) by sending a "Confidential & Without Prejudice" (emphasis not added) email to Sanofi's UPC Representative (a lawyer) on costs on 19 February 2025, (ii) in the obvious scheme to use this email a few weeks later in order to create Zentiva's exhibit No. TW D 10 intending to disparage Sanofi, Sanofi's lawyer, and Sanofi's strategic decisions: […].

This is -to say the least -a totally unacceptable behaviour from Zentiva's lawyers, which should not be tolerated by the Court. This is the second time (after medac's UPC representative in the STADA case) that Sanofi's rights to confidentiality of its correspondences are blatantly breached, and Sanofi obviously reserves all its rights to seek relevant sanctions against such disloyal and undignified behaviour.

Sanofi will nevertheless provide the following comments:

In the Statement of claim, Sanofi provided detailed explanation at e.g. paragraph (7) concerning the standing to sue of each Claimant, along with the related license agreements as Exhibits B.1.1, B.1.1.1, and B.1.1.2, in the English language.
In the Statement of claim, Sanofi listed its "requests" under "Section III. The requests from the Claimants" as from page 21, in compliance with the RoPs. These "requests" included notably (i) a request for a "permanent injunction" at paragraph (49) which was formalised as the second request under paragraph (59), (ii) a request for a declaration of infringement (not limited to direct infringement) by Zentiva at paragraph (55) which was formalised as the first request under paragraph (59), (iii) a request for the payment of damages "subject to further assessment" (i.e. a request for the payment of interim damages) at paragraph (50) which was formalised as the third request under paragraph (59), (iv) a request for the recall of the infringing products at paragraph (55) which was formalised as the fifth request under paragraph (59), (v) a request for the right of information at paragraph (56) which was formalised as the sixth request under paragraph (59), (vi) a request for legal costs at paragraph (57) which was formalised as the seventh request under paragraph (59), and (vii) a request for enforceability of these requests notwithstanding any appeal at paragraph (58) which was formalised as the eighth request under paragraph (59).

In this respect, although (i) there are no legal provisions making mandatory a specific wording for these "requests", (ii) the case law already confirms that acts of infringement committed in one country could trigger corrective measures for other countries, and (iii) a request for amending the case is not even necessary in the present case, Sanofi nevertheless obviously elected notably (i) to comply with the Court's order to draft the "requests" according to the template for decisions, and (ii) to streamline the debates by limiting to some extent its requests on a country per country, claimant per claimant, and defendant per defendant basis(though Sanofi considers that all Claimants had interest in seeking e.g. a permanent injunction for all countries against all defendants; indeed, it is not challengeable that the defendants (three entities from the same group) are perfectly capable of circumventing an injunction limited to e.g. Zentiva France and France, by relying on Zentiva k.s. to resume marketing in France once Zentiva France would be prohibited from continuing marketing the infringing products in France).

GROUNDS FOR THE ORDER

Item 3 of the order dated 8 May 2025 is to be understood as granting Zentiva the right to file a brief in accordance with Rule 29(d) of the Rules of Procedure (RoP).

Similarly, item 4 of the same order is to be understood as providing Sanofi with the possibility of filing a brief according to Rule 29(e) of the RoP. There is a typo in the order, possibly caused by a Microsoft Word feature.

These two items are not intended to increase the scope of these briefs.

Rule 35 of the Rules of Procedure (RoP) only provides for one date on which the written procedure will be closed. Therefore, Item 5 mentions 8 August 2025, the date on which the brief according to Item 4 is due.

The dilemma to which Zentiva refers has been considered in the order dated 8 May 2025. As it is primarily related to the calculation of damages, the panel supports the judgerapporteur's decision that the defendants could accept it, since the final calculation of damages will be referred to separate proceedings. To prepare an estimation of a possible interim award of damages, the current situation can be tolerated. Any unnecessary efforts can be considered in the cost decision.

In the next brief, Zentiva will have an opportunity to respond to any points raised by Sanofi in its reply to the defence regarding standing to sue. Therefore, there is no need to comment further on the concerns that have been voiced.

The panel sees no reason to grant leave to appeal, since Zentiva's defence arguments are not being rejected, but will be addressed later.

ORDER

The judge-rapporteur`s decision of 8 May 2025 (ORD_10069/2025) regarding the management of the subsequent proceedings is confirmed under the condition that the typo in item 4 of the order is corrected to ' Rule 29(e) of the Rules of Procedure '. Zentiva's requests are dismissed.

Done in Munich on 27 June 2025

DETAILS OF THE ORDER

Order no. ORD_26472/2025 in ACTION NUMBER: ACT_16120/2024

UPC number: UPC_CFI_148/2024

Action type:

Infringement Action

Related proceeding no. Application No.:

24524/2025

Application Type:

APPLICATION_ROP_333