Procedural Order
of the Court of First Instance of the Unified Patent Court
Local Division Munich
issued on 26 March 2025
CLAIMANTS – UPC_CFI 146/2024
1) Sanofi Mature IP
2) Sanofi Winthrop Industrie
3) Sanofi-Aventis France
4) Sanofi-Aventis GmbH
5) Sanofi Belgium
6) Sanofi-Aventis Deutschland GmbH
7) Sanofi S.r.l.
8) Sanofi B.V.
9) Sanofi - Produtos Farmaceuticos Lda
10) Sanofi AB
11) Sanofi A/S
represented by: Frédéric Chevallier (Herbert Smith Freehills).
DEFENDANTS – UPC_CFI_146/2024
1) STADAPHARM GmbH
2) STADA Arzneimittel AG
3) STADA Nordic ApS
represented by: Daniel Hoppe (Preu Bohlig).
Local Division Munich
UPC_CFI_146/2024
UPC_CFI_146/2024
2
APPLICANT – UPC_CFI_146/2024
Medac Gesellschaft für klinische Spezialpräparate m.b.H.
represented by: Alexander Eisenführ (Uexkull + Stolberg)
PATENT AT ISSUE
European patent n° 2 493 466
PANEL/DIVISION
Panel 1 of the Local Division Munich
DECIDING JUDGE/S
The order was made by the 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
Application RoP262.1(b) - App_34720/2024
Application for leave to withdraw an action (RoP265) dated 21 October 2024 -
App_11680/2025
PROCEDURAL HISTORY
By brief dated 26 June 2024, Medac filed a RoP262.1(b) application. A letter from Sanofi to
Medac dated 3 June 2024 was uploaded in unredacted form as "Exhibit 2". No applications
under Rule 262.2 or 262A RoP had been made by Medac. The letter had originally been sent
by e-mail marked "privileged and confidential":
UPC_CFI_146/2024
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Sanofi objected to the granting of access to file and argued that Exhibit 2 should not have
been uploaded at all.
By briefs dated 21 October 2024 (App_34720/2024) and 10 March 2025 (App_11680/2025),
Medac withdrew the RoP262.1(b) application.
REQUESTS BY THE PARTIES
Medac requests:
- the request under Rule 262.1(b) RoP is hereby withdrawn
- withdraws from the proceedings Applicant`s “Exhibit 2” as being privileged and confidential
as requested by Sanofi
- does not order any measures against Applicant`s representative in request for access
APP_34702/2024, and
- does not issue an order as to costs with regard to the withdrawn request for access
APP_34720/2024.
Sanofi requests:
- withdraw from the proceedings the Applicant's "Exhibit 2" as being privileged and
confidential, and enjoin the Applicant, the Defendants in the main action and their respective
representatives from ever invoking, relying on or submitting such document in any
circumstances, under penalty of €10,000,000 per reference to such document;
- order any measures it deems relevant against the Applicant's representative;
- in any case, acknowledge the Applicant's withdrawal of the present request dismiss the
Applicant's request for access as being unfounded and meritless;
In the alternative:
- Only allow access to the Statement of claim with the redaction detailed above by Sanofi,
and to the Exhibits except Exhibits Nos. B.1.1, B.1.1.1, B.1.1.2, D.2, and D.2.1;
in any case:
- the Applicant has to bear the costs of the application;
- grant leave to appeal to Sanofi if any of its requests were dismissed.
GROUNDS
1. Medac and Sanofi requested that Exhibit 2 be withdrawn, arguing that it should not
have been submitted in the first place due to its privileged and confidential nature. The
application to withdraw the Rule 262.1(b) application and exhibit 2 must be granted, as no
party to the proceedings has raised any concerns. The withdrawal of Exhibit 2 can be based on
Rule 262A.1 RoP. Paragraph 1 provides that a party may apply to the Court for an order
prohibiting the use of evidence in the proceedings.
2. In order to ensure that neither Medac nor Stada makes use of Exhibit 2 or discloses it
to third parties, a periodic penalty payment must be ordered (Rule 354.3 RoP). The amount
will be determined in the event of a culpable breach of the court order.
UPC_CFI_146/2024
4
3. The CMS does not provide a tool for users to withdraw uploaded files. Therefore, a
ticket must be opened with the current CMS service provider. The current CMS service
provider charges an additional fee for tickets that are not related to a malfunction of the CMS,
as is the case here. According to Art. 69(3) UPCA, a party should bear any unnecessary costs it
has caused the court or another party. In this case, Medac is causing unnecessary costs to the
court by requiring an exhibit previously uploaded to the CMS by Medac to be deleted. To
ensure that these costs are reimbursed, the opening of a ticket is subject to a prior deposit.
The deposit may also be paid by another party.
4. With regard to Sanofi's requests for a decision on costs, reference is made to the order
of the Central Division Paris Seat, of 8 January 2025 (APP_56782/2024 UPC_CFI_189/2024).
Consequently, an application under Rule 262(1)(b) of the Rules of Procedure or its withdrawal
does not justify an award of costs.
5. As regards Sanofi's request that the Court orders such measures as it considers
appropriate against Medac's representative, the Court expresses its disapproval of the
negligent conduct of Medac's representative and issues a warning:
a. Sanofi submits that, by communicating to the Court and to STADA Exhibit 2, which is a
privileged and confidential document, Medac's representative breached his duties to the Court
under Rule 290.2 of the Rules of Procedure and Rule 2.1 of the Code of Conduct for
Representatives. Sanofi also considers that Medac's conduct violated German civil and criminal
law and French criminal law.
b. Medac's representative and Medac responded as follows
“It is believed that the accusations against the applicant and its representative raised in the
claimant’s submission dated 25 July 2024 are unfounded. At the time of filing the subject
request, neither the applicant nor its representative had any reasons to assume that the
document submitted as Exhibit 2 would have to be treated as confidential. Moreover, the
subject request has meanwhile become moot because the claimant’s statement of claim in
parallel proceedings against Accord (ACT_16112/2024 UPC_CFI_145/2024) has become public
as part of the EPO’s public file for EP 2 493 466, thereby providing the applicant with the
information which it sought to obtain through the present request. On this background, the
request under Rule 262.1(b) RoP is hereby withdrawn. It is believed that there is no need for
an order for costs.”
c. The Court finds that Sanofi has sufficiently demonstrated that Exhibit 2 has always been
privileged and confidential and that Medac and Medac's representative have always been
aware of the privileged and confidential nature of Exhibit 2. As regards any civil or criminal
consequences, the Court considers that these should be dealt with by Sanofi as the injured
party. As regards the UPC's Code of Conduct for Representatives, the Court finds that Medac's
representative culpably breached the Code of Conduct in that Exhibit 2 should not have been
uploaded at all, or at least not in an unredacted version, and thus made available to Stada,
without an application pursuant to Rules 262.2 or 262A RoP. As the proceedings regarding the
RoP 262.1(b) application have been concluded, an exclusion from the proceedings pursuant to
UPC_CFI_146/2024
5
Rule 291.1. RoP would be pointless. However, the court expresses its disapproval of the
negligent conduct of Medac's representative and issues a warning.
ORDER
1. The withdrawal of the RoP262.1(b)-application is permitted.
2. The proceedings on the RoP262.1(b)-application are closed.
3. This decision shall be entered on the Register.
4. Medac's "Exhibit 2" filed on 26 June 2024 in App_34720/2024 UPC_CFI_146/2024 is
withdrawn from the proceedings.
5. Exhibit 2 shall, as far as possible, be removed from the CMS and replaced by this order.
6. Medac shall pay the costs incurred by the Court in this connection.
7. The execution of paragraph 5 is subject to a prior deposit of costs of EUR 600,00.
8. Medac and Stada and their UPC representatives shall not use Annex 2 or disclose it to third
parties, subject to payment of a recurring penalty to the Court.
9. All further requests are rejected.
10. Leave to appeal is granted.
INFORMATION ABOUT APPEAL IN CASE OF AN ORDER FALLING UNDER ART. 73(2)(B) UPCA:
The present order may either - be the subject of an appeal by any party which has been
unsuccessful, in whole or in part, in its submissions together with the appeal against the final
decision of the Court of First Instance in the main proceedings, or - be appealed by any party
which has been unsuccessful, in whole or in part, in its submissions at the Court of Appeal
with the leave of the Court of First Instance within 15 days of service of the Court of First
Instance’s decision to that effect (Art. 73(2)(b) UPCA, R. 220.2, 224.1(b) RoP)
INSTRUCTIONS TO THE PARTIES
The deposit is to be transferred to a bank account of the UPC. The details of which will be
communicated by the Sub-Registry on request.
INSTRUCTIONS TO THE REGISTRY
After the deposit has been received a ticket with the CMS service provided shall be opened to
deleted exhibit 2 from the CMS and to replaced it by this order.
DETAILS OF THE ORDER
Order no. ORD_13509/2025 in ACTION NUMBER: ACT_16116/2024
UPC number: UPC_CFI_146/2024
Action type: Infringement Action
Related proceeding no. Application No.: 11680/2025
Application Type: Application for leave to withdraw an action (RoP265)
Order no. ORD_41504/2024 in ACTION NUMBER: ACT_16116/2024
UPC number: UPC_CFI_146/2024
UPC_CFI_146/2024
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Action type: Infringement Action
Related proceeding no. Application No.: 34720/2024
Application Type: APPLICATION_ROP262_1_b
Dr. Zigann
Presiding Judge
Zana
Legally Qualified Judge
Pichlmaier
Legally Qualified Judge
Wagner
Technically Qualified Judge
Matthias
ZIGANN
Digital unterschrieben
von Matthias ZIGANN
Datum: 2025.03.26
16:47:50 +01'00'
Digital signiert von Carola
Wagner
DN: cn=Carola Wagner, c=DE
Datum: 2025.03.28 10:25:20
+01'00'
Carola
Wagner
Alima ZANA
Firmato digitalmente
da Alima ZANA
Data: 2025.03.28
16:27:34 +01'00'
Tobias Günther
Pichlmaier
Digital unterschrieben von
Tobias Günther Pichlmaier
Datum: 2025.03.30 10:24:59
+02'00'