Local Division Munich
UPC_CFI_145/2024 - UPC_CFI_463/2024
UPC_CFI_146/2024 - UPC_CFI_496/2024
UPC_CFI_147/2024 - UPC_CFI_374/2024
UPC_CFI_148/2024 - UPC_CFI_503/2024
UPC_CFI_145/2024 - UPC_CFI_463/2024
UPC_CFI_146/2024 - UPC_CFI_496/2024
UPC_CFI_147/2024 - UPC_CFI_374/2024
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 15 September 2025

CLAIMANTS
1) Sanofi SA as successor of Sanofi Mature IP
2) Sanofi Winthrop Industrie
3) Sanofi Winthrop Industrie as successor of Sanofi-Aventis France
(not a party in UPC_CFI 145/2024)
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 (McDermott Will & Emery).

DEFENDANTS – UPC_CFI_145/2024 - UPC_CFI_463/2024
1) Accord Healthcare S.L.U.
2) Accord Healthcare GmbH (AT)
3) Accord Healthcare BV
4) Accord Healthcare GmbH (DE)
5) Accord Healthcare Italia Srl
6) Accord Healthcare B.V.
7) Accord Healthcare, Unipessoal Lda.
8) Accord Healthcare AB
represented by: Jules Fabre (Taylor Wessing)

DEFENDANTS – UPC_CFI_146/2024 - UPC_CFI_496/2024
1) STADAPHARM GmbH 2) STADA Arzneimittel AG 3) STADA Nordic ApS
represented by: Daniel Hoppe (Bonabry).

DEFENDANTS – UPC_CFI_147/2024 - UPC_CFI_374/2024
1) Reddy Pharma SAS
2) betapharm Arzneimittel GmbH
3) Dr Reddy's Srl
represented by: Dr. Christian Meyer (Maiwald).

DEFENDANTS – UPC_CFI_148/2024 - UPC_CFI_503/2024
1) Zentiva France
2) Zentiva Pharma GmbH
3) Zentiva, k.s.
represented by: Dr. Anja Lunze (Taylor Wessing).

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.

LANGUAGE OF THE PROCEEDINGS
English

SUBJECT-MATTER OF THE PROCEEDINGS
R.105.5 RoP following the second interim conference of 12 September 2025.

POINTS RAISED DURING THE SECOND INTERIM CONFERENCE
1) EPO BoA
The EPO BoA has not yet uploaded the written reasoned decision following the oral hearing
on 2–4 June 2025, at which the patent was upheld. The BoA has communicated the
following possible upload dates: 15 September 2025 or the end of September.
Parties may comment on the written reasons provided by the EPO BoA by 8 October 2025 at
the latest. This deadline is independent of the date on which the written reasons are served
to the parties. If service occurs after 8 October 2025, parties may comment on it during the
oral hearing.
2) Frech First Instance Nullity Decision
Sanofi explains that the French first-instance decisions that invalidated the French part of
the European patent are under appeal. The appeal court has scheduled an oral hearing for
18 June 2026.
3) Expert Testimony
Expert testimony from two party experts. JR confirms that they will be heard as requested
by Sanofi and the four defendants. This will be based on their written submissions, as
follows:
Dr Exhibit B26 (Sanofi).
Dr Exhibits PM 5.1 and 5.2 (Accord); D54 and PBP1 (Stada); DFMP D116
(Zentiva); and MWCC 22 (Reddy).
The experts may use written notes and shall answer the main question:
'What information would a person working in the industry at the priority date have derived
from the Phase III TROPIC study and the time that has passed since it started? Was there a
reasonable expectation of success?'
broken down into the following more detailed questions:
a) What are the respective aims of oncological clinical trials of phase I, II and III? Is
there a difference to clinical trials with non-oncological drugs?
b) What circumstantial data is needed to support an oncological phase III trial getting
started?

c) Can a phase II study be omitted? If so, what data would support a phase I/III
transition?
d) Clinical phase III trials are evaluated by the Data Safety Monitoring Board (DSMB).
What is the role of DSMB during the study? When will the DSMB intervene?
e) Is a phase III trial discontinued or not authorized by the EMA if the investigated drug
is not superior in efficacy to the comparator?
f) What is the success rate in oncological phase III trials in general?
g) What is the success rate in oncological phase III trials with the comparator
mitoxantrone/prednisone?
h) In the present case the TROPIC trial is not supported by a phase II trial with the same
patient group. Is this uncommon in the field of oncology, respectively in the field of
taxanes?
i) What kind of indicative data was needed to support the start of the phase III study
TROPIC?
j) Did the skilled person have reason to expect the TROPIC study to be successful, given
that the skilled person knew the study had been approved and had been ongoing for three
years without premature interruption?
During the interim conference, the defendants expressed concerns about these questions,
stating that legal questions should not be answered by experts.
The panel is aware of the distinction between legal and factual questions. Hearing the two
experts will enable the panel to answer the legal question of obviousness. Subject to R.
178.5 RoP, parties may put their own questions to the experts after the panel.
4) Dr. (Sanofi)
Sanofi has deposited an amount for the fees. An additional amount for travel costs will be
paid by Sanofi directly. If successful, Sanofi will ask the defendants for reimbursement. Dr
will be invited via email.
5) Dr. (Accord, Reddy, Stada, Zentiva)
Dr will waive his entitlement to costs and fees against the court and will instead
be reimbursed directly by Accord. The other defendants will reimburse Accord in proportion
to their respective shares. If successful, the defendants will ask Sanofi for reimbursement.
Dr will be invited by email.

6) Schedule, structure, format and scope for oral hearing 14-17 October 2025;
coordination of the defendant`s oral submissions
The following schedule will be followed for the oral hearing:
Tuesday, 14 October 2025
9.00-10.00 Introduction by the Presiding Judge
10.00-10.30 Break
10.30-11.30 Oral submissions by defendants on validity
(lack of inventive step – Tropic Study)
11.30-11.45 Break
11.45-12.45 Oral submissions by claimant on validity
(lack of inventive step – Tropic Study)
12.45-14.00 Break
14.00-16.00 Questions by the panel to the two experts
16.00-16.30 Break
16.30-18.30 Questions by the parties to the two experts and pleadings by the parties
(lack of inventive step – Tropic Study – after having heard the two experts)
Wednesday, 15 October 2025
10.00-10.15 A panel announcement regarding whether the proceedings will continue or
end.
10.15-11.15 Oral submission by defendants on validity (rest) – and/or possible additional
hearing of experts
11.15-12.15 Oral submission by claimant on validity (rest) - and/or possible additional
hearing of experts
12.15-13.30 Break
13.30-14.30 Morning session continued
14.30-15.00 Break
15.00-17.00 Infringement Stada
Thursday, 16 October 2025
9.00-10.30 Infringement Accord
10.30-11.00 Break
11.00-12.30 Infringement Zentiva
12.30-14.00 Break
14.00-15.30 Infringement Reddy
Friday, 17 October 2025
[Possible continuation of the oral hearing]
This schedule may be subject to amendment.

The four counterclaims will be heard together. The four infringement actions, however, will
be heard separately.
UPC representatives for the defendants are encouraged to coordinate their oral submissions
for the joint counterclaim hearings.
7) Seating plan for oral hearing; additional VC possible
A seating plan for Hearing Room 212 has been emailed to the relevant parties. This plan
only applies to joint hearings. Spare chairs are reserved for members of the public.
Additional participants from the parties are invited to follow the hearing in either overflow
room 220b or one of the breakout rooms via the parallel video conference. The draft plan
communicated earlier has been amended to accommodate comments made by the parties
during the second interim conference. There will be a parallel video conference.
8) Sanofi v. Zentiva
Zentiva requests that the following documents be admitted into the proceedings:
- DFMP D116 (Dr declaration); and
- DFMP D117 (Prof second affidavit, dated 8 August 2025).
Sanofi requests that exhibit DFMP D117 be dismissed as inadmissible.
The rules that DFMP D117 was filed late and will be disregarded. However, DFMP D116
(Dr declaration), is admitted. Zentiva explained that the second submission by
Prof. had been prompted by the first interim conference. Therefore, an application
to file further evidence could have been made earlier.
9) Accord v. Sanofi
Accord expressed the need for clarification regarding the requests on which Sanofi intends
to rely. The other defendants agreed. Sanofi explained that the still-relevant requests had
been filed with the 20 March 2025 brief.
10) Value in dispute – agreement on lump sum reimbursement of costs?
JR confirms the values set out in the order of 22 January 2024.
Once again, the JR suggests that the parties conclude an agreement on a lump sum payment
for cost reimbursement prior to the date of the oral hearing.
11) Housekeeping
Parties are asked to submit a list of participating individuals (in person (212, 220b, breakout-room,
VC)) by email no later than 8 October 2025.

ORDER
1. The dates of the oral hearing are confirmed as 14–17 October 2025 at 09:00. The
oral hearing on Wednesday will start one hour later.
2. The four counterclaims will be heard together; each of the four infringement actions
will be heard separately.
3. All parties are summoned for all four days. As discussed at the interim conference,
the schedule may be amended. The oral hearing may end on Wednesday morning or
continue until Friday.
4. Parties are asked to submit a list of individuals participating in person (rooms 212
and 220b, breakout rooms, VC) by email no later than 8 October 2025.
5. Dr and Dr are invited to testify as party experts on 14 October 2025
at 2:00 pm and possibly on 15 October 2025 at 10:00 am, in person in Munich. Dr
will testify on behalf of Sanofi and Dr on behalf of all four defendants. The two
experts will be summoned by email.
6. The late submission of Dr declaration is permitted for Zentiva.
7. Zentiva's late submission of the second affidavit by Prof. dated 8 August
2025 (DFMP D117), is rejected. This exhibit will not be considered by the panel.
8. Parties may comment on the EPO BoA's written reasons in writing by no later than 8
October 2025.

INFORMATION ABOUT REVIEW BY THE PANEL
Any party may request that this Order be referred to the panel for a review pursuant to R.
333 RoP. Pending review, the Order shall be effective (R. 102.2 RoP).
INFORMATION ABOUT ORAL HEARING HELD IN COURT
The oral hearing shall be open to the public unless the Court decides to make it, to the
extent necessary, confidential in the interests of one or both parties or third parties or in the
general interest of justice or public order (R. 115 RoP).

INFORMATION ABOUT AUDIO RECORDING
The oral hearing shall be audio recorded. The recording shall be made available at the
premises of the Court to the parties or their representatives after the oral hearing (R. 115
RoP).

INFORMATION ABOUT ABSENCE OR DELAY OF A REPRESENTATIVE
A decision by default may be given, upon request, against a party that was duly summoned
but fails to appear at the oral hearing (R. 355.1 (b) RoP.

INFORMATION ABOUT DECISION BY DEFAULT
Should a party fail to comply with the present Order within the time period specified, a
decision by default may be given in accordance with R. 355 RoP (R. 103.1, last subparagraph
and .2 RoP).
Dr. Zigann
Presiding Judge
Matthias
ZIGANN
Digital unterschrieben
von Matthias ZIGANN
Datum: 2025.09.15
11:37:53 +02'00'

DETAILS OF THE ORDER
Order no. ORD_69479/2024 in ACTION NUMBER: ACT_16112/2024
UPC number: UPC_CFI_145/2024
Action type: Infringement Action
Order no. ORD_69480/2024 in ACTION NUMBER: ACT_16116/2024
UPC number: UPC_CFI_146/2024
Action type: Infringement Action
Order no. ORD_69481/2024 in ACTION NUMBER: ACT_16119/2024
UPC number: UPC_CFI_147/2024
Action type: Infringement Action
Order no. ORD_69482/2024 in ACTION NUMBER: ACT_16120/2024
UPC number: UPC_CFI_148/2024
Action type: Infringement Action