Local Division Munich
UPC_CFI_14/2023

Headnotes:
Unanimous requests by all parties directed to a Local or Regional Division to refer a counterclaim
for revocation to the Central Division for decision will be granted unless strong
counterarguments require a different decision.

Keywords:
Article 33(3) UPCA; Rule 37 RoP; agreement of parties; discretion to refer counterclaim for
revocation to central division; discretion to proceed with infringement proceedings; discretion to
stay infringement proceedings.
UPC_CFI_14/2023

Order
in the proceedings before the
Court of First Instance of the Unified Patent Court
relating to European Patent 3 666 797
delivered on 02/02/2024

Date of receipt of Statement of claim : 01/06/2023

CLAIMANT
1) Amgen Inc.
One Amgen Center Drive, Mail-Stop 28-2-C -
91320-1799 - Thousand Oaks - US
Represented by
Johannes Heselberger

DEFENDANTS
1) Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, Brüningstraße 50 -
65926 - Frankfurt am Main - DE
Represented by
Niels Hölder
2) Sanofi-Aventis Groupe S.A.
54 rue La Boétie - 75008 - Paris - FR
Represented by
Niels Hölder
3) Sanofi Winthrop Industrie S.A.
82 avenue Raspail - 94250 - Gentilly - FR
Represented by
Niels Hölder
4) Regeneron Pharmaceuticals Inc.
81 Columbia Turnpike - 12144 - Rensselaer -
US
Represented by
Niels Hölder
UPC_CFI_14/2023

PATENT AT ISSUE
Patent no. Proprietor
EP3666797 Amgen Inc.

DECIDING JUDGES
COMPOSITION OF PANEL – FULL PANEL
Presiding judge and
Judge-rapporteur Matthias Zigann
Legally qualified judge Tobias Pichlmaier
Legally qualified judge Samuel Granata
Technically qualified judge Xavier Dorland-Galliot
This order has been issued by the full panel.

LANGUAGE OF PROCEEDINGS: English

SUBJECT-MATTER OF THE PROCEEDINGS
Patent infringement and counterclaim for revocation.
here: decision according to Rule 37 RoP.
SUMMARY OF FACTS
The Claimant alleges infringement of European Patent 3 666 797 by the defendants` drug
Praluent (Alirocumab).
Defendants 1-3 have filed oppositions with the European Patent Office and a stand-alone nullity
action with the Central Division (ACT_459505/2023 UPC_CFI_1/2023). The Claimant`s
preliminary objections in this respect were unsuccessful. The oral hearing is scheduled for
04/06/2024. The Central Division has decided not to hold an interim conference.
Defendant 4 has filed a counterclaim for revocation with the Local Division Munich
(CC_586764/2023).
The Local Division Munich has set the following dates:
Interim Conference by video conference: 01/07/2024
Main oral hearing in person: 16/10/2024
Main oral hearing in person (additional day): 17/10/2024
UPC_CFI_14/2023

The Panel has informed the parties that it intends to take an early decision under Rule 37.2 of the
Rules of Procedure on how to proceed with the counterclaim. The parties were invited to submit
observations. The Claimant and all four defendants agree that the counterclaim for revocation
should be referred to the Central Division. However, the parties disagree on how to proceed with
the infringement action.
Claimant requests that the infringement proceedings be continued.
Defendants request that the infringement proceedings be stayed pending a final decision in the
revocation action.
Defendants also request a stay for other reasons not directly related to the revocation action.

GROUNDS
I. Pursuant to Rule 37.1 of the Rules of Procedure, the panel shall, as soon as practicable after the
conclusion of the written procedure, decide by way of order how to proceed with respect to the
application of Article 33(3) of the Agreement. The parties shall be given an opportunity to be
heard [Rule 264]. In its order, the panel shall briefly state the reasons for its decision. Under Rule
37.2 of the Rules of Procedure, the panel may, if appropriate, by order give an earlier decision
after considering the parties' written submissions and after giving the parties an opportunity to
be heard [Rule 264].
According to Art. 33(3) UPCA, the local or regional division concerned may, after hearing the
parties, either
(a) proceed with both the action for infringement and the counterclaim for revocation and
request the President of the Court of First Instance to designate from the pool of judges referred
in Article 18(3) a technically qualified judge with qualifications and experience in the field of
technology concerned; or
(b) refer the counterclaim for revocation to the central division for decision and stay or proceed
with the action for infringement; or
(c) with the agreement of the parties, refer the case to the Central Division for decision.
II. In the exercise of its discretion, this Panel refers the counterclaim of Defendant Regeneron
(CC_586764/2023) to the Central Division for decision.
While it is true that there are usually advantages in having the infringement action and the
counterclaim for revocation heard together by the same panel, the circumstances of this case
require a different decision.
1. All parties requested that the counterclaim be referred to the Central Division. Unanimous
requests by all parties will be granted unless strong counterarguments require a different
decision.
2. This Panel cannot find a single strong counterargument. Indeed, this panel considers that, in
the circumstances of this case, a referral of the counterclaim to the Central Division is the most
practical solution to avoid inconsistent decisions and duplication of work on validity. In view of
the date of the oral hearing scheduled by the Central Division, an early decision by this panel is
UPC_CFI_14/2023 necessary.
III. In the exercise of its discretion, the Panel decides to proceed with the infringement
proceeding, but reserves the right to consider the possibility of suspending the infringement
proceeding pursuant to Art. 33.3.c UPCA or to suspend the proceedings for any other reason put
forward by the Defendants.
1. Where the panel decides to proceed under Article 33(3)(b) of the Agreement, the panel may
stay the infringement proceedings under Rule 37.4 RoP pending a final decision in the revocation
proceedings and shall stay the infringement proceedings if there is a strong likelihood that the
final decision in the revocation proceedings will invalidate the relevant claims of the patent for
any reason.
2. According to the timetable set by both the Central Division and the Local Division Munich, it is
expected that a first instance decision of the UPC on validity will be available before the summer
break. This decision can then be taken into account by this panel when considering the possibility
of suspending the infringement proceedings pursuant to Art. 33.3.c UPC and Rule 37.4 RoP.
Therefore, there is no need for this panel to consider now whether the defendants have
demonstrated a strong likelihood that the relevant claims of the patent will be held invalid on
any ground by the final decision in the revocation proceedings.
3. The date for the interim conference, currently scheduled for 01/07/2024, may be postponed
to allow the Central Division the full six weeks to issue the written decision on validity. The
Interim Conference may then be held with knowledge of the outcome and the written reasons.
4. The dates for the main oral hearing in the infringement action, currently 16/10/2024 and
17/10/2024, may be maintained for the time being.
5. If defendants 1-3 had wished to have the Local Division Munich decide exclusively on the
validity arguments, they could have filed counterclaims for revocation pursuant to Rule 75 of the
Rules of Procedure together with their Statement of Defence, in addition to the independent
revocation actions already filed. If they had done so, the Local Division Munich would have been
able to decide on all four counterclaims. The Central Division would have been obliged to stay
the proceedings on the individual revocation actions pursuant to Rule 75(3) of the Rules of
Procedure.
IV. In the exercise of its discretion, the Panel decides to proceed with the infringement
proceeding, but reserves the right to reconsider the possibility of suspending the proceeding for
any other reason put forward by the Defendants.
1. Under the Rules of Procedure, the panel has ample power to stay proceedings. The defendants
have put forward many reasons, not directly related to the invalidity arguments, why this Panel
should stay the infringement proceedings.
2. This Panel considers that the main question to be answered first is whether the patent is valid.
If the patent was invalid, there would be no reason to consider the other issues. Therefore, it is
UPC_CFI_14/2023 efficient to proceed with the infringement proceedings for the time being and to consider these other issues at a later stage.

ORDER
1) The Local Division Munich refers the counterclaim of the Defendant Regeneron
Pharmaceuticals Inc. (CC_586764/2023) to the Central Division for decision and proceeds with
the infringement action (Art. 33.3.b UPCA).
2) The Local Division Munich reserves the right to reconsider the possibility of suspending the
infringement action pursuant to Art. 33.3.c UPCA or to stay the proceedings for any other reason
put forward by the Defendants.

INSTRUCTIONS TO THE JUDGE-RAPPORTEUR
(1) The judge-rapporteur shall communicate to the Central Division the dates fixed for the in-
terim conference and the oral hearing pursuant to Rule 28 RoP (Rule 37.5).
(2) The judge-rapporteur may, after hearing the parties, consider postponing the interim confer-
ence.

DR. ZIGANN
PRESIDING JUDGE AND JUDGE-RAPPORTEUR
PICHLMAIER
LEGALLY QUALIFIED JUDGE
GRANATA
LEGALLY QUALIFIED JUDGE
DORLAND-GALLIOT
TECHNICALLY QUALIFIED JUDGE

INFORMATION FOR THE PARTIES AND THE REGISTRY
1) The Registry is requested to execute the referral of the counterclaim of Regeneron
Pharmaceuticals Inc. (CC_586764/2023) to the Central Division.
2) The next step in the infringement proceedings will be the filing of the Rejoinder to the Reply to
the Defence (Rule 29.d RoP), due on 25/03/2024.
Matthias

ZIGANN
Digital unterschrieben von
Matthias ZIGANN
Datum: 2024.02.02 16:17:57
+01'00'
Tobias Günther
Pichlmaier
Digital unterschrieben von
Tobias Günther Pichlmaier
Datum: 2024.02.03
14:54:58 +01'00'
Samuel Rocco
M Granata
Digitally signed by Samuel
Rocco M Granata
Date: 2024.02.03 15:23:34
+01'00'
XAVIER THOMAS
OLIVIER DORLAND
Signature numérique de XAVIER
THOMAS OLIVIER DORLAND
Date : 2024.02.05 06:49:03
+01'00'
UPC_CFI_14/2023

INFORMATION ABOUT APPEAL
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 (!rt. 73(2)(b) UPCA, R. 220.2, 224.1(b) RoP).

ORDER DETAILS
UPC number: UPC_CFI_14/2023
Action number: ACT_459916/2023
Counterclaim number: CC_586764/2023
Order number: ORD_392/2024
Order type: R 37