UPC_CFI_624 17 October 2025
UPC_CFI_624/2025
ACT_32414/2025
ORDER
of the Court of First Instance of the Unified Patent Court
Local Division in The Hague
issued on 17 October 2025
concerning EP4344633 (R.211 provisional measures)
APPLICANT
Abbott Diabetes Care Inc. Represented by: Christian Dekoninck
1360 South Loop Road –
CA 94502 - Alameda - US
DEFENDANTS
1) Sinocare Inc.
no. 265, Guyuan Road,
Hi-tech Zone - 410205 –
Changsha,
Hunan Province CN
Represented: by Tjibbe Douma
2) A.Menarini Diagnostics s.r.l.
Via Sette Santi 3
50131 - Firenze - IT
Represented by Edoardo Barbera
PATENT AT ISSUE
European patent with unitary effect EP4344633 (hereafter UP 633 or the patent)
PANEL
Panel of the local division in The Hague
DECIDING JUDGES
This order has been issued by presiding judge Edger Brinkman, judge-rapporteur Margot Kokke,
legally qualified judge Camille Lignieres and technically qualified judge Alain Dumont.
LANGUAGE OF PROCEEDINGS: English
UPC_CFI_624 17 October 2025
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I. BACKGROUND AND SUMMARY OF THE FACTS
The parties and the products
1. Applicant, Abbott Diabetes, hereafter Applicant or “Abbott”, develops and is a market leader
in solutions for continuous glucose monitoring ("CGM") systems for diabetes in Europe where
it claims to have a market share of 80%. In 2014 it launched the FreeStyle Libre CGM system,
with an easy-to-use and accurate CGM, which was factory calibrated, meaning the user did
not have to calibrate the device using finger-pricks. Abbott has continued to innovate the
FreeStyle Libre since, with the latest version named the FreeStyle Libre 3 Plus. All versions are
collectively referred to as FreeStyle Libre. The device comprises an applicator (i.e., an insertion
device), an on-body unit consisting of an analyte sensor (sensing for glucose) and sensor elec-
tronics as an integrated unit, and a display device (such as a reader or smartphone) with soft-
ware and functionality to facilitate the user's management of the glucose data. The applicator
and the corresponding on-body unit (“OBU”, including an analyte sensor and sensor electron-
ics) for several versions of the FreeStyle Libre are depicted below.
2. Defendant 1, “Sinocare”, manufactures and distributes CGM systems internationally. Sinocare
is a Chinese company that was established in 2002 and is headquartered in Changsha, China.
Sinocare is the largest manufacturer of CGMs in Asia. Sinocare manufactures, inter alia, the
GlucoMen iCan to which it refers as a 3rd generation CGM System. The on-body-unit and the
applicator are shown below:
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3. Defendant 2, hereafter “Menarini” and together with Sinocare; “Defendants”, is an Italian
company established in Florence, Italy and is part of the Menarini Pharmaceutical Group.
Menarini markets inter alia glucose self-testing systems for people with diabetes.
4. On 4 December 2024, Sinocare published a press release announcing an exclusive distribution
agreement with Menarini to register, promote, distribute, and market the new Sinocare 3rd
Generation CGM system within reimbursed markets in Europe. A similar press release was
issued by Menarini on 3 December 2024. This was described as a landmark agreement which
grants Menarini exclusive rights to introduce the CGM system in more than 20 countries in
Europe. Screenshots of the first part of the press releases on Defendant’s websites
(menarini.com and sinocare.com) are depicted below:
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5. On 3 December 2024 the GlucoMen iCan was registered as a medical device on the Eudamed
database, mentioning that the product pertained to the same device family as the so-called
Sinocare iCan i3, listing Sinocara as the manufacturer and indicating that the device will be
placed on the EU market in Italy.
6. At the latest on 24 April 2025, Menarini launched the GlucoMen iCan in certain territories in
Europe. On that date, the Glucomen user guide was released online on the dedicated website
glucomen-ican.com, on the home page of which the following picture is depicted:
UPC_CFI_624 17 October 2025
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In the user guide Sinocare is mentioned as the manufacturer of the product.
7. On 28 April 2025, a GlucoMen iCan was purchased via the Dutch website
www.diabetesmagazijn.nl of a supplier of medical equipment. A screenshot of the website
and a screenshot of the purchase are shown below.
UPC_CFI_624 17 October 2025
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8. The GlucoMen iCan is advertised on another Dutch website (bol.com). On Menarini’s website
www.manarinidiagnostics.com, affiliates in a number of countries are mentioned, including in
The Netherlands:
9. Abbott also successfully commissioned purchases of Glucomen iCan in Austria (on 24 April
2025) and in Italy (purchase on 30 April 2025).
The patent
10. Abbott is the sole proprietor of the patent-in-suit EP 4 344 633 B1 (hereinafter “the patent”
or “UP 633”). The patent was granted on 4 June 2025 for ‘Analyte Sensor Assemblies’ upon a
divisional application derived from an original application filed on 11 December 2012, invoking
priority of 11 December 2011. Unitary effect for the patent was registered.
11. The patent has fifteen claims. Independent claim 1 covers a sensor assembly. Product claims
2-14 depend on claim 1 and claim variations to the sensor assembly of claim 1. Product claim
15 relates to a kit and incorporates the sensor assembly of (in any case) claim 1. The claims
are discussed in more detail below at III.C.
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12. The patent contains among others the following figures:
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13. The description of the patent contains inter alia the following paragraphs:
BACKGROUND
(…)
0006] To realize fully the advantages associated with such systems, what is needed are applicator
systems configured to handle insertion, as well as packaging and user interface issues, that are
easy-to-use, reliable and minimize both user inconvenience and pain. The present invention
provides such solutions and additional or alternative advantages as described below and/or as may
be appreciated by those of skill in the art upon review of the subject disclosure.
SUMMARY
[0007] (…) The approaches variously involve the use of unique sensor and unique ancillary element
arrangements to facilitate assembly of separate on-body devices and sensor assembly units that
are kept apart until the user brings them together.
(…)
[0011] In accordance with embodiments of the invention, systems and methods are provided for
assembling and applying the on-body device including assembling the sensor assembly to the
electronics assembly and inserting a portion of the sensor under the skin of a user. Thus, the sensor
assembly includes the sensor that has a distal tail portion for operative contact with a fluid of the
user. The on-body device may also include an electronics assembly including a housing defining a
distal surface adapted for attachment to the skin of the user and a circuit coupleable to the sensor
for detecting electrical signals from the sensor. In some embodiments, the system also includes an
applicator assembly that has a sleeve defining a distal surface for placement on the skin of the
subject, a handle for a user interface, and various internal support, coupling, guide, grasping, stop
and detent features as well as driver elements. In some embodiments, the system may also include
a container that stores one or more of the sensor, the sharp, and/or the mount/electronics
assembly in a sealed environment within. The container is configured to releasably interface with
the applicator assembly for the purpose of loading one or more of the sensor, the sharp, and/or
the electronics assembly into the applicator assembly, and readying the applicator assembly for
use.
UPC_CFI_624 17 October 2025
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(…)
BRIEF DESCRIPTION OF THE DRAWINGS
[0013] (…)
FIGS. 33A-33G are plane, side, magnified, and sectional views of an additional sensor configuration;
FIGS. 34A-34D are perspective views illustrating combination electrical connector and sensor
isolator in yet another advantageous sensor arrangement;
(…)
FIG. 36 is a perspective assembly view illustrating a sensor connection approach related to that in
FIGS. 34A-34D for a sensor with contacts on a single side;
FIG. 37 is a perspective partial assembly view illustrating a mount-and-socket interface for the
sensor assembly employing the components in FIG. 36;
FIG. 38 is a complete assembly view of that illustrated in Fig 37;
(…)
FIG. 47A-47C are assembly and cross-sectional views of an on-body device including an integrated
connector for the sensor assembly;
(…)
DETAILED DESCRIPTION
(…)[0022] Next, once the user has chosen an application site, an on-body device application
operation (108) is performed. In the application operation (108), the user places the applicator on
the skin of the insertion site and then applies a force to install the on-body device. The applicator
is driven to insert the distal end of the sensor through the user's skin, adhere the on-body device
to the skin surface, and retract the sharp into the applicator for disposal. In some embodiments,
the user performs the application operation (108) by applying force to the applicator where the
force applied is a single, continuous pushing motion along the longitudinal axis of the applicator
that once started, causes the applicator to perform the application operation (108) such that the
applicator does not stop operation until completion. The applicator is configured to relay
action/audible cues to the user so that all three of the above listed actions happen automatically in
response to applying the force to the applicator causing it to trigger. Advantageously, an adhesive
of the on-body device does not contact the user until the application operation (108) is performed.
So, the even after the applicator has been placed on the skin, the applicator can be moved to a
different location up until the application operation (108) is performed without damage to the
apparatus or other system components. In a post application stage (110), use of the sensor for
monitoring the user's analyte level occurs during wear followed by appropriate disposal.
(…)
[0077] FIGS. 33A-33G depict a low-profile multilayer sensor configuration with the electrical
contacts all on one side and some details of its construction. FIGS. 33A and 33B illustrate the two
sides of this embodiment of a sensor 3300 and its overall shape. The example sensor 3300 includes
a tail portion 3302 that is initially supported by a sharp and then disposed within the user’s
interstitial fluid or dermal space below the skin upon application of the on-body device. The tail
portion 3302 includes electrodes 3304, 3306, 3308 that are used to contact the interstitial fluid and
to sense (e.g., transmit and receive) the electrical signals used to measure the analyte
concentration within the interstitial fluid. The sensor 3300 also includes an electrical contacts
portion 3310 which includes electrical contacts 3312, 3314, 3316 that are disposed all on one side
of the sensor 3300 and are in electrical communication with the electrodes 3304, 3306, 3308 via
conductive traces (not visible in FIGS. 33A and 33B but see FIG. 33F). Note also that the electrical
contacts portion 3310 is shaped to facilitate being securely held and sealed into a connector
support that will be described below. For example, the electrical contacts portion 3 310 includes
securement features that hold the sensor to be secured to the connector support by friction fit,
interference fit, etc., herein shown as tabs 3310A and notches 3310B that allow the electrical
contacts portion 3310 to be held securely in the connector support which includes mating features.
[0078] The sensor 3300 also includes a bendable portion 3318 that allows the electrical contacts
portion 3310 to be arranged parallel to the circuit board of the electronics assembly to facilitate a
relatively flat or low profile within the electronics assembly. The bendable portion 3 318 also allows
the tail portion 3 302 to extend down from the electronics assembly so that it can be inserted below
the skin of the user while the electrical contacts portion 3310 lays parallel to the circuit board. (…)
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(…)
[0079] FIG. 33C depicts a side view of the sensor 3300. The encircled portion labeled D is shown in
more detail in FIG. 33D. FIG. 33D provides a magnified side view of the distal most part of the tail
portion 3302 of the sensor 3300. The encircled portion labeled E is shown in more detail in FIG.
33E. FIG. 33E provides an even further magnified view of the electrodes 3304, 3306, 3308 of the tail
portion 3302. As can be seen in FIG. 33E, the electrodes 3304, 3306, 3308 are formed as layers on
a substrate 3322. The substrate 3322 is made of a flexible, non-conductive dielectric material. In
some embodiments, a clear, high-gloss, heat stabilized polyester film may be used for
the substrate 3322 and conductive carbon ink can be used to create the trace layers used for
the electrodes 3304, 3306, 3308. In other embodiments, other materials may be used for
the substrate 3322 such as polymeric or plastic materials and ceramic materials and for the trace
layers such as carbon or gold.
(…)[0084] Turning now to FIGS. 34A-35D, an alternative connector arrangement, according to
embodiments of the present invention as claimed in claim 1, for connecting a circuit board to a
sensor 3300 such as depicted in FIGS. 33A, 33B, and 33J is described. As shown in FIG. 34A, a flexible
one-piece seal or connector 3402 is molded in silicone or other practicable elastic material.
Separate doped silicone conductive elements are set therein which provide electrical contacts 3410
for connection to a circuit board. In some embodiments, the conductive elements can alternatively
be over molded or insert-molded into place. The result is a generally malleable/flexible hybrid
connection and sealing unit or connector 3402 incorporating a living hinge joining two (as-shown)
symmetrical sections. Alternatively, a two-piece design is possible. Yet, with the unitary design, the
arrangement can be neatly secured using a single catch boss or post 3412 opposite the hinged
section. In some embodiments, two or more posts can be used to secure the connector 3402 folded
around and sealing both sides of the contacts portion of the sensor 3300. Thus, even if a dielectric
coating on the sensor 3300 fails (e.g., pinhole leaks), the connector 3402 insures [ensures] that the
sensor contacts 3312, 3314, 3316 are protected from moisture or any contaminants. The one-piece
design also facilitates assembly as illustrated, in which the flexible connector 3402 is set in a rigid
or semi-rigid housing or connector support 3404 with one side located on the post 3412. Then a
sensor 3300 is inserted, and bent approximately ninety degrees at the bendable portion 3318 of
the sensor 3300. Once bent, the sensor 3300 is then captured with the upper part of the connector
3402 by folding over the connector 3402 as indicated by arrow S in FIG. 34C. The connector 3402 is
illustrated as bilaterally symmetrical, however, the connector 3402 can be formed in a direction-
specific orientation because in some embodiments, certain of the electrical contacts 3410 may not
be necessary. In some embodiments, all the sensor’s electrical contacts 3312, 3314, 3316 can be
provided on a single side of the sensor 3300 or, in other embodiments, both sides of the sensor
3300.
(…)
[0088] A related arrangement to that described in connection with FIGS. 34A-34D and 35A-35D is
presented in FIGS. 36 to 38. In FIG. 36, a sensor 3300 with all electrical contacts on the same side is
shown with a sharp 3602 for insertion in a connector support 3604. The connector support 3604
includes an elastomeric (e.g., silicone) seal backing. Once such a sensor assembly set is in a
container (or alternatively in an applicator), the sensor assembly can be coupled to the sensor
electronics to form an on-body device 222. As shown in FIG. 37, the sensor assembly 3702 is shaped
to fit within a socket 3704 that includes a second elastomeric unit with electrical contacts in the
elastomer body of the socket 3704. Note that in FIG. 37, the enclosure of the electronics assembly
is not shown so that the socket can be more clearly displayed. The socket 3704 is affixed to a circuit
board 3706 via any practicable method. The socket 3704 and/or the connector support 3604 can
include various coupling features (e.g., a snap fit lip and hook arrangement) to ensure that the
electrical contacts are pressed tightly together and sealed within the socket 3704 and sensor
assembly 3702. Once the sensor assembly 3702 is received within the socket 3704, the on-body
device (e.g., with the complete over-mold enclosure around the circuit board 3706 and adhesive
patch 3802 as shown in FIG. 38) is ready for use.
(…)
[0093] Turning now to FIGS. 47A to 47C, an alternative sensor assembly/electronics assembly
connection approach is illustrated. As shown, the sensor assembly 4702 includes sensor 4704,
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connector support 4706, and sharp 4708. Notably, sensor assembly 4702 does not include a
separate connector or seal to enclose the sensor’s connectors within the connector support 4706
as in the embodiment depicted in FIGS. 34A to 34D (i.e., no seal 3402). Instead, a recess 4710
formed directly in the enclosure of the electronics assembly 4712 includes an elastomeric sealing
member 4714 (including conductive material coupled to the circuit board and aligned with the
electrical contacts of the sensor 4704). Thus, when the sensor assembly 4702 is snap fit or
otherwise adhered to the electronics assembly 4712 by driving the sensor assembly 4702 into the
integrally formed recess 4710 in the electronics assembly 4712, the on-body device 4714 depicted
in FIG. 47C is formed. This embodiment provides an integrated connector for the sensor assembly
4702 within the electronics assembly 4712.
II. PROVISIONAL MEASURES SOUGHT, SUBMISSIONS OF THE PARTIES AND PROCEDURE
14. With an Application for provisional measures dated 4 July 2025, arguing that Defendants in-
dividually and jointly (directly or indirectly) infringe the patent in the Contracting Member
States by making, offering, placing on the market, using, importing, and storing the Gluco-
Men iCan CGM, Abbott, seeks the following measures:
(a) an immediately enforceable injunction for infringement of the patent by prohibiting the Defend-
ants, individually and jointly, on a provisional basis, from infringing the patent in any way, with
immediate effect after service of the order to be rendered in this matter, in particular by making,
offering, placing on the market, and / or using, supplying or offering to supply the GlucoMen iCan
(or components thereof) as well as by importing or storing the GlucoMen iCan for those purposes;
(b) a declaration that the GlucoMen iCan is considered “goods suspected of infringing an intellectual
property right” within the meaning of Article 2(7)(a) of Regulation (EU) No 608/2013;
(c) order the provision by the Defendants to counsel for Abbott, within 4 weeks after service of the
order rendered in this matter, with a written statement, substantiated with appropriate docu-
mentation, drawn up and signed by an independent auditor – _or any other professional that this
Court deems suitable for providing such a statement – comprising, in each case, for each of the
Contracting Member States in which the patent is in force:
(i) the origin and distribution channels of the GlucoMen iCan, including the full names and
addresses of the legal entities that are involved in the manufacture of and trade in these
systems;
(ii) the total number of each GlucoMen iCan product that the Defendants and / or any of
their affiliates still have in stock either administratively or physically as of the date of the
order;
(iii) the total number of GlucoMen iCan products that the Defendants, including any of its
affiliates, have traded, sold, supplied, transferred and / or delivered to its customers and /
or distributors since 3 April 2024, or since 4 June 2025, or from another date to be deter-
mined by this Court, as well as any and all copies of invoices pertaining to those acts
which also shows the price obtained for these products;
(iv) the identity including the full name(s) and address(es) of any non-consumer third per-
son(s) involved in the production, distribution, trade and / or sale of the GlucoMen iCan
and / or in the use of the GlucoMen iCan since 3 April 2024, or since 4 June 2025, or from
another date to be determined by this Court;
(v) the internal cost calculated, or the purchasing costs paid, as well as the sales prices
charged for the GlucoMen iCan by the Defendants, including their affiliates, since 3 April
2024, or since 4 June 2025, or from another date to be determined by this Court;
(vi) the total amount of gross and net profit which the Defendants, including their affili-
ates, have gained as a result of trading the GlucoMen iCan since 3 April 2024, or since 4
June 2025, or from another date to be determined by this Court, and the calculation
thereof;
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(d) order the Defendants to deliver up to a bailiff appointed by Abbott, at their own expense, or al-
ternatively orders the seizure, of any GlucoMen iCan product in stock and / or otherwise held,
owned or in the direct or indirect possession of the Defendants in the Contracting Member States
in which the patent is in force, within 1 week after service of the order to be rendered in this mat-
ter, and to provide counsel for Abbott with proper evidence of the full and timely compliance
with this order within 10 days after the delivery up to the bailiff or seizure;
(e) orders the Defendants jointly and severally to comply with the orders under 1.2(a) and 1.2(c)-
1.2(d), subject to a recurring penalty payment of EUR 250,000.00 for each violation of, or non-
compliance with, the order(s), plus EUR 100,000.00 for each day, a part of a day counting as an
entire day, that the violation or non-compliance continues, or a recurring penalty of EUR 5,000.00
for each of the GlucoMen iCan with which the order(s) is / are violated, or another amount as de-
termined by this Court in the proper administration of justice;
(f) appends an order for the enforcement to its decision, while declaring that the judgment is imme-
diately enforceable
(g) orders the Defendants to jointly and severally bear reasonable and proportionate legal costs and
other expenses incurred by the Applicant in these proceedings and orders, insofar such costs are
to be determined in separate proceedings for the determination of such costs, that the Defend-
ants pay to the Applicant by means of an interim award of costs in the amount of EUR 11,000.00
or another amount as the Court may order within 14 days after service of the order in this matter.
15. By order of 1 August 2025, in response to an application of Menarini to postpone the oral
hearing date, the Court confirmed that the oral hearing is scheduled for 3 September 2025,
and gave the Defendants the opportunity to file an objection on or before 18 August 2025.
16. In the objection, Defendants request the Court to dismiss the application for provisional
measures, asserting that it does not infringe the patent with the Glucomen iCan because (i)
features 1.4 and 1.6 are missing and (ii) the patent is more likely than not to be invalid be-
cause it lacks novelty and/or inventive step, the subclaims add matter and insufficiently dis-
close the invention.
17. The Applicant was given the opportunity to reply to the invalidity defences raised in the ob-
jection, which reply was filed on 25 August 2025.
18. The oral hearing took place on 3 September 2025.
III. GROUNDS FOR THE ORDER
III.A – SUMMARY AND POINTS AT ISSUE
19. The proceedings concern a request for a provisional injunction and other measures based on
alleged infringement of the patent. The Court finds below (in part III.B) that it has jurisdiction
and is competent to hear the case. The application was also made in a timely manner and
meets other urgency requirements, as will also be discussed in III.B. The assessment of the
alleged infringement and the alleged invalidity of the patent (argued as a defence), depends
on claim construction. This will be addressed in Part III.C together with the patent’s teaching
and the definition of the skilled person. The Court will conclude in part III.D, addressing the
invalidity defences, and in part III.E concerning infringement, that it is more likely than not
that the patent will be considered valid and infringed. The (objective urgency and proportion-
ality of the) requested measures are discussed in part III.E.
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III.B – JURISDICTION AND OTHER PRELIMINARY ISSUES
Jurisdiction and competence
20. The patent is a European patent with unitary effect. Accordingly, this Court has exclusive
competence to hear actions for actual or threatened infringement of the patent within UPCA
territory (Art. 1 and 32(1)(a) and (c) UPCA). In its application, Abbott provided evidence of al-
leged infringement within UPCA territory in any case by Menarini, in particular also in the
Netherlands, which creates internal competence for the LD The Hague pursuant to Art. 33
(1)(a) UPCA.
21. Regarding Sinocare, jurisdiction of the Court is contested. If a defendant is not domiciled in an
EU member state, jurisdiction over that defendant by a court common to several member
states, like the UPC, is governed by Chapter II of the Brussels Regulation (“BR”) regardless of
the defendant’s domicile, pursuant to Art. 71b(2) BR. This paragraph also specifies that an ap-
plication may be made to [the UPC] for provisional measures even if the court of a third state
has jurisdiction as to the substance of the matter. Sinocare argues that (threatened) infringe-
ment by Sinocare in the UPCA territory has not been substantiated. This defence is rejected.
Not in dispute is that Sinocare is the manufacturer of the allegedly infringing products and
named as such in the Eudamed entry for the GlucoMen iCan and in the user guide. Further-
more, Menarini and Sinocare announced that they would cooperate in bringing the Glucomen
iCan to the European market. At least there is then combined/joint threatened infringement
in UPCA territory. Furthermore, this concerns alleged (threatened) infringement of the same
patent in the same territory with the same product. Jurisdiction vis-à-vis Sinocare can therefore
be based on Art. 7(2) BR.
urgency
22. Defendants argue that the application is not admissible or should be dismissed for lack of
urgency. As the publication of the grant of the patent was on 4 June 2025, and the application
was filed early July 2025, the Court finds that there is no unreasonable delay in seeking
provisional measures. In addition, Abbott has sufficiently argued the presence of objective
urgency/necessity to obtain provisional measures to stop (imminent) infringement. Why this
is the case will be explained in more detail together with the weighing of the interests of the
parties in part III.D below.
III.C – THE PATENT, BACKGROUND AND CLAIM CONSTRUCTION
The patent
23. The patent relates to continuous glucose monitoring systems. Specifically, it relates to the sen-
sor assembly of a CGM system. As mentioned above, a CGM system typically includes an appli-
cator and an on-body device. The on-body device is configured to be worn on the patient’s
body and contains electronics coupled with a glucose sensor. The applicator is used by the
patient to apply the on-body device to the skin while inserting a portion of the sensor in the
patient’s body using a sharp with the applicator.
24. In the background section, the patent identifies a need for applicator systems configured to
handle insertion, as well as packaging and user interface issues, that are easy-to-use, reliable
and [that] minimise both user inconvenience and pain (see [0006] of the patent specification).
The original patent application covers various aspects of a CGM system. The claims of the di-
visional at issue here are directed to providing a CGM system with a sensor assembly in which
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a seal protects the portion of the sensor that makes electrical contact with the electronics in
the on-body device, from moisture, contamination and/or current leakage due to fluid intru-
sion (see [0084] of the patent specification), thereby ensuring a sealed, reliable connection
(see [0045]).
25. The case primarily evolves around claims 1 and 15. Product claim 1 for a sensor assembly reads
as follows, divided into features:
1.1 A sensor assembly (3702) comprising:
1.2 a sensor (3300) having a tail portion (3302), a contacts portion (3310), and a bendable portion
(3318);
1.3 a seal (3402) including electrical contacts (3410) disposed to align with the contacts portion of
the sensor and to allow electrical signals to pass through the seal;
1.4 a support (3404) including a distal surface and features for sealably coupling to an electronics
assembly; and
1.5 a sharp (3408) including a channel for supporting the tail portion of the sensor and a hub (3414)
for griping the sharp during retraction,
1.6 wherein the seal is shaped to enclose the contacts portion of the sensor within the support.
26. Product claim 15 to a kit can be divided into features as follows:
15.1 A kit comprising:
15.2 the sensor assembly (3702) of any one of the preceding claims; and
15.3 an on-body device (222) comprising: an adhesive patch (3802) for adhering the on-body device
to the skin of the user; and
15.4 an electronics assembly including:
15.4.1 sensor electronics;
15.4.2 an enclosure surrounding the sensor electronics, the sensor electronics including a circuit
board, a processor and a communications facility; and
15.4.3 a socket (3704);
15.5 wherein the socket of the electronics assembly of the on-body device is configured to receive the
sensor assembly (3702), and
15.6 wherein the sensor assembly (3702) is shaped to fit within the socket (3704).
Claim interpretation
27. The parties disagree on the interpretation of several features of the claims. The Court of Appeal
of the UPC (“CoA”) has set out the following principles regarding interpretation of a patent
claim according to Art. 69 of the European Patent Convention (“EPC”):1 The patent claim is not
only the starting point, but the decisive basis for determining the protective scope of a
European patent. The interpretation of a patent claim does not depend solely on the strict,
literal meaning of the wording used (…). Rather, the description and the drawings must always
be used as explanatory aids for the interpretation of the patent claim and not only to resolve
any ambiguities in the patent claim. However, this does not mean that the patent claim merely
serves as a guideline and that its subject-matter also extends to what, after examination of the
description and drawings, appears to be the subject-matter for which the patent proprietor
seeks protection.
The CoA also clarified (i) that the principles for interpreting a patent claim apply equally to the
assessment of the infringement and to the validity of a European patent and (ii) that a patent
1 Order CoA UPC, NanoString Technologies -v- 10x Genomics, UPC_CoA_335/2023, App_576355/2023 of 26
February 2024, as rectified by the order of 11 March 2024. See also G1/24, Enlarged Board of Appeal EPO.
UPC_CFI_624 17 October 2025
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must be interpreted from the point of view of the average person skilled in the art (the “skilled
person”).
28. The parties did not debate or define the skilled person. The Court assumes the skilled person
to be a mechanical engineer with several years of experience in the design of CGM systems.
29. For this order, the interpretation of features 1.4 and 1.6 is relevant. Defendants argue that
Abbott relies on an overly broad reading of these claim features, which interpretation would
not correspond to the meaning of the claim features as understood by the skilled person in
light of the claims, drawings and description as a whole, nor with the technical interaction
between the features.
Feature 1.4
a support (3404) including a distal surface and features for sealably coupling to an electronics assembly;
30. Defendants submit that it follows from feature 1.4 that the support must have a distal surface,
that is a surface that is directed towards and to be placed on the user’s skin. Thus, the term
distal in this regard refers to the surface that is not only directed towards but also (suitable
to be) placed on the user’s skin (see also par. [0011] of EP633).
31. The Court agrees that from these disclosures in the patent, it follows that the support may
have a distal surface adapted for (direct) placement or contact on the skin of the subject
([0011]). However, “distal” more generally means “away”, i.e. – as a skilled person would un-
derstand from the patent as a whole – away from the hand of the user handling the applicator.
For instance, this can be understood from para [0022] where it is described that ”the user
places the applicator on the skin of the insertion site and then applies a force to install the on-
body device. The applicator is driven to insert the distal end of the sensor through the user's
skin, adhere the on-body device to the skin surface, and retract the sharp into the applicator
for disposal”. Para [0079] also makes this clear: “FIG. 33D provides a magnified side view of the
distal most part of the tail portion 3302 of the sensor 3300”.
32. The adjective “distal” does not imply that the surface is also actually placed on the user’s skin.
Furthermore, contrary to what Defendants assert with reference to Fig. 34, feature 1.4 does
not specify the relationship of the distal surface and the features for sealably coupling to an
electronics assembly with respect to the patient’s skin, i.e. on which side of the sensor assem-
bly (proximal or distal) electrical contact with the electronics assembly takes place. Such limi-
tation cannot be based on Fig. 34 as the Court judges below that the claimed invention is not
limited to the embodiment illustrated in Fig. 34. In that, it differs from the subject-matter dealt
with in the Order by the Court of Appeal dated 14 February 2025 in case UPC_CoA_382/2024,
which relates to another patent of the same patent family, wherein the invention was directed
to embodiments depicted in Fig. 47 of the patent specification, wherein the relative position
of the distal surface of the support to the sensor assembly is part of the claim. Fig. 47 falls
outside the scope of protection of UP 633.
Feature 1.6
wherein the seal is shaped to enclose the contacts portion of the sensor within the support.
33. Defendants argue that the only seal ‘shaped to enclose the contacts portion of the sensor
within the support’ is the specific one-piece seal consisting of two halves of the embodiment
shown in Fig. 34 and described in [0084] to which embodiment the scope of protection of the
UPC_CFI_624 17 October 2025
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claim is limited. The latter is confirmed by the phrase ‘according to embodiments of the present
invention as claimed in claim 1’ in [0084] of the specification, which was added during
prosecution, according to Defendants.
34. The Court provisionally disagrees. Firstly, it cannot be derived from the phrase cited above that
the claim is limited to the embodiment of Fig. 34. The text only clarifies that that embodiment
falls within the scope of the invention. The embodiment of Fig. 34 discloses a generally flexible
seal 3402 (also referred to as ‘sealing unit’ and ‘connector’) incorporating a hinge joining two
symmetrical sections. The two sections of the connector 3402 can be folded around and seal
both sides of the contacts portion 3310 of a sensor 3300. It further follows from the last sen-
tences of para. [0084] of the patent specification that the connector can be bilaterally sym-
metrical with electrical contacts 3410 on both sides (as depicted in fig 34D in 12 above). It is
further explained that, as some sensors have electrical contacts 3312-3316 (see fig 33B and
34C above in 12) on one side only, such symmetry is not always necessary:
‘The connector 3402 is illustrated as bilaterally symmetrical, however, the connector 3402 can be
formed in a direction-specific orientation because in some embodiments, certain of the electrical
contacts 3410 may not be necessary. In some embodiments, all the sensor’s electrical contacts 3312,
3314, 3316 can be provided on a single side of the sensor 3300 or, in other embodiments, both sides
of the sensor 3300.’
35. From the above it is apparent to the skilled person that the function of the enclosing by the
seal in feature 1.6 is to seal the electrical contacts of the sensor to protect them from moisture
or contaminants. As mentioned, an example of the contacts portion 3310 of the sensor is
shown in fig. 33A and 33B above. This is a flat portion with electrical contacts on one side of
the sensor (as is also described in [0077], cited in 13 above). In addition, it is expressly
mentioned that the sensor’s electrical contacts can be provided on both sides of the sensor
(see the part of [0084] cited above).
36. In this context, a further embodiment expressly described as “related” to Figs. 34A to 34D and
described in para. [0088] in relation to Fig.36-38 of the patent specification, is relevant. This
embodiment has a seal/connector which has electrical contacts only on one side. The support
of this embodiment includes an elastomeric (e.g. silicone) seal backing on the side opposite to
the electrical contacts. Sealing is then achieved in use when the sensor assembly is fitted into
a socket (or recess) of the electronics assembly of the on-body device, so that the electrical
contacts are pressed tightly together and sealed within the socket and sensor assembly,
thereby also sealing the side comprising the electrical contacts with a second elastomeric
sealing member comprised in the socket ([0088] and Figs. 36-37). In this embodiment the
function of feature 1.6 to enclose the electronical contacts of the sensor to protect them is
also achieved, but with a one-piece connector that does not consist of two halves. The result
of this embodiment, when assembled, is also that the seal encloses the contact portions of the
sensor within the support and thus also falls within the scope of protection of the claim.
37. This is also confirmed by subclaims 4 and 5 which narrow the broader independent claim 1 as
follows:
4. The sensor assembly (3702) of any one of the preceding Claims, wherein the seal (3402) is formed
from flexible material and includes a hinge allowing the seal to be folded around the contacts
portion (3310) of the sensor, sealing both sides of the contacts portion.
UPC_CFI_624 17 October 2025
19
5. The sensor assembly (3702) of Claim 1, wherein the seal (3402) is formed from flexible material
and includes two pieces to seal the contacts portion of the sensor (3300) therebetween, sealing
both sides of the contacts portion.
Claims 4 and 5 thus specifically limit the seal of the sensor assembly of claim 1 to a seal that
folds around the contacts portion (claim 4) e.g. by including two pieces (claim 5), as parts
described in [0084].
38. Feature 1.6 must therefore be interpreted more broadly and also covers, for instance, the
embodiments of Fig. 37.
III.D – VALIDITY DEFENCE
39. As a defence to (non)infringement, Defendants argue that it is more likely than not that UP 633
will be found to be invalid in main proceedings because of lack of novelty and/or inventive
step, insufficiency of disclosure and added matter.
Novelty
The Dexcom patent family
40. Defendants cite prior art patent applications and patents (US 2007/0208245 A1 (Brauker), US
7,905,833 B2 (US 833), US 2011/290645 and US 2006/0142651 A1 (Brister)), which can all be
seen as members of a “Dexcom family” of patents, disclosing very similar CGM systems in their
parts that are potentially relevant for UP 633. Defendants qualify this body of prior art as
“variants” of prior art documents (i.e. slightly different patent applications or granted patents
with similar inventors and inventions). The Court will thus address these disclosures
collectively, referring to them as the “Dexcom patent family” and the system disclosed as the
Dexcom CGM system. US 833, first published as a US application in 2006, will be used as
reference. Defendants argue that US 833 relates to the same field as the patent in suit and
anticipates the subject-matter of claims 1 and 15. It discloses sealing in order to protect the
electrical connection of the sensor with the electronics unit from damage due to moisture,
humidity, dirt, and other external environmental factors. In particular, a sealing member (36;
Fig.4A of US 833, see below) provides a watertight seal around the portion of the sensor
ensuring electrical connection with the electronics unit. A sharp (72; Figs.6 and 7D of US 833,
see below) is used for insertion of the sensor into the patient’s body.
41. Abbott argues that in the Dexcom CGM system the sensor, the sharp and the seal are part of
separate sub-assemblies, from the time after manufacture and prior to insertion, and that
the Dexcom CGM system as among others disclosed in US 833, does therefore not disclose all
elements of a sensor assembly pursuant to claim 1, nor as part of a kit as required by claim
15. This is in any case apparent because the "sensor assembly" of claim 1 of the patent explic-
itly comprises a sharp (feature 1.5). In contrast, the needle (or sharp, 72) disclosed in US 833
is not a part of the contacts subassembly 26, but instead is part of needle subassembly 68
(shown as one item of Fig. 6 of US 833) which resides in a separate component, the applica-
tor, and only makes contact with the contacts subassembly 26 during the brief moment of
sensor insertion (shown in Fig. 7 of US 833). Figures 6 and 7 of US 833, depict are depicted
below.
UPC_CFI_624 17 October 2025
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42. Fig. 1 and 4A of US 833 disclose a sensor kit as part of a CGM system. According to the
description of US 833, Fig. 1 ‘is a perspective view of a transcutaneous analyte sensor system,
including an applicator, a mounting unit, and an electronics unit’ and Fig.4A ‘is an exploded
perspective view of a contact sub-assembly, showing its individual components’.
UPC_CFI_624 17 October 2025
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43. The kit of the Dexcom CGM system comprises a sensor (32) and a contact sub-assembly (26)
with a seal (36) including electrical contacts (28) and a support (34) (shown in Fig. 4A above).
This is not contested.
44. The Court agrees with Abbott that US 833 in any case does not disclose a sharp as part of a
sensor assembly as required by claim 1 of UP 633. The sharp (referred to as “needle” 72 in US
833) of the Dexcom CGM system is part of a separate sub-assembly (68), pictured in Fig. 6
above. This sharp engages with contact sub-assembly (26) only during insertion into the host’s
skin (col. 32, lines 35-36 and 46-50). An applicator (12) is used to insert the sensor disposed
within the sharp into the host’s skin (col. 32, lines 13-14). During insertion, the sharp pushes
the sensor through the seal (Figs. 7A to 7D) with an angle alpha relative to the skin (Figure 10B).
At this point in time, the sensor is brought into alignment with the electrical contacts and
enclosed in the seal. After insertion, the sharp is retracted and the support is pivoted around
its hinge (38) into its position for use, i.e. parallel to the host’s skin surface (col.12, lines 29-40;
Figure 11B). Fig. 10B and 11B of US 833, showing the position of the sensor assembly
immediately following sensor insertion into the host’s body and in its (final) functional position,
respectively, as mentioned, are reproduced below.
45. Thus, the sensor and the sharp of the Dexcom CGM system do not form part of the contact
(sub-)assembly (26) and the afore-mentioned elements are combined only during insertion and
before retraction of the sharp, i.e. for a very brief moment in time.
46. In contrast, a sharp forms an integral part of the sensor assembly of claim 1 of UP 633 which
is a unit that is pre-assembled. This is also mentioned in [0006] as an objective of the inven-
tion of the patent and [0007]) as follows: ‘(…) to facilitate assembly of separate on-body de-
vices and sensor assembly units that are kept apart until the user brings them together.'
47. As a result, none of the cited prior art documents concerning the Dexcom CGM system disclose
a single separate sensor assembly comprising all the features of claim 1, within the meaning
given to an assembly in the patent. At any rate, even if US 833 were considered to disclose in
fig. 7, at the moment of the needle engaging with the contact sub-assembly and the sensor,
such sensor assembly, and this were considered to anticipate claim 1, claim 15 of UP 633 would
be novel. Claim 15 relates to a kit consisting of two separate parts, one of them being the
sensor assembly of claim 1 and the other the OBD. This makes even more clear that the sensor
assembly and the on-body device with electronics are separate items of the kit. Such kit is not
disclosed during the brief moment mentioned above, while before that instance there are
many separate items in US 833, none of which qualify as the sensor assembly of claim 1.
UPC_CFI_624 17 October 2025
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Inventive step
48. Defendants argue that any difference of the invention claimed in UP 633 with US 833 and other
members of the Dexcom patent family, are, in any case, obvious and lack an inventive step.
Defendants further cite WO 2011/119896 A1 (WO 896) mentioning a “compressed anisotropic
zebra”, which according to Defendants would be a silicone elastomeric connector sealing
consisting of alternating conductive and insulating regions.
49. Abbott rightly argues that US 833 and family disclose an entirely different applicator system
with entirely differently designed components which cooperate – and are connected – in an
entirely different manner.
50. It is thus not apparent for the Court how the skilled person, starting from any of the
arrangements disclosed in the Dexcom patent family, would modify the parts disclosed therein
to arrive at the sensor assembly of claim 1 and at the kit of claim 15 of UP 633. There is no
incentive to bring the sharp together with the other features required by claim 1 of UP 633 to
yield the sensor assembly according to claim 1 prior to insertion, ensuring an easy-to use
application of the on-body device. This would require a completely different insertion
procedure into the user’s skin, with differently designed components, which is not suggested
in the prior art at hand (if it is even possible). In addition, the role of the anisotropic zebra is
not disclosed in WO 896 ([00281]), especially not as a seal enclosing the contacts portion of
the sensor.
51. In conclusion, the subject-matter of claim 1, and of claim 15, involves an inventive step over
any of the prior art documents cited by Defendants.
Sufficiency of disclosure
52. Defendants contend that the skilled person cannot carry out the subject-matter defined in
claim 1 over the whole claimed scope without undue burden, in case Abbott’s implicit overly
broad interpretation of feature 1.6 is followed.
53. The Court’s interpretation of feature 1.6 is explained above and essentially matches Abbott’s
interpretation. The description gives concrete examples of a seal enclosing the contacts
portion, either with two elastomeric members in the sensor assembly or with one elastomeric
member in the sensor assembly cooperating with one elastomeric member in the socket of the
electronics assembly to fully seal the contacts portion within the support, when the assembly
is inserted in the socket. The Court is satisfied that the wording of feature 1.6 is commensurate
with the scope of the invention as described.
54. Thus, the patent discloses the invention in a manner sufficiently clear and complete for it to be
carried out by a person skilled in the art.
Added subject-matter
55. Defendants contend that the subject-matter of claims 2, 6-8, 10, 12-15 is not directly and
unambiguously derivable from the whole of the Original Application. No objection is raised
against claim 1. The objection against claim 15 is not substantiated. As the court opined above
that both claim 1 and 15 are likely to be held valid in main proceedings, there is no need to
address added matter defence regarding the other dependent claims.
UPC_CFI_624 17 October 2025
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Conclusion on the validity defence
56. Thus, the grounds for revocation raised by Defendants are not expected to affect the validity
of the patent in main proceedings.
III.E - INFRINGEMENT
57. Defendants assert that the GlucoMen iCan does not use features 1.4 and 1.6 of the patent
because the GlucoMen does not have a support with a distal surface that rests on the skin
according to feature 1.4 and it does not have a seal consisting of two parts as required by
feature 1.6. These non-infringement arguments (only) hold if the limited interpretation of
these features proposed by Defendants were followed. In view of the correct claim
interpretation discussed above, these features are also met in the GlucoMen iCan. As it is not
disputed that features 1.1, 1.2, 1.3 and 1.5 are also present, the Court considers it more likely
than not that Defendants infringe the patent with their GlucoMen iCan.
III.F – NECESSITY, RELIEF, BALANCE OF INTERESTS AND COSTS
58. In view of the likelihood of infringement and validity discussed above, the requested measures
shall be granted in so far as necessary and proportionate.
59. The injunction will be granted for the UPCA territory, as requested. The provisionally estab-
lished infringement warrants a generally worded injunction.2 Abbott explained convincingly
that an injunction is necessary and urgent at this moment to avoid Defendants from (further)
entering the reimbursement market and to avoid further sales via ‘cash pay’. Within UPCA ter-
ritory, sales of CGM systems are either in the cash pay segment (where the user self-funds the
purchase) or in the 'reimbursement' segment (typically where a product is prescribed by a phy-
sician, and the cost is borne by the healthcare system). The cash pay segment is less than 5%
of the total CGM market in each country. Currently, pending often time-consuming national
approvals for the reimbursement market, the GlucoMen iCan is CE marked which means that
the Defendants can and effectively sell into the cash pay segment of the market. Such sales are
at prices which are comparable with or below the price of Abbott's FreeStyle Libre. There is
nothing to stop the Defendants from offering discounts to undercut Abbott's prices, and such
aggressive pricing is to be expected. This can be prevented further, by a provisional injunction.
As far as Abbott claims to know, the GlucoMen iCan has not yet been approved for the reim-
bursement market. An injunction can stop this, preventing expected lost sales and price ero-
sion in the much larger part of the market. The damage caused by such loss of sales and price
erosion is difficult to quantify and may run for many years due to long contracts with payers
and the irreversibility of price reductions. The Defendants’ argument that the grant of an in-
junction will cause them irreparable harm because it will give them an unacceptable disad-
vantage in the reimbursement market even possibly leading to black-listing in Italy, is dis-
missed. Abbott disputes that an injunction may lead to black-listing, and this cannot be estab-
lished here. Furthermore, a provisional injunction is deemed proportionate in view of the in-
fringement. Defendants’ request to make an injunction subject to security is dismissed as De-
fendants did not argue let alone demonstrate that there is a risk that Abbott will not or is un-
able to pay Defendants’ damages in case the injunction is reversed in appeal or in proceedings
on the merits.
2 See UPC CoA dated 14 February 2025, Abbott/Sibio (UPC_CoA_382/2024)
UPC_CFI_624 17 October 2025
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60. The requested declaration that the GlucoMen iCan is considered “goods suspected of
infringing an intellectual property right” within the meaning of Article 2(7)(a) of Regulation
(EU) No 608/2013, is dismissed. Whatever the merits, such declaration is not possible as
provisional measure.
61. The order for the provision of information, requested at c), will be limited as set out in the
order below. Information regarding distribution channels and the (further) origin of the prod-
ucts is deemed urgent and necessary for Abbott to prevent possible further infringement by
third parties. Information regarding prices, numbers of sales and costs are only deemed nec-
essary for the calculation of damages, as Defendants rightly point out, which is premature at
this stage. As this order will be made subject to a penalty payment, as requested, under the
terms set out below, this is considered a sufficient incentive to comply without the need of the
requested involvement of an independent auditor. Defendants request that the provision of
any information be made subject to confidentiality, is rejected in view of the limited scope of
the order to be granted.
62. The requested order to deliver up to a bailiff appointed by Abbott any GlucoMen iCan product
in stock and / or otherwise held or owned by Defendants in the Contracting Member States is
also considered proportionate to avoid further infringement. Defendants did not substantiate
why this additional measure is not proportionate.3 The period will be extended to two weeks
after service of this order. The additional request to provide counsel for Abbott with proper
evidence of the full and timely compliance with this order within ten days after the delivery up
to the bailiff or seizure, is dismissed as superfluous in view of the delivery to a bailiff appointed
by Abbott, who can be assumed to communicate with Abbott.
63. The requested recurring penalty payments are limited and maximised as set out in the order.
As Sinocare and Menarini are independent companies, Defendants shall not be ordered to
comply jointly and severally to comply with the orders as rightly objected to by Defendants.
64. The judgment shall be declared immediately enforceable; Abbott may request the registry to
issue an authentic copy of the order.
65. Abbott requests the Defendants to jointly and severally bear reasonable and proportionate
legal costs and other expenses incurred by the Applicant in these proceedings and orders,
which costs are to be determined in separate proceedings for the determination of such costs.
This order shall be granted as requested, apart from the ‘jointly and severally’. In this context,
it is relevant that the value of this case is set at EUR. 4.000.000, as requested by Abbott and
not objected to.
66. Defendants will be ordered to pay to the Applicant by means of an interim award of costs, an
amount of EUR 11,000.00 within 14 days after service of the order on Defendants. Here, joint
and several liability for payment is considered reasonable.
3 See also UPC CoA 3.10.2025 UPC_CoA_534/2024, UPC_CoA_683/2024 and UPC_CoA_19/2025), Belkin/Philips
UPC_CFI_624 17 October 2025
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ORDER
Having heard the parties, the court by way of provisional measures:
a) Prohibits Defendants by way of preliminary injunction from directly infringing European
patent EP 4 344 633 with unitary effect in the territories of the UPC, with immediate effect
after service of this order, in particular by making, offering, placing on the market, and / or
using, supplying or offering to supply the GlucoMen iCan (or components thereof) as well
as by importing or storing the GlucoMen iCan for those purposes (Articles 63(1) and 25(a)
UPCA);
b) Orders Defendants to provide, within four weeks after the service of this order, to Ab-
bott’s representative a written account with the full names and address details of (i) the
origin and distribution channels of the GlucoMen iCan, including the full names and ad-
dresses of the legal entities and of any other non-consumer third person(s) that are in-
volved in the manufacture of and trade in these systems within the territory of the UPC
(R. 211 (1) RoP);
c) Orders Defendant to deliver up, within two weeks after the service of this order, to a bailiff
appointed by Abbott, at their own expense, any GlucoMen iCan product in stock and / or
otherwise held or owned by the Defendants in the territory of the UPC, so as to prevent
their entry into or movement within the channels of commerce (R. 211(1)(b) RoP);
d) Orders each Defendant to pay to the Court a penalty payment of up to EUR 100,000 for
each day or part of a day that it does not comply with the injunction at a) with a maximum
of EUR 1,000,000 per Defendant and a penalty of EUR 10,000 for each day that it does not
comply with the orders at b) and c) with a maximum of EUR 100,000 per Defendant, or EUR
100 for each GlucoMen iCan with which the orders are violated; the penalties will be
determined by this Local Division of the Court upon request by Abbott (Article 63(2) UPCA;
and R.354.3 RoP);
e) Orders the Defendants, jointly and severable, to pay to Abbott an interim award of costs in
the sum of EUR 11,000.00 (R. 211.1(d) RoP);
f) The above is immediately enforceable;
g) Rejects the claims in all other respects;
h) Determines that the Defendants shall bear the costs of the proceedings;
i) Sets the date as referred to in R. 213.1 RoP at 31 calendar days or 20 working days,
whichever is the longest, after the date of this order;
j) Sets the value of the dispute at EUR 4,0000.000.
UPC_CFI_624 17 October 2025
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