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Umedwings Netherlands B.V., Sibio Technology Limited v. Abbott Diabetes Care Inc.
ACT_14945/2024
The Hague (NL) Local Division
Application for provisional measures
EN
EP3831283
UPC_CFI_131/2024 ACT_14945/2024
concerning: provisional measures in the matter of EP3831283
Application for provisional measures denied. On the balance of probabilities patent will more likely than not be held to be invalid in proceedings on the merits, due to added matter.
K EYWORDS :
provisional measures; validity; added matter
R EFERENCE C ODE ECLI: Not provided
(Applicant) - 1360 South Loop Road - CA 94502
(Defendant) - 6/F., Manulife Place, 348 Kwun
Tong Road - - - Kowloon - HK
Represented by Eelco Bergsma
Represented by Thomas Gniadek
(Defendant) - Treubstraat 1 - 2288 EG -
Rijswijk - NL
Presiding judge and judge-rapporteur
Edger Brinkman
Legally qualified judge Legally qualified judge Technically qualified judge
Petri Rinkinen
Margot Kokke
Renaud Fulconis
L ANGUAGE OF P ROCEEDINGS
Application for a preliminary injunction and other provisional measures filed on 20 March 2024 (R. 206 Rules of Procedure (RoP)).
The facts presented below are mostly based on the application as they were not opposed by the defendants.
Applicant (hereinafter also referred to as 'Abbott') is the proprietor of European patent number EP 3 831 283 ('the patent') with the following claims 1-26: 1
(1) a glucose sensor assembly (3702, 4702) comprising: a proximal section comprising a connector support (3604, 4706) coupled with a proximal portion (3310) of a glucose sensor (3300, 4704); a distal tail section comprising a distal portion (3302) of the glucose sensor (3300, fluid of a subject;
1 To be found in the EPO Espacenet register at:
https://worldwide.espacenet.com/patent/search/family/047891854/publication/EP3831283B1?q=EP3831283B1
a base portion (5004) configured to be adhered to the skin surface of the subject by an adhesive patch (3802, 5104); and
(3) sensor electronics positioned within the enclosure, the sensor electronics comprising a processor (4804), and a communications facility, wherein the base portion of the enclosure comprises a recess (3704, 4710) in a bottom exterior surface, the recess (3704, 4710) comprising a distal-facing opening, wherein the connector support (3604, 4706) is received through the distal-facing opening and into the recess (3704, 4710), and wherein the glucose sensor (3300, 4704) is electrically coupled with the sensor electronics by the connector support when the connector support is received into the recess (3704, 4710).
wherein the glucose sensor assembly (3702, 4702) comprises a proximal section comprising a connector support coupled with a proximal portion (3310) of a glucose sensor (3300, 4704), and a distal tail section comprising a distal portion (3302) of the glucose sensor (3300, 4704) configured to be positioned under a skin surface and in contact with a bodily fluid of a subject, wherein the enclosure comprises a top portion (5002) and a base portion (5004), wherein the base portion (5004) comprises a recess (3704, 4710) in a bottom exterior surface, and wherein the recess (3704, 4710) comprises a distal-facing opening, the method comprising:
positioning the sensor electronics within the enclosure of the on-body device, wherein the sensor electronics comprise a processor (4804), a communications facility;
after positioning the sensor electronics within the enclosure, inserting the connector support (3604, 4706) through the distal-facing opening of the recess (3704, 4710) in the bottom exterior surface of the base portion (5004) and into the recess (3704, 4710), causing the glucose sensor (3300, 4704) to electrically couple with the sensor electronics.
to electrically couple with the sensor electronics, wherein the connector support (3604, 4706) is electrically coupled with the sensor electronics via an interface that is external to the enclosure, and wherein the interface between the connector support (3604, 4706)and the sensor electronics is disposed within the recess (3704, 4710).
The patent was filed as a second generation divisional application (the 'application'), stemming from a parent application (published as EP 3 300 658, the 'parent application'), itself originating from a Euro-PCT application originally published as WO 2013/090215 (the 'original application'). The filing date of the patent is the filing date of the original Euro-PCT application, namely 11 December 2012 and it has an earliest priority date of 11 December 2011. The application was published on 9 June 2021 and the mention of the grant of the patent was published on 26 April 2023. No opposition was filed against the patent within the statutory time limit. The patent is in force in UPCA (the Agreement on a Unified Patent Court) Contracting Member States Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Ireland, Italy, Latvia, Lithuania, Luxembourg, The Netherlands, and Sweden. It is also in force in other countries, including the UK and Spain. The patent was opted-out of the UPC competence, but this opt-out was withdrawn by Abbott on 14 March 2024.
Abbott is a developer, manufacturer and marketer of continuous glucose monitoring ('CGM') devices since 2007. The series of its devices is called FreeStyle Libre. Since 2014, these devices have comprised an applicator (i.e., an insertion device), an on-body unit consisting of an analyte sensor (for glucose) and sensor electronics as an integrated unit, and a display device (such as a reader or smartphone) with proprietary software. According to Abbott, this technology utilizes the invention disclosed in the patent.
Abbott is the main supplier of CGM products in the Contracting Member States. In Europe, Abbott serves over 1.3 million patients with its FreeStyle Libre products and has a market share of approximately 80%.
Defendant 1 ('Sibio') also manufactures CGM systems. Since 2021, Sibio has been on the market in China with a CGM device. Recently, end of 2023, Sibio entered the market in Europe with its CGM device, called GS1. Defendant 2 ('Umedwings' and together with Sibio 'Sibio c.s.' or 'Defendants') is named in the documentation for the GS1 device as an EU importer.
olly resldue and allow
Cautlon: The Pack should be put
Step 4 Uncover the cap from the sensor applicator,
to a stop.
Step
Diabetes Mellitus is an incurable chronic disease in which the body does not produce or properly utilize insulin. Insulin is a hormone produced by the pancreas that regulates blood sugar (glucose). In particular, when blood sugar levels rise, e.g., after a meal, insulin lowers the blood sugar levels by facilitating blood glucose to move from the blood into the body cells. Thus, when the pancreas does not produce sufficient insulin (a condition known as Type 1 Diabetes) or does not properly utilize insulin (a condition known as Type II Diabetes), the blood glucose remains in the blood resulting in hyperglycemia or abnormally high blood sugar levels (patent, para. [0002]).
The vast and uncontrolled fluctuations in blood glucose levels in people suffering from diabetes cause long-term, serious complications. Some of these complications include blindness, kidney failure, and nerve damage. Additionally, it is known that diabetes is a factor in accelerating cardiovascular diseases such as atherosclerosis (hardening of the arteries), leading to stroke, coronary heart disease, and other diseases. Accordingly, one important and universal strategy in managing diabetes is to control blood glucose levels (patent, para [0003]).
One element of managing blood glucose levels is the monitoring of blood glucose levels. Conventional in vitro techniques exist, such as drawing blood samples, applying the blood to a test strip, and determining the blood glucose level using colorimetric, electrochemical, or photometric tests. The patent is concerned with in vivo analyte monitoring systems, which measure and store sensor data representative of glucose levels automatically over time (patent, para [0004]).
Unlike conventional in vitro blood glucose monitoring approaches, in vivo analyte monitoring systems use an insertable or implantable in vivo sensor that is positioned to be in contact with interstitial fluid of a user for a period of time to detect and monitor glucose levels. Prior to use of an in vivo sensor, at least a portion of the sensor is positioned under the skin. An applicator assembly can be employed to insert the sensor into the body of the user. For insertion of the
sensor, a sharp engaged with the sensor, pierces the skin of the user, and is then removed from the body of the user leaving the sensor in place. The in vivo -positioned sensor can be connected to other system components such as sensor electronics contained in a unit that can be held onto the skin (patent, para [0005]).
To realize fully the advantages associated with such in vivo 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 invention of the patent provides such solutions and additional or alternative advantages (patent, para [0006]).
Abbott lodged the Application for preliminary injunction and other provisional measures on 20 March 2024 in the UPC Local Division The Hague.
As per the instructions of the Judge-Rapporteur, the Defendants lodged an Objection to the application for provisional measures on 23 April 2024.
Again, as instructed by the Judge-Rapporteur, on 8 May 2024 Abbott lodged a Reply to the Objection to the application for provisional measures.
The Defendants lodged a Rejoinder to this Reply on 15 May 2024, equally as stipulated by the Judge-Rapporteur.
An oral hearing was held in the matter on 22 May 2024 in the Local Division of The Hague. The hearing was recorded. Abbott and Sibio c.s. submitted notes of their pleadings.
The following attorneys attended the oral hearing of 22 May 2024:
Wim Maas (Taylor Wessing, lawyer) Eelco Bergsma (Taylor Wessing, lawyer) David Mulder (Taylor Wessing, lawyer) Faziel Abdul (Taylor Wessing, lawyer) Iris van der Heijdt (Taylor Wessing, lawyer)
Peter Haartsen (AOMB - patent attorney) Raimond Haan (AOMB - patent attorney)
Dr Thomas Gniadek, Simmons & Simmons LLP Dr Fritz Lahrtz, Simmons & Simmons LLP Oscar Lamme, Simmons & Simmons LLP Diptanil Debbarma, Simmons & Simmons LLP
Abbott contends that its patent is valid and independent claim 1 as well as dependent claims 6, 7, 9, 11, 12, 13, 14 and 26 of the patent are (threatened to be) infringed by the Defendants, among others by the offering for sale of the GS1 Devices through Sibio's website sibionicsshop.com
directed at Europe. It therefore requests that the Court, for the Contracting Member States in which the patent is in force : 2
(Art. 62(1) and 67 UPCA; and R. 211 RoP)
2 Abbott made clear in its Reply to the Objection that their request does not extend to Ireland.
determination of such costs, that the Defendants pay to Abbott by means of an interim award of costs of the sum of EUR 11,000.00 or another amount as the Court may order (Art. 69 UPCA; and R. 118.5 and R. 150.2 RoP).
Abbott also requests that the amount of security, if any, be fixed separately for each enforceable part of the Court's decision.
Sibio c.s. argue that this court is not competent for Ireland. In addition, they disagree with Abbott that the patent is infringed. They further assert that the patent is (likely) invalid owing to concerns regarding added matter, lack of novelty and lack of inventive step. Additionally, they contend that the application was brought with unreasonable delay and that Abbott lacks sufficient interest in the current application. Sibio c.s. further request that the court impose on Abbott an obligation to pay for the fees and costs since Abbott did not send a warning letter before initiating these proceedings and hence unnecessary costs were incurred. They finally also wish for the court to make any measure granted subject to a security pursuant to R.211.5 RoP.
proceedings on the merits, in which facts giving rise to the entitlement to initiate proceedings and the infringement or imminent infringement of the patent, as well as other circumstances favorable to the infringement ac on, are to be presented and proven by the right holder (Art. 54, 63, 64 and 68 UPCA, R. 13.1(f) and (l)-(n) RoP), whereas the burden of presentation and proof with regard to the facts from which the lack of validity of the patent is derived and other circumstances favorable to the invalidity or revocation lies with the opponent (Art. 54 and 65(1) UPCA, Rules 44(e)-(g), 25.1(b)-(d) RoP). 3
3 See UPC CoA 26 February 2024, 10X and Harvard/Nanostring, UPC_CoA_335/2023 App_576355/2023, page 28.
electronics by the connector support when the connector support is received into the recess (3704, 4710).
4 See Case Law of the Boards of Appeal (hereinafter also 'CLBA'), 10 th edition 2022, II.E.1.1 and i.a. G2/10
5 G 3/89, OJ 1993, 117; G 11/91, OJ 1993, 125
6 CLBA, II.E.1.3.4.a
7 CLBA II.E.1.1, G1/93
Clause 32. An on-body device, arrangeable in position by way of the apparatus according to any of the preceding clause, the on body device comprising:
[0145] A related arrangement to that described in connection with FIGS. 34A-34D and 35A35D 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
8 CLBA, II.E.1.6.1.
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.
FIG. 37
FIG. 36
FIG 38
[0150] 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, 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.
FIG. 47A
FIG. 47B
FIG. 47C
9 CLBA, II.E.1.9.1, especially 4th and 5th paragraphs
FIG. 34A
FIG. 34B
FIG. 34C
[0141] Turning now to FIGS. 34A-35D, an alternative connector arrangement 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 10 that the sensor contacts 3312, 3314, 3316 are protected from moisture or any
10 The court assumes 'ensures' was meant.
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.
[0130] An alternative embodiment is contemplated in connection with the sensor approach illustrated in FIGS. 29A-29D. Using a sensor 2902 with a vertically disposed "flag" connector portion that is supported by coupling 2904, coupling 2904 is configured to snap into connector block 2908 which is attached to PCB 2914. Connector block 2908 includes a connector socket 2910 to receive the contacts portion of the sensor 2902. Connector block 2908 also includes a coupling feature 2912 to receive snap-fit tab 2906 on the coupling 2904 which retains the sensor 2902 in the connector socket 2910.
FIG. 29D
conclusion that it is more likely than not that claim 1 of the patent will be held to be invalid. All dependent claims relied on by Abbott suffer from the same problem. For the sake of clarity: claim 10 (which recites ' an elastomeric sealing member (4714) disposed within the recess (4710) ') was not invoked by Abbott.
An appeal to this order may be brought in accordance with Art. 73 UPCA and R. 220.1 within 15 calendar days of the notification of this order.
Order no. ORD_30431/2024 in ACTION NUMBER: Not provided
UPC number: UPC_CFI_131/2024
Action type:
Not provided
Related proceeding no. Application No.:
14945/2024
Application Type: