Abbott and Dexcom have been embroiled in a series of patent disputes concerning their continuous glucose monitoring (CGM) devices and systems.
A previous win for Abbott at the Unified Patent Court (UPC) saw one of Dexcom’s patents revoked in its entirety across all contracting states (as previously reported here: Dexcom vs Abbott at the UPC – Appleyard Lees). The case highlighted that applicants considering a patent with unitary effect face a strategic decision as to whether the broad and cost-effective territorial coverage provided by a unitary patent (UP) justifies the risk of central revocation – under which a single finding of invalidity at the UPC can result in the patent being revoked across all UPC jurisdictions.
Abbott’s run of success has continued at the UPC, with the Court recently issuing a preliminary injunction over two other competitors, Sinocare and Menarini.
In this article, we take a look at the decision and consider the considerable power of preliminary injunctions as a remedy at the UPC. We also touch on the UPC’s developing reputation as a “patent friendly” jurisdiction – a reputation that could encourage more applicants to obtain a Unitary Patent or to opt in to the jurisdiction of the UPC (in the transition period).
Background: Continuous Glucose Monitors
Traditionally, diabetic patients have monitored their glucose levels by taking small blood samples using the familiar ‘finger‑prick’ method. In the past two decades, however, CGM systems have emerged as a more convenient and informative alternative. CGM devices comprise small sensors inserted just under the user’s skin, typically on the upper arm or torso. Once applied, they take frequent readings of glucose concentrations in the interstitial fluid to estimate blood glucose levels. These readings are transmitted wirelessly to an external device, such as a smartphone, which displays the data and can alert the user when glucose levels fall outside a predetermined range.
CGMs have transformed glucose control for diabetic patients who must routinely check and adjust their blood glucose levels to help minimise the effects of blood sugar imbalance. CGMs are now also marketed to the wider public looking to assess and improve their general health.
Due to the high prevalence of diabetes, and the increased interest in fitness tracking, the market for CGM devices is already huge, and it is set to grow.
A number of devices are available on the market, including products from Dexcom (G6 and G7 and Stelo), Abbott (Freestyle Libre, Freestyle Libre 2 and 3), Sinocare (Sinocare iCan i3) and Menarini (GlucoMen iCan). In the UK, Abbott’s devices are supplied to patients on the NHS. The GlucoMen iCan device is available in the UK, and is approved for non-adjunctive use, meaning that it can be used as the sole basis for insulin dosing decisions without a confirmatory finger prick blood glucose test.
EP4344633 (EP’633)
In June 2025, Abbott were granted a European patent, EP4344633 (EP’633), for their CGM technology, which was registered with unitary effect. The CGMs described in the patent comprise three distinct components:
- a sensor assembly, which contacts the user’s interstitial fluid to obtain measurements;
- an electronics assembly, which provides the necessary circuitry for sensor operation; and
- an adhesive patch, which secures the combined assemblies to the user’s skin.
Claim 1 concerns the sensor assembly:
1. A sensor assembly comprising:
a sensor having a tail portion, a contacts portion, and a bendable portion;
a seal including electrical contacts disposed to align with the contacts portion of the sensor and to allow electrical signals to pass through the seal;
a support including a distal surface and features for sealably coupling to an electronics assembly; and
a sharp including a channel for supporting the tail portion of the sensor and a hub for gripping the sharp during retraction, wherein the seal is shaped to enclose the contacts portion of the sensor within the support.
For the sake of this discussion, the key feature of claim 1 is that the sensor assembly must comprise “a sharp” including a channel for supporting part of the sensor and a hub for gripping the sharp during retraction. The sharp may be a needle, for example, and it essentially facilitates insertion of the sensor under the skin of a user.
Claim 15 relates to a kit that includes the sensor assembly described above, together with an on‑body device. The on‑body device is required to comprise an adhesive patch and an electronics assembly including sensor electronics and an enclosure surrounding said sensor electronics. It is also required that the sensor electronics include a circuit board, a processor and a communications facility.
Application for Provisional Measures
In December 2024, GlucoMen iCan was registered on the European Database on Medical Devices (EUDAMED), mentioning that the product pertained to the same family of medical devices as Sinocare iCan i3. The devices were made available in Europe under a distribution arrangement in which Sinocare (a Chinese company) manufactured the product, while Menarini (an Italian company) was responsible for their marketing and distribution within the European market. In April 2025, Menarini launched the GlucoMen iCan in certain territories in Europe, including the Netherlands.
In July 2025, Abbott filed an application for provisional measures before the Hague Local Division of the UPC against Sinocare and Menarini. In the application, Abbott alleged that both companies were individually and jointly infringing EP’633 in contracting member states by commercialising the GlucoMen iCan CGM device.
In particular, Abbott sought an immediately enforceable injunction to provisionally prevent either defendant from infringing EP’633 in any way.
Response by the Defendants
In response, the Defendants argued that no form of interim relief should be granted.
In doing so, they argued that it is more likely than not that main proceedings would determine they were not infringing and, further, that EP’633 would be found invalid for lack of novelty and inventive step over several patent applications from Dexcom relating to their CGM technology (US2007/0208245, US7905833, US2011/290645 and US2006/0142651; the “Dexcom patent family”). It was also contended that the granted claims contained added matter.
Finally, the Defendants argued that the case lacked the necessary urgency required for interim relief.
Proceedings before the UPC: First instance decision
The scope of the UPC to grant preliminary injunctions is provided for under Article 62 of the UPC Agreement, which is substantiated by Rule 211(2) of the UPC’s Rules of Procedure. In a nutshell, the UPC must be convinced that:
- The Patentee is entitled to bring actions before the Court;
- The patent in question is valid (or at least more likely than not valid);
- The patent is being infringed or that infringement is imminent (i.e., that the product infringes the patent and that there is an existing or imminent infringing act);
- An injunction is necessary when considering i) the interests of the parties and ii) the potential for harm (for either side) should the injunction be granted or refused; and
- There has been no unreasonable delay in seeking the preliminary injunction.
Each of these points were thus considered by the Court.
Jurisdiction
The Court began by establishing its jurisdiction over the case.
The Hague Local division concluded that it was competent to hear this matter because Abbott had successfully shown evidence of infringement in the Netherlands. It further concluded that, despite Sinocare having domicile in China, they were subject to the UPC jurisdiction because they were undisputedly the manufacturer of the allegedly infringing products. They were also actively cooperating with Menarini to bring these devices to the European market.
Urgency
The Court found that Abbott had successfully demonstrated the necessity for urgent relief to prevent imminent alleged infringement. In particular, it was noted that Abbott’s application had been brought within only a month of the European application being granted.
Infringement
The Court also concluded that it was more likely than not that the Defendants were infringing the patent, rejecting a narrower interpretation of the claims presented by the Defendants.
Validity
In the assessment of validity, the Court focused on claims 1 and 15, because these claims were considered most relevant to the alleged infringement. On this point, Sinocare argued that some of the dependent claims included added matter (and were thus invalid). However, interestingly, the Court noted that this objection did not apply to independent claims 1 and 15. It therefore concluded that there was no need to decide on this point in the context of proceedings for a preliminary injunction.
When assessing novelty, the Court concluded that the sensor system of Abbott was novel over the Dexcom patent family. This is because the sharp of the Dexcom devices – or needle as referred to in the relevant documents – is part of a separate sub-assembly wherein the sharp only engages with contact sub-assembly only during insertion in the user’s skin. In contrast, the claims of EP’633 require the presence of a sharp as an integral part of the sensor assembly.
Turning to inventive step, the Court found that the skilled person would not be motivated to incorporate a sharp into a sensor assembly based on the teaching of the Dexcom patent family. This is because, in the Court’s view, doing so would require a completely different insertion procedure, with differently designed components, which is not disclosed in the prior art. It further concluded that Dexcom did not provide the necessary incentives for making these changes. It was therefore considered more likely than not that the claims were inventive.
The UPC therefore concluded that it is more likely than not that the patent will be considered valid and infringed.
Balance of Interest and the Decision
As a result, the Court concluded that in the balance of interests to each party, a provisional injunction should be issued against the sale of the GlucoMen iCan CGM device. The injunction was generally worded to stop any form of sale, including by prescription or private purchase and was not subject to any kind of security – in which Abbott would have to set money aside in order to reimburse the defendants for losses in the event that they were later found to be not infringing the patent.
Abbott were further awarded information on the Defendants’ distribution channels, an order to deliver up to a bailiff any GlucoMen iCan CGM devices in UPC contracting states, and an interim award of costs.
Appeal
Unsurprisingly, the Sinocare and Menarini lodged an appeal against the decision.
As well as reiterating their previous arguments, they further argued that the injunction was worded too broadly meaning that it wrongly encompassed their Sinocare iCan i3 device, for which the requirement for urgency had not been established. Sinocare iCan i3 has been on the market since October 2023 (compared to the GlucoMen iCan CGM deice, which was launched more recently). Additionally, it was argued that the Court did not have jurisdiction, that the decision should be set aside on the basis of a number of procedural and substantive issues, and that the main claims contain added matter.
The UPC Court of Appeal rejected each of these arguments in turn.
Regarding the broad wording of the injunction, it noted that the injunction was appropriately worded in line with previous case law. Abbott did, in any case, clarify that the injunction was solely intended to cover the GlucoMen iCan device and this was noted in the appeal decision.
On the question of the competency of the Court to hear the case, Menarini attempted to challenge the jurisdiction for the first time on appeal. This was swiftly dismissed by the Court of Appeal on the basis that the objection could not be raised for the first time on appeal. In any case, it noted that the GlucoMen iCan device was offered on a website available throughout Europe, including the Netherlands, and so the Hague Local Division did have jurisdiction.
In contrast, Sinocare had challenged the jurisdiction of the Court at first instance. Nevertheless, the Court of Appeal concluded that the Hague Local Division did have jurisdiction, noting that it is not disputed that the Sinocare is the manufacturer of the allegedly infringing products and is named as such in the EUDAMED entry for the GlucoMen iCan. It further noted that there is at least a joint threat of infringement in UPC territories because Menarini and Sinocare announced that they would cooperate in bringing the product to the European market.
Regarding the procedural issues, the Appeal Board noted that these issues were unfounded and, in any case, were irrelevant to the first instance decision.
Although the added matter objections were deemed irrelevant to proceedings at first instance because they were only raised in respect of dependent claims, the Appellants raised a new added matter argument against claim 1. Not only did the Court of Appeal dismiss the arguments as late-filed, but it also considered that there was support for the claims in the application as filed.
The UPC Court of Appeal therefore agreed with the Hague Local Division that the patent is more likely than not valid and infringed and, thus, upheld the preliminary injunction.
Take home
This case illustrates the considerable power of preliminary injunctions as a remedy, particularly in preventing potentially irreparable harm arising from patent infringement.
Because of the significant and often immediate impact that an injunction can have on an alleged infringer, courts, rightly, impose strict conditions before granting such relief. As discussed above, both the UPC and national courts (including the UK under the American Cyanamid framework) require, among other things, that the applicant has acted without unnecessary delay in seeking the injunction. This underscores the importance for patent holders of remaining vigilant in monitoring potential infringements and of acting promptly to enforce their rights once infringement is identified.
There is also a growing body of evidence that the UPC is a “patentee-friendly” jurisdiction, which may further encourage applicants to “opt into” the system.
Cases are heard – and decisions are issued – within a short timeframe, making it a promising forum for patent enforcement, particularly when considering that a multi-jurisdiction injunction could be obtained very quickly. As highlighted above, as well as the advantage of speed, the UPC appears to be taking a favourable approach to proceedings for preliminary injunctions, making it easier for Patentees to prevent potential infringement.
As a final point, it is worth noting that Sinocare have challenged the validity of EP’633 at the EPO by filing an opposition. Proceedings are in the very early stages, with the notice of opposition having been filed in March, but they have been expedited in light of the related UPC action. It will be interesting to see if the EPO come to the same, or a different, decision on the validity of the claims (or likely validity of the claims in the case of the UPC decision). We’ll be keeping a close eye on it!
