Abbott Diabetes Care Inc v. Shenzen SiSensing Co. Ltd, SiBionics GmbH, Sibio Technology Limited, Sibio PTE Ltd & Shanghai International Holding Corp, GmbH,Decision of the Milan Local Division, 7 September 2026, UPC_CFI_1086/2026
Summary
The UPC Milan Local Division (“LD”) has granted a UPC-wide preliminary injunction (“PI”) in favour of Abbott Diabetes Care (“Abbott”) in a dispute concerning continuous glucose monitoring (“CGM”) devices.
This decision is important because it provides useful guidance on considerations that should be taken into account when assessing the admissibility of late arguments in PI proceedings, with the LD adopting a flexible approach to the front-loaded nature of UPC proceedings in the context of a provisional measures action.
The LD also determined the potential liability of an EU Authorised Representative.
Background
Abbott is a leading manufacturer of CGM devices which are used to monitor blood glucose levels in diabetic patients.
Abbott’s patent in issue, EP 3 960 072 B1, concerns a glucose-sensor insertion for positioning an on-body patch device, including sensor and sensor electronics assembly. The patent was initially opted out of the UPC, but the opt-out was withdrawn on 22 August 2025. Two EPO Oppositions are pending.
Abbott sought a PI before the Milan LD against five respondents (Shenzen SiSensing Co. Ltd (“SiSensing”), SiBionics GmbH (“SiBionics”), Sibio Techology Limited (“SiBio Tech”), Sibio PTE Ltd (“Sibio PTE” and Shanghai International Holding Corp, GmbH (“Shanghai International”) (collectively the “Respondents”)).
Abbott alleged that the Respondents intended to manufacture, sell, import and place on the market an allegedly infringing CGM named the GS3-R System. The GS3-R System had not yet launched in the UPC territory, but the Respondents had given Abbott notice of an intended launch and had undertaken the regulatory and commercial preparations necessary to market it.
Four of the Respondents are part of the same corporate group:
- Shenzen SiSensing Co. Ltd (“SiSensing”) is the Chinese manufacturer of the GS3-R System, and involved in the importation of the products into at least Bulgaria, Germany, Italy, Latvia, Lithuania and Slovenia. It is the parent company of Sibio Techology Limited (“SiBio Tech”);
- SiBionics GmbH (“SiBionics”) is a German company responsible for the importation of the GS3-R System into those same countries. It is a wholly owned subsidiary of Sibio Tech;
- SiBio Tech is a Hong Kong based company that controlled and operated the website (sibionicscgm.com) and was involved in the offering/selling or importing of the GS3-R System. It is a wholly owned subsidiary of SiSensing and owns shares of Sibio PTE Ltd (“Sibio PTE”); and
- Sibio PTE, a Singaporean company, is also involved in the operation of the website and offering/selling or importing the GS3-R System. It is a subsidiary of SiBio Tech.
Shanghai International, a German company, is the EU Authorised Representative of the GS3-R System under the Medical Device Regulation (Regulation 2017/745, the “MDR”).
The Respondents denied infringement and challenged validity on the grounds of insufficiency, added matter and inventive step.
Decision
The Milan LD granted the PI in favour of Abbott, holding it was more likely than not that the patent was valid, and more likely than not that the GS3-R System literally infringed claim 1 of the patent. In doing so, the LD made important observations about the admissibility of late filed arguments in the context of proceedings for provisional measures, the construction of functional claims and the liability of an EU Authorised Representative.
Admissibility of late filed arguments
The Respondents raised certain arguments concerning the interpretation and infringement of a particular feature of independent claim 1, feature 1.6 (“a cap configured to provide a closure or seal on an open end of the insertion device”) for the first time in their final written submission.
The LD allowed the arguments to be admitted in the specific circumstances of the case. Its reasoning is instructive for practitioners:
- First, the LD found that patent claim construction is a matter of law on which the Court may elaborate ex officio. Had the arguments been excluded, the UPC Court of Appeal (“CoA”) could in all likelihood have taken them into account anyway, meaning one level of jurisdiction on a substantive issue would have been lost.
- Second, the LD opined that, in accordance with the adversarial principle and right of defence, it is “essential and indispensable” that the opposing party is always given the opportunity to be heard. In this scenario, the Respondents introduced the argument one month before the oral hearing, relying on no new factual material or documents.
- Third, the LD found that significance must be attached to the applicant’s conduct. Here, Abbott merely objected to admissibility but did not request a short period in which to submit a written response, and was given an adequate opportunity to address the issue at the oral hearing.
- Fourth, the LD considered that the above factors should be assessed in the context of provisional measures proceedings, where there are considerable time pressures and parties are required to respond, and therefore formulate their arguments, within very short timeframes.
In the circumstances, the LD said that a “different conclusion would amount to an overly rigid application of the front-loaded character of UPC proceedings, at least in the specific context of proceedings for provisional measures”. This, it said, would have imposed a disproportionate restriction on the respondents’ rights of defence.
Claim construction
The LD identified the technical problem being addressed by the patent as improving the safety, ease and comfort of use of a CGM device. The solution, it said, is a fully integrated sensor insertion assembly where the sensor and its electronics are pre-assembled within the housing of an insertion device, allowing for a simplified, single-action deployment onto the user’s skin, followed by an automatic retraction of the introducer (the needle). The LD found that the core inventive concept was a single action deployment of an integrated assembly CGM.
The dispute essentially turned on whether the claims were to be read functionally (as submitted by Abbott, and implicitly favoured by the EPO OD in its Preliminary Opinion) or limited structurally to the single embodiment described in the patent (as submitted by the Respondents) which would mean that the GS3-R System would fall outside the scope of the claim.
Specifically, Abbott submitted that the relevant claim, claim 1, defines the invention by reference to its function, with the mechanism shown in the drawings of the patent being merely one way of how the invention may be carried out, and relied on UPC case law according to which claims should not be limited to preferred embodiments (i.e. a broader construction).
In contrast, the Respondents argued that the claimed functions, in particular movement and retraction of the needle, are enabled only by “movable inner housing” which, although not expressly named or numbered in the patent or its drawings, is structurally and functionally essential, meaning that any device achieving those functions by a different mechanism would fall outside the scope of the claim (i.e. a narrower construction).
The LD reiterated the ordinary principles of clam interpretation applied by the UPC, namely that the claims are the starting point, while the description and drawings must be used to interpret those claims. As such, the LD opined that limiting the claim to an element which is not described in the text of the patent but is inferred only from a drawing (as Abbott proposed), would be difficult to reconcile with the principle that the claim wording is the starting point for interpretation. On the other hand, a purely functional construction which disregards the only mechanism expressly described in the patent (as the Respondents suggested) would also be undesirable.
Ultimately, the LD rejected both extremes and adopted a balanced construction: the functional wording of the claim should be interpreted in the light of the principles disclosed in the embodiment, without being strictly confined to every structural detail of that embodiment.
Assessment of provisional measures application
The court restated the guiding principles for the assessment of an application for provisional measures, namely that the applicant must provide:
(1) reasonable evidence with a sufficient degree of certainty of their entitlement to initiate proceedings;
(2) reasonable evidence with a sufficient degree of certainty that the patent is valid and infringed, or that infringement is imminent;
(3) urgency; and
(4) a balance of interests favouring provisional relief.
For entitlement, validity and infringement, “sufficient degree of certainty” means that the relevant proposition is at least more likely than not. The respondent bears the burden of demonstrating invalidity. The LD said that this prima facie standard does not apply in the same way to jurisdiction, urgency or the balance of interests. Failure on any one cumulative condition is enough to dispose of the application, with the LD noting that “Such limited assessment is in line with the purpose of an application for provisional measures and the procedural-economy of such proceedings which should not lead to a mini-trial on the merits.”
The LD dismissed all of the Respondents’ validity challenges (insufficiency, added matter and inventive step), on the facts, finding it not more likely than not that the patent is invalid, and more likely than not that the patent is infringed on a literal basis.
Of particular interest are the LD’s observations in respect of the sufficiency of functional claims. The LD reviewed the UPC CoA’s defined standard of sufficiency, and, drawing together the principles established by UPC case law, stated that in practical terms the patent proprietor must disclose at least one clear way of carrying out the invention. Where the claim is broad and expressed in functional terms, insufficiency does not merely follow from the fact that certain embodiments falling within the claim may not work or are not specifically described, but the claim may be found to be insufficient if the opponent establishes that a substantial range of embodiments cannot be carried out without undue burden because the patent is silent on an important aspect of the invention.
In this scenario, the Respondents’ position was that the breadth of the claim must be matched by a corresponding disclosure capable of supporting it and, here, if “movable inner housing” is not considered a necessary feature of the invention according to Abbott’s broad construction of the claim, then the patent is insufficient because it does not disclose how to carry out the invention without it. However, the LD found that the patent provided the skilled person with alternative, known mechanisms.
The LD went on to observe that the Respondent’s arguments on sufficiency and inventive step appeared contradictory: they argued that practising the invention without the inner housing was a physical impossibility imposing undue burden, while also arguing that a spring-and-trigger mechanism without an inner housing was obvious from the prior art. This, the LD said, weakened their assertion that they met the “very high burden of proof” for insufficiency.
For practical purposes, this reinforces the need for consistency between insufficiency and obviousness cases to avoid damaging credibility further down the line.
In weighing the competing interests of the parties, the LD held that it entirely plausible that mechanisms of price erosion may arise in reimbursement-linked markets (both tender-based in Italy and insurance-driven in Germany), the effects of which are particularly difficult to reverse.
Additionally, the possibility for patients to switch to a lower-priced alternative exposes Abbott to a concrete risk of losing a significant portion of its customer base.
As such, the LD concluded that the balance of interests favoured Abbott.
Liability of EU Authorised Representative
Most notable in terms of liability for infringement were the LD’s findings in respect of Shanghai International, the German EU Authorised Representative.
Pursuant to Article 11 of the MDR, a non-EU medical-device manufacturer cannot lawfully place a device on the EU market without appointing an authorised representative. The LD noted that this is not merely a formal role, and, by accepting and performing that role, the representative made a material and legally relevant contribution to placing the allegedly infringing product on the market.
Relying on the UPC Court of Appeal’s approach in Philips v Belkin, the court said that “infringer” under Articles 25 and 63 UPCA is not confined to someone personally carrying out an Article 25 act. It can include an instigator, co-perpetrator or accessory to whom a third party’s acts are attributable.
As such, the LD held that Shanghai International was an infringer, and could not “be regarded as a mere passive intermediary.”
Comment
This is an interesting decision, which raises some useful practical and strategic considerations for practitioners. The key take away is that there is, where supported by the circumstances, a degree of flexibility concerning the admission of late-filed evidence in proceedings where the timetables are very tight. The decision provides guidance as to how a party wishing to object to such late filed evidence should proceed, it being prudent to accompany objections to late filed arguments with an alternative request for a written response to support procedural prejudice.
A copy of the Order can be read here.
