Short Summary
Abbott Diabetes Care sought provisional measures before the Unified Patent Court against Sinocare and Menarini concerning European patent EP 4 344 633 for 'Analyte Sensor Assemblies' related to continuous glucose monitoring (CGM) systems. Abbott alleged that the GlucoMen iCan CGM system, manufactured by Sinocare and distributed by Menarini in Europe, infringed its patent. The court granted the preliminary injunction, finding Abbott had established a strong prima facie case of infringement, the patent appeared valid, urgency existed, and the balance of interests favored Abbott.
Detailed Summary
This case concerns an application for provisional measures (R.211) brought by Abbott Diabetes Care Inc. before the Local Division in The Hague of the Unified Patent Court against Sinocare Inc. (a Chinese CGM manufacturer) and A.Menarini Diagnostics s.r.l. (an Italian pharmaceutical company).
Background: Abbott is a market leader in continuous glucose monitoring (CGM) systems in Europe with an 80% market share, having launched the FreeStyle Libre CGM system in 2014. The device comprises an applicator, an on-body unit (OBU) with an analyte sensor and sensor electronics, and a display device. Sinocare, the largest CGM manufacturer in Asia, manufactures the GlucoMen iCan, a 3rd generation CGM system. In December 2024, Sinocare and Menarini announced an exclusive distribution agreement granting Menarini rights to introduce the CGM system in more than 20 European countries. The GlucoMen iCan was registered on Eudamed on 3 December 2024 and launched in Europe by Menarini in April 2025. Abbott successfully purchased GlucoMen iCan devices in the Netherlands, Austria, and Italy.
The Patent: Abbott is the sole proprietor of EP 4 344 633 B1 for 'Analyte Sensor Assemblies,' granted on 4 June 2025 upon a divisional application from an original filing on 11 December 2012 (priority date 11 December 2011). The patent has 15 claims, with independent claim 1 covering a sensor assembly and claim 15 relating to a kit incorporating the sensor assembly.
Abbott's arguments: Abbott argued that the GlucoMen iCan infringes claims 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, and 15 of the patent. Abbott contended that the Defendants' sensor assembly includes all features of claim 1, including a sensor with a tail portion, a support, a sharp, and a sensor electronics unit with specific structural features. Abbott also argued that the Defendants' applicator assembly and container assembly infringed dependent claims.
Defendants' arguments: The Defendants argued that Abbott had not established a strong prima facie case of infringement, that the patent was invalid (particularly for added subject-matter under Article 138(1)(c) EPC), that there was no urgency since Abbott had known about the GlucoMen iCan since December 2024 but only filed the application in May 2025, and that the balance of interests favored them due to potential harm to public health and their commercial interests.
Court's reasoning: The court found that Abbott had established a strong prima facie case of infringement. The court analyzed the claim construction, particularly the meaning of 'sensor electronics unit' and 'mount,' and concluded that the Defendants' sensor assembly likely infringed the relevant claims. On validity, the court found that the patent appeared valid, rejecting the Defendants' added subject-matter arguments. On urgency, the court found that Abbott had acted promptly upon learning of the launch in Europe, and that the situation was urgent given the imminent expansion of the GlucoMen iCan across UPC territories. The court also found that the balance of interests favored Abbott, as the potential harm to Abbott from continued infringement outweighed the harm to the Defendants from the injunction, particularly given that the GlucoMen iCan was a new product not yet widely distributed.
Order: The court granted the provisional measures, prohibiting the Defendants from infringing EP 4 344 633 in UPC territories by making, offering, placing on the market, using, supplying, or importing the GlucoMen iCan. The Defendants were ordered to provide a written account of the origin and distribution channels of the GlucoMen iCan, to deliver up any products in stock, and to pay penalty payments for non-compliance (up to EUR 100,000 per day, maximum EUR 1,000,000 per Defendant). The Defendants were ordered to pay Abbott EUR 11,000 in costs, and the value of the dispute was set at EUR 4,000,000.
Practitioner Note
This case demonstrates the evidentiary and procedural standards applied in patent matters before The Hague (NL) Local Division. Understanding the court's reasoning in Abbott Diabetes Care Inc. vs Sinocare Inc. and A.Menarini Diagnostics s.r.l. is valuable context for structuring arguments or assessing risk in similar proceedings.
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