2025 Week 46
The last month or so has seen a significant number of decisions on preliminary injunctions (PIs) for medical devices. What’s been noticeable about many of these cases is that they come in multiples. Patentees are seeking to obtain a PI against essentially the same product, but using different patents and sometimes using different Local Divisions (LDs) of the UPC. This diversification seems to help mitigate the risk. By stacking multiple PI proceedings against the same product, the patentee only has to win once to cause serious problems for the defendant as early as possible.
We reported on two PI cases between Cilag and Rivolution in UPC Weekly 2025 w36 (Undue delay in requesting preliminary injunction – how long is too long?). In that case, Cilag had launched PI proceedings against Rivolution in relation to surgical staplers and stapler cartridges. On 6 August 2025, the Munich LD granted the PI, although without written reasons. But on 29 August 2025, and with knowledge of the outcome of the Munich LD case, The Hague LD refused to grant a PI. This was on the grounds that Cilag had delayed for too long before starting the PI proceedings. In these cases, each LD had a panel of four judges, and two judges were common to both cases.
Here we report on two more sets of PI decisions on the same product with the same “won one, lost one: product off the market” outcomes.
Grounds for a UPC PI
Assuming that the claimant is the patentee or otherwise has standing, in order to grant an inter partes PI, the UPC LD needs to be satisfied that:
- the patent is (probably) valid
- the relevant product (probably) does infringe the patent
- there is an infringing act, or infringement is imminent
- the patentee has acted without undue delay
- the PI is necessary and the balance of interests favours the PI being granted
Round 1: Abbott v. Sinocare (17 October 2025 decision)
Abbott’s patent is EP 4344633 B1 which is registered as a unitary patent. The patent claims a sensor assembly which in practice is part of an on-body device adhered to the skin and locating a sensor under the skin of the user.
Sinocare’s product is the GlucoMen iCan system for continuous glucose monitoring. The system has a sensor device, a transmitter device and a mobile app. The GlucoMen iCan had been registered as a medical product on the EUDAMED database, and a distribution agreement was announced between Sinocare and Menarini, both in early December 2024. Various online test purchases of the product had been made by Abbott at the end of April 2025. The patent was granted 4 June 2025, and the PI application was filed at The Hague LD in early July 2025. The court had no problem concluding that Abbott had moved fast enough, presumably on the basis that the PI application could not have been filed before grant.
Sinocare defended against the PI by arguing against infringement based on claim interpretation. One of their main arguments was that claim 1 should be interpreted narrowly so that it was limited to a specific embodiment in the patent. The court disagreed. In part, this was based on some of the dependent claims more clearly being directed to that embodiment, and so the court considered that claim 1 should be given a broader interpretation than the dependent claims.
On validity, the court was satisfied that claim 1 was novel and inventive. One interesting point was that Sinocare argued that some of the dependent claims included added matter. The court dealt with this by concluding that this objection did not apply to the main claims and therefore there was no need to decide on this point in the context of PI proceedings. Note that the relevant dependent claims here were not the ones that were used to assist in interpreting claim 1, which otherwise would have seemed odd.
There was evidence that the GlucoMen iCan was available in the cash pay market, made possible by the CE marking, but not yet approved in the (much larger) reimbursement market. The risk of price erosion therefore led the court to decide that the PI was necessary and proportionate. The wording of the injunction is to prohibit infringement of the patent by acts relating to the “GlucoMen iCan (or components thereof)”, rather than by reference to the wording of the claims.
Another interesting point is that Abbott asked the court to include a declaration relation to seizure of alleged infringements by EU customs authorities. The court declined to do this, saying it was beyond the scope of PI proceedings.
Round 2: Abbott v. Sinocare (22 October 2025 decision)
This case was also heard at The Hague LD and with exactly the same panel of judges as the first case. The alleged infringement was the overall GlucoMen iCan system, including the mobile phone app.
Abbott’s patent in this case is EP 3988471 B2, which was maintained in amended form after an EPO opposition. Claim 1 is lengthy, defining a glucose monitoring system including the sensor, transmitter unit and a receiver unit (e.g. mobile phone). Most of the claim concerned what the display on the receiver unit could show to the user in relation to the glucose measurements. Part of this is a “timeline graph” of glucose levels. The key part of claim 1 is shown below (with feature numbering added by the court):
A glucose monitoring system, comprising:
a glucose sensor (101) …
a transmitter unit (102) …
a receiver unit (104, 200) comprising a processor, and a user interface having a display (210) …
…
1.13 and wherein … the display (210) is configured to render the timeline graph screen (400) on the display (210),
1.13(a) wherein the timeline graph screen (400) comprises a timeline graph comprising the plurality of monitored glucose levels,
1.13(b) wherein the timeline graph comprises a lower glucose target indicator (312) and upper glucose level target indicator (314) that can be changed by the user,
1.13(c) wherein the timeline graph includes event data icons (318),
1.13(d) and wherein, in response to user selection of a particular even data icon (318) by using an input button or touching the event data icon on the display (210), the display (210) is configured to display details of the selected event.
According to the user guide of the GlucoMen iCan, the app can display this screen, showing a “trend graph” glucose level (in mmol/L) against time, with certain events shown below the graph:
The key question for infringement was therefore whether the app meets the requirement that: “the timeline graph includes event data icons”. Abbott argued that this feature is satisfied if the screen showing the graph also shows the event data icons.
The court considered that the layout of the display was the main teaching of the patent, and so a different layout of the display would be meaningful, even though it may provide the same function. On this basis, they decided that the GlucoMen iCan display shown above was not inside the scope of claim 1, because the event data icons are shown on a separate panel, before the timeline graph.
There was no discussion of infringement by equivalence. As we saw in UPC Weekly 2025 w37, the courts can consider DoE in PI proceedings. Although here the court seems to agree that the GlucoMen iCan display provides the same function as the claim, possibly their comments point to a view that the patent insists on overlaying the event data icons onto the timeline graph.
The PI was not granted, on the grounds of lack of infringement. But the court was satisfied that there had been no unreasonable delay, on the basis that it had only been possible for Abbott to assess the GlucoMen iCan from late April 2025, with the PI proceedings being launched on 27 June 2025.
Round 1: Occlutech v. Lepu (decision of 21 October 2025)
This was a PI application filed at the Hamburg LD. Occlutech’s patent is EP 2387951 B1, defining a medically implantable occlusion device, for example for closing an atrial septal defect, implanted by advancing the device in a collapsed state and then expanding it in position. The claim defines the structure of the device in terms of the shape of braided threads as they curve around the device.
Lepu’s products include the MemoCarna (ASD). This had been exhibited at trade shows in May and June 2025 and had CE marking approval.
At issue was whether it had been established that there was imminent infringement of the patent. The leading case at the UPC on this question is the UPC Court of Appeal (CoA) decision in Boehringer Ingelheim v. Zentiva, which we reviewed in UPC Weekly 2025 w33. In that case, the CoA agreed that obtaining marketing authorisation for a generic medicine is not “imminent infringement”. However, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine sets the scene for launch and can amount to imminent infringement.
Implantable medical devices are not subject to the same requirements as pharmaceuticals. They are, though, subject to different EU regulation and must be CE-marked before they can be marketed, which requires clinical evaluation.
Lepu had obtained CE marking for their products an announced this on social media in early April 2025. In combination with appearances at various trade shows and conferences, the court decided that this amounted to imminent infringement. The court did not reach a view on whether the presentation of the products at trade fairs amounted to an “offer to supply” the product, which would be an actual infringement, rather than imminent infringement.
Had there been undue delay by Occlutech in bringing the PI action? Details of the Lepu product had been in the public domain since 2023. The court explained that it was not relevant what information the patentee had before the CE marking was approved. In view of the regulatory restrictions on marketing for medical devices, the CE marking is the starting point for the patentee to investigate and assess the situation. The patentee only had access to the physical products on 18 June 2025 at a Frankfurt trade fair, and finalised and filed the PI application the same day. There was no undue delay.
The court set out a detailed consideration of claim interpretation, validity and infringement which we will not go into here, but considered that the patent was probably infringed and probably valid.
The court then turned to an assessment of the necessity of a PI and the balancing of the interests of the parties. Since the parties are in direct competition in the same market, the court assessed that there would likely be price erosion by launch of the Lepu products would be irreparable. It is not necessary for the patentee to quantify this, which was significant because there was no evidence of specific prices for the Lepu products.
The PI was granted for Germany, France, Italy, the Netherlands and Ireland. Ireland is not yet inside the UPC system, but the defendants apparently did not specifically try to resist the PI being extended to Ireland, given that one of the defendants is domiciled in a UPC country (the Netherlands).
Round 2: Occlutech v. Lepu (decision of 31 October 2025)
This was a PI application filed at the Düsseldorf LD, but with an entirely different panel of judges compared with the Hamburg LD case above. The patent asserted by Occlutech in this case was EP 1998686 B2. This defines an occlusion device for implantation in the body, such as to close an atrial septal defect. The case included the same alleged infringements from Lepu.
In UPC Weekly 2025 w44 we commented on this decision, but only about how the court used the file wrapper to interpret the claims and decide against infringement. The result was that the court did not award a PI. However, the court did go on to give its view on various other points.
Had there been undue delay? This PI application was filed on 4 July 2025, about two weeks after the one filed at the Hamburg LD. The court specifically agreed with the Hamburg LD that the start date for considering delay is the date that the patentee became aware of the CE marking. There was no undue delay.
Was there infringement or imminent infringement? If the products had fallen inside the scope of the claims, the LD explained their view that the presentation of the products at a trade fair would be an “offer” in the sense of a direct infringement of the patent. This was based on the CoA Philips v. Belkin decision, explained in UPC Weekly 2025 w41. The Düsseldorf LD did not need to decide on whether there was imminent infringement, and did not criticise the decision of the Hamburg LD. The CoA Philips v. Belkin decision may not have been available at the time the Hamburg LD was writing its decision.
The court also agreed in principle with the Hamburg LD on the points about necessity and the balance of interests between the parties. The risk of price erosion would again have been the key point.
