UPC Weekly brings you timely, thoughtful and joined-up insight into the evolving landscape of patent litigation at the Unified Patent Court.
2026 Week 37
Since our last UPC Weekly instalment on preliminary injunctions in June 2026, the UPC has issued several new cases containing some interesting and helpful nuggets for those seeking or defending against a PI at the UPC. In Part 1 of this update, we focus on three of particular interest in the medical devices space, with more to follow in the coming weeks.
Recap: 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 court needs to be satisfied that:
- the patent (probably) is 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
AngelAlign v. Align Technology
Align is the well-known pioneer company of the “Invisalign” system of orthodontic treatment, in which a patient wears a set of sequential clear retainers to gradually reposition teeth into a desired arrangement. The Appellant, AngelAlign, is one of numerous competitors which have begun operating following the expiry of Align’s first generation patents. This dispute concerned Align's patent EP 4346690 B1, covering automated real-time modification of orthodontic treatment plans, which was asserted against AngelAlign's "iOrtho" software and its "Live Now" update feature which was said to practise the “real-time” integers of Align’s patent.
The UPC Court of Appeal (CoA) upheld the PI awarded by the LD Düsseldorf, holding that the patent was more likely than not to be valid and infringed, though in doing so disagreed with the LD on several points of claim construction. We do not discuss those here, but it is a reminder of how the CoA may well examine matters afresh on these limbs. Instead, we focused on some significant procedural aspects.
The CoA had to consider several requests from AngelAlign under R. 222.2 RoP for the admission of new evidence in the appeal. It observed that particular consideration may apply when exercising its discretion under R 222.2 RoP in the content of PI proceedings. For example, the expedited nature of proceedings may lean in favour of admissibility of the evidence in this case. On the other hand, if a defendant had knowingly launched a product at risk, this may lean against admissibility. It then considered the individual requests.
The LD had disregarded new non-infringement arguments AngelAlign raised for the first time in its Rejoinder, together with a supporting witness statement, as late filed. The CoA, however, was prepared to admit these arguments, noting that Align had had several months to consider them from the date of the AngelAlign’s Rejoinder. This is an important reminder to parties that putting arguments on file, even where those arguments are held inadmissible at first instance, may set a clock running which assists in getting those same arguments admitted in the appeal. We can think of these as “sleeper” arguments.
The CoA took a different view, however, towards AngelAlign’s request to file additional validity arguments and infringement arguments which had not been before the LD. On validity, the Appellant sought to introduce new evidence to support a prior use attack – a video of AngelAlign’s software and an accompanying witness statement – which was firmly rejected by the CoA. The explanation for why this evidence could not have been presented at first instance was found to be inadequate. The CoA noted in particular that similar evidence had been filed at the EPO at an early stage of proceedings, and that AngelAlign had engaged the witness at least at the point of the first instance hearing. Admitting the evidence on appeal would prejudice Align which would have been deprived of a defence at first instance. On infringement, the CoA took a similar view that the arguments had been presented at too late a stage and its admission would unfairly prejudice Align.
On the necessity/weighing-of-interests limb, the CoA noted that AngelAlign's own marketing had promoted the infringing "Live Now" feature as a way to win over clinicians. The CoA viewed this as supporting an argument of loss of market share, coupled with a finding that a clinician's choice of aligner platform tends to be sticky and that a market-share loss caused by continued infringement would not be adequately remedied by damages alone.
Abbott Diabetes Care v. Shenzhen SiSensing
UPC_CFI_1086/2026, LD Milan, 7 September 2026
In this case, the LD Milan granted Abbott a PI based on EP 3960072 B1 against various Chinese and European companies to restrain the latter’s launch of a competing continuous glucose monitoring (“CGM”) device. A number of interesting points emerge from this decision.
Abbott objected to the admissibility of a late non-infringement argument advanced by SiSensing only in its final written submission roughly a month before the oral hearing, but notably did not ask for permission to file a short supplementary reply confined to that point. The LD admitted the SiSensing argument, with reasoning that we can see echoing the CoA approach in AngelAlign v. Align above.
The LD explained that claim construction is a matter of law the Court can address ex officio, and SiSensing’s argument concerned only the interpretation of a claim feature, and introduced no new facts or evidence. In addition, the LD felt that, had it excluded the arguments, the CoA would likely admit them into appeal proceedings, meaning the parties would be deprived of ventilating the arguments both at first instance and on appeal. Further, because Abbott had an adequate opportunity to respond at the oral hearing and had not sought permission to file further arguments in writing, admitting the argument did not offend the adversarial principle. As we saw in AngelAlign v. Align, the LD stressed this conclusion was reached "in the specific context of proceedings for provisional measures", where the front-loaded procedural model must flex somewhat given the very short time limits imposed on both sides.
However, that procedural win was of limited assistance to SiSensing. On claim construction, the LD adopted what it called a "balanced" approach to claim construction – neither Abbott's broad, purely functional reading, nor the respondents' narrow reading tied to a particular embodiment – from which it decided that, on the standard application to PI proceedings, the patent was more likely than not valid and infringed.
On acts of infringement, the fifth respondent was SiSensing’s “EU Authorised Representative” for the impugned product under the Medical Devices Regulation. In this capacity, it did not carry out directly acts of infringement such as importing, offering to sell or selling, but instead carried out regulatory steps on behalf of the Respondents’ group. The Court held that such activities amounted to acts of infringement based on the Court of Appeal’s decision in Philips v. Belkin (UPC_CoA_534/2024, 2 October 2025, Headnote 3). The concept of an “infringer” is not limited to a person who personally performs the acts referred to in Article 25 UPCA, but rather, it encompasses persons to whom the infringing acts of a third party are attributable because they acted as “an instigator, co-perpetrator or accessory”. The fact that the 5th Respondent’s acts were a pre-requisite to marketing the products lawfully and were not those of a “mere passive intermediary” led to the Court’s conclusion that the 5th Respondent was liable as an infringer. However, the Court declined to grant the specific injunctive request against the 5th Respondent (essentially restraining its regulatory activities), on the basis that the injunction against the other Respondents was adequate to protect Abbott’s interests.
The decision is also notable for how the LD assessed the balance of interests, in particular the detailed examination of the relevant market. SiSensing’s product had not yet been launched in the UPC territories, which meant the interests of patients did not have to be examined. However, the product had been launched in Spain, and also the CGM market generally had been subject to competition in the UPC states and the effects of competitor entry had been examined by the Court of Appeal in previous litigation brought by Abbot (Abbot v. Sibio, UPC_CoA_382/2024, 14 February 2025). The LD considered that two markets for CGM were relevant: the state reimbursement market (accounting for c.95% of sales) and the private consumer market. The LD was persuaded that price erosion was “entirely plausible” at least in the reimbursement market which operated a tender system (such as in Italy) or where contracts were negotiated directly with insurance companies (such as Germany). Accordingly, this factor weighed in Abbott’s favour.
Finally, on urgency/necessity, the LD held that Abbott had met this by bringing its application within 6 weeks of SiSensing notifying Abbott of its intended launch. There was clear approval of this arrangement between the parties whereby SiSensing had agreed to give at least two months' notice of its intended launch to Abbott and, perhaps as to encourage future use of such arrangements, awarded Abbot interim costs of the application at a lower rate of 30% of the ceiling of recoverable representation costs (rather than the usual 50%) in recognition of SiSensing’s good behaviour.
Cilag v. RiVOLUTION
UPC_CFI_1535/2026, LD Hamburg, 25 August 2026
Cilag obtained a PI against RiVOLUTION (a German distributor) and its EU Authorised Representative based on EP 2615984 B1, covering battery-powered surgical stapling instruments. RiVOLUTION's products are the "EnDrive Orca" and "EnDrive Zero". Both were successors to the earlier "EnDrive Beluga", which had already been the subject of separate UPC PI proceedings, including one granted by the LD Munich and one refused by the LD The Hague for lack of urgency.
RiVOLUTION argued the PI application was too late. It said the successor products were structurally identical to the predecessor as regards the battery unit and dock, that Cilag had known since 2025 that a design-around was coming, and that drawings alone should have sufficed to establish infringement well before Cilag finally issued proceedings in May 2026.
The LD rejected this. Applying the CoA's guidance in Guardant v. Sophia (UPC_CoA_19/2026 – no general market-monitoring duty, but a duty to investigate diligently once specific circumstances raise suspicion) and in Abbott v. Sinocare (UPC_CoA_901/2025 – urgency runs from when a physical sample became available, if drawings alone could not establish infringement with sufficient certainty), the LD found Cilag's had acted with the requisite speed. They had identified a source of supply on 13 February 2026, ordered the product and received it on 6 March. They had commissioned analysis in the US, received the results on 2 April, and filed the PI application on 4 May 2026. Overall, the PI application was filed within 2 months of possession of physical samples.
This case also considered the position of the EU Authorised Representative, but took a different approach to the LD Milan in Abbott v. SiSensing above. RiVOLUTION argued that the EU Authorised Representative had no standing to be sued, on the basis it was merely the point of contact for the authorities and did not carry out any specific acts that are intrinsically linked to the patent infringement or constitute an adequate causal contribution to the infringement. RiVOLUTION therefore argued that the claim for measures against the EU Authorised Representative should be suspended pending a referral to the ECJ. This question is already the subject of a pending referral as we explained in UPC Weekly 2026 w10.
The LD Hamburg declined this request, reasoning that procedural economy required that the cases between the Respondents were not separated by such an act. However, to protect the EU Authorised Representative's position in the event that the currently pending CJEU referral decided this question in the Respondents’ favour, the Court required Cilag to post security equal to the value in dispute (EUR 1,000,000) before the order against it could take effect. This is a pragmatic middle path and a notably different route to that taken in Abbott v. SiSensing, where the order against the EU Authorised Representative was simply not made despite a finding of liability.
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