UPC medtech decisions offer insight into court process for preliminary measures

The decisions also highlight the processes for other provisional measures regarding possible patent infringements, experts in European patent litigation have said.

Abbott Diabetes Care Inc (Abbott) issued two applications for provisional measures against SiBio Technology Limited (SiBio) and Umedwings Netherlands B.V. on the same day. The applications related to two of Abbott’s patents - European patent number EP2713879 (EP879) and European patent number EP3831283 (EP283) – both for continuous glucose monitoring (CGM) devices used in the management of diabetes. The defendants are the manufacturer and an EU importer of SiBio’s CGM device called GS1.

Both patents were initially opted out of the UPC, but the opt-outs were withdrawn on 14 March 2024, a few days before the applications for provisional measures were filed on 20 March 2024.

The decisions were handed down on same day by a judicial panel comprised of the same judges, but have diverging outcomes. 

The first decision concerned Abbott’s PI application in respect of EP879, which is in force in UPC member states Germany, France, and the Netherlands. It is also in force in Ireland, which has signed, but not yet ratified, the UPC Agreement, and the UK. 

The UPC granted the provisional measures. The Local Division’s decision was made on the basis that SiBio opted not to contest the validity or infringement of EP879. This was contrary to SiBio’s earlier filed protective letter which argued that its product would not infringe Abbott’s patent. SiBio also did not challenge the urgency of the PI application, or the competence of the court. Instead, SiBio relied on the fact that it had given a unilateral cease-and-desist declaration with certain undertakings concerning the withdrawal of the GS1 device from certain European markets, which, it said, meant that application had become devoid of purpose. 

However, the court found that the defendants were not complying with this unilateral declaration because Abbott was, in fact, able to place orders for the GS1 device in both the Netherlands and Germany after SiBio made the declaration.  

“Parties seeking to provide undertakings in lieu of provisional measures being granted against them should heed to lessons of this decision in how best to frame their undertaking and also ensuring that commercial activities are suitably aligned with the form of the undertaking given,” said Chris Dixon, patent litigation specialist at Pinsent Masons.

SiBio was ordered to pay the interim costs award requested by Abbott. For importers or wholesalers within the UPC’s jurisdiction dealing in products that may be held to be infringing, it is necessary to make sure that relevant undertakings are in place with other parties such as manufacturers or suppliers to insure against the risk of adverse costs orders.

The court did not criticise Abbott despite the company failing to send warning letters to SiBio before commencing PI proceedings. 

Dixon said: “Companies should therefore be aware that they may receive little to no warning that provisional measures are being sought. As such, it remains important that where there is a threat that provisional measures will be sought by a patentee that alleged infringers have considered their strategy in response before the patentee commences PI proceedings.”

One further interesting aspect of this decision was the court’s approach to the scope of its jurisdiction.  

The UPC considered that as Abbott had indicated that the patent was in force in Ireland amongst other EU member states and that it was seeking an order than the PI cover Ireland as well. SiBio did not object that the UPC lacked competence to extend the effected of the PI to Ireland.  The court’s order therefore extended to Ireland.

Karen Gallagher, Dublin-based patent litigation expert at Pinsent Masons, said: “From an Irish perspective, this decision is very interesting. The court’s competence over Ireland as a jurisdiction was not challenged and therefore the court had no issue with extending the scope of the preliminary injunction to Ireland, on the basis that Ireland was a contracting state to the UPC. If this trend continues, we may see parties based in Ireland being subject to UPC decisions without access to the benefits that full participation in the UPC would offer. It is only through ratification that Ireland will be in a position to influence the system of the UPC and ensure that Irish companies can reap the benefits of the unitary patent system.”

Although it was indicated that the patent was in force in the UK, the UPC considered that the application for a PI in the UK was not intended as it is no longer a contracting EU member state.

The second decision related to Abbott’s application for provisional measures in respect of EP283. 

In this instance, the court denied the application. It stated that on the balance of probabilities the patent would likely be held invalid due to added matter in subsequent proceedings on the merits. The court’s decision hinged on the validity issue and emphasised the importance of thorough examination during patent prosecution.

Further, although Abbott similarly indicated that the patent in suit was in force in UPC contracting member states, including Ireland, in this case, SiBio objected that the UPC Local Division was not competent for Ireland. In its reply to the objection, Abbott made clear that its request for provisional measures did not apply to Ireland. Consequently, the UPC decided that it was unnecessary to determine whether it had competence to order measures affecting Ireland.

“The differing approaches to the court’s competence in respect of Ireland is interesting,” said Gallagher. “Applicants should ensure that their requests to the court are clearly defined, and respondents must take care to respond in a robust manner as failure to do so may mean that the scope of any proposed order may include UPC member states which have not yet ratified the UPC Agreement, therefore increasing the scope of any relief.”

Regardless of whether the parties appeal these PI decisions, the UPC is nevertheless starting to develop a body of case law in respect of its approach to provisional measures which will provide comfort and certainty to businesses seeking to litigate before the UPC, the experts said.

There was a third case between the parties, this time before the Dusseldorf Local Division UPC. The PI application hearing in that case was on 3 July, at which the parties entered into a case-specific settlement agreement.