Abbott Diabetes Care Inc. v. Sibio Technology Limited and Umedwings Netherlands B.V., UPC Court of Appeal, 14 February 2025, Case no. UPC_CoA_382/2024
In its order of 14 February 2025, the Court of Appeal granted an application for provisional measures by Abbott Diabetes Care against Sibio Technology, a Hong Kong company, and Umedwings Netherlands. The order contains noteworthy considerations on added subject matter and the possible scope of an injunction against infringement.
The patent concerned an “on-body device”, which forms part of an applicator system configured to handle insertion of an in vivo glucose sensor, for the continuous monitoring of glucose values in the interstitial fluid of patients suffering from diabetes mellitus.
In first instance, the application for provisional measures was denied by the Local Division of The Hague. On the balance of probabilities, it was held that the patent would more likely than not be held to be invalid in proceedings on the merits due to added subject matter. Claim 1 of the patent was amended during prosecution to include features from an exemplary embodiment of the invention in the description. The description specified the presence of an “elastomeric sealing member” in the on-body device, to seal the electrical contacts of the glucose sensor. According to the Local Division, omission of this feature in the on-body device of the claim resulted in an unallowable intermediate generalization.
This decision was overturned on appeal.
In order to determine whether there is added subject matter, the Court held that it must be ascertained what the skilled person would derive directly and unambiguously – using his common general knowledge and seen objectively and relative to the date of filing – from the whole of the application as filed, whereby implicitly disclosed subject matter, i.e. matter that is a clear and unambiguous consequence of what is explicitly mentioned, shall also be considered as part of its content. The Court noted that the assessment of added matter cannot be restricted to only those parts of the original application which the patentee indicated as basis for an amended claim during prosecution, since a proper understanding of those parts would also require an assessment of their content in the context of the disclosure of the application as a whole.
When applying this standard, the Court held that the claim would not – more likely than not – be held to be invalid due to added matter in main proceedings.
The specific question of unallowable intermediate generalization was decided in the context of the object of the invention and the technical teaching of the claim.
The Court of Appeal held that the skilled person would understand from the application that the object of the invention was to provide an on-body device that is part of an applicator system which is configured to handle insertion of an in vivo analyte monitoring system, which is easy-to-use, reliable and minimizes both user inconvenience and pain. Furthermore, the on-body device would be configured such that it allows the applicator containing the on-body device to be moved freely over the skin to find the right insertion position, before the on-body device was subsequently adhered to the skin in a single step.
Against this background, the Court of Appeal held that the omission of an elastomeric sealing member did not result in an unallowable intermediate generalization.
According to the Court, the application as filed provided various detailed examples of how the sensor- and electronics assemblies of an on-body device may be configured. However, a skilled person would not consider the exact configuration of those assemblies to be relevant for the invention, as long as a configuration was chosen that would allow the aforementioned objectives to be achieved.
Although sealing was considered by the Court to be important to ensure that electrical contacts in the on-body device are protected from moisture and contaminants, the application disclosed various ways to do this other than by inclusion of an elastomeric sealing member, and the skilled person would not consider the use of an elastomeric sealing member to be necessary for achieving the overall aim and effect of the invention.
Furthermore, the novelty and inventive step arguments of Sibio Technology and Umedwings were also rejected, and it was considered that it was more likely than not that their GS1 device would be held to infringe upon the claim. For this reason, an injunction was awarded with effect in all Contracting Member States where the patent is in force.
Notably, on the scope of that injunction, the Court of Appeal settled an ongoing debate in the UPC, and held that an injunction can be awarded on general terms, without the need to restrict it to specific infringing products. According to the Court, the need for a limitation of an injunction to specific infringing products cannot be inferred from Article 62(1) UPCA.
The order can be read here.
- Geert Theuws represented Abbott in this matter.
