Context: On 20 March 2024, Abbott Diabetes Care Inc. filed an application for a preliminary injunction (PI) in the Unified Patent Court’s (UPC) Local Division in The Hague against Chinese medical manufacturer Sibio Technology Limited and its European partner company Umedwings Netherlands. Abbott alleged that Sibio’s GS1 continuous glucose monitor was infringing EP831283. However, last June, the Local Division in The Hague denied the application against Sibio (while granting the one against Umedwings), ruling that, due to added subject matter, the patent would more likely than not be held to be invalid in proceedings on the merits (June 25, 2024 ip fray article). Abbott appealed against the Sibio order. It should be noted that it has been impossible for about a week to access the UPC public case registry, and the Decisions & Orders page hasn’t been updated during the same period, but ip fray is still keeping an eye on UPC developments, including this one.
What’s new: The UPC’s Court of Appeal (CoA) on Friday reversed the lower court’s decision and granted Abbott the PI. The CoA ruled that the claim would “not more likely than not” be held to be invalid due to added matter in the main proceedings. Sibio and Umedwings had also presented novelty and inventive step arguments, but the CoA rejected those too. It found that it was more likely than not that their device would be held to infringe upon the claim.
Direct impact and wider ramifications: Most notably, the CoA’s decision settled a debate in the UPC by stating that an injunction can be awarded on general terms, without the need to restrict it to specific infringing products. “The need for a limitation of the issued injunction to the specific infringing products cannot be inferred from Art. 62(1) UPCA,” it held.
The patent involved in the dispute is:
- EP Patent No. 3,831,283 (“Analyte sensor devices, connections, and methods”)
In its ruling in June, The Hague Local Division found:
“On the balance of probabilities, it is more likely than not that claim 1 and (consequently) the asserted dependent claims 6, 7, 9, 11, 12, 13, 14 and 26 of the patent will be held to contain added matter relative to the original application as filed and relative to the parent application (EP 3 300 658 A1) as filed and to the application as filed, due to the omission of an elastomeric sealing member or a second elastomeric unit in the wording of the claim.”
Claim 1 had been amended during prosecution to include features from an exemplary embodiment of the invention in the description. That description specified the the presence of an “elastomeric sealing member” in the on-body device, to seal the electrical contacts of the glucose sensor. The omission of this feature in the on-body device of the claim resulted in an unallowable intermediate generalization, it held.
On appeal, Abbott argued that the court was wrong to find that claim 1 contains added matter and that the patent was threatened to be infringed by Sibio by the offering for sale of its so-called GS1 Devices through Sibionics’ website sibionicsshop.com. It also made a request to leave to change the claim in case the CoA would consider a request to issue an injunction in general terms to be inadmissible.
But the CoA ruled on Friday (PDF) that Abbott’s request for a general injunction is admissible. According to the CoA, the need for a limitation of the issued injunction to the specific infringing products cannot be inferred from Art. 62(1) UPCA. It also found that the omission of an elastomeric sealing member did not result in an unallowable intermediate generalization.
While the CoA noted that sealing was an important way 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 – so 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.
It added:
“The scope of the general injunction requested by Abbott – which always has to be interpreted in the light of the reasoning underlying the order whereby the injunction is issued – is sufficiently clear, and not too broad.”
The CoA granted Abbott a PI in the contracting Member States in which the patent is in force: Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, The Netherlands, and Sweden.
Judges and Counsel
Presiding Judge and judge-rapporteur Rian Kalden was joined on the panel by Judge Ingeborg Simonsson and Judge Patricia Rombach, as well as technically qualified judges Patrik Rydman and Judge Marc van der Burg.
Abbott was represented by Taylor Wessing’s Dr. Wim Maas, Eelco Bergsma, Geert Theuws, David Mulder, and Iris van der Heijdt, and AOMB’s Peter Haartsen, Raimond Haan and Teun van Berkel.
Sibio was represented by Simmons & Simmons’s Dr. Thomas Gniadek, Sebastian Horleman, Dr. Fritz Lahrtz, and Dr. Diptanil Debbarma.