UPC Weekly - UPC uses EPO approach to added subject matter

2024 Week 25

There was lots of UPC news to hold the interest this week but for me the standout was a pair of orders from the UPC Local Division in The Hague. Abbott Diabetes Care filed applications for preliminary injunctions against Sibio Technology based on two related patent applications, EP2713879B1 and EP3831283B1, for continuous glucose monitoring devices.

What caught the eye was that the preliminary injunction based on EP2713879B1 was granted more or less on the nod, without much of a fight from the defendant, whereas the court refused a preliminary injunction based on EP3831283B1. The court decided that the patent was probably invalid due to added subject matter, following the EPO’s strict approach to this issue.

The patent family – and more in the pipeline

EP2713879B1 is the granted patent based on the original PCT application. Looking at the EPO online file, claim 1 was granted nearly as filed – just a few tidying up amendments were made during examination. The patent was granted in 2017, and no opposition was filed.

EP3831283B1 was granted in March 2023 from a second generation divisional application. Again, no opposition was filed. The claims of this divisional application were radically different to the claims of the original PCT application. During examination, the EPO examiner raised some strong objections of added subject matter, on the grounds that the claims included several features taken from different embodiments in the application, but without including all of the associated features of those embodiments. This is a typical EPO “intermediate generalisation” objection. However, the applicant replied with extremely detailed arguments in support of the amendments, and after a few further rounds of examination reports, succeeded in persuading the EPO examining division to allow the application.

It is notable that these two patents are not the only ones in this family. Another divisional yielded EP3300658B1, which was granted in December 2023 and therefore is open to an EPO opposition until September 2024. EP4056105B1 was granted from a further divisional. This was granted in October 2023 and its opposition deadline expires in mid July 2024 ... and so the clock is ticking on that one. There is also a further divisional application that has not yet been examined.

Opt-outs filed – and withdrawn

Both of the asserted patents were opted out from the UPC but then the opt-outs were withdrawn on 14 March 2024. If they were watching the files, this may have been a warning sign for Sibio, because the applications for preliminary injunctions were filed on 20 March 2024.

Even while the patents were still opted out, Sibio had filed a protective letter in relation to EP2713879B1, arguing for non-infringement.  Interestingly, it appears that no protective letter had been filed in respect of EP3831283B1.

Application for preliminary injunction on EP2713879B1 – granted

In the hearing for the preliminary injunction on EP2713879B1, Sibio did not rely on their protective letter arguments.  Instead, they provided a unilateral cease and desist (C&D) declaration with various undertakings and said that the preliminary injunction was therefore no longer needed. Sibio requested costs because of the lack of warning from Abbott. Based on their arguments, it seems that Sibio accepted that their product infringed the patent.

The court decided against Sibio on essentially all points. Abbott pointed to evidence that Sibio had not sufficiently complied with the C&D declaration, and that the C&D declaration did not include any requirement to pay financial penalties of the type that would normally be included in a UPC preliminary injunction.

Although Sibio complained about the lack of advance warning from Abbott, the court observed that Sibio had filed a protective letter. The court took this as meaning that Sibio was sufficiently on notice of the risk of a preliminary injunction. Sibio had to pay costs as the losing party.

Application for preliminary injunction on EP3831283B1 – refused

Here, the main issue was the validity of the patent. Infringement was not discussed, and no prior art grounds for validity were considered.

The court took the opportunity to explain their view of the standard for assessing whether an amendment unallowably adds subject matter over the content of an original patent application. Very clearly, the court explained that they were following the EPO’s approach to the assessment of added matter. They specifically referred to what the EPO calls the “gold standard” for assessing this issue, which can be paraphrased as:

Any amendment can only be made within the limits of what a skilled person would derive directly and unambiguously, using common general knowledge, from the whole of the European patent application as filed. After the amendment, the skilled person may not be presented with new technical information.

Now, it is newsworthy that a court of the UPC has decided explicitly to follow the EPO’s approach to added matter. We wondered aloud a few weeks ago about this. However, having read through the EPO file for this divisional application, it is not at all surprising that this objection was raised. The amendments made compared with the content of the original application were radical and needed 11 pages of detailed explanation and argument by the applicant. Ultimately, the EPO examining division accepted these claims. However, the UPC took a fresh look and came to the view that the number of choices that needed to be made to omit features from the various different embodiments when assembling the claim were too many. In all likelihood an EPO opposition division would have agreed with the UPC rather than with the EPO examiner.

A further point to note is that this issue was decided only in summary proceedings. In a full trial on the merits, it is still possible that the UPC will consider expert testimony on this topic of the type that is not usually available in EPO proceedings. Even in the EPO’s “gold standard” test, the key is what the skilled person would understand from the original application. With actual evidence of the knowledge and abilities of the skilled person, it is possible that the UPC would arrive at a different answer to the same question compared with the EPO.

Final thoughts

Although the big news in this case is the UPC’s reasoning for deeming EP3831283B1 to be (probably) invalid, in fact presumably Abbott will be satisfied. They have their preliminary injunction. Perhaps they will not appeal the added matter case.

The thinking of the UPC on validity is starting to become clearer.  Assuming that other divisions of the UPC, and the UPC Court of Appeal in due course, agree that EPO case law on added matter should be followed as a matter of principle, then the same logic may apply to novelty, inventive step and sufficiency of disclosure. We will see. Part of the UPC’s reasoning in this case was an assertion that the EPO’s test for added matter is followed in many national courts of UPC states. Even if this is correct, the test for inventive step is not so uniform between different national courts.

One last thought is about the relationships between opt-outs and the possibility of an EPO opposition. In this case, Abbott carefully shielded these patents from the UPC until they were ready to use them for these preliminary injunction applications. However, because of the opt-out, Sibio could have launched national proceedings in order to lock the patents out of the UPC and so avoid a UPC-wide injunction. Given that European patents are in any event open to EPO opposition for 9 months after grant, then there already exists a central revocation route against the patent for this period. For proprietors for whom opting-out is routine, it may make sense to file an opt-out only after the end of the EPO opposition period, provided that no opposition has been filed.