The UPC has been issuing orders and decisions dealing with patent validity for over a year (with the Court’s first substantive, albeit summary, decision on patent validity having been provided by the Munich LD when it granted an application for provisional measures in 10x Genomics v Nanostring). Since then, the Court has issued numerous decisions and orders dealing with many aspects of patent validity. With the number of substantive decisions issued by the Court expected to accelerate over the coming months, we look at some themes on how the Court has approached various issues of patent validity thus far, and contrast this with the approach taken at the EPO and national courts.
In this series, we have looked at a different emerging themes in UPC case law, namely the role of expert evidence, and claim interpretation. This final article in our three-part series looks at how the Court is approaching added subject matter and the extent that it is relying on EPO case law in particular.
The EPO’s Approach to Added Matter through Intermediate Generalisation
The added matter test, which has been developed at the technical boards of appeal of the EPO, is referred to as the “gold standard” and the question is whether or not an amendment gives rise to new technical information which would not have been derived clearly and unambiguously from the application as filed (or parent application, in the case of divisional applications).
Under this approach, the EPO has developed relatively strict case law with respect to impermissible intermediate generalisations. An intermediate generalisation is a specific kind of amendment that introduces features from a particular embodiment of the invention into a broader context or broadens from a specific example to a broader term. Under EPO practice, this can result in an added matter issue unless the broader context of the application justifies the generalisation (for example, the omitted features are not necessary or essential features of that embodiment). Under EPO practice, if a generalisation cannot be justified by the broader disclosure of the application, then it may be seen as providing new information to the skilled person, and thus contravening the “gold standard” disclosure test.
This approach has been followed by a number of UPC divisions which have found patent claims to be invalid through impermissible intermediate generalisation.
Abbott v Sibio
In Abbott v Sibio (The Hague LD UPC_CFI_131/2024 19 June 2024, discussed in our previous article), a request for a preliminary injunction was denied by The Hague LD because it held that the asserted claims were more likely than not invalid for reasons of added matter.
The patent concerned an on-body device with a sensor, an enclosure and sensor electronics. It had been granted from divisional application with newly drafted claims, based on disclosure of description (rather than original claim wording). The Court found that there had been an intermediate generalisation. The asserted claims did not specify a feature of an ‘elastomeric seal’.The Court found that this had been an intermediate generalisation of the original disclosure because the feature in question was present in all embodiments which might provide basis for the claim.
The Court also considered this intermediate generalisation to be impermissible, and therefore contrary to the added matter rules of the UPC.
The Court’s reasoning had a distinctly EPO flavour.
The Court noted that “the original application cannot be treated by the patent proprietor as a reservoir of features, from which he can pick and choose features to assemble them as he wishes to draft new claims. There must be a pointer towards the combination of features selected by the proprietor.” (paragraph 4 of the reasons).
In particular, the Court reasoned the generalisation that arose from not specifying the seal was not permissible because “Abbott has failed to demonstrate the absence of a structural and functional link between the seal and the recess [of the base portion]” (paragraph 5.4 of the reasons). The Court instead considered that “the elastomeric seal would appear to be important for the proper functioning of the device … to ensure a sealed connection (keeping out moisture) as the device is assembled by the end-user” (id.).
The phrases “reservoir of features” and “structural and functional link” are notable because they are both time-tested staples of EPO case law on claim amendments based on isolating features from the description.
Thus, the Court’s reasoning in this case seems to be consistent with the added matter principles established at the EPO.
As to why the Court chose to apply EPO principles, it is notable that this is the basis of the arguments of both of the parties which is particularly interesting as the Dutch judges sitting at UPC ones did not draw on their own national case law on this aspect:
“3.4 Both parties relied on the case law of the (Technical and Enlarged) Boards of Appeal of the European Patent Office (EPO) to substantiate their arguments regarding added matter. They did not indicate whether – and if so in which way – the court should apply a different standard. This court will also apply that long-standing case law, and the court will therefore in particular apply the so-called “gold standard” disclosure test in this context, which is also the standard used in many Contracting Member States of the UPC.” (Paragraph 3.4 of the reasons).
It is also notable that from the large body of case law on added matter at the EPO, and commentary on the subject provided in the EPO’s combined case law publication, the Court in this instance noted the following:
“3.5. It is not sufficient if the claimed subject-matter is “obvious” to the skilled person in view of the original application in order to comply with the added matter provision. It is necessary that the claimed subject-matter be directly and unambiguously derivable from the original application (including any information which is implicit for the skilled person), and this is a stricter test.
3.6. This is a matter of legal certainty for third parties relying on the content of the original application and is necessary to ensure that patent proprietors do not benefit from an unwarranted advantage.”
Therefore the Court highlighted that the principle of added matter was not formalistic, but an important one to ensure is legal certainty for third parties who may be subject to patent infringement proceedings – no-one should be ‘surprised’ by the claims granted from an EP in light of the disclosure of the original application (or parent application in the case of a divisional).
It remains to be seen what will happen if the Court is presented with a different added matter standard (perhaps one more lenient to patent proprietors. For example based on national case law, or indeed if the Court were asked to consider developing a standard of its own. It may be, however, that the Court sees the EPO’s standard as the correct one to apply in order to guarantee the legal certainty that the UPC system seeks to provide.
In other cases, different divisions have reached decisions on added matter which are seemingly in line with the EPO’s approach to generalising amendments, even if EPO case law has not been specifically cited in the . However, added matter has also been dismissed for not being a ‘patentability’ argument in the oral hearing relating to 10x Genomics’s application for a preliminary injunction against Curio; albeit the decision (UPC_CFI 463/2023, 30 April 2024) states that it was unnecessary to look at added matter because the attack solely related to a claim that was not infringed.
Dexcom v Abbott
In Dexcom v Abbott (Paris LD UPC_CFI_230/2023, 4 July 2024, discussed in our previous article), the Paris LD held that an auxiliary request was not permissible on the basis that it added matter through intermediate generalisation.
The application as filed had disclosed a number of communication protocols, and the independent claim was amended to specify pairing using a protocol (generally) without specifying the particular communications protocol which had been specified in the description as being used for pairing:
“26.1 Compared to claim 1 under Auxiliary request 1, Claim 1 under Auxiliary request 2 adds the feature that the display device (20) is “configured to use the second communication protocol to facilitate pairing of the display device (20) and the sensor electronics unit (6) for communication of the first portion of the analyte measurement data indicative of analyte levels using the first communication protocol.”
26.2 DEXCOM submits that the addition is based on the description of Figure 8 […] showing how one communication protocol can be used to facilitate pairing for communication using another communication protocol. […] From all the embodiments described in connection with Figure 8, the skilled person understands that facilitating pairing is the consequence or the beneficial effect achieved by using NFC or RFID for sending commands or information from one device to another, as shown in steps 802 and 804. However, there is no basis for a broadening or a generalisation to any use of the second protocol that would be suitable for achieving the effect of facilitating pairing. […]”.
Meril v Edwards
In Meril v Edwards (Paris CD, UPC_CFI_255/2023 UPC_CFI_15/2023, 19 July 2024, discussed in our previous article) the Paris CD found the claims of the patent invalid for reason of added matter. In that case, the proprietor had generalised from a specific structure of a prosthetic cardiac valve which was disclosed in the description. The Court found that this amounted to added matter as an intermediate generalisation:
“54. It is worth noting that, pursuant to Articles 76 (1) and 123 (2) ‘EPC’ a European divisional application may only be filed in respect of subject-matter which does not extend beyond the content of the earlier application as filed. Such an extension occurs if the subject-matter cannot be directly and unambiguously deduced from the earlier application by a person skilled in the art. An undue extension may result from an amendment to the claims or the description consisting of an intermediate generalisation, i.e. by extracting one or more isolated features which, in the initial application, were disclosed only in combination with other features, thereby extending the claimed subject matter, which is no longer limited to this initial combination of features.”
It is notable in that case that the Court cited a decision issued by the first instance opposition division on a patent in the same family. That decision concerned a claim which, although different from the claim of the patent before the UPC, contained the same feature which was being considered. The opposition division of the EPO held that feature to add matter, and the Court found that decision to support its own:
“67. This conclusion is supported by the decision of the Opposition Division of the European Patent Office (‘EPO’) issued on 15 December 2022 (Gide 16), concerning EP ‘920, a patent from the same family, which states that the feature “the frame is made up entirely of hexagonal cells” adds subject matter extending beyond the content of the earlier application as filed.”
Ultimately, the Proprietor overcame the added matter issue by filing a request at the UPC to amend the claim, incorporating the omitted wording from the description to specify the structure. The patent was upheld by the UPC on that basis.
Conclusion
What can we learn from these cases?
It seems the UPC is happy to apply the EPO’s approach to added subject-matter (at least with respect to intermediate generalisations) and indeed is happy to cite even first instance decisions to support its reasoning on specific points.
However, it remains to be seen how the Court’s approach to claim interpretation will impact its added matter considerations – there is a long-established line of case law at the EPO (see Case Law of the Boards of Appeal 10e, II-F-1.3.9(b)) that added matter problems cannot be avoided by reading a broad claim narrowly (in line with the description) if its claim wording is clear and credible.
In the future there may be some interplay with the UPC’s principles of interpreting the claims in line with the description and its approach to added matter – could some potentially objectionable intermediate generalisations be ‘read away’ by interpreting broad claims narrowly in line with the description?
Moreover, whilst the UPC seems to be applying EPO principles thus far, it remains to be seen if it would be receptive to alternative approaches, based either on practice before national courts of UPC contracting states, or indeed develop its own approach.
As with other invalidity grounds, time will tell how the practice will develop.
