Inventive step at the UPC: two years on
Assessment of inventive step at the Unified Patent Court (UPC) has included a mix of the problem-solution approach from the European Patent Office (EPO), the approach applied by the German Federal Court of Justice, and a smattering of national patent court assessments sprinkled in for good measure.
In this article, we discuss Edwards Lifesciences Corporation v Meril Life Sciences Pvt Ltd (UPC_CFI_501/2023) in which the Munich Local Division stated that the EPO’s problem-solution approach should be primarily applied to the extent feasible and to align with the EPO for the assessment of inventive step throughout the UPC.
A short history of inventive step at the UPC
Shortly after the launch of the UPC, we proposed that precisely how and under which criteria the UPC would assess inventive step during invalidity was unknown. At the time, we considered it was possible that the UPC might adopt the approach of the Boards of Appeal of the EPO; approaches of member states with broadly similar approaches to the EPO, such as France, Sweden, and Italy; or markedly different approaches such as those used in Germany.
Twelve months on, we investigated how the UPC Court of Appeal had evaluated inventive step in the long running Nanostring Technologies v 10x Genomics Inc dispute. In this decision the Court of Appeal appeared to follow a somewhat similar approach to the problem-solution approach at the EPO, without endorsing or criticising any particular approach, nor referring to any case law.
Two years after the launch of the UPC, the Munich Local Division (notably the most active of the local divisions, with over 120 cases lodged in 2024) appears in Edwards Lifesciences Corporation v Meril Life Sciences Pvt Ltd to suggest that the varying approaches to the assessment of inventive step by the UPC Courts of First Instance and Court of Appeal may need to align. In the decision, the Munich Local Division states that the UPC should align with the established jurisprudence of the EPO, namely by primarily following the EPO’s problem-solution approach for the assessment of inventive step.
Key UPC inventive step decisions
In an early decision, UPC_CFI_2/2023, issued on 19 September 2023, between NanoString Technologies and 10x Genomics Inc, the Munich Local Division stated, “An important criterion in choosing the most promising starting point is the similarity of the technical task”. The court dismissed prior art references on the basis that “the court cannot see that this document suggests the invention according to the patent”, appearing to follow a problem-solution approach for the selection of the closest prior art.
In UPC_CoA_335/2023, issued on 11 March 2024, also between NanoString Technologies and 10x Genomics Inc, the Court of Appeal found that the document dismissed by the Munich Local Division (Göransson – D6) “would have been of interest to a person skilled in the art”.
In UPC_CFI_1/2023, issued on 16 July 2024, between Sanofi-Aventis and Amgen Inc, the Munich Central Division laid down some basic steps to follow for the assessment of inventive step. These were:
- determining a realistic starting point in the art, which has a similar underlying technical problem;
- comparing the claimed subject matter, after interpretation, to this starting point; and
- establishing whether it would be obvious for the skilled person to, starting from the realistic starting point, in view of the underlying problem, arrive at the claimed solution.
Notably in UPC_CFI_1/2023, the Munich Central Division stated that for a piece of prior art to be realistic it merely needed to be “of interest” to the skilled person. Additionally, the underlying technical problem was first to be established from the background section of the patent, and when that failed, from the patent description as a whole. This establishment of the underlying technical problem diverged from the EPO’s problem-solution approach, where the technical problem is formulated objectively and based upon the closest prior art.
Accordingly, it appeared that the UPC was in the midst of developing its own approach to the assessment of inventive step. This approach possessed some similarities to the EPO’s problem-solution approach, whilst simultaneously possessing marked differences, particularly in the selection of “any realistic starting point”, and consideration of the “underlying” technical problem as opposed to an “objective” technical problem.
The present case background
Edwards Lifesciences Corporation’s patent (EP 3 669 828 B2) concerns a transcatheter prosthetic heart valve and was first opposed by Abbott Cardiovascular Systems in February 2022 at the EPO. Following opposition proceedings, the patent was maintained in an amended form. In particular, claim 9 as granted was deleted from the granted claims and claim 10 was maintained in an amended form. The remaining claims, including independent claim 1 remained as granted. No subsequent appeal was filed.
Subsequent to these opposition proceedings, Edwards bought an infringement action in the UPC Munich Local Division against several Meril entities. A counter-claim for revocation was filed. In the decision from the Munich Local Division, UPC CFI 501/2023, the patent was upheld in the form maintained by the EPO’s Opposition Division. The Munich Local Division further handed down an injunction enforceable by Edwards, alongside damages, and other remedies. As part of the decision the Munich Local Division made what could be considered a “landmark ruling” on the assessment of inventive step at the UPC, although this decision and statement may still be challenged at the UPC Court of Appeal.
The Munich Local Division’s ruling
The second headnote of the decision states: “For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach developed by the European Patent Office shall primarily be applied as a tool to the extent feasible to enhance legal certainty and further align the jurisprudence of the Unified Patent Court with the jurisprudence of the European Patent Office and the Boards of Appeal.”
In its assessment of inventive step, the Munich Local Division discussed the current legal standard of the assessment of inventive step at the UPC.
First, the Munich Local Division set out that both the UPC Courts of First Instance and the UPC Court of Appeal have assessed inventive step in a variety of ways, with some using the problem-solution approach of the EPO, and others using a test that is similar if not identical to the one applied by the German Federal Court of Justice. The Munich Local Division then opines that, if applied correctly, both tests should result in the same outcome in the majority of cases. This suggests an admittance that the use of different assessments of inventive step may not always result in the same outcome, which is an uncomfortable position for any UPC user to deal with. However, the Munich Local Division stated explicitly its intention to use the EPO’s problem-solution approach, and further, that there is a “need for legal certainty for both the users of the system and various divisions of the Unified Patent Court”.
Of interest to those involved in both UPC and EPO proceedings is that when discussing a document cited as closest prior art during the prior opposition proceedings, the Munich Local Division explicitly included the appropriate passage from the EPO’s Opposition Division’s decision in its decision. Further, the reasoning of the Munich Local Division is reminiscent of decisions from the EPO; for each document taken as closest prior art, it considers the difference, the technical effect associated with this difference, and then proceeds to formulate an objective technical problem. The final step is a consideration of whether the skilled person “would” be motivated to arrive at the claimed solution from the prior art.
If this case is taken to the UPC Court of Appeal, the Munich Local Division appears to be inviting the UPC Court of Appeal to comment, and provide explicit legal certainty on this issue. Whether it will choose to do so is another matter entirely.
Moving forward, does the UPC intend to align fully with the EPO?
Users of the UPC system and patent practitioners welcome clarity and legal certainty on any substantive issue the UPC Courts provide. As the system continues to develop, even small changes in assessment of issues such as inventive step could result in significant divergence between the case law at the EPO and UPC.
Whilst this particular case appeared to also follow the established EPO practice in its assessment of novelty, not all UPC Courts seem to agree, with the Paris Local Division notably departing from standard EPO practice by finding a single selection from a list novel. One would think that if the UPC takes the stance that it should follow EPO jurisprudence on one substantive issue (for example, inventive step) that it would also want to align on other issues, such as novelty.
We will be keeping a close eye on future decisions, to see if this adherence to established EPO jurisprudence becomes a mainstay of UPC practice.
If you are considering initiating a legal action within the UPC and want more information on how the assessment of inventive step at the UPC may affect such action, please contact your usual D Young & Co representative for further information.
Case details at a glance
Decision level: Munich Local Division
Case: ORD_598588/2023
Parties: Edwards Lifesciences Corporation v Meril GmbH, Meril Life Sciences Pvt Ltd and Meril Italy Srl
Date: 04 April 2025
Decision: dycip.com/upc-ord-598588-2023
Related articles
Inventive step? How will the UPC decide?, 11 October 2023: dycip.com/upc-inventive-step-oct2023
Inventive step at the Unified Patent Court: 12-months in, what do we know so far?, 06 June 2024: dycip.com/upc-1year-inventive-step
UPC Annual Report 2024 (PDF): dycip.com/upc-annual-report-2024
UPC departs from EPO selection principle in novelty analysis: Dexcom v Abbott, 08 August 2024: dycip.com/dexcom-abbott-aug24
