Since the launch of the UPC, there has been great anticipation regarding how case law will develop with regard to inventive step (Art. 56 EPC). The present article highlights three relevant UPC decisions dealing with the assessment of inventive step and shows the nuances compared to the approach developed by the European Patent Office (EPO). These decisions rely on i) claim interpretation, ii) the formulation of the technical problem, iii) a “realistic” starting point, and iv) obviousness. In a recent decision, however, the UPC calls out for the application of the EPO’s problem-solution-approach for the sake of legal certainty and consistency with the case law of the EPO and the Boards of Appeal. UPC case law on inventive step is still evolving.
UPC Court of Appeal 26 February 2024, UPC_CoA_335/2023 (10x Genomics v. NanoString)
10x Genomics applied for a preliminary injunction against Nanostring based on EP 4 108 782, a patent claiming a multiplex method for detecting analytes in cell or tissue samples. The UPC Court of First Instance (LD Munich) had previously granted that injunction. That decision was overturned by the UPC Court of Appeal (Luxembourg) on 26 February 2024: it denied 10x Genomics’ PI on appeal.
The appeals court set out ground rules for claim interpretation. Referring to Article 69 EPC, the Court set out that patent claims must be interpreted from the skilled person’s point of view. The patent’s claims are “not only the starting point, but the decisive basis for determining the protective scope of a European patent“. The patent’s description and the drawings must always be used as explanatory aids. That does not mean the patent claims merely serve as a guideline. These principles apply to both validity and infringement.
Having found the patent novel over the prior art, the appeals court’s decision turned on inventive step. First, the appeals court sets out the standard to be applied in PI proceedings. The standard to be applied is the balance of probabilities: when it is “more likely than not” that the patent is valid and infringed, a PI will in principle be granted.
The appeals court held that the injunction should be refused as it ruled it was “more likely than not” that the invoked patent was obvious in light of the prior art. The closest prior art, Göransson 2009 (D6), disclosed an in vitro method for detecting amplified single molecules (ASMs) using repeated hybridization and decoding steps. The Court ruled it would have been obvious for a skilled person to adapt this method to an in situ setting involving actual cell or tissue samples, as claimed. The Court cited prior references, including in situ applications of similar techniques, confirming this motivation. The appeals court rejected the notion that technical obstacles would have deterred such a transfer.
UPC Munich Central Division, 16 July 2024, UPC_1/2023 (Sanofi v. Amgen)
The day the UPC entered into force, Sanofi filed a revocation action against Amgen’s EP3666797, a patent claiming a PCSK9 antibody for use in treating hypercholesterolemia and certain other diseases related to elevated cholesterol levels. This case is part of a larger dispute between the parties. The Munich Central Division revoked the patent for lack of inventive step, putting forward certain ground rules on claim interpretation and inventive step assessment. An appeal is pending.
When interpreting the claims, the Court referred to the principles set out in the above-mentioned 10x Genomics v. NanoString case. It stresses that the skilled person “does not apply a philological understanding but determines the technical meaning of the terms used with the aid of the description and the drawings”. The Court added that even if the terminology used in the patent deviates from commonly used wording, the patent may provide its own lexicon which is authoritative for claim interpretation.
Having found that the patent validly claimed priority and is novel, the court then turned to inventive step. From its decision, a four-step assessment framework can be inferred that deviates from the EPO’s classic problem-solution approach:
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- The underlying problem of the claimed subject matter – While not included as an explicit step in the Court’s analysis (instead, it is part of the technical introduction), it lays the basis for step (ii) below. To determine said problem, and without a concrete formulation in the patent, the Court looked at the patent description as a whole.
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- A realistic starting point – Second, the Court looked at what could be a realistic starting point, i.e. a teaching that “would have been of interest to a skilled person who, at the priority date of the patent at issue, was seeking to develop a similar product or method to that disclosed in the prior art which thus has a similar underlying problem as the claimed invention”. There can be several realistic starting points, without it being necessary to identify the “most promising” one.
- An incentive to consider and implement the claimed solution as a next step – Third, the Court opined that a claimed solution is generally obvious if, starting from the prior art, the skilled person would be motivated (have an incentive) to consider the claimed solution and to implement it as a next step in developing the prior art.
- Reasonable expectation of success – Finally, the Court looked at whether the skilled person would have expected any particular difficulties in taking any next steps.
In applying this framework, the Court found that in casu, there was a strong incentive based on an article by Lagace to develop antibodies targeting PCSK9. A skilled person would have developed such antibodies as a next step, ending up with the claimed antibodies. The patent was therefore considered obvious.
UPC Paris Central Division, 5 November 2024, UPC_CFI_315/2023, App_571801/2023 (NJOY v. Juul Labs)
NJOY Netherlands B.V filed a revocation against the patent EP 3 504 991 B1 owned by the company Juul Labs International Inc. The patent claims a vaporization device system.
Referring to Article 56 EPC, the Paris Central Division recalled that the assessment of inventive step should be based on an objective approach, therefore excluding subjective elements such as the knowledge and skill of the named inventor(s) or the parties to the case.
Evaluation of the obviousness involves looking at whether the claimed invention did follow from the prior art in such a way that the skilled person would have found it in its attempt to solve the underlying problem based on its knowledge and skills.
Since the patent did not explicitly state the underlying problem to be solved, the Paris Central Division relied on the claim interpretation to define the technical problem based on an interrelation between claim features.
Deriving from the classical EPO approach consisting in selecting the closest prior art, the Central Division then stated that inventive step should be assessed having regard to any element that forms part of the state of the art. On the other hand, procedural efficiency may justify focusing the debate on key elements of the prior art.
While inventive steps attacks can be developed based on multiple starting points, it is still up to the claimant to define the scope of the considered prior art. That is why the Central Division explicitly did not assess the alleged obviousness of the claimed invention having regard to prior art documents raised in support of a novelty attack.
UPC case law on inventive step is still under development
In summary, the above case law shows that the UPC applies the concept of a “realistic starting point” in the assessment of inventive step, which is a teaching that “would have been of interest for the skilled person”. Unlike the strict and formalistic problem-solution approach of the EPO, this UPC approach does not require identifying the closest prior art being the “most promising springboard” for an obvious development in direction of the claimed solution. Moreover, under the UPC’s approach the underlying objective technical problem appears to be defined on the basis of the patent itself, thus, one problem of the invention that does not change regardless of the relevant prior art. Under obviousness, the UPC and EPO approach have in common that the skilled person requires a motivation or incentive to consider the claimed solution as a next step in developing the prior art.
Conversely, in a recent decision of the Local Division Munich issued 4 April 2025, UPC_CFI_501/2023 (Edwards LifeScience vs. Meril) the Court deviated from the above case law and explicitly applied the EPO’s problem-solution approach in the assessment of inventive step. The LD Munich confirmed that EP 3 669 828 directed at implantable prosthetic heart valves was inventive. In its headnote, the LD Munich outlines that the problem solution approach 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.
Two years after launch of the UPC, it still needs to be seen, in which direction the UPC approach for inventive step is evolving and further case law of the UPC Courts of Appeal will need to provide clarification to the extent of harmonization of EPO and UPC practice and case law with regard to the assessment of inventive step under Art. 56 EPC.
By Daphné Sauvajon, Ine Letten, Dirk Henderickx, Alexander Crames and Tung-Gia Du