2025 Week 14
It’s been a big week at the UPC. So many decisions issued that normally it would be a struggle to pick out a few to report on. But one really stands out – including in effect a policy suggestion on how the UPC should assess inventive step.
Edwards Lifesciences and Meril have been battling it out since the start of the UPC over Meril’s Myval prosthetic heart valves, with claims and counterclaims of infringement and invalidity of various Edwards patents. The latest instalment is the decision on infringement and validity of Edwards’ EP 3669828 B2.
Here, in a monster 106 page judgment, the busy and influential UPC Local Division Munich decided in Edwards v Meril that the patent is valid and infringed. They took the opportunity to propose that the UPC should align itself with the EPO and routinely decide inventive step using the EPO’s problem-solution approach.
The patent and the opposition
The patent had already survived an EPO opposition, filed not by Meril but by Abbott. In the opposition, the independent claims had survived unscathed, but some dependent claims had been adjusted, to address added matter objections. No appeal was filed in the opposition.
The issues at the UPC
There were a few procedural points raised but the main issues in the case were substantive, turning on claim interpretation and inventive step. Meril relied on similar prior art to the EPO opposition.
The invention and the origami
It’s worth understanding the claimed invention, so that we can discuss the court’s claim interpretation. Claim 1 is reproduced below, including the feature numbering used by the court.
Claim 1
An implantable prosthetic heart valve (10), comprising:
1. an annular frame (12) comprising a plurality of leaflet attachment portions (30); and
2. a leaflet structure (14) positioned within the frame (12) and secured to the leaflet attachment portions (30) of the frame (12),
a) the leaflet structure (14) comprising a plurality of leaflets (40),
b) each leaflet comprising
(aa) a body portion,
(bb) two opposing primary side tabs (116) extending from opposite sides of the body portion,
(cc) and two opposing secondary tabs (112) extending from the body portion adjacent to the primary side tabs (116);
characterised in that
3. a) the secondary tabs (112) are folded about a radially extending crease
b) such that a first portion (142) of the secondary tabs (112) lies flat against the body portion of the respective leaflet (40),
4. a) and the secondary tabs (112) are folded about an axially extending crease
b) such that a second portion (144) of the secondary tabs (122) extends in a different plane than the first portion (142).
One of the embodiments helps to illustrate what all of this means. The overall valve looks like this, with a frame formed of wire and the leaflet structure being attached to the frame at 30:
There are three leaflets in the leaflet structure, each leaflet having tabs 116 and 112:
The leaflets are joined together to form the leaflet structure, which is attached to the frame. The key part of the claim is that the secondary tab 112 is folded around one crease and then folded around a perpendicular crease. In the embodiment, this leads to the folded secondary tab having first portion 142 lying flat against the leaflet 40 and second portion 144 extending in a different plane:
The patent explains that this construction provides advantages in terms of the performance of the valve when implanted, in terms of where the leaflets bend during blood flow, and also good performance during the implantation procedure, allowing it to be compressed to a small diameter and then expanded in situ without compromising its integrity.
Claim interpretation
The court followed the now-standard UPC approach to claim interpretation, but was at pains to stress this point:
… it must be emphasised that a narrowing construction of a broader claim language on the basis of the description or drawings should only be allowed in exceptional cases.
Meril had argued that the claim must be interpreted as requiring the bottom edge of the leaflet to be V-shaped, in order to achieved certain technical advantages discussed in the description. The court did not agree – this feature is not in claim 1 but is set out in different terms in a dependent claim. Also, the court noted that the description suggested other ways of achieving the same technical advantages.
In contrast, though, the court did read a limitation into claim 1 that is not explicitly there. The court considered that each leaflet is a one-piece body, noting that that there were no embodiments where this was not true. The claim says that the tabs “extend from” the body portion, and the court decided that this indicates that these tabs are an integral part of the leaflet, and that a “crease” suggests one-piece leaflets.
Inventive step – which test to use?
After rattling through and dismissing objections of added matter and lack of novelty, for essentially the same reasons as the EPO opposition division, the court came to inventive step.
Much has been said about the development of the UPC’s approach to inventive step. We’ve all been trying to understand whether the standard applied in various UPC decisions is in effect a re-badged German national approach, an approximation of the EPO approach, or an entirely new UPC approach.
The Munich Local Division decided to grab the bull by the horns and said this:
For assessing whether an invention shall be considered obvious having regard to the state of the art, the problem-solution approach (PSA) developed by the European Patent Office (EPO) 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 EPO and the Boards of Appeal (BoA).
They went on to say that, in the majority of cases, the approach used in various previous UPC decisions should lead to the same result as the EPO approach.
This statement of proposed policy really is a welcome development. The EPO has a huge volume of case law on inventive step, developed by the Boards of Appeal over many years. The problem-solution approach has been applied in practice to various different technical fields, acquiring a slightly different flavour for example in computer implemented inventions compared with life science inventions, dependent on the practical context. The key point made by the UPC is that this policy choice helps to enhance legal certainty for parties considering litigating at the UPC. The problem-solution approach may not be perfect, but it is widely understood.
After about a year’s worth of substantive decisions from the UPC, it’s becoming clear that their approach to deciding cases is well-suited to the problem-solution approach for similar reasons as at the EPO. The UPC divisions are reaching their judgments based primarily on the prior art documents submitted by the parties and relying on the scientific understanding of the technically qualified UPC judges. It is relatively rare for a decision to turn on the evidence of one of the party’s experts. In these circumstances, the problem-solution approach works well as an objective framework for reaching a predicable view on obviousness.
PSA bingo
Having decided to follow the problem-solution approach, the court’s judgment reads a bit like the EPO Guidelines. All the greatest hits were there, including mention of the technical effect, the objective technical problem, the could-would approach, discussion of motivation and the avoidance of hindsight. All perfectly at home in other tests for inventive step, to be sure, but seeing them all together drives home the message.
However, to be fair, the court made it clear that different starting points were possible for applying the problem-solution approach, using three different candidates as the closest prior art in this case. This is acknowledged by the EPO, but still EPO examiners prefer to identify just one document as the closest prior art.
Outcome and next steps
In the end, the court decided that the patent was valid and infringed. Having lost on validity, Meril was left with little to play with for their non-infringement arguments. The court awarded an injunction, ordered damages and various other remedies to Edwards.
We have to hope that this case gets to the UPC Court of Appeal. It feels like the Local Division’s declaration that the UPC should use the problem-solution approach was done in order to have the Court of Appeal deliver some certainty on this key issue.
