UPC Weekly - Go compare – UPC follows EPO approach for every substantive validity ground

2025 Week 30

For a big chunk of the 2020s, Edwards and Meril have been fighting it out in various courts over prosthetic heart valve technology.  The advent of the UPC has opened up a new front between the companies, with 6 patents being litigated so far in this jurisdiction.  

This week we are able to compare a decision on the merits by the UPC with the decision of the EPO opposition division with respect to the same objections, the same amendments and the same prior art.

Having cake, eating cake

Before we get into the UPC litigation, it’s worth taking a look at Edwards’ nuanced use of the UPC for this family, which speaks volumes as to the thought that goes into the use of opt-outs, withdrawals of opt-outs and the use of the unitary patent option, particularly where EPO oppositions are expected.

Edwards are using opt-outs or the unitary patent on a case-by-case basis, carefully exposing some members of the family to the UPC.

The UPC dispute and the EPO opposition

The case reviewed this week is an infringement action brought by Edwards based on their unitary patent EP 3769722 C0 with a counterclaim for revocation by Meril.  Meril’s product is the Navigator™ THV delivery system for transcatheter heart valves.  Meril counterclaimed for revocation of the patent.  

There is also an ongoing EPO opposition, filed in the name of a patent attorney firm.  The first instance opposition hearing took place on 17 January 2025, the day after the oral hearing at the UPC.  The EPO opposition division issued its written decision very quickly (3 February 2025), maintaining the patent in amended form.  The UPC decision in infringement and validity in Edwards v. Meril issued on 21 July 2025.

The invention

When navigating a catheter through blood vessels to get to the heart, it is necessary to flex the distal tip of the catheter to allow it to be steered.  The invention is an apparatus to show the physician how much the distal tip is flexed.

Granted claim 1 is shown below, with certain features shown in strikethrough that had been deleted compared with the wording of sections of the description providing basis for the claim (paragraphs 0030 and 0031), and some features that have been added compared with those sections shown in underlining.

1. An apparatus for indicating flex of a distal end of a catheter comprising:

an elongated shaft (152);

at least one pull wire (174) connected to a distal end portion (188) of the elongated shaft (152);

a handle portion (158) comprising a flex activating member (154), the flex activating member (154) being coupled to the at least one pull wire (174) such that adjustment of the flex activating member (154) causes the distal end portion (188) of the elongated shaft (152) to flex;

a slide member (192) connected to the at least one pull wire (174); and

a flex indicating member (156);

wherein adjustment of the flex activating member (154) causes the flex indicating member (156) to move relative to the handle portion (158) to indicate an amount of flex of the distal end portion of the shaft, and

wherein the flex activating member (154) comprises a rotatable member (155, 157) which includes an internally threaded surface portion (160) and an externally threaded surface portion characterised in that the flex activating member also has an externally threaded surface portion (162), wherein the internally threaded surface portion (160) is configured to receive the slide member (192) connected to the at least one pull wire (174), and the externally threaded surface portion (162) is configured to receive an extending portion (166) of the flex indicating member (156).

Although the claim looks a bit fierce, the reference numbers can be mapped onto the drawings below.  The user turns the rotary knob 154 which both moves the indicator 156 along its slot 164 and moves the pull wire 174 to flex the distal tip 188.

Claim interpretation

This turned on just one feature.  Meril’s argument was an over-arching one: that the patents in this family relate in general to Edwards’ technology that uses an “off-balloon crimping” approach, in which both a guide catheter and a balloon catheter are used.  They therefore asserted that the “elongated shaft” in claim 1 must be considered to be part of a guide catheter or guide tube.

The court disagreed, focussing on the breadth of the wording of the claim – there was no indication in the claim that the elongated shaft must be part of a guide catheter.  Furthermore, although the patent disclosed various other original embodiments that did include guide catheters, there was no reason to read into claim 1 a limitation from these original embodiments.  The court noted that the patent derives from a divisional application having lots of different embodiments in the original disclosure.  This fact did not mean that the claims of the patent must be interpreted in the light of non-claimed original embodiments.

Added matter

The court’s explanation of its approach to added matter was as we have seen in other UPC decisions.  This is now becoming clearly established.

Meril’s arguments on this ground included the same point as they raised in claim interpretation – that the invention should be defined as including a guide catheter.  The court disagreed for essentially the same reasons as above.

Meri’s remaining arguments were that claim 1 included unallowable intermediate generalisations.  Their problem with many of these objections was that claim 1 was closely based on some broad wording set out in the statements of invention in the original application (at paragraphs 0030 and 0031).  The court dismissed each of these objections in turn, except one.

Looking at granted claim 1 above, the court agreed with Meril that subject matter had been added due to the omission of the requirement that it is the rotatable member that has an externally threaded surface portion.

This was precisely the conclusion of the EPO opposition division (OD), who, like the UPC, also considered that dependent claims 7, 9 and 10 added subject matter.  The UPC considered that dependent claims 11 and 12 were also bad for added subject matter, which was different to the conclusion of the OD, but this was due to a difference in approach to the effect of the dependencies of these claims.

Sufficiency

The court was happy with the sufficiency of claim 1, criticizing Meril’s argument as a disguised clarity objection.  However, the court decided that dependent claim 9 was insufficient.  This tallied with the provisional opinion of the EPO OD, although this reasoning was not needed in the opposition decision because by that point claim 9 had been deleted to address the added matter objection.

Inventive step – which approach?

The court (the UPC Nordic-Baltic Regional Division) took the opportunity to say this about suitable approaches for assessing inventive step:

For assessing whether an invention shall be considered obvious, having regard to the state of the art, in a structured form, the EPO has developed a test that normally is referred to as the problem-solution approach (PSA). This test is regularly used by the EPO, including the BoA, and by most national courts in the participating member states. However, there is no legal obligation to apply the PSA. Some national Courts use a different test but normally come to the same result. 

So far, the UPC has explicitly referred to and applied the PSA in some cases, but in other cases the Court has applied a test that is very similar if not identical to the test for inventive step applied by the German Federal Court of Justice. 

The parties had both used the problem-solution approach and so this division of the UPC did the same.

Outcome on inventive step

Meril had attacked claim 1 from two starting points, a document called Marchard (US 2008/065011 A1, D1 at the EPO) and a document called Bowden (EP 0787019 B1, D9 at the EPO).

Formulating the objective technical problem to be solved over the closest prior art (a key step of the PSA), the UPC said: 

The objective technical problem must be formulated in such a way that it does not contain such pointers or partially anticipate the solution. Hence, the objective technical problem relative to Marchand is to provide an apparatus which allows the indication of the adjusted flex at the distal end in a reliable and safe fashion.

The UPC came to exactly the same decision at the EPO opposition division – claim 1 was considered to be inventive.

Auxiliary requests

Earlier in the UPC proceedings there had been a dispute about the number of auxiliary requests, Meril arguing that 21 was unreasonable. The UPC thought this was OK in the circumstances.  There were even more at the EPO – 32 in total.

The UPC worked through the auxiliary requests strictly in the order that had been requested by Edwards.  The court dismissed various auxiliary requests in turn at least for including dependent claim 7, which added matter.  The first auxiliary request reached that addressed the added matter problems simply included amended independent claim 1, and no dependent claims.

After the UPC oral hearing and after the issuance of the EPO opposition division decision, Edwards asked the court to decide to allow the patent to be amended in a similar way to the EPO.  The court refused.  They said that the EPO had allowed an auxiliary request that had not been submitted in the UPC proceedings.  The court would not go into different auxiliary requests and consider the validity of individual claims separately.

Infringement – no equivalence needed

Having done the hard work on claim interpretation, the courts conclusion on infringement was straightforward.  Edwards had advanced arguments for infringement on the basis of equivalence, but these were not needed and the court did not address them.

The outcome of the case at the UPC was therefore that the auxiliary request was valid and infringed. Edwards were awarded an injunction, damages, costs and other relief.

What happens next?

The existence of EPO opposition proceedings and UPC litigation in parallel was of course foreseen when the UPC was set up.  The EPO opposition has been accelerated and the EPO Board of Appeal hearing has been scheduled for March 2026.  It is of course possible that the parties will appeal at the UPC too.

But it is not quite clear (to anyone, as far as I know) exactly what happens next to the patent in the UPC.  At present, the patent in the UPC is restricted to one amended independent claim and no dependent claims.  But there is no corresponding claim request in front of the EPO Board of Appeal.  Therefore it is entirely possible that the EPO Board of Appeal will maintain the patent in a form which the UPC has expressly refused to do.  Which takes precedence in the UPC?  Does it depend on the sequence of the EPO and UPC appeals?  Should there be a stay of any UPC appeal until the outcome of the EPO appeal is known?

This is the great thing about a new system like the UPC.  We’re all learning as we go along.  We’ll watch and report again.