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 Local Division (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 multiple aspects of patent validity. With the number of substantive decisions issued by the court expected to accelerate over the coming months, it is possible to build a picture of how the court has approached various issues of patent validity thus far and to compare this with the approach taken at the EPO and national courts.
Inventive step has been an important issue in a number of substantive UPC decisions to date. In this series of articles, however, we will focus on several other emerging themes in UPC case law, namely the role of expert evidence, claim interpretation, and the Court’s approach to added matter.
In this article, we will look at the role of expert evidence in the Court’s examination of patent validity.
Expert evidence
Expert evidence plays a role in the assessment of patent validity in the national courts of a number of UPC member states, albeit to varying degrees. For example, in FRAND cases in Germany, expert declarations are often filed by parties but the experts are rarely asked questions during the hearings. In contrast, in the Nordic countries, the submission of expert evidence is most often followed by the questioning of those experts during the hearing. Expert evidence also plays a key role in patent proceedings at the UK High Court, whereby expert reports are lengthy and the experts are subject to substantive cross-examination during trial. The substantial reliance of the High Court on expert evidence has led to strict requirements in the way that expert evidence for UK patent proceedings is prepared.
In contrast to these national courts, expert evidence generally has a limited role in the vast majority of proceedings before the EPO. In most cases, parties do not submit expert evidence and, even where evidence is submitted, the EPO will often not rely on that evidence in its reasoning. It is also rare for the EPO to take evidence from expert witnesses at hearings.
We have now seen a number of validity cases before the UPC in which parties have relied on expert evidence. From the emerging decisions in these cases, it is possible to gain some insight on how the Court is approaching such evidence.
The role of expert evidence
In Sanofi v Amgen (Munich CD, ORD_598362/2023, 16 July 2024, discussed in our previous article), inventive step was the focus of the discussion at the oral hearing and also formed the main part of the Munich CD’s decision. The parties relied heavily on expert evidence in support of their positions.
In its decision revoking the patent, the Munich CD set out the legal framework for assessing inventive step. Of note for this article, the Court stated the following:
“8.3 Whether inventive step is acknowledged is always to be assessed in each individual case and requires a legal evaluation of all relevant facts and circumstances. As held by the Court of Appeal in NanoString/10x Genomics (p. 30, fourth par.) the burden of presentation and proof with regard to the facts from which the lack of validity of the patent is derived and other circumstances favourable to the invalidity or revocation lies with the claimant in a revocation action (Art. 54 and 65(1) UPCA, Rules 44(e)-(g), 25.1(b)-(d) RoP). Even though proof of certain facts, if contested, may thus be required, the ultimate assessment of the relevant facts circumstances is a question of law which does not lend itself to the taking of evidence.”
Therefore, it is the proof of certain facts in dispute between the parties where the Court is likely to consider expert evidence to be most relevant. This is consistent with the Rules of Procedure on evidence, in particular Rule 172.1 RoP:
“Evidence available to a party regarding a statement of fact that is contested or likely to be contested by the other party must be produced by the party making that statement of fact.”
In broad terms, the approach set out in the Sanofi v Amgen decision is similar to the approach taken by the national courts of UPC member states and the UK, where expert evidence may assist the court in making certain findings of fact, but the assessment of facts and the ultimate decision on whether a patent claim is obvious is a question of law to be decided by the court.
A good illustration of how expert evidence is to be used following the above approach is found in Alexion v Samsung Bioepis (Hamburg LD, ORD_38059/2024, 26 June 2024). In that case the Hamburg LD relied heavily on expert evidence to identify the common general knowledge of the skilled person at the priority date and used that to decide how the skilled person would have read the claims in issue.
The hearing of expert witnesses – a diverging approach?
As noted above, in proceedings in the UK and Nordic countries (for example) it would generally be expected that an expert witness would be heard and potentially cross-examined at the hearing on the merits. In Germany, on the other hand, the Courts are more likely to rely solely on written expert evidence. Moreover, at the EPO, the hearing of expert witnesses is exceedingly rare. The UPC provides for the hearing of expert witnesses in hearings, but already a divergence in approach may be emerging in the circumstances in which divisions of the UPC consider it appropriate to take expert evidence at a hearing.
Before the Munich LD, in Edwards v Meril (ACT_459987/2023) both parties requested that either their own expert witnesses be heard at the hearing on the merits, or else that the court appoint an expert. However, in a procedural order the interim conference (ORD_598441/2023, 6 September 2024) the Court refused requests from both parties to have their witnesses heard. The hearing duly took place without hearing experts from either side, but with the decision on the merits now available (ORD_598479/2023, 15 November 2024) it is clear that the Court was happy to refer to, and to some extent rely upon, the expert evidence provided in writing without the need to hear the experts in person, in spite of this being requested by the parties.
Conversely, the Nordic-Baltic regional division (RD) seems to be more open to the hearing of expert witnesses, perhaps in line with the expectation of local judges from their national practice. For example, in a preliminary order in Abbot v Dexcom (ORD_55063/2024, 7 October 2024), the Court has scheduled a full day for hearing evidence from the party experts the day before the hearing on the merits. Interestingly, the same order has invited both parties to clarify in writing the reasons to hear their expert witnesses and the topics on which they will present. Thus, it appears that the Nordic-Baltic RD is happy to schedule time to hear expert witnesses, even in the absence of a specific technical issue to which they would speak having been identified.
At present, then, it appears that some divisions may be more receptive to the hearing of evidence from expert witnesses than others, perhaps informed by judges’ experience from local national courts. It remains to be seen how the Court’s approach to the hearing of witnesses will evolve and whether or not practice will converge between the divisions on the circumstances in which the hearing of witnesses is required.
Expert evidence should be used in a specific manner by parties – Paris CD
The Paris CD also dealt with expert evidence in its first revocation decision, in the case of Meril v Edwards (Paris CD, ORD_598365/2023, 19 July 2024), in which Meril had sought revocation of Edwards’ patent relating to a prosthetic valve and delivery catheter system.
One aspect of Meril’s case was that one of the auxiliary requests lacks inventive step because the combination of features in the relevant claim does not offer any discernible technical effect over the prior art. Meril asserted that that there were no data in the patent demonstrating the technical effects promised by the patent and that, furthermore, there is no overall technical effect provided across the whole of the relevant claim (at most, the technical effect extends to one embodiment only).
The Court noted that the burden was on Meril to present evidence for the alleged lack of a technical effect, in order to rebut the presumption of validity accorded to the granted patent. Although Meril relied on expert evidence in support of its arguments, the Court found this evidence did not meet the required threshold:
“125. The claimant fails to provide such evidence and the reported declarations do not appear to be conclusive as the reference to Prof. […] declaration seems to be generic, lacking a specific indication of the relevant passage. Nevertheless, the fact that a feature is not sufficient for achieving a specific technical effect does not mean that this feature is not relevant.”
The Court criticised both the content of the expert evidence and the manner in which it had been used. With respect to the content of the evidence, the Court noted that the fact that a feature is, by itself, not sufficient for achieving a technical effect does not mean that the feature is not relevant. In this regard, it appears that the Court was looking for positive evidence that the feature has no technical effect. With respect to the manner in which Meril had relied on the expert evidence, the Court noted that the evidence had been relied on in a generic way, without a reference to the specific passage of the declaration that supported Meril’s position.
This decision provides another example of the UPC taking into consideration expert evidence before it. In fact, the Paris CD’s criticism of the expert evidence demonstrates that the judges must have read the evidence and considered it in some detail.
An important take-away is that evidence needs to be used in a specific manner so that the Court is clear which parts of the expert evidence support the legal arguments. Failure to do so may result in the Court placing less weight on the evidence.
The UPC is equipped to deal with expert evidence – Court of Appeal
Of course, one significant feature of the UPC is its deep bench of technically qualified judges (“TQJs”). In 10x v Nanostring, the UPC Court of Appeal (“CoA”) has provided guidance on the role of the TQJs and how this enables panels to deal with expert evidence placed before them.
At first instance, the Munich LD held that there was a “sufficient degree of certainty” that the patent is valid and granted a preliminary injunction against Nanostring (Munich LD, ACT_459746/2023, 19 September 2023). On appeal, the CoA overturned the first instance decision on the basis that it was more likely than not that the patent is not valid due to lack of inventive step.
On the question of whether there were technical issues which meant that there was no reasonable expectation of success, the CoA concluded as follows:
“The Applicants’ objection that there was no reasonable expectation of success from a technical point of view because they would have been confronted with problems such as “molecular crowding” (the difficulty of distinguishing between multiple analytes occurring in close proximity) or “autofluorescence” (unpredictable interactions) in the cell or tissue sample cannot be accepted either. In the opinion of the Court of Appeal, adjudicating with two technically qualified judges, these are problems that regularly arise in connection with the in situ detection of analytes in tissue or cell samples – but which a person skilled in the art would have been able to deal with on the basis of their expertise at the priority date and which therefore would not have prevented them from carrying out tests in the aforementioned sense due to insufficient prospects of success (see also the Swedish Intellectual Property Office, PRV Consulting Report, B10, p. 5).”
This finding led to a conclusion that it is more likely than not that the patent will prove to be invalid in proceedings on the merits due to a lack of inventive step.
10x subsequently filed an application for a reopening of the proceedings pursuant to Rule 245 RoP, arguing that here had been a fundamental procedural violation in the appeal proceedings.
According to 10x, one of these procedural errors was that the CoA had based its decision based on the personal expertise and views of the TQJs, as shown by the following words used in the CoA’s decision: “In the opinion of the Court of Appeal, adjudicating with two technically qualified judges…”. 10x argued that this fundamentally violates the rules on the burden of proof and the taking of evidence, because it amounted to the CoA relying on evidence provided by the panel itself, which was not evidence provided for by the Rules of Procedure. This approach is contrary to Article 76(2) of the UPC Agreement:
“Basis for decisions and right to be heard
- […]
- Decisions on the merits may only be based on grounds, facts and evidence, which were submitted by the parties or introduced into the procedure by an order of the Court and on which the parties have had an opportunity to present their comments.”
The second panel of the CoA hearing 10x’s application rejected this argument. It explained that the wording used by the first panel of the CoA had been the CoA expressing “that it was particularly equipped and qualified to assess the arguments and evidence presented in a technically complex matter”. 10x’s interpretation of the wording amounted to a “manifestly incorrect understanding”. The wording did not indicate that the first panel of the CoA had based its reasoning on the personal opinion of one or more of its judges. It was clear from the decision that the decision of the first panel of the CoA was made based on evidence, including the patent specification and a party opinion (B10 in the proceedings).
On this basis, the second panel of the CoA found that there had been no fundamental procedural error in this regard. 10x’s application for a rehearing was rejected as inadmissible.
Conclusion
It is clear from the decisions set out above that the UPC can and will take into account expert evidence, even in PI proceedings, although it may not always consider it necessary to hear the experts at a hearing. Moreover, if necessary, the Court is able to rely on the expertise of its TQJs to deal with any complex technical matters raised in the arguments and evidence from the parties.
In future decisions, we will likely learn more about how much the UPC intends to rely on expert evidence and also whether there will be any divergence in how different divisions approach the issue of expert evidence.
