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5 December 2025 (late published)
Nordic-Baltic Regional Division, Edwards v Meril c.s.
UPC_CFI_775/2025; UPC_CFI_776/2025; UPC_CFI_777/2025
Stay
Facts
- On 21 July 2025, the Court issued its decision, which includes a decision on the obligation to pay costs.
- On 21 August 2025, the parties applied for costs and confidentiality pursuant to R. 262.2 RoP.
- On 30 September 2025, the parties asked for a stay in the cost proceedings pending the outcome of the decision of the Board of Appeal of the European Patent Office.
The JR
- The parties agreed on requesting a stay and on confidentiality obligations specified in the order.
- The Court orders the stay and that pending the stay, the content of the requests in the cost proceedings will be treated as confidential.
- The final decision with respect to R. 262.2 RoP will be made after the stay.
Comment
- It is difficult to know what parties have agreed but it may be that they have reached an agreement about costs that depends on the outcome of the opposition proceedings with respect to the patent at issue.
- You know I advocate for agreeing on costs. It tends to be easier to reach such an agreement before the decision is published. An added advantage of a cost agreement is that you generally do not have to (publicly) specify such costs. That is, of course, assuming that the Court does order that the costs be published in the general interest of the Court’s users.
9 December 2025
Local Division The Hague, Amycell v X
Default
Facts
- X loses PI proceedings.
- X appeals which resulted in a default judgment.
- X’s revocation case in Milan also ended in a default judgment.
- In the proceedings on the merits, X was served via an alternative service method as he (a Polish national) refused service.
- A patent attorney filed an appearance as representative after the alternative service.
- The defence of X was filed late.
- A default judgment was passed against X.
- X filed an application to set aside the judgment by default.
The Court
The Court referred to R. 356.3 RoP, which stipulates that an application to set aside a default judgment shall be allowed “unless a party has been put on notice in an earlier decision that a further decision by default shall be final”.
On two earlier occasions, the Court referred to the fact that “a decision by default would be taken”.
The Court’s default decision did not state it was a “final” decision. The Court decided that R. 356.3 RoP is nevertheless applicable, correcting the omission of the word “final” in the default decision, and pointing out to X that he can appeal the order to refuse the application together with the default decision.
Comment
- I fully understand that the Court is fed up with X and his representative, but it will be interesting to see whether the Court’s interpretation of R. 356.3 RoP is correct.
- I have always read that Rule as avoiding multiple requests to set default judgements aside. The Court reads “further” as “subsequent”, and refers to the French text “une decision ultérieure”. But what about the German text “eine neuerliche Versäumnisentscheidung”? That seems to indicate that there must have been an earlier default decision that (moreover) states that a further decision by default is final.
- There is no earlier default decision here. In addition, the decisions referred to by the Court do not even say that a subsequent default decision will be final.
- I think the Court thinks (or hopes) that X will not appeal anyway!
12 December 2025 (late published)
Local Division Munich, Sanofi v Stadapharm
Inventive step / second medical use
Facts
- Sanofi companies started infringement proceedings against Stadapharm, Reddy Pharma and Zentiva.
- The patent in suit (EP 2 493 466) is a second medical use patent for treating prostate cancer in a specific patient group.
- The defendants filed a counterclaim for revocation.
- The Paris Court invalidated the French EP patent in first instance.
- The Opposition Division (“OD”) and the Board of Appeal of the European Patent Office (“EPO”) rejected the opposition.
The Court
- One case was settled. The Court decided to hear the remaining three revocation cases together.
- The experts of the generic companies were asked the question “What information would a Phase III study and the time which had passed since the start of that study (Hoyng: at the priority date) haven given to the skilled person and what was the reasonable expectation of a positive outcome?”
- On the second day, the Court announced that they were inclined to declare the patent invalid, and then closed the hearing.
- The defendants argue the disclosure of the protocol of a phase III clinical trial (corroborated by various clinical and preclinical data) creates a reasonable expectation of success for the skilled person.
- In addition to the protocol for the Phase III study, a NHSC document showed promising results.
- Based on the description, the Court formulated the technical problem to be solved as (finding) a therapeutical option for treating patients suffering from castration-resistant metastatic prostate cancer who were previously treated with a docetaxel-based regime and have prostate cancer that progressed during or after treatment. This included both increased survival and palliative treatment only.
- The solution introduced the use of cabazitaxel in accordance with claim 1.
- The Court interpreted the different claim features applying the Nanostring criteria as formulated by the Court of Appeal (UPC_CoA_335/2023).
With respect to inventive step, the court stated:
“The elements of the prior art are destructive of an inventive step only if taken in isolation or placed together in a combination reasonably accessible to the person skilled in the art, they clearly enabled the latter to provide the same solution to the problem solved by the invention as the latter.”
- The Court also stated that the EPO and certain national jurisdictions applied the problem-solution-approach.
- The Court then cites the considerations of the Court of Appeal in Amgen v Sanofi of 25 November 2025 with respect to inventive step.
- The Court did not find it necessary to reopen the oral argument, as the approach of the national Paris Court (which revoked the patent) was similar to the approach of the Court of Appeal. During the oral argument the different parties had already presented extensive arguments for and against this approach.
- The Court discussed the testimony of the experts about phase I, II and III trials in oncology. The experts agreed that the failure rate in phase III trials is 40-50% and that that percentage goes down with the progress of the trial.
- The Court discussed the different prior art documents and makes the observation: “Again reasonable expectation of success is not the certainly or even near certainty of success.”
- The Court continues: “As a result […] the encouraging results […] could give him (Hoyng: the skilled person) expectation of a favorable effect in survival […].”
- The fact that the Phase III study had already been underway for three years at least shows that the sponsor of the study did not consider the study disappointing at any time up to the priority date.
- Having considered all the prior art, the Court concluded the patent should be revoked.
*The decision date of 26 February 2023 mentioned by the Court should be 26 February 2024 in conjunction with the decision of 11 March 2024.
Comment
- The patent was upheld by the OD and the Board of Appeal of the EPO and is now invalidated by the Munich Division of the UPC applying the criteria of the Court of Appeal? That seems strange. Of course, I have not studied all prior art or the exchanged submissions, and I do not know what was said during the oral hearing.
- However, reading the judgment and comparing this with the decision of the Court of Appeal in Amgen v Sanofi, I have serious doubts about this decision. In another decision, this same Division stated that applying the same test as the EPO would be good for legal certainty (although the Division accepted that the EPO test can easily be tainted by hindsight in that decision).
- I fully agree that it is better for legal certainly if the Board of Appeal outcome is the same as the UPC outcome (of course, this will not always be possible when the facts underlying the decision are different). You therefore would have expected a convincing step-by-step application of the decision of the Court of Appeal and a solid reasoning why the Board of Appeal is wrong. That is, however, missing.
- Instead, the Division’s decision seems to use their own approach (see above under 9). I get serious doubts about the decision when reading “could give him expectation of a favorable effect”. A 40%-50% (and I would say even 60%) is, in my opinion, certainly not “a reasonable expectation of success”, but a hope to succeed.
- I therefore look forward to the decision of the Court of Appeal in this case.
- I conclude with the observation that if for second medical use patents it is required to have evidence in the application that indeed the product/therapy has the claimed effect but on the other hand we say that quite early before you have all the evidence there is already a reasonable expectation of success, then something goes wrong with the stimulation of innovation, certainly in the important field of human health. A three months more survival rate may, if you are healthy, not seem impressive or important, but may make a big difference for many people if confronted with a terminal situation.
12 December 2025 (late published)
Local Division Milan, Cardo v Shenzhen Asmax Infinite
Service in China
Facts
- Cardo Systems filed an infringement suit against defendants on 16 December 2024.
- The Chinese Central Authority rejected the service.
The JR
- The The Hague Service Convention is applicable, as the defendant is registered in China.
- The Chinese Central Authority rejected service for the reason that the Statement of Claim mentioned Hong Kong, instead of Hong Kong, China. That is not a valid reason to refuse service: the Statement of Claim is only an attachment and not the service document.
- The JR applied Art. 15(2) of the The Hague Convention as service has proven to be impossible which allows the Court to give judgment if the conditions of that provision are fulfilled.
Comment
- Excellent decision in my opinion! The JR does not refer to Service by alternative method (R. 275 RoP) as some decisions do. That provision is indeed irrelevant in this situation (and does not provide for a valid service in conformity with the The Hague Convention in my opinion).
- For PI proceedings the 6-months waiting period (which applied in this case) is not necessary: see Art. 15 (3) of the The Hague Convention.
- Advice for representatives: if your Statement of Claim refers to Hong Kong, always refer to Hong Kong, China!
12 December 2025 (late published)
Local Division Munich, Asus v Oppo
Security costs in Taiwan
Facts
- Asus, a Taiwanese Company, sues Oppo et al. (9 defendants).
- The defendants lodge an application for security for costs.
The JR
- The JR refers to the Court of Appeal (“The fact that defendant is located outside the EEA weighs against the possibility that without undue burden costs decisions can be executed particularly if there is no guarantee that the decision will be recognized.”).
- The JR concludes that the statement of the Taiwanese professor (submitted by claimant) seems to confirm that a costs decision cannot be executed without undue burden.
- The JR orders security for € 200.000.
Comment
- This is the first case that I have seen in which the non-German judge in the panel of a German Local Division is acting as JR.
- I consider this as an excellent development for several reasons. First of all, it means that the heavy workload of the German Divisions is better divided over the panel.
- You immediately see the result in this case, because the decision of the JR is the result of very thorough procedural steps and the decision itself is very elaborately motivated.
- The second reason is that it emphasizes that the Division (and the UPC) is an international Court.
This does not mean that this is an invitation to file in the already busy German Divisions. To the contrary: it is preferred that cases are (better) spread over all UPC Divisions for reasons of UPC acceptance (also in other UPC countries), the credibility of the UPC as a truly international Court, the quality of the UPC proceedings, and also for the users of the system.