Promosome LLC v. BioNTech SE, UPC CFI Local Division Munich, 7 July 2026, Case nos. UPC_CFI_846/2024, UPC_CFI_485/2025, UPC_CFI_535/2025
Background
Promosome in December 2024 started infringement proceedings based on EP 2 401 365. BioNTech and Pfizer counterclaimed for revocation. Defendants BioNTech and Pfizer had cooperated earlier which resulted in a vaccine against Covid.
Competence pre-June 2023 infringement
The Court, referring to the case law of the Court of Appeal, stated that it is competent even with respect to infringement that started prior to the start of the UPC and is ongoing.
Standing of an exclusive licensee
An exclusive licensee has standing to sue. “To assess whether a party is the holder of an “exclusive licence” within the meaning of Art. 47(2) UPCA, it is decisive whether a licensee is entitled to solely use and to exclude others, including the patent proprietor, from using the patented invention, which includes, in the case of an infringement, the right to assert claims.” However, an exclusive licence may be limited in terms of its geographical scope, field of use or duration.
Novelty
The Court ruled that the counterclaim for revocation was successful due to lack of novelty.
On novelty: “Against this background, the Court in principle agrees with the Counterdefendants that in order for a prior art disclosure to be relevant for novelty, the disclosure must be such that the skilled person can reproduce it using common general knowledge, i.e. the skilled person must be able to carry out the teaching of the prior art. Absent such an enabling disclosure, there is no (complete) technical teaching in the prior art and hence no potentially novelty-destroying disclosure.”
Auxiliary Requests
With respect to the auxiliary requests, the Court while referring to Court of Appeal case law (UPC_CoA_528/2024, UPC_CoA_529/2024, Amgen/Sanofi and CoA_464/2024, Meril/Edwards) held regarding obviousness:
“205. A claimed solution is obvious if the skilled person would have taken the next step in expectation of finding an envisaged solution of his technical problem. This is generally the case when results of the next step were clearly predictable, or where there was a reasonable expectation of success.
206. The burden of proof that the results were clearly predictable or the skilled person would have reasonably expected success, i.e. that the solution he envisages by taking the next step would solve the objective problem, lies on the party asserting invalidity of the patent.
207. A reasonable expectation of success implies the ability of the skilled person to predict rationally, on the basis of scientific appraisal of the known facts before a research project was started, the successful conclusion of that project within acceptable time limits.
208. Whether there is a reasonable expectation of success depends on the circumstances of the case. The more unexplored a technical field of research, the more difficult it was to make predictions about its successful conclusion and the lower the expectation of success. Envisaged practical or technical difficulties as well as costs involved in testing whether the desired result will be obtained when taking a next step may also withhold the skilled person from taking that step. On the other hand, the stronger a pointer towards the claimed solution, the lower the threshold for a reasonable expectation of success.”
There were 25 Auxiliary Requests. The Court considered the first auxiliary request not to be inventive. The second one was rejected due to added matter and lack of inventive step. The third due to lack of novelty and/or inventive step.
Mere aggregation of two independent methods
Auxiliary Request 4 combined the subject matter of granted claims 1 and 10 (which claim referred back to claim 1). The Court held:
241. In sum, both methods are presented as stand-alone, independent techniques and the skilled person will understand this accordingly. Put yet differently, the features of claim 1 of AR 4 (the two methods) each serve their own purpose; the skilled person does not understand them to functionally interact or have a combined effect (cf. UPC_CoA_71/2025, decision of 29 December 2025, VMR Products/NJOY, par. 81).
[…]
244. In conclusion, the combination of features of AR4 constitutes a mere aggregation of two independent methods, whereby the features of these methods do not interact functionally to produce an effect that goes beyond mere addition in solving the objective problem of increasing protein expression efficiency. In other words, the features are simply juxtaposed; no effect beyond the mere addition is apparent from the application/the Patent. As there is (rightfully so) no real discussion between the parties that the additional features of AR4 are clearly disclosed in D9 and D10, the combination of these two methods, both being not novel or at least non-inventive, cannot be held inventive. The skilled person would, as a matter of routine, combine these two methods and/or carry them out separately, one after the other, which is not excluded by claim 1 of AR4.
Auxiliary Request 5 was found to lack novelty as the Counterdefendants did not provide any explanation as to why AR5 would be novel or inventive over Matsuda (D2). It also lacked novelty over D1.
ARs 6-25 are combinations and permutations of ARs 1-5. The Counterdefendants have not provided any additional reasons in support of the validity of these requests compared to the individual ARs 1-5. Therefore, these ARs are invalid, at least for the same reasons as ARs 1-5, which apply to ARs 6-25 mutatis mutandis.
The patent was revoked.
Infringement
Despite the invalidity, the Court motivated extensively that even if the patent would have been valid, the claimant did not adequately substantiate that there was infringement, and its experimental evidence is not suitable to provide the necessary substantiation.
A copy of the judgment can be read here.
