1. Key takeaways
The applicant bears the burden of proof for infringement in provisional measures and must demonstrate with sufficient certainty that infringement is more likely than not (Art. 62 UPCA, R. 211 RoP)
The Court confirmed that the burden of presentation and proof for facts establishing infringement lies with the applicant. It is not the defendant’s primary task to prove non-infringement. The defendant bears the burden only with regard to facts concerning lack of validity.
All claim features must be realized in one single appliance where the patent claim, read in light of the description, relates to a single product (Art. 69 EPC)
The Court construed the method claim as requiring that all features, including opposing counter moments applied to different groups of teeth, must be generated by the tooth receiving cavities of one single aligner. Different treatment phases performed by different aligners cannot be combined to establish infringement.
Promotional materials alone may be insufficient to establish infringement, particularly in technically complex fields requiring feature-by-feature analysis
The applicant’s infringement case relied entirely on the defendants’ website, product brochures, and webinars without any independent technical assessment of the accused method or any specific aligner. The Court found this evidence base inadequate to meet the required standard of proof for provisional measures.
Speculative reasoning and assumption-based witness evidence do not satisfy the standard of proof for provisional measures
The applicant argued that a counter moment “must necessarily” continue to be applied to certain teeth during a later treatment phase. The Court rejected this as too general and based on mere assumptions. The witness statement merely repeated the same assertion without specific substantiation relating to the accused product.
Incremental multi-stage treatment processes pose particular infringement proof challenges when patent claims require all features in a single product
Clear aligner therapy involves many stages, each performed by a differently shaped aligner worn for a short period. By referring only to treatment phases rather than to the shape profile of an individual aligner’s tooth receiving cavities, the applicant failed to substantiate that the claimed features were realized in any one single aligner.
Where infringement is not established, the Court need not examine validity, urgency, necessity, or other requirements for provisional measures
The defendants raised defenses of insufficiency of disclosure and lack of inventive step, contested the liability of the holding company, disputed urgency and necessity, and requested security for enforcement. The Court left all of these issues undecided, as the application was dismissed solely on the ground that infringement was not sufficiently demonstrated.
2. Division
Local Division Düsseldorf
3. UPC number
UPC_CFI_1747/2025
4. Type of proceedings
Proceedings for provisional measures
5. Parties
Applicant: Align Technology, Inc.
Defendants: Angelalign France Technology SASU, Europe Angelalign Technology B.V., Angelalign Technology (Germany) GmbH, Italy Angelalign Technology S.R.L.
6. Patent(s)
EP 4 295 806 B1
7. Jurisdictions
UPC
8. Body of legislation / Rules
R. 209.1 RoP, R. 211 RoP, R. 220.1(c) RoP, R. 224.2(b) RoP
Art. 62 UPCA, Art. 31 UPCA, Art. 32(1)(c) UPCA, Art. 33(1)(b) UPCA, Art. 73(2)(a) UPCA
Art. 69 EPC
Art. 4(1), 7(2), 8(2), 71b(1) Brussels I Recast Regulation
