Background
Align Technology, the maker of Invisalign clear aligners, sought a preliminary injunction from the Unified Patent Court against Angelalign, a Chinese dental technology company expanding aggressively into European markets. Align asserted EP 4,295,806 B1, a European patent covering methods for orthodontic treatment using clear aligners that apply opposing counter moments to different groups of teeth.
Align’s infringement case was built entirely on Angelalign’s marketing materials — website content, product brochures, and promotional webinars — rather than on independent technical analysis of Angelalign’s actual products. The case raised the question of how much evidentiary rigor the still-young Unified Patent Court requires for provisional measures in patent cases.
The Court’s Holding
The Düsseldorf Local Division dismissed Align’s application for provisional measures, finding that Align failed to establish that infringement was “more likely than not” as required by Article 62 of the UPC Agreement and Rule 211 of the Rules of Procedure.
The court’s analysis rested on two critical holdings:
All claim features must be realized in a single appliance. The court construed the method claim as requiring all claimed features — including the application of opposing counter moments to different groups of teeth — to be performed by one single aligner. Clear aligner therapy involves sequential treatment phases, each using a differently shaped device. Align’s argument that different aligners across multiple treatment stages collectively practiced the claimed method was rejected: combining features across multiple appliances cannot establish infringement of a claim directed to a single device.
Promotional materials are insufficient evidence. The court held that “the applicant’s infringement case relied entirely on the defendants’ website, product brochures, and webinars without any independent technical assessment.” For provisional measures, the applicant bears the full burden of presenting and proving infringement facts. Speculative arguments that certain features “must necessarily” be present lack adequate substantiation. Applicants must provide feature-by-feature technical analysis referencing individual product specifications, not general marketing descriptions of treatment phases.
Because Align failed at the threshold infringement stage, the court did not need to examine Angelalign’s validity challenges, urgency arguments, or other defenses.
Key Takeaways
- The UPC demands rigorous infringement proof for provisional measures. Marketing materials and promotional webinars are not substitutes for independent technical analysis — even at the preliminary injunction stage.
- Multi-stage processes face a single-device hurdle. When a patent claims features of a method performed by a single device, practicing individual features across separate devices in sequential treatment phases does not constitute infringement.
- Cascading analysis saves judicial resources. The UPC applies an efficient “cascade” approach: when the infringement threshold is not met, the court declines to analyze validity, urgency, or other requirements, leaving those issues for the merits stage.
Why It Matters
This decision provides early guidance from the Unified Patent Court on the evidentiary standard for provisional measures — a key enforcement tool in European patent litigation. For patent holders accustomed to German court injunctions based on limited evidence, the UPC’s insistence on independent technical analysis raises the bar significantly. The decision also matters for the fast-growing clear aligner market: as Chinese competitors like Angelalign enter Europe, Align’s patent enforcement strategy will need to involve detailed technical reverse engineering of competitor products, not just screenshots of marketing materials. More broadly, the ruling signals that the UPC will apply claim construction rigorously, requiring patent holders to demonstrate infringement within the bounds of each individual claim — not across a product ecosystem.