Boehringer Ingelheim International has seen the Unified Patent Court reject a request for provisional measures against Zentiva related to its generic nintedanib medicines used to treat lung fibrosis and cancer. The Lisbon Local Division found no imminent risk of patent infringement and held that Zentiva’s administrative steps in Portugal did not amount to concrete plans for market entry before the patent’s expiry in April next year.
Boehringer Ingelheim International has been denied provisional measures at the Unified Patent Court against Zentiva related to its generic nintedanib medicines used to treat lung fibrosis and cancer. Judges ruled yesterday that the pharmaceutical innovator failed to demonstrate a risk of imminent patent infringement.
The UPC Lisbon Local Division concluded that Zentiva’s administrative steps in Portugal did not amount to conduct indicating that it was more likely than not to launch its product before Boehringer Ingelheim’s European Patent 2,837,843 expires in April next year (see here).
Boehringer alleged that Zentiva’s recent receipt of a public evaluation protocol from a Portuguese medicine agency Infarmed — after earlier obtaining two marketing authorizations for its nintedanib products — created an imminent threat of market entry.
The German company argued that the administrative sequence was the final step required before Zentiva could supply its medicine to public hospitals in Portugal and asked for injunctive relief from the UPC.
But the Lisbon panel disagreed. While the panel of judges led by Presiding Judge Rian Kalden accepted that the medicines fall within the claims of the patent, they held that regulatory preparation does not mean imminent infringement.
“The administrative steps alone taken by the defendant do not establish a risk of imminent infringement,” the court said.
It cited consistent UPC case law, including a September 2024 ruling from the Düsseldorf Local Division in a case between Novartis and Genentech against Celltrion. Judges said that an assessment of imminence must be based on the “concrete likelihood” of unlawful market entry.
The court found that Zentiva had not taken any specific steps — such as pricing submissions, procurement participation or marketing activity — that indicated it would launch its product before the ‘843 patent expired.
Zentiva had also argued that the issue was already resolved through an injunction granted by a Portuguese court in earlier proceedings involving Supplementary Protection Certificate 679, and that the UPC action had therefore "lost its utility and legal basis."
The UPC panel rejected this, however. It found that the Portuguese proceedings concerned a different party, Boehringer Portugal, and a different right that only covered Portugal.
Meanwhile, the UPC application sought cross-border provisional measures for the ‘843 patent, which remains in force in multiple UPC contracting member states. The court noted that the Portuguese injunction remained provisional, could be appealed and was contingent on further litigation.
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