German pharmaceutical company Boehringer Ingelheim filed a patent lawsuit against Zentiva, trying to prohibit Zentiva from selling generic versions of its respiratory drug Ofev. Recently, a judge of the UPC Lisbon Regional Chamber rejected Boehringer Ingelheim's request for an injunction. (Case number: UPC_CFI_41/2025)
Founded in 1885, Boehringer Ingelheim's core businesses include prescription drugs, animal health and biopharmaceuticals. Zentiva, headquartered in Prague, Czech Republic, was founded in 2003 and its main business is the research and development, production and sales of generic drugs.
After receiving the notification from the Portuguese National Agency for Medicines and Health Products that Zentiva generic drugs can be marketed, Boehringer Ingelheim decided to file an application for a preliminary injunction, requesting the court to prohibit Zentiva from manufacturing, offering to sell, selling, using, importing or storing products containing nintedanib, especially Zentiva generic drugs, in the UPC jurisdiction.
The patent in question is EP 1 830 843 B1, which protects the use of nintedanib or nintedanib esylate and is valid until December 21, 2025. The patent is valid in the UPC countries of Austria, Belgium, Bulgaria, Denmark, Estonia, Finland, France, Germany, Italy, Latvia, Lithuania, Luxembourg, the Netherlands, Portugal, Romania, Slovenia and Sweden.
Boehringer Ingelheim claims that its patent EP 1 830 843 B1 (EP 843) is at risk of infringement from December 12, 2024. However, the Trial Chamber held that Zentiva was not at risk of infringement and that “there was no evidence of imminent infringement”. The Trial Chamber therefore rejected Boehringer Ingelheim’s application for a preliminary injunction. Boehringer Ingelheim can appeal the decision, but has not yet expressed its intention to do so.
Earlier this year, the plaintiff and defendant also clashed in the Portuguese courts. In Portugal, medicines containing nintedanib as an active ingredient are restricted to hospital use. Almost all of Ofev's purchases come from public hospitals under the National Health System, and supplying hospitals requires special authorization and contracts. Currently, Boehringer Ingelheim is the only manufacturer supplying nintedanib. Despite this, the company applied for a preliminary injunction from the Portuguese Intellectual Property Court and was granted.