2025-08-13 - CoA - Boehringer Ingelheim v. Zentiva - UPC_CoA_446/2025; UPC_CoA_520/2025

In the context of marketing of generic medicines, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one. Completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case. A request for an order to communicate information in a case of alleged imminent infringement has been denied since there is no indication that the requested information actually exists and that moreover any explanation that the requested information is reasonably necessary for the purpose of advancing that party's case is lacking. Although national law is a source of law pursuant to Art. 24 UPCA, it is for the parties to bring forward facts and evidence about the content of national law and its application.

The Court of Appeal set aside a decision by the Lisbon Local Division and granted an application for provisional measures regarding generic medicines. The Court of First Instance had previously denied the application due to a lack of imminent infringement. The CoA then assumed imminent infringement, considering the national procedures for health technology assessment and going into detail regarding the requirements for ordering a preliminary injunction in this regard. [To be amended...] -