UPC-Court of Appeal: Substantive law decision on imminent infringement

The defendant obtained marketing authorization to distribute a generic drug in Portugal. In addition, the national health authority approved the defendant's request to supply public hospitals at an agreed price and reimbursement rate. The plaintiff filed a request for preliminary injunction. The Lisbon Local Division rejected the request on the grounds that the market authorization and the approval for distribution in public hospitals did not constitute sufficient risk of first infringement. The Court of Appeal upheld the appeal. In connection with the distribution of generic drugs, the request for marketing authorization does not in itself constitute an imminent infringement of rights, nor does the granting of such authorization. However, the completion of the national procedures for benefit assessment, pricing, and reimbursement for a generic drug means that the defendant can offer the generic drugs to public hospitals in Portugal without further administrative steps or procedures. The evidence available to date does not support the assumption that there are any obstacles at the national level—other than self-restraint on the part of the defendant—that would prevent participation in public tenders, direct awards, or prior consultations. Thus, an imminent infringement is highly probable (UPC 13.8.2025, CoA 446/2025, CoA 520/2025).