UPC CoA, 13 August 2025: Imminent infringement of marketing generics - Prior Evaluation Procedure (PEP) long before expiry of patent
23-10-2025 Print this page
Succesfull appeal: preliminary injunction granted because of imminent infringement (Article 62 UPCA, R. 206 RoP). In the context of marketing of generics, 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. Whether a premature Prior Evaluation Procedure (PEP) application can constitute imminent infringement depends on what can be done on the Portuguese market during the period before the patent expires. Obtaining of PEP long before the expiry of the patent without any justification can be an indication that the implementer is setting the stage for infringing acts. The absence of any hard mechanism to stop an infringing offer of the products, and the absence of prenotification being immediately visible to third parties to allow action to be taken by the patent holder to prevent infringement creates expectations from public – as well as private – hospitals that the generics will be offered ahead of patent expiry. This gives credence to the claim that the preliminary measures are necessary.
As per Art. 34 UPCA, decisions of the Court shall cover the territory of those Contracting Member States for which the patent has effect.
Injunctions, as a rule, will cover all those Contracting Member States. A restriction requires the presence of certain circumstances, such as when a claimant has restricted the territorial scope of its action (Art. 76(1) UPCA).
Application for an order to communicate information of existing infringement denied (Article 67 UPCA).
When there is no allegation of any completed infringement and no indication that the requested information actually exists, as well as any explanation that the requested information is reasonably necessary for the purpose of advancing that party's case, the purpose of such an order 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.
