Following a slow start, the number of drug patent cases before Unified Patent Court (UPC) is set to rise. With a quickly growing collection of case law, including from the court of appeal which clarifies key legal questions, interest in the UPC in the pharmaceutical sector is starting to increase.

At the UPC, patentees may request preliminary injunction (PI) relief intended to prevent either an "imminent infringement," or the continuation of an existing infringement. Recently, the UPC Court of Appeal clarified that the test for imminent infringement in pharmaceutical cases is whether a generic has "set the stage" for infringement to occur. The UPC confirmed that the application for, or grant of a marketing authorization (MA), does not amount to an imminent infringement. However, completion of the national procedures for health technology assessment, pricing, and reimbursement for a generic medicine may be sufficient to establish imminent infringement.

Another key issue for patentees is the requirement of "urgency" in PI proceedings. The UPC Court of Appeal has clarified that applicants should act without "unreasonable delay," which is calculated from the day on which the patentee knew or should have known about the circumstances of the infringement that enable the patentee to file a PI request.

Notably, awareness of an imminent infringement may start the clock on the question of urgency for PI proceedings, as the UPC found that waiting until the first act of infringement occurs may constitute "unreasonable delay." Keeping a close eye on national market authorization proceedings and price/reimbursement rate setting procedures may prevent this.

Intriguing strategic questions remain regarding the interplay between imminent infringement and the urgency requirement at the UPC. Since a patentee can request PI relief for all UPC Contracting Member States (CMS) based on a finding of imminent infringement in one CMS, the question arises as to whether the requirement for urgency must be interpreted with corresponding territorial scope. We expect future litigation to reveal whether the urgency timer starts rolling for the entire UPC territory the moment an imminent infringement first materializes in just one CMS.