ASSESSING IMMINENT PATENT INFRINGEMENT FOR MEDICINAL PRODUCTS UNDER THE UPC FRAMEWORK: INSIGHTS FROM THE DÜSSELDORF DECISION UPC_CFI_165/2024

On 6 September 2024, the Local Division of the Unified Patent Court (UPC) in Düsseldorf issued a significant decision concerning the concept of "imminent infringement" in the pharmaceutical sector, particularly in relation to biosimilar and generic medicines. The legal framework under the Unified Patent Court Agreement (UPCA) allows patent holders to request relief in two main situations: where a direct act of infringement has already taken place (such as manu-facturing, offering, or placing a product on the market, under Article 25 UPCA), or where infringement is about to occur, meaning there is a clear risk based on concrete preparatory actions (as provided in Arti-cle 62(1) UPCA). The Düsseldorf Court decision focused on the latter scenario and assessed the legal threshold for when an infringement can be considered imminent. The case involved a biosimilar monoclonal antibody. The company accused of infringement had al-ready obtained a marketing authorization (MA) for the product in question and had started promoting it during a specialist medical conference. It had also initiated negotiations with health authorities in several EU Member States for pricing and reimbursement, and had offered product samples for evaluation to po-tential customers. However, it had not yet finalized these negotiations, nor had it communicated a specif-ic date for the product’s commercial launch. While the first requirement of imminent infringement—that the biosimilar product be identical to the pa-tented original—was satisfied, the Court ruled that the second requirement was not. According to the decision, preparatory steps such as applying for and obtaining a marketing authorization, promoting the product, or beginning price negotiations are not sufficient, on their own, to constitute imminent in-fringement. The Court emphasized that only when all regulatory and commercial conditions are met and the company is effectively in a position to enter the market and supply the product promptly, can an in-fringement be considered imminent. The Court highlighted that a risk of infringement must be real and immediate. There must be tangible evidence that the alleged infringer has completed all steps necessary for commercialization, including final pricing, reimbursement decisions, and availability of the product for sale. In this case, since such conditions had not yet been fulfilled, the infringement remained only hypothetical, and therefore, the re-quest for provisional measures was denied. This decision aligns with existing national case law in several EU countries, including Italy, where it is well established that merely obtaining a marketing authorization does not amount to patent infringement. The judgment reinforces the view that even when combined with other public or commercial activities, the presence of an MA and promotional efforts are not, in themselves, sufficient to demonstrate imminent infringement under the UPC framework. The ruling sets an important precedent for future pharmaceutical patent disputes before the UPC. It clarifies that in order to obtain interim relief based on imminent infringement, patent holders must demonstrate that the allegedly infringing product is not only authorized and promoted but also effectively ready for immediate launch. Without this level of commercial and regulatory readiness, the claim of imminent infringement is unlikely to succeed. Bibliography: Düsseldorf Local Division Order, UPC_CFI_165/2024; Unified Patent Court Agreement (UPCA); Further clarification on imminent infringement of a medicinal product in Unified Patent Court law – C. Germinario.