The Unified Patent Court has become the focal point of a high-stakes legal confrontation in which the notion of 'imminent infringement' under Art. 62(1) of the UPCA is undergoing a rapid evolution in the case-law.
This core issue is under the spotlight not only as it is being shaped by the evolving dialogue between the UPC Local Divisions and the Court of Appeal, but also because the CoA’s current position on the imminence requirement may clash with the proposed EU legislative reforms for the Bolar exemption that are being now finalised by the European Parliament as part of the “EU Pharma Package”.
The first decision of UPC on this topic signalled a pro-market entrant stance, as the Düsseldorf Local Division held that a biosimilar launch was not considered "imminent" while pricing and reimbursement negotiations have not yet been finalised (UPC_CFI_165/2024). The Court reasoned that for an infringement to be considered imminent, all pre-launch preparations must have been completed, which, however, was not the case in the matter at hand, as there was insufficient evidence that price negotiations had already taken place or were in progress. Furthermore, it found that promotional activities at a medical congress were inconclusive to establish imminent infringement, as they lacked a specific timeline for market entry and evidence that price negotiations or reimbursement applications by the defendants had already started or were ongoing.
In this evolving landscape, the CoA (UPC_CoA_446/2025) elaborated further on the threshold for imminent infringement, moving toward a more assertive posture that strengthens the position of pharmaceutical patent holders. While the CoA reaffirmed that a marketing authorization alone does not constitute imminent infringement, it held that completing all national procedures - including those regarding pricing and reimbursement - can, depending on the context, cross the threshold into imminence.
The case before the CoA concerned the respondent company’s attempt to launch a generic equivalent in Portugal. Despite the originator's patent having over a year of validity remaining, the respondent had already obtained marketing authorizations and completed the national procedure for pricing and reimbursement, namely the Prior Evaluation Procedure (PEP).
With a decision issued on 13 August 2025, the CoA granted a preliminary injunction across 17 UPC territories against the generic company, overturning the decision of the Lisbon Local Division, which had previously denied relief to the applicant on the grounds that, without concrete evidence of a forthcoming market entry, the completed administrative steps did not, per se, indicate the respondent’s intention to infringe imminently.
After having examined the Portuguese legal context for marketing commencement and participation in public tenders, the judges of the CoA determined that once an entity has completed all the administrative procedures for market entry, the only remaining barrier to launch is voluntary self-restraint, a scenario the CoA found sufficient to constitute imminent infringement.
Indeed, finding that the respondent offered no credible explanation for obtaining such approvals so far in advance, the CoA concluded that, from an objective point of view, the only way a completed PEP could be of use for the company was the commercialisation of the generic products on the market.
Therefore, adopting a 'balance of probabilities' approach, the CoA determined it was more likely than not that the generic manufacturer had effectively set the stage for market entry. By completing all necessary preparations, the respondent had reached a point where infringement was no longer a hypothetical risk, but “only a matter of starting the action, because the preparations for it have been fully completed.”
This judicial evolution carries significant weight for the European pharmaceutical landscape, as it suggests that generic manufacturers must now proceed with heightened caution: completing the regulatory and administrative steps too far in advance of the expiration of the patent rights may be interpreted as setting the stage for an immediate launch, potentially triggering a pan-European preliminary injunction.
With that said, the current framework remains highly fact-specific, as courts must weigh the nuances of diverse national regulatory contexts, noting in particular that UPC member states do not all adopt the same pricing and reimbursement procedures.
In this scenario, while the proposed changes to the Bolar exemption currently being finalised by the European Parliament and the Council as part of the "EU Pharma Package" aim to clarify the permissible pre-launch activities - specifically, among others, those conducted for the purpose of obtaining pricing and reimbursable approval - that, once finally approved, would expressly legitimize such actions, the 'timing' factor remains a critical grey area.
Since the timeline for price and reimbursement negotiations with regulatory authorities may vary significantly and, not infrequently, may encounter unexpected delays, it is crucial for generic companies to strategically determine how far in advance they can safely begin the process to align with the end of the originator exclusivity and ensure market entry immediately afterwards.
This is a question the UPC Courts have yet to address that currently poses a significant variable for generic market-entry strategies.
by Fabrizio Jacobacci and Daniela Gervasio
