Imminent Infringement in Pharma: UPC's emerging jurisprudence and its implications
Imminent infringement in the pharmaceutical sector presents distinct challenges due to its highly regulated nature. This article looks at how the Unified Patent Court (UPC) has addressed such cases so far, requiring compelling evidence that a company intends to infringe before a patent expires. Recent UPC decisions demonstrate a case-by-case assessment based on overall conduct, while also highlighting the role of national regulatory contexts. These developments raise important questions about consistency and cross-border enforcement within the UPC framework.
What is the risk of imminent infringement in the pharmaceutical sector?
In the European legal system, a patent holder can seek injunctive relief not only in response to an ongoing infringement, but also where the latter is imminent (see Article 9 of the Enforcement Directive). When it comes to the pharmaceutical sector, the assessment of imminent infringement presents unique and complex challenges, due to the highly regulated framework and the industry-specific dynamics.
On the one hand, the lengthy and multi-step regulatory procedures required for the market entry of medicinal products often involve activities - such as the ones necessary to obtain a marketing authorisation – that, although lawful per se, may nonetheless signal a concrete intention to infringe. Even more so if such regulatory activities are coupled with other strategic business actions. On the other hand, balancing the protection of pharmaceutical innovation with timely access to generics or biosimilars requires a nuanced and careful approach.
In most European jurisdictions, the granting of a marketing authorisation alone is generally not sufficient to establish the imminent commercialization of a pharmaceutical product: in order to obtain a preliminary injunction, the plaintiff must present further evidence of the impending infringement. In this regard, the threshold to be met differs from country to country. In principle, national Courts tend to take into account acts such the inclusion of the generic drug in the regulator's pricing list, the stocking of products, the lack of (satisfactory) response to a warning letter, the launch of an information campaign among health care organisations, the establishment of a distribution network or the circulation of marketing materials.
Nonetheless, the absence of a uniform interpretation of the imminent infringement standard across different jurisdictions complicates the patent holder’s ability to assess the chances of success in securing interim relief. In some countries, a patent holder may be able to obtain a preliminary injunction more easily than in others, depending on the local judicial approach and the specific criteria applied. This lack of consistency creates an additional layer of uncertainty for patent holders in the pharmaceutical industry.
The UPC and the concept of imminent infringement in the pharmaceutical sector
The possibility for the patent holder to seek preliminary remedies in case of imminent infringement is expressly recognized by the Unified Patent Court Agreement (Article 62 UPCA).
Since the entry into force of the UPC system (on 1 June 2023), three significant decisions have been issued that shed light on the concept of imminent infringement in the pharmaceutical sector. All the cases involved preparatory steps undertaken by generic and biosimilar manufacturers prior to the expiry of the patent.
In two parallel decisions (UPC_CFI 165/2024 and UPC_CFI 166/2024, 6 September 2024, Novartis v Celltrion, LD Düsseldorf), the UPC ruled on preliminary applications filed by the proprietors of a patent claiming a pharmaceutical formulation of an antibody against a biosimilar company and its local subsidiaries respectively.
According to the Court, for a patent infringement to be considered imminent, there must be concrete indications in the overall circumstances, which indicate that the infringement has not yet occurred but that the potential infringer has already set the stage for it to occur, to be assessed on a case-by-case basis. It must be established that the potential infringer’s conduct leads to the conclusion that it more likely than not intends to offer or place the product on the market before the patent expires. In other words, there must be compelling evidence to conclude that all pre-launch preparations have been completed in such a way that an offer of the product can be made at any time.
Applying the above principle, the Court excluded the risk of imminent infringement in the case at issue. In particular, although the defendants had already obtained a marketing authorisation and publicly announced the intention to launch the biosimilar product on the market, the Court emphasized that the communications disseminated on the market were vague, that the defendants had not yet started any price negotiations or reimbursement applications, and that there had not been any situation in which samples of the product were actually presented to potential customers.
In a more recent decision (UPC_CFI_41/2025, 8 May 2025, Boehringer v Zentiva, LD Lisbon), the Court further clarified the requirements for establishing an imminent infringement in the pharmaceutical sector.
The case involved a generic manufacturer that had obtained marketing authorisations and successfully completed the Prior Evaluation Procedure (PEP) in Portugal, a prerequisite for supplying medicines to public hospitals. The applicant argued that the conclusion of these regulatory steps demonstrated the defendant's intention to launch the generic product soon, thereby creating an imminent risk of infringement. However, the Court rejected this view, holding that the completion of the administrative steps alone does not suffice to establish the likelihood of an impending market entry. Instead, the Court reaffirmed that imminent infringement requires concrete and compelling evidence that the potential infringer is more likely than not to offer or place the product on the market before the patent expires, based on an overall assessment of the defendant’s conduct.
In this case, the absence of commercial acts beyond the regulatory steps - such as participation in public tenders, marketing activities or actual product offers - led the Court to conclude that no imminent infringement had been demonstrated.
Takeaways and open questions
The UPC's decisions to date already provide valuable initial guidance on the criteria for the assessment of an imminent infringement in the pharmaceutical sector. Accordingly, all preparatory steps prior to market entry must be completed in such a manner that an offer for the respective product can be submitted at any time, and that it is more likely than not that the potential infringer intends to do so.
Clearly, the assessment of the overall circumstances must be carried out on a case-by-case basis and involves judicial discretion. Nonetheless, a key takeaway is that completing regulatory steps - such as obtaining marketing authorisation - is necessary but not sufficient for preliminary relief to be granted.
Notably, in these decisions, the UPC clarifies that the imminent infringement must be assessed independently based on the interpretation of the UPCA and not on national patent legislation. However, even the UPC ultimately refers to the national regulatory market entry requirements when assessing imminent infringement in individual cases, as these determine which administrative steps are still required for a market entry of the specific medicinal product. This demonstrates that national legislation and administrative procedures must always be considered when assessing imminent danger in the pharmaceutical sector under the UPCA.
However, consideration of national administrative procedures raises further questions, particularly arising from the interplay between the strictly regulated national environment in the pharmaceutical sector and the UPCA. Since the actual market entry in different countries depends on the respective administrative and regulatory framework and required steps, it is currently difficult to imagine that an imminent infringement in one country would automatically lead to an imminent infringement in another country. Further, the consideration of national market access requirements already anticipates significant challenges regarding unitary patents.
So far, it remains open how the assessment of an imminent infringement should be conducted if a company operates in several UPC Contracting Member States that have different administrative procedures for the market entry of a medicinal product. This could lead to the situation in which an imminent infringement is found in one Contracting Member State, while in others further administrative steps are required, so that the risk of an imminent infringement should be excluded there.
An approach consistent with general principles and previous UPC case law (although unrelated to the pharmaceutical sector) would suggest concluding that the Court may issue an injunction extended to all Contracting Member States where the patent is in force, if the imminent infringement has been proven for at least one of them. A different conclusion could potentially induce patent owners to start individual national procedures – at least during the transitional period – before national courts that have adopted more flexible approaches in the assessment of the imminent infringement and then bring an action before the UPC with a limited territorial scope. This would contradict the UPC's very purpose of harmonising the European patent system and prevent fragmentation of patent disputes. Hence, it will be particularly important to see which criteria the UPC will apply in such a case.
In addition, it will be interesting to see to what extent the UPC’s assessment of the imminent infringement for one or more Contracting Member State is affected if a company already conducts patent infringing activities in a Contracting or non-Contracting Member State. Although the UPC has not yet issued a decision on this issue specifically for the pharmaceutical sector, the Local Division of Munich has already issued an order related to this question in a case concerning an herbicide (UPC_CFI_201/2024, 27 August 2024, Syngenta v. Sumi, LD Munich). In this case, the respondents already marketed the product in question in the Czech Republic, thereby infringing the Czech designation of the patent in suit. Although the product was not marketed within any Contracting Member States, the respondents have obtained identical marketing authorisations and advertised the product within the Contracting Member States. The Local Division Munich ruled that this conduct constitutes at least a risk of first infringement in the territory of the Contracting Member States. If this approach was to be applied to the pharmaceutical sector, a patent infringing activity in one country could already indicate an imminent infringement in other countries. However, it remains to be seen whether the considerations from this case can also be applied to the pharmaceutical sector, given the highly regulated framework and the industry-specific dynamics.
