The Court of Appeal has granted a preliminary injunction (PI) across all 17 UPC territories where the patent in suit was in force, overturning a decision of the Lisbon Local Division (LD) that Zentiva's activity was not sufficiently imminently infringing. The CoA held that unusually early applications for regulatory permissions for medical products can indicate 'imminent infringement' (Boehringer Ingelheim International GmbH v. Zentiva Portugal LDA. UPC_CoA_446/2025 13/08/2025). The decision provides useful guidance to pharmaceutical patentees in relation to establishing imminent infringement sufficient to trigger a PI at the UPC, in particular in relation to infringement in Portugal.
Case summary
In infringement proceedings brought by Boehringer and appealed by Zentiva, the UPC Court of Appeal (CoA) overturned the Lisbon LD's refusal to grant a PI. The CoA held that Zentiva's "completion of national procedures for health technology assessment, pricing and reimbursement for a generic medicine" amounted to a likelihood of imminent infringement of Boehringer's patent EP1830843 for "Indolidone derivatives for the treatment or prevention of fibrotic diseases". A PI against Zentiva offering these generics was issued in 17 UPC territories where the EP is in force.
Legal context
Under Article 62 of the UPC Agreement (UPCA), the court may issue an injunction to prevent imminent infringements as long as "reasonable evidence...to a sufficient degree of certainty" is provided by the applicant. In this case, the CoA determined that completing all necessary steps to commercialise a generic drug before the end of the patent constituted an imminent threat of infringement, and noted that the 'Bolar Exemption', which allows certain pre-launch activities, does not extend to pricing and reimbursement steps in current law.
The Court of Appeal agreed with Boehringer that a situation of imminent infringement may be characterised by certain circumstances which suggest that the infringement has not yet occurred, but that the potential infringer has already set the stage for it to occur and the preparations for it have been fully completed, and the actual infringement is only a matter of starting the infringing action. These circumstances must be assessed on a case-by-case basis however.
The CoA was keen to confirm that 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. However, completion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine can amount to an imminent infringement. The assessment must be made with due regard to the national regulatory and legislative context and considering the circumstances of the case.
Imminent infringement and the necessity for a PI
The issue on the facts in this case was that Zentiva had applied and been approved for a Prior Evaluation Procedure (PEP), which establishes the conditions (such as maximum pricing and state reimbursement) for acquisition of medicines by relevant public entities in Portugal, over a year before the patent term was due to end but had not provided the Court with credible reasons for the early application.
The CoA analysed four questions in relation to the significance of what could be done in the Portuguese market with PEP approval, specially confirming whether:
(1) there were any "further administrative steps or procedures" required for commercialisation of the product;
(2) a "precontractual" characterisation of public procurement under Portuguese law while a patent is in force amounts to "offering" under Article 25 UPCA;
(3) there was only one procedure by which hospitals could acquire the product; and
(4) Zentiva "was effectively hindered from taking part in any proceedings for the acquisition of the generics".
The CoA found that the answers to all these all pointed towards Zentiva having no further administrative barriers to prevent the offering of its generic drug on the Portuguese market.
As PEP approval is the final administrative step in Portugal, the CoA held that only "self-restraint" was preventing Zentiva starting to offer its product. As such, Zentiva had "set the stage for offering generics in Portugal so that infringement was only a matter of starting the action because the preparations for it have been fully completed". The fact that Zentiva not offered "any credible explanation" why, absent patent infringement, it would be useful for it to obtain the PEP more than one year before the patent expired, led the CoA to conclude that "the only way a completed PEP can be of any use for Zentiva from an objective point of view is for the offering of the generics".
The CoA further concluded that participating in public procurement while a patent is in force amounted to "offering" even if classified as pre-contractual.
Finally, the availability of multiple procurement avenues by hospitals for products and the undisputed existence of a Framework Agreement for the acquisition of the drug in question from Boehringer alone, did not alter this decision as it did not operate to ensure that Boehringer was the exclusive source of the drug:
"While it is not disputed that there is a Framework Agreement in place for nintedanib in Portugal, and that currently Boehringer Ingelheim Portugal is the only entity listed for the acquisition of nintedanib, contracting entities can purchase outside the framework agreement, if they can demonstrate that there is an alternative with a price at least 10% lower for an object with the same characteristics and level of quality. Furthermore, new framework agreements can be opened at any time. In addition, other procedures, such as prior consultation or direct awards, can be initiated by contracting entities and private hospitals can negotiate directly with Zentiva the terms of an acquisition of nintedanib." (paragraph 21)
The CoA found that the necessity requirements for a PI were also met in that the significantly lower price for the generic drug (likely 30% lower) would impact the immediate market for Boehringer's product. Referencing its earlier decision in Sumi v Syngenta on this point (CoA, order of 3 March 2025, UPC_CoA_523/2024, APL_51115/2024), the CoA held:
A move from a market situation where only one product is available, to one where there are two competing products can be expected to lead not just to price pressure but to a permanent price erosion. This risk is an important factor when considering whether a provisional injunction is necessary.
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