2025 Week 33
It’s great to see stories and case law developing week-on-week at the UPC. In May this year we reported on the UPC Local Division Lisbon refusing – just – to award a preliminary injunction (PI) in favour of Boehringer Ingelheim against Zentiva. That was in UPC Weekly 2025 w19, and here we are reporting on the outcome of the appeal.
All it took was a marginal shift in emphasis on a key point, but the outcome of the appeal is that the PI has now been granted.
The first instance decision – no imminent infringement
Boehringer Ingelheim have European patent EP 1830843 B1, which expires in December 2025, covering the active substance nintedanib for use in the treatment of idiopathic pulmonary fibrosis. There is also an SPC for nintedanib, but this depends from a different patent (EP 1224170). The SPC will expire in April 2026. Boehringer Ingelheim’s product is Ofev®.
Zentiva have set themselves ready to launch a generic nintedanib in Portugal. They have done this by getting their paperwork in order, specifically by obtaining marketing authorisations and a Prior Evaluation Procedure (PEP) notice from the relevant Portuguese authority Infarmed that was issued on 6 December 2024. With this PEP in place, Zentiva are ready to agree sales of generic nintedanib to public hospitals in Portugal, but have not yet done so.
A different Boehringer Ingelheim entity already has a PI against Zentiva in respect of the same generic product. This PI was granted by a Portuguese national court based on the SPC.
The UPC LD first decided that the existence of the Portuguese PI should not stop there being a UPC PI. The UPC action was based on a different patent, had been brought by a different Boehringer Ingelheim entity and was in respect of the wider UPC territory rather than only Portugal.
Boehringer Ingelheim argued that completing the various administrative steps meant that infringement by Zentiva was imminent. Zentiva argued that it is normal in Portugal to request a PEP before the expiry of the patent. However, the court acknowledged that getting a PEP more than a year before expiry might be unusual. Nevertheless, the first instance court sided with Zentiva here:
In light of the regulated nature of the pharmaceutical field, the Court finds no evidence that merely requesting the PEP after receiving the MAs indicates the timing of market entry for the Defendant’s medicine. The timing of the PEP request at that date does not, under the specific circumstances presented to the Court, make it more likely than not that the Defendant intends to enter the market unlawfully before the expiration of EP 843.
According to the first instance decision, there was no evidence that Zentiva themselves had engaged in conduct likely to result in infringement. For example, there was no evidence of other steps to indicate that Zentiva will market the medicine. The court wanted to see evidence that the defendant was “highly likely to imminently enter the market with its nintedanib medicines”. Without it, the Local Division decided not to grant a PI.
The appeal – infringement is imminent enough
The decision of the UPC CoA in Boehringer Ingelheim v. Zentiva makes for a good case study, because there was only really one contentious point – whether infringement was imminent. It was uncontested that the Zentiva generic product fell inside the scope of the claims and there were no arguments about validity. It was also accepted that when the generic product is ultimately launched, there will be irreversible price erosion, at least in Portugal, and that this could have spill-over effects into other UPC territories.
What’s the legal standard for “imminent” infringement for generics?
The CoA said that a situation of imminent infringement can be where infringement has not yet occurred, but:
… the potential infringer has already set the stage for it to occur. The infringement is only a matter of starting the action. The preparations for it have been fully completed.
In the field of generics medicines, the CoA noted that a generics company applying for and being granted a MA does not by itself amount to an imminent infringement. 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.
Does the (current) Bolar exemption help?
The Bolar exemption, based on EU law, provides protection from patent infringement for generics companies when preparing their products for regulatory approval. Zentiva accepted that in its current form, the Bolar exemption did not help them. However, there is a draft revision to the legislation which also takes into account activities for pricing and reimbursement, and Zentiva encouraged the court to look at the spirit of the revisions. Not surprisingly, the CoA said that they must apply the legislation as it stands, not as it is proposed to be amended. So this argument failed.
How does the test for imminent infringement apply in this case?
The CoA was interested to understand whether any further administrative steps or procedures were required before Zentiva could offer and sell its generic products to public hospitals. To do this, the court needed to understand certain issues under Portuguese national law and practices.
The court decided that there was a notification that Zentiva would need to make to the Portuguese authority Infarmed. But that this was a simple formality and that the patentee would not be given advance warning of this. The court considered certain other issues of Portuguese law and practice, but concluded:
The Court of Appeal finds it more likely than not that the PEP approval by the national authority means that Zentiva can offer the generics to public hospitals in Portugal without any further administrative steps or procedures. The evidence so far does not support that there is anything in place nationally but self-restraint on Zentiva’s side to prevent it from taking part in public procurement procedures, direct awards or prior consultations, acts that would likely constitute infringement by offering the products.
This meant that Zentiva had, in the view of the CoA, “set the stage” for infringement. Having addressed this key point, the CoA went on to consider the other key headings for awarding a PI – whether it is necessary and whether the patentee has acted with due urgency.
Necessity – permanent price erosion
The price erosion point was enough for the CoA to agree that a PI was necessary.
Urgency – about 6 weeks was urgent enough here
A nice data point from the CoA here. Boehringer Ingelheim became aware of the Zentiva PEP on 12 December 2024. The PI application was filed on 23 January 2025. This was not an unreasonable delay, in the view of the CoA, and so the urgency criterion was met.
PIs in generics pharmaceutical cases going forwards
This is of course a landmark decision. However, the reversal of the LD decision seems to arise from just a small shift in emphasis applied by the CoA to the question of imminent infringement.
In our commentary on the first instance decision, we noted that the LD decision was so finely balanced that Zentiva were clearly on notice that if they took any further steps towards launch of their product in Portugal, the imposition of a UPC PI would be near-automatic.
What this decision has done is to shift the balance towards the patentee. Generics companies must take additional care that their preparations for launch don’t cross over the line freshly drawn by the UPC Court of Appeal.
