2025 Week 19
Your patent is valid and in force. The alleged infringement falls squarely inside the scope of the claims. You have come to the UPC fast enough to meet the urgency requirements. When the infringing product hits the market there will be irreversible price erosion. So, can you get a UPC preliminary injunction?
Well, it depends. A key issue that led to the outcome in Boehringer Ingelheim v. Zentiva was whether the infringement was also imminent. And in this case, the UPC Local Division Lisbon said no.
The facts
Boehringer Ingelheim have EP 1830843 B1, which expires in December 2025, the patent 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 in PEP place, Zentiva are ready to agree sales of generic nintedanib Zentiva to public hospitals in Portugal.
Jurisdiction – overlap with national proceedings
An interesting point in the case is that there is already a Portuguese national court preliminary injunction against Zentiva’s generic nintedanib. The UPC Local Division Lisbon decided that they still had jurisdiction in this case though – the national action was based on the SPC (which itself depends from a different patent) and had been brought by a different Boehringer Ingelheim subsidiary. The court was therefore not obliged to decline jurisdiction. So the UPC had no problem in principle with overlaying their own preliminary injunction (covering Portugal and all other UPC states for the patent) on top of the national Portuguese injunction.
Imminent infringement?
The patentee held back from arguing that the administrative steps taken by Zentiva in Portugal could themselves be considered to be acts of infringement. However, the patentee did argue that completing these administrative steps meant that infringement was imminent. See here for our previous explanation of the factors that the UPC must take into account when considering a PI.
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 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 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 court decided not to grant a PI.
Is this a surprise?
Is the refusal of the PI a surprise? It really isn’t. At least not in view of the UPC’s own recent case law. And this is where the interest in this case lies.
It probably does no-one much good to try to work out what will happen in a pharma litigation case based on non-pharma case law. So all the previous discussion about “necessity” of PIs from cases involving avalanche rescue devices, surgical devices or herbicides should not be relied on too heavily.
But the facts of this case were very similar to Novartis/Genentech v. Celltrion in which a PI was sought for omalizumab biosimilar antibodies. We reviewed this case in UPC Weekly 2024 w36. The defendants had their marketing authorisation and had even made an announcement of their plans to launch their product in Europe in 2024.
The UPC Local Division Düsseldorf decided that the marketing authorisation and the commercial announcements were not quite enough to show that infringement of the patent was imminent. For example, pricing had not been confirmed. Therefore it could not be concluded that the defendants “more likely than not intend to enter the market during the patent term without any further ado.”
The Novartis/Genentech decision was published in September 2024 and this new PI application was filed in January 2025. Considering the similarity of the facts of the cases, it is easy to see that the LD Lisbon might well follow a similar rationale to the LD Düsseldorf. And then the outcome for Boehringer Ingelheim would likely be the same: a denial of a PI, which is what happened. In each case, the failed PI application led to costs awards against the applicants. Novartis/Genentech were ordered to pay €138k and Boehringer Ingelheim were ordered to pay €92k.
But in both cases, the UPC Local Division essentially affirmed that, if the competing products were to be launched while the patent remained in force, then there would be patent infringement. Perhaps the costs of a failed PI application is an acceptable price to pay to keep further commercial preparations for launch of the competing products firmly frozen until the expiry of the patent.
