Pharmaceutical patents and the UPC: is the Court hostile to them?
The question has been asked since the Unified Patent Court's first months. The decisions handed down in 2023 and 2024 worried proprietors in the pharmaceutical sector to the point that the Court's hostility towards them became received wisdom. Three years of case law now allow that view to be tested against the figures.
A reputation forged in the early months
The early signals were indeed unfavourable. The central division revoked Amgen's patent on anti-PCSK9 antibodies at Sanofi's request. The Court of Appeal set aside the preliminary injunction granted to 10x Genomics against NanoString, on proportionality grounds among others. The Hamburg local division dismissed Alexion's applications for provisional measures concerning eculizumab. On 6 September 2024, the Dusseldorf local division dismissed the application brought by Novartis and Genentech against Celltrion over a biosimilar of omalizumab.
Four unfavourable decisions in a row are enough to create a reputation. They are not enough to establish a trend.
What the figures now show
We have read and coded the operative part of every decision on the merits handed down by the Court in infringement and revocation. Among the decisions ruling on validity, the patent is revoked in its entirety in 16.3% of cases, revoked in part or maintained in amended form in 37.2%, and maintained as granted in 46.5%. In other words, the patent survives in more than eight decisions out of ten. Among the decisions ruling on infringement, infringement is found in 53.5% of cases. The detail is set out in our UPC statistics.
These figures cover all sectors. They do not describe a court that destroys patents: they describe a court that reshapes them. The most frequent outcome of a serious validity attack is not full revocation but maintenance in amended form, often enough for the competitor and not enough for the proprietor.
The preliminary injunction, the real friction point
If there is a difficulty specific to the sector, it does not lie in the examination of validity but in access to provisional measures. The pharmaceutical model rests on a generic or biosimilar entry that must be blocked before it produces its price effects. At that stage, however, the Court requires a high degree of certainty on validity and on infringement, and carries out a balancing of interests that an launch at risk does not by itself carry.
The Novartis and Genentech v Celltrion decision illustrates the decisive point. Preparatory steps towards launch, a marketing authorisation obtained and commercial steps taken, do not in themselves establish imminent infringement. The claimant must show that the act is about to occur, not that it has become possible.
What is really at stake: proving imminence
For an originator, the consequence is operational. The imminence file is built before the writ, by dated collection of marketing evidence, and not after the application has been lodged. For a generic or biosimilar manufacturer the symmetry is exact: the protective letter lodged in advance, and control of the launch calendar, largely determine the outcome of the application for provisional measures.
The supplementary protection certificates add a further layer of choice, since disputes concerning them fall to the Paris seat of the central division, and not to the Milan section competent for section A of the international classification.
What this changes in practice
Three consequences follow. The Unified Patent Court is not hostile to pharmaceutical patents; it is demanding on evidence, which is not the same thing and is not handled in the same way. Aninfringement action on the merits remains favourable ground for a proprietor whose patent is solid, whereas an application for provisional measures presupposes an imminence file built in advance. Finally, anrévocation action brought as a main action by a competitor most often leads to a limitation of the European patent rather than to its disappearance, which must be anticipated when drafting auxiliary requests.
Decisions in the sector are tracked one by one in Pharma Litigation Watch. Our firm acts in these disputes before the UPC as before the French courts, in particular as correspondent in France for patents and the UPC. Contact us.
This article is an updated adaptation of two analyses by Matthieu Dhenne first published on Kluwer Patent Blog, on 2 September 2024, Is UPC hostile to pharmaceutical patents?, and on 25 September 2024, Biosimilars: new rejection of an application for preliminary injunction by a UPC German local division (omalizumab). The statistics cited come from our UPC Litigation Watch database, as of 26 September 2026.