The United Patent Court (UPC) is two years old and it is proving popular for infringement actions, particularly in the life sciences sector, where many early cases concern pharmaceuticals, biotech, and medical devices, indicating that the case law of the UPC will be significantly shaped by the life sciences industry.
In this article, we examine how the UPC is shaping patent infringement law in life sciences. Key observations are:
- infringement actions relating to life sciences subject matter figure highly in the UPC
- the pan-European nature of the UPC favours disputes for life sciences products protected by multiple patents
- important areas of patent law relating to life sciences subject matter are already being decided, see recent caselaw below.
What the statistics say
By May 2025, the UPC had seen 320 infringement actions, with 26% involving life sciences patents, particularly in pharma, biologics, and medical devices.
Success rates remain finely balanced. In decisions on the merits, patentees have prevailed in about 50% of cases; in preliminary injunction proceedings, the figure drops slightly to 45%. These numbers offer a useful benchmark but should be interpreted with caution as outcomes still turn on case-specific complexities.
Strategy considerations
Patent litigation in medical devices and biologics often involves companies that both develop and manufacture products and hold their own patent portfolios. These inventions are typically complex, with multi-functional features covered by extensive portfolios, including divisionals.
As these products evolve, new patents are frequently filed and granted, leading to a dynamic and growing patent landscape, which has its specific strategic implications. When a product is protected by a broad portfolio, the commercial risk of a single patent being revoked is relatively low. This gives patentees greater freedom to pursue injunctions across up to 18 countries in one UPC action.
The UPC’s speed of approximately one year or even less for the proceedings on the merits also benefits patentees, especially when a pipeline of new patents and divisionals aligns with the evolving nature of the product, enabling timely enforcement.
In contrast, small-molecule pharmaceuticals are often protected by just one or two key patents. Revocation of one of these can be commercially significant, which initially led many traditional pharma companies to opt out such patents. While few such cases were seen early on, this trend appears to be shifting, so we can expect to see more pharmaceutical UPC cases.
Developing case law
Pre-launch activity: When does preparation become infringement?
Where is the line between lawful preparation and imminent infringement? This question is especially relevant for biosimilars and generic products in the life sciences sector. Recent UPC case law provides first guidance - no injunction without concrete launch steps.
In Novartis and Genentech v Celltrion (Düsseldorf LD, UPC_CFI_165/2024), the claimants sought provisional measures, alleging that Celltrion intended to launch a biosimilar of their product, protected by still existing formulation patent. Although Celltrion had filed an opposition at the EPO, launched revocation actions in the UK and the Netherlands, and obtained EU marketing authorisation in May 2024, the court found no evidence of imminent infringement.
The Düsseldorf Local Division dismissed the application, holding that there was no indication of concrete market activity—no pricing negotiations, no reimbursement requests, and no distribution of product samples. The court clarified that imminent infringement requires more than preparatory regulatory steps: the infringer must have completed all preparations and be ready to launch.
Regulatory approval is not enough.
The same principle was confirmed by the Lisbon Local Division in Boehringer v Zentiva (UPC_CFI_41/2025). The court ruled that holding a marketing authorisation and prior evaluation approval does not in itself prove an intention to market an infringing product before patent expiry. There must be clear indications that the product is about to enter the market. According to the court, a risk of imminent infringement only exists if the defendant’s conduct makes infringement more likely than not.
Second medical use claims
In its first substantive ruling on second medical use claims, Sanofi & Regeneron v Amgen (UPC_CFI_505/2024, 13 May 2025), the Düsseldorf Local Division states that for a successful finding of infringement of a second medical use claim, the alleged infringer must offer or place the medical product on the market in such a way that it leads or may lead to the claimed therapeutic use and that the alleged infringer knows or reasonably should have known that it does.
These requirements cannot be defined in an abstract manner but require an analysis of all relevant facts and circumstances of the individual case.
Relevant aspects that may be considered when assessing the knowledge or the expectation of a patented use are
- the extent or significance of the allegedly infringing use
- the structure and customs of the relevant market
- the market share of the claimed use
- actions of the alleged infringer taken to influence the respective market, either encouraging the patented use or taking measures to prevent the product from being used for the patented use.
The test of infringement for such claims has been a vexed issue in some national courts, with objective, subjective and presentational tests all being raised at one time or another. Here (for an EPC 2000 claim, though not expressed to be restricted to that form) the court seems to be laying out a test that combines presentational aspects and objective knowledge.
Prospects and missing pieces
The UPC has quickly gained traction in the life sciences sector, offering much-needed clarity on complex issues with its early well-reasoned and balanced decisions. Although some key questions remain open, such as the scope of the Bolar and experimental use exemptions or supplementary protection certificates, the court is steadily building a body of case law in areas critical to the industry. After just two years, the UPC is becoming a central forum for life sciences patent litigation in Europe, which is a significant development in the field. The system is evolving, so companies and their patent teams will need to follow developments closely.
