Since becoming operational in mid-2023, the Unified Patent Court (UPC) has begun shaping substantive and procedural patent law across the contracting member states. Almost exactly two years on, clear patterns are emerging: the UPC is not only adhering to its own procedural timelines, delivering first instance decisions on its merits approximately one year from the start of the proceedings, but is also establishing itself as an important forum for patent litigation in Europe and a key component of global enforcement strategies.
While early pharma and biotech cases are relatively few in number, they are closely watched given their complexity and commercial impact. In contrast, the medical device sector is more active in bringing disputes before the UPC, reflecting its faster development cycles and broader patent portfolios. Nevertheless, even the smaller number of pharma and biotech cases provides early indications on how the UPC approaches sector-specific issues, particularly in relation to injunctions, the infringement of second medical use claims by off-label use and public interest considerations, but also with regard to the application of specific exceptions like the Bolar exemption. This article distils seven practical lessons from UPC rulings of the past year that are of particular relevance to the life sciences sector.
Strength of the European Patent Office opposition file indicative of patent validity and possibility of injunctive relief
It is crucial for life science innovators to put up a fight and defend their patents during European Patent Office (EPO) opposition proceedings. Conversely, generic companies and biosimilars should also file oppositions in a timely manner. An opposition that casts doubt on the validity of the patent can be detrimental during preliminary injunction proceedings. In Alexion v Samsung Bioepis (UPC_CoA_402/2024) and Alexion v Amgen (UPC_CFI_124/2024), both the Court of Appeal (CoA) and the Local Division Hamburg stressed the need for a sufficient degree of certainty as to both infringement and validity before granting a preliminary injunction. In both cases, the Court analysed the ongoing EPO opposition file in depth, including the technical substance of the challenges, to assess whether the requested injunction could be justified.
Claim language and sequence listings interpreted strictly
In the few biotech disputes that have reached the Court, the UPC adopted a literal and highly detailed approach to claim interpretation. In the Alexion v Samsung Bioepis cases (UPC_CoA_405/2024 and UPC_CoA_402/2024), the CoA ruled that the claimed sequence (SEQ ID NO:4) included the signal peptide, based on the claim wording and the prosecution history. Importantly, the CoA rejected arguments to narrow the claim retrospectively, even though the signal peptide was not part of the final therapeutic product. This approach signals limited judicial flexibility in redefining the scope of claims post grant.
The Bolar exemption has limits—especially post European Medicines Agency approval
In Novartis & Genentech v Celltrion (UPC_CFI_166/2024), the Local Division Düsseldorf held that commercial preparations made after European Medicines Agency (EMA) marketing authorisation may still constitute imminent infringement, despite ongoing clinical studies that fall within the scope of the Bolar exemption. The decision underscores that the Bolar exemption does not provide carte blanche for all kinds of pre-launch activities once EMA approval has been granted. This decision emphasises that strategic timing and regulatory coordination by generics are key.
Patentability of Biotech strains affirmed
In Amycel v Polish farmer (UPC_CFI_195/2024), the Local Division The Hague upheld the patentability of a brown mushroom strain under Art. 53(b) EPC, confirming that such biological materials are not per se excluded from protection.
This decision reinforces the notion that plant-related biotechnological inventions, when sufficiently characterised, can enjoy patent protection across UPC member states. The UPC emphasised consistency with the TRIPS Agreement and Directive 98/44/EC, which allow for the patenting of biological material under certain conditions, ensuring that the decision aligns with international and EU legal standards.
The test and evidence for establishing infringement of second medical use claims by off-label use
In Sanofi vs Amgen (UPC_CFI_505/2024), the Local Division Düsseldorf set a precedent for analysing the infringement of second medical use claims, particularly when off-label or bonus effects are involved. The Court made it clear that infringement is not just about what is written in the patent or the product label but about how the product is actually marketed, presented, and used in practice, especially whether it leads to the patented therapeutic use.
Second medical use claims require that the product is used for a specific therapeutic purpose not comprised in the state of the art eg a new indication or a new patient group. The Court formulated a test in assessing infringement: it must be shown that the alleged infringer 1) offers or places the product on the market in a way that leads or may lead to the claimed therapeutic use, and 2) knows or should reasonably have known that it does.
It is also not required that the claimed therapeutic use be the sole purpose of administration. It is sufficient that the therapeutic use (eg reduction of Lp(a)) is also intended, even if alongside other approved uses (eg lowering LDL-C). Where information in the Summary of Product Characteristics (SmpC) explicitly refers to the patented use, it is sufficient to demonstrate inducement or encouragement of infringement if it leads prescribers to use the product for the patented indication.
Patient interests can influence injunctive relief
In some cases the UPC has shown a willingness to consider third-party interests in shaping injunctive relief. In Edwards v Meril (UPC_CFI_15/2023) the Central Division Paris held that third-party interests, such as those of patients, can weigh against granting an injunction. Under Article 63(1) UPCA, the Court may consider such interests at its discretion. Whether the infringer sought a license – or initiated compulsory licensing – can indicate both the presence of third-party interests and the infringer’s willingness to license. Failure to initiate such proceedings may suggest that the infringer was unwilling, which could justify not limiting the injunction. However, even if the infringer is unwilling, third-party interests may still be considered. In this case, although the infringer was found unwilling, the Court recognised patient interests and limited the injunction slightly, allowing implantation of already scheduled infringing implants. Further guidance emerged in Insulet v EOFlow (UPC_CoA_768/2024), where the CoA acknowledged the challenges of transitioning patients between medical consumables. These cases show that, while injunctive relief remains available, it is not immune from balancing considerations in life sciences contexts.
Conclusion: cautious optimism with strategic precision
The UPC’s early decisions in the biotech and pharma domain demonstrate a commitment to detailed legal reasoning and a structured procedural approach. For rights holders on the one hand, this offers encouraging signs, particularly in terms of enforceability and timing. For potential defendants on the other hand, that same emphasis on timing highlights the importance of proactive risk management, such as carefully scheduling product launches. At the same time, the early case law raises the bar for evidentiary precision, claim drafting, and regulatory alignment. Practitioners should thus pay close attention to the emerging jurisprudence, particularly with respect to claim interpretation, the evidentiary burden for preliminary relief, and the treatment of exceptions. These early lessons offer both strategic guidance and cautionary tales for patent enforcement and defence under the new regime.
