We expect this trend to continue as the Court of Appeal issues further harmonizing guidance on key substantive patent issues. In this overview we explore some of the key aspects and decisions of the UPC, and how they affect the life sciences industry.
State of play on patent validity
The UPC has developed its own approach to patent validity, in particular claim interpretation, inventive step, added matter, sufficiency, and plausibility.
Claim interpretation
In NanoString Technologies v. 10x Genomics2, the UPC Court of Appeal held that, although the claims are the starting point for patent interpretation, their meaning must always be determined in light of the description and drawings. This isn’t restricted to cases of ambiguity—claim construction is a holistic exercise carried out through the eyes of the skilled person. In G 1/243, the Enlarged Board of Appeal (EBA) of the European Patent Office (EPO) endorsed this principle, resolving diverging EPO case law and emphasizing the need for consistency with UPC and national court practice. This contributes to greater legal certainty and harmonization across Europe.
The Court of Appeal has also reaffirmed4 that claim interpretation is a matter of law to be assessed by the court, not by party-appointed experts. The court emphasized that the “person skilled in the art” is a notional legal construct, representing the general specialist knowledge, experience, and abilities customary in the relevant technical field, rather than the knowledge of any particular individual or expert.
While expert opinions may be considered, the court must independently construe the claims, taking into account the understanding of a notional “person skilled in the art.” Please see our more detailed article on this issue.
Inventive step
Two coordinated decisions issued by the (at that time) two different panels of the UPC Court of Appeal have clarified the court’s holistic approach to inventive step5.
First, the objective technical problem (or inventive concept) is defined by assessing the claim as a whole and not its individual features, in light of the description and drawings. To avoid hindsight, this should not include pointers to the claimed solution such as naming the already-patented medicine6.
An invention will be considered obvious if the person skilled in the art without inventive skill or imagination would have arrived at the claimed solution as a next step, either prompted by a pointer or motivation from a realistic starting point in the prior art, or as a matter of routine.
There can be more than one realistic starting point, and the invention should be inventive in view of each of them. It is a “would, not could” approach. There must be a reasonable expectation of success or predictable results—the mere feasibility of an option or the fact that other teams were working on the same project are not sufficient for an invention to be obvious. For claims in “medical use” format, the expectation needs to be of an effective treatment that has a meaningful therapeutic effect, not just some degree of biological effect.
Overall, the approach seems to be in line with EPO and national (such as German or Dutch) practice. It requires the party seeking to revoke the patent to establish that any next steps required from the prior art would be predictable or carried out with a reasonable expectation of success. Patentees can defend the inventiveness of patents by demonstrating that the research required to undertake the next step from the prior art was unattractive or uncertain at the priority date, or that it would be costly, involve practical or technical difficulties, or have a reasonable failure rate.
The UPC’s view on whether or not the fact that a clinical trial is being conducted is a sufficient indicator of an expectation of success is still evolving. Contrary to the EPO Board of Appeals7, the LD Munich has ruled that a phase III clinical trial near completion, with no interruption or discontinuation, may constitute a reasonable expectation of success8. You can read more about this in our previous article on the UPC’s approach to inventive step.
Added matter
The UPC Court of Appeal, in another life sciences case9, confirmed that each patent claim must be directly and unambiguously derivable from the original application as filed. Implicit disclosure and clear and unambiguous consequences of explicit disclosure may be relied upon, but the wording must not convey additional technical information beyond the teaching or original filing.
The UPC accepts implicit technical features where the person skilled in the art would recognize them from the technical context and language of the application (e.g., the Court of Appeal has checked how a sensor must be positioned based on the language of the claim and the description10). Hence, patentees should only rely on the original language and the technical disclosures in the original patent description. Whether the UPC will take a strict approach to added matter, as the EPO does, or will be more lenient, for example the German courts, is still to be seen.
Sufficiency
The UPC Court of Appeal11 has advocated a holistic assessment to sufficient disclosure and determined that the decisive factor is whether or not the patent, read as a whole and considering general technical knowledge, enables a person skilled in the art to reproduce the invention without undue burden, even if this requires a reasonable amount of trial and error. Laborious, time-consuming, and/or demanding methods do not automatically constitute an unreasonable burden, because occasional failures must be accepted as part of scientific work, especially in life sciences. The disclosure does not have to cover “each and every” embodiment of functional claims—the non-availability of some variants is immaterial if suitable embodiments can be obtained by the skilled person. Fair protection extends to equally effective variants of the disclosed embodiments, even if those variants would not have been envisaged without the invention.
What do UPC rulings mean for provisional measures concerning threatened infringement?
Imminent infringement
The UPC has clarified the requirement for an imminent infringement for preliminary injunctions (PIs), both for medicines and medical devices.
The Court of Appeal considers that completion of administrative procedures for a generic medicine, such as pricing and reimbursement procedure or health technology assessment, can evidence a risk of imminent infringement before launch, provided that the patent-holder demonstrates that this enables commercialization without the need for further steps, and the only reason for taking such steps is to offer the generic medicine12. Further details on this can be found in our article about the Court of Appeal’s judgment.
Obtaining and announcing a CE mark for a medical device is insufficient in itself, but when paired with marketing steps, such as providing ordering information and demonstrating products at a trade fair, it may establish a risk of imminent infringement13 justifying a PI. You can read more about this in our previous article on imminent infringement.
Inspection and preservation of evidence
The UPC has shown a readiness to grant ex parte provisional measures for inspection and preservation of evidence, months in advance of the launch of a potentially infringing product, and before trade fairs. The patent-holder needs to demonstrate:
- a high likelihood of validity (for example, maintenance of the patent in an EPO procedure)14 and infringement (for example by acquiring an identical product commercialized outside of UPC territories15 or a biosimilar referring to the reference medicine16). The LD Brussels considers that the threshold is lower in these applications than in a case on the merits or a request for preliminary injunction17.
- that evidence is likely to disappear or otherwise cease to be available (for example, because the information might cease to be available at the defendant’s premises after starting proceedings on the merits, and it is at least not common to seize the dossier held by the European Medicines Agency (EMA) at the EMA administrative office)18.
According to the LD Brussels, urgency is not a compulsory condition but left to the court’s discretion. If there is a risk of evidence being destroyed, an ex parte measure should be ordered, even without urgency. On the other hand, urgency may be of paramount importance for an order being made ex parte, e.g., when products are presented at trade fairs or when the marketing authorization for a biosimilar has been granted and the company makes various declarations referring to an imminent product launch19.
The LD Brussels also considered the proportionality of the measures: access to evidence may be limited to parties’ representatives and access to non‑UPC territory materials (e.g., FDA submissions) is refused. Security may be required for measures to preserve evidence.
What has the UPC held on medical devices and infringement?
The UPC has held that there can still be an infringement even if customers do not normally use the patented infringing element of a medical device and the device manufacturer specifies a different use of its device. It suffices that the use of the patented feature remains possible, provided that such use is in line with professional practices and recognized rules of medical sciences, such as correctly applying the device and performing a medical procedure20.
While the UPC recognizes that injunctions are normally granted when infringement is established, it has carved out an exception for a life-saving medical device which is the only available treatment for particular patients21. Patentees should therefore consider the proportionality of the injunction they are seeking and whether there are any alternative treatments.
What about second medical use claims?
The LD Dusseldorf22 decided the UPC’s first case on second medical use claims, confirming that a substance for any specific use in a method of treatment can be patentable, provided that the specific therapeutic use is novel. The key question is whether or not the therapeutic use as claimed is directly and unambiguously disclosed in the application.
The court also set a two-step test to determine infringement of these types of claims:
- 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.
- The alleged infringer must know or reasonably should have known that it does.
This cannot be considered in the abstract but requires an analysis of all the facts and circumstances of the alleged infringing use, including the relevant market and the share of claimed use compared to others, what is customary on the market, and actions taken by the alleged infringer, either to encourage or dissuade the patented use. What is said in the package insert or summary of product characteristics (SmPC) of a pharmaceutical product can be important but is not decisive in relation to any “skinny labeling”23.
What impact will the UPC’s “long-arm” jurisdiction have on future cross-border disputes?
One key aspect of the UPC’s decisions over the last 18 months has been the court’s growing willingness to extend its jurisdiction beyond its member states (long-arm jurisdiction). This makes it increasingly likely that more international life sciences disputes will be decided in the UPC than originally anticipated.
UPC-domiciled (e.g., manufacture or distributor)
The suitability of long-arm jurisdiction in patent litigation was only recently put on the table of strategic litigation possibilities by the CJEU24 when it ruled that, despite a validity challenge, an EU national court can adjudicate on infringement of a foreign European Patent (EP), including in territories outside the EU, if the defendant is domiciled in its home territory25.
The UPC has readily adopted this possibility in cases of UPC-domiciled defendants for all countries where an EP is validated, regardless of whether the states concerned are members of the UPC, EU, or Lugano Convention26. Those wishing to stop the manufacture and distribution of infringing products can therefore bring one UPC action covering not only manufacturing and distribution in UPC member states but also infringements in the UK, Spain, Poland, Switzerland, and Turkey.
Anchor defendants
A UPC-domiciled defendant can “anchor” other (non-UPC domiciled) defendants to disputes for “closely connected” acts infringing an EP counterpart in other EU states27, Lugano states28, and third states such as the UK29.
This has allowed the UPC30 to take jurisdiction over non-UPC group entities based on sales of the same pharmaceutical product31 in connection with a UPC entity. For example, jurisdiction was adopted concerning Spanish and Norwegian local group entities infringing in their respective home countries, “anchored” by a Dutch group company, which was central to sales across Europe32.
This could also lead to potential exposure for non-EU manufacturers and their EU-based intermediaries, such as marketing authorization holders of medicinal products and authorized representatives for medical devices imported into the EU. At first instance, a German authorized representative for a Hong Kong manufacturer was subject to an injunction preventing infringement of an EP in UPC member states and Spain33. This was due to its critical role in EU distribution, even though it didn’t manufacture or import the products. Furthermore, the German authorized representative was held to “anchor” jurisdiction against the non-UPC co-defendant, the Hong Kong manufacturer, for infringements in Spain (a non-UPC territory) because the claims were closely connected34, as both defendants infringed there35.
This decision has been appealed and the Court of Appeal has made a reference to the CJEU asking it to clarify whether the UPC’s jurisdiction over a non-EU defendant insofar as it extends beyond the UPC, may be derived from a connection to the acts of the EU authorized representative, over which it did have jurisdiction by virtue of its domicile in a UPC Member State. Alternatively, if the UPC nevertheless has the power to grant provisional measures in respect of such acts. The CJEU will also answer whether the EU authorized representative is an intermediary whose services are being used to infringe, and therefore capable of being subject to a preliminary injunction.
Place where the harm occurred
Of course, the UPC can also hear infringement claims against non-EU defendants if the harmful event occurs (or may occur) within its territory. This includes cases where the damage occurs (or may occur) within the UPC territory36, such as infringing a UPC patent by direct supply into the UPC. A Chinese medical device manufacturer and its Dutch subsidiary were subject to a PI for alleged infringement of an EP for implantable occlusion devices because they had obtained a CE marking for their product and participated in a device parade in Frankfurt37. As such, the harm would arise in Germany38. For a more detailed analysis of this case you can read our previous article.
A number of UPC first instance decisions implied that this can also include cases where the event giving rise to the damage occurs in the UPC territory. A Korean manufacturer was therefore subject to the UPC’s jurisdiction because it shipped products to Poland, Spain, and the UK via its distributors in the UPC territory39, the place of the events giving rise to the damage40. Furthermore, the LD Paris held that foreign companies with a website via which infringing products are offered can infringe if the website is accessible in UPC Member States41, and that the UPC’s jurisdiction extends to damage occurring outside the UPC territory (i.e., Switzerland, Spain, UK, Ireland, Norway, and Poland). However, this decision was appealed and the UPC Court of Appeal has now confirmed42 that, where the UPC has jurisdiction based on it being the court of the place where the damage occurred or is threatened to occur, there is no jurisdiction for infringement in territories that are not member states of the UPC. Claimants cannot therefore rely on infringing products being available on a website accessible in the UPC and the global nature of internet-based damage to expand the UPC’s territorial reach.
Further reading
For further expert analysis of other UPC cases concerning the life sciences sector, please refer to our dedicated UPC Insights page:
Footnotes
1. The UPC local divisions have had more than 690 infringement actions, 350 counterclaims for revocation, and 125 actions for provisional measures; the central division has had 120 standalone revocation actions and the Court of Appeal 300 appeals (UPC Docket Navigator, February 2, 2026).
2. UPC_CoA_335/2023.
3. G 0001/24.
4. Insulet v. EOFlow UPC_CoA_768/2024.
5. Meril/Edwards Lifesciences, UPC_CoA_464/2024, UPC_CoA_530/2024, UPC_CoA_21/2025, UPC_CoA_457/2024, UPC_CoA_532/2024, UPC_CoA_27/2025, UPC_CoA_458/2024, UPC_CoA_533/2024; Amgen/Sanofi, UPC_CoA_528/2024, UPC_CoA_529/2024.
6. Sanofi /Stadapharma, Reddy Pharma, Zentiva, UPC_CFI_146/2024, UPC_CFI_496/2024, UPC_CFI_147/2024, UPC_CFI_374/2024, UPC_CFI_148/2024, UPC_CFI_503/2024.
7. T 136/24.
8. Sanofi/Stadapharma, Reddy Pharma, Zentiva, UPC_CFI_146/2024, UPC_CFI_496/2024, UPC_CFI_147/2024, UPC_CFI_374/2024, UPC_CFI_148/2024, UPC_CFI_503/2024.
9. Amgen/Sanofi, UPC_CoA_528/2024, UPC_CoA_529/2024.
10. Abbott Diabetes Care/Sibio, UPC_CoA_382/2024.
11.UPC_CoA_528/2024.
12. Boehringer v. Zentiva, UPC_CoA_446/2025, UPC_CoA_520/2025.
13. Occlutech/Lepu Medical, UPC_CFI_553/2025.
14. Genentech, F. Hoffmann-Laroche/Organon, UPC_CFI_407/2025, UPC_CFI_408/2025.
15. LiNAMedical AG/Shutz Medical, UPC_CFI_1598/2025.
16. Genentech, F. Hoffmann-Laroche/Organon, UPC_CFI_407/2025, UPC_CFI_408/2025.
17. Ibidem.
18. Genentech, F. Hoffmann-Laroche/Organon, UPC_CFI_407/2025, UPC_CFI_408/2025.
19. Genentech, F. Hoffmann-Laroche/Organon, UPC_CFI_407/2025, UPC_CFI_408/2025.
20. Emboline/Aortic, UPC_CFI_628/2024, UPC_CFI_125/2025.
21. Meril v. Edwards, Ibid.
22. Sanofi/ Regeneron v. Amgen, UPC_CFI_505/2024.
23. i.e., carving out protected indications in the (SmPC) to avoid infringements.
24. BSH Hausgeräte v. Electrolux (C-339/2022).
25. Art 4 Brussels Regulation (recast).
26. Fujifilm v. Kodak, UPC_CFI_365/2023, Dainese v. Alpinestars, UPC_CFI_792/2024, Mul-T-Lock v. IMC Creation, UPC_CFI_702/2024, Black Sheep v. HL, UPC_CFI_386/2024, Dyson v. Dreame, UPC_CFI_387/2025.
27. Dyson v. Dreame, UPC_CFI_387/2025. This decision is currently on appeal.
28. Mul-T-Lock v. IMC Creation, UPC_CFI_702/2024.
29. Dyson v. Dreame UPC_CFI_387/2025. There needs to be a plausible allegation of infringement of the relevant part of the EP in each jurisdiction.
30. Moderna v. Genevant Sciences and Arbutus Biopharma, UPC_CFI_191/2025.
31. a Covid vaccine.
32. Moderna v. Genevant Sciences and Arbutus Biopharma, UPC_CFI_191/2025.
33. Provided there is a plausible allegation of infringement in each country.
34. Dyson v. Dreame, UPC_CFI_387/2025. This decision is on appeal.
35. The Hong Kong based company infringed by offering via its website (also) in Spain, which would not have been possible without the authorized representative, a company domiciled in Germany in that case, which was thus considered a necessary intermediary (which is liable under Art. 63(1) UPCA) for the infringement by the court. Given jurisdiction of the UPC under Art. 4(1) Brussels-Ia for the intermediary due to its seat in Germany, the Hong Kong defendant could be “anchored”, according to Art. 8(1), 71b(2) Brussels-Ia; Dyson v. Dreame, UPC_CFI_387/2025, Order of 08.14.2025, margin no. 56-65.
36. Art, 7(2) and Art, 71b Brussels Regulation (recast), Aylo v. Dish, UPC_CoA_188/2024.
37. Occlutech v. Lepu Medical, UPC_CFI_630/2025.
38. The injunction also covered Ireland, which is in line with Electrolux long-arm decisions. Jurisdiction to do this was not challenged.
39. Hurum v. NUC Electronics, UPC_CFI_162/2024.
40. The action was ultimately dismissed because the infringing acts could not be attributed to the Korean defendant.
41. Keeex v. Adobe and Open AI, UPC_CFI_530/2025.
42. Keeex SAS v Adobe and Open AI, UPC_CoA_922-925/2025, 03.13.2026
.jpg%3Fh%3D1520%26iar%3D0%26w%3D2026&w=256&q=90)