Novartis/Genentech v. Celltrion

In Novartis/Genentech v. Celltrion, Celltrion had already obtained a marketing authorization in spring 2024 for its omalizumab biosimilar Omlyclo, referencing the originator product Xolair marketed by Novartis and Genentech. Novartis and Genentech then applied for a preliminary injunction to prevent a market entry before the expiration of EP 3 805 248.

The Local Division Düsseldorf (UPC_CFI_165/2024 and UPC_CFI_166/2024, 6 September 2024) rejected the application. According to the local division, imminent infringement requires that all prelaunch preparations must have been completed in such a way that an offer can be made at any time. In the underlying case, beyond the marketing authorization, there were no further indications of an imminent market launch. Pricing and reimbursement negotiations had not yet been concluded, and there was no evidence of sales offers or tenders in which Celltrion had participated. Novartis and Genentech did not appeal against the rejection of the application.

Boehringer Ingelheim v. Zentiva

This case concerned Zentiva’s generic version of nintedanib, which competes with Boehringer Ingelheim’s originator product Ofev, used for the treatment of idiopathic pulmonary fibrosis and related conditions. Zentiva had not only obtained a marketing authorization for this generic drug, but had also completed a full pricing and reimbursement procedure (PEP) in Portugal more than a year before the expected patent expiration in December 2025.

The PEP in Portugal is a central procedure to set the reimbursable price and conditions under which Portuguese public hospitals may procure medicines. It therefore largely determines whether and how a product can compete in Portugal’s state healthcare system.

The Local Division Lisbon rejected Boehringer’s application for a preliminary injunction (UPC_CFI_41/2025). The mere existence of a marketing authorization or a PEP was considered an administrative act and, on its own, insufficient to establish an imminent infringement. Boehringer had not shown any more conduct by Zentiva pointing to a likely market entry.

The UPC Court of Appeal (CoA) disagreed. It held that an imminent infringement can already be assumed if the generic drug manufacturer has set the stage and the infringement depends only on pulling the trigger. The completed PEP had removed all objective hurdles to market entry. Zentiva’s statement that it would not launch before patent expiration was insufficient because mere self-restraint is not a reliable barrier.

Assessment and significance

The formulated principle that an imminent infringement is to be assumed once the potential infringer has set the stage, and all that remains is to launch on the market corresponds to the moment when the generic drug manufacturer is actually in a position to immediately commence making offers and deliveries of the relevant generic product.

This appears to be a significantly stricter approach than that of other jurisdictions. For example, German courts have consistently applied the concept of imminent infringement more restrictively. Obtaining a marketing authorization or initiating a pricing and reimbursement procedure alone are not sufficient. Further indications of a concrete intention to launch on the market are required. Only when objective circumstances show a serious intention to start offering or selling before patent expiration will German courts consider a preliminary injunction. It may even suffice in Germany to eliminate the risk of imminent infringement for a generic drug manufacturer to respond to a warning letter with a simple declaration without offering contractual penalty that the generic drug manufacturer will not launch before expiration of the patent.

The CoA in Boehringer Ingelheim v. Zentiva, however, appears to set the threshold at the point when all regulatory and administrative requirements for market entry have been fulfilled. In this situation, it does not matter whether the generic drug manufacturer simply and non-bindingly declares that it will wait; self-restraint is not considered a reliable, objective safeguard.

Abstracted from the specific case, this definition may look like a very early assumption of imminent infringement. But on closer inspection of the case, this is not a penalty for a generic drug manufacturer’s thorough and early preparation of a market launch.

The CoA emphasized that the assessment of imminent infringement must take into account the national regulatory and legislative context as well as the circumstances of the individual case. In the case at hand, the following particularities were considered:

• Zentiva had completed the pricing and reimbursement procedure unusually early – more than a year before patent expiration. It must be noted that this pre-evaluation is subject to certain deadlines and may lapse. Completing the procedure that early in advance is therefore not common practice.
• Zentiva also failed to provide a credible explanation as to why it would have been useful for the company, absent an intention to infringe the patent, to obtain the PEP more than a year before patent expiration. The CoA therefore concluded that a completed PEP could only be of objective use to Zentiva if its generic product were to be offered before patent expiration.

Had Zentiva provided understandable reasons for the early timing of its PEP, the assessment might have been different.

The CoA is therefore best understood as meaning that the mere setting the stage may not be sufficient and that concrete indications of an intention to infringe are also required. In this case, the CoA seems to have seen such indication in the unusually early and not credibly explained completion of the PEP.

This approach would be a coherent one: In other fields of business where there are no regulatory steps, such as a marketing authorization or a PEP in the first place, the stage for an infringement will often be set while any indications of an intention to infringe may still be lacking. As an example, a competitor of the patentee may be able, without obtaining any market authorization, to launch a patent infringing dowel. In that sense, the patent could be infringed in the future and the stage for infringement would be set, yet pending any indication that the competitor would infringe in the future, it may appear disproportionate to grant injunction claims. Therefore, the criterion of the stage being set alone may not necessarily be a standard that can be consistently applied to the broad range of possible settings.

German case law deals with such situations in a similar way: There must always be specific circumstances indicating that the potential infringer has already decided to infringe and that an infringement will occur if they wish. According to German courts, such circumstances are present when a potential infringer publicly asserts their right to commit certain infringing acts, for example.

The requirement of necessity

Beyond imminent infringement, a clear infringement read and a high probability of patent validity are required for granting a preliminary injunction. But they are not sufficient in themselves; the grant of a preliminary injunction also requires necessity of provisional measures.

The CoA has set out several guidelines in this respect:

• Seriousness of the impending interference: Irreversible harm is not mandatory but can be a strong indicator (Mammut v. Ortovox, UPC_CoA_182/2024). Thus, a strong reason or harm to the patentee must be shown that cannot be remedied by the main proceedings.
• No mere assertions: General references to market losses are not sufficient. Patentees must present concrete and substantiated reasons why only a preliminary injunction will ensure effective protection of their rights (Biolitec v. Lightguide, UPC_CoA_540/2024).
• Limits of urgency: Conversely, a long-standing market situation with competition by the accused products may argue against necessity, as it may be reasonable for the patentee to await the outcome of the main proceedings (Biolitec v. Lightguide).

In generic drug cases, however, it may be straightforward to establish that a preliminary injunction is necessary. Boehringer argued that Zentiva’s generic drug would be at least 30% cheaper than the originator product Ofev. Such a price difference would, in practice, not only lead to an immediate reduction in Ofev sales but also to an almost complete switch to cheaper generic products. As it had done before in the proceedings Sumi v. Syngenta (UPC_CoA_523/2024, 3 March 2025), the CoA accepted that the entry of a second, significantly cheaper product into a previously monopolized market will typically lead not only to short-term price pressure but to permanent price erosion. This risk was seen as a decisive factor when assessing necessity.

Conclusion and key takeaways

In Boehringer Ingelheim v. Zentiva, the CoA defined a relatively patentee-friendly test for imminent infringement. It remains to be seen whether this standard will be applied verbatim in future cases or whether UPC divisions will adapt the test to circumstances of the individual case, in particular introducing nuance to nongeneric drug cases. For now, the following should be noted:

• Low threshold at the UPC: Unlike in jurisdictions such as Germany, the CoA may assume imminent infringement as soon as all regulatory hurdles for a market launch are overcome. Mere self-restraint by the generic drug manufacturer will not exclude an imminent risk of first infringement.
• Price erosion as a strong argument for necessity: In generic drug cases, necessity is easy to establish since generic market entry typically results in permanent price erosion.
• Practical consequences: Patentees can claim protection earlier; generic drug manufacturers must carefully consider the timing of regulatory steps and be prepared to plausibly justify taking these early steps, to avoid creating the appearance of an imminent market launch. For making use of the favorable CoA decision, patentees should monitor filings from generics companies for pricing and reimbursement procedure, such as the Portuguese PEP.