Context: Three months ago, the Unified Patent Court’s (UPC) Lisbon Local Division (LD) denied an application for provisional measures (which in some other jurisdictions would be called a motion for a preliminary injunction (PI)) by Boehringer Ingelheim against Zentiva, holding that an infringement did not appear imminent (item 2 of our May 10, 2025 UPC Roundup). As we noted at the time, even the formal loss probably had value to Boehringer as Zentiva’s representations that there wasn’t going to be an infringement could have been held against it in follow-on proceedings. But, at any rate, either party appealed the unfavorable parts of the decision.
What’s new: Today the UPC’s Court of Appeal (CoA) reversed the lower court’s view that an infringement was unlikely to be imminent and ordered an injunction (PDF) for 17 UPC contracting member states over a second medical use patent, but denied Boehringer’s request for information. The patent-in-suit will expire on December 21, 2025.
Direct impact: It could be that this decision has only cost implications and will impact other cases where a generics product is being readied for a potential launch. Zentiva may not have dared to launch its product prior to expiration of this patent and even a few months beyond, given that Supplementary Protection Certificate No. 679 (relating to a different patent) may have to be respected by Zentiva in Portugal, the only country in which it has sought marketing authorization. But with this PI, Boehringer has a more reliable basis for the next four months.
Wider ramifications: The headnotes and the reasons perform some line-drawing regarding generics. While the CoA says a “mere application” for marketing authorization or even its grant are not tantamount to an imminent infringement, but “[c]ompletion of the national procedures for health technology assessment, pricing and reimbursement for a generic medicine” may rise to an imminent infringement, which is subject to a case-specific assessment taking the regulatory framework into account. It will generally be difficult now in the UPC to prevail on a request for information if an infringement has not occurred yet, given that the information sought does not necessarily even exist. The last headnote is of particularly transcendental importance because it clarifies that national law can be a source of law in accordance with Art. 24 of the UPC Agreement (UPCA), but “it is for the parties to bring forward facts and evidence about the content of national law and its application.” That is a key holding because it means the concept of “da mihi facta, do tibi ius” (give me the fact, I give you the law) applies only to other source of UPC law than national laws.
The product which Boehringer Ingelheim seeks to shield from competition for a few more months is sold under the Ofev brand in Portugal. The patent-in-suit is EP1830843 (“Indolidone derivatives for the treatment or prevention of fibrotic diseases”). The accused products are named Nintedanib Zentiva soft capsules 100 mg and 150 mg.
Boehringer based its theory of imminent infringement on Zentiva’s regulatory activity in Portugal. But on March 25, the Tribunal da Propriedade Intelectual (Portuguese Intellectual Property Court) entered, by default judgment, a preliminary injunction against Zentiva over Supplementary Protection Certificate (SPC) No. 679. That one was granted on the basis of EP1224170 (“6-position substituted indoline, production and use thereof as a medicament”), protects the substance itself as opposed to the claims-in-suit (claims 1 and 2 of EP’843), which are second medical use claims. The SPC will remain in force until April 9, 2026. The SPC injunction is specific to Portugal, which Zentiva argued was the only market in which it had taken certain steps at all.
While the lower court had bought Zentiva’s argument that it’s normal to go through the Prior Evaluation Procedure (PEP) even when a patent is still in force, it did not agree (nor did the CoA) that these UPC proceedings were unnecessary just because of the Portuguese PI over SPC 679.
The CoA threw out untimely facts and evidence presented by either party (in Zentiva’s case, by affirming the related holding by the Lisbon LD).
Zentiva made an argument based on Art. 85 of the present proposal for a new EU SPC directive, which shields certain pre-launch regulatory steps from patent infringement claims, but the CoA unsurprisingly applied the existing statute, and Zentiva had not pleaded a so-called Bolar exemption under the law as it stands.
Para. 54 of the decision defines the key question:
As explained, the legal test when an infringement has not yet occurred, is whether the potential infringer has already set the stage for it to occur, so that the infringement is only a matter of starting the action because the preparations for it have been fully completed. In the present case it is disputed what action, if any, could be started without further preparations by Zentiva.
With only a formality (pre-notification) missing, the CoA then holds that “[t]aking part in public procurement procedures with the generics while the patent is still in force will generally constitute infringement through offering, regardless of whether a public procurement procedure is classified as pre-contractual under national law.”
The CoA focuses on “whether there are further administrative procedures required that prevent Zentiva from offering [emphasis in original] the generics in Portugal after it has obtained a market authorisation and PEP.”
The parties disagreed on whether public hospitals in Portugal could acquire medicaitons outside of public procurement procedures. Here, Boehringer’s winning argument was that it is possible. For example, “with reference to the Portuguese Public Procurement Code, that public hospitals can place orders up to € 5,000.00 as direct awards.”
The last part of the imminent-infringement assessment was then “[w]hether Zentiva is effectively hindered from taking part in any proceedings for the acquisition of the generics.” Here, the CoA would have wanted to see a legal mechanism that stands between Zentiva and offering its generics, short of the PI that Boehringer requested.
In arguing that there would be a requirement to respect intellectual property, Zentiva “made a reference to Article 77 of the Portuguese Public Contracts Code,” but the CoA would have wanted to see facts and evidence about what that one means and how it works.
The CoA found that there was no sufficient likelihood of Portuguese public entities assessing a vendor’s compliance with patent rights. Therefore, the CoA held:
74. Zentiva’s defence ultimately comes down to the argument that any participation by it in public procurement procedures in relation to nintedanib prior to patent expiry would constitute patent infringement and that it could incur liability. This, however, means that self-restraint by Zentiva is the real mechanism for preventing infringement. This applies equally to the patent and SPC 679.
75. In addition and as already explained, there is more than one way for public hospitals and entities to purchase medicines.
76. The Court of Appeal does not find it more likely than not that Zentiva would be prevented from participating in procedures for the acquisition of nintedanib products in Portugal.
While all of that argument about imminent infringement is confined to Portugal, where the CoA considers it more likely than not that Zentiva could offer its products to public hospitals in the absence of the injunction that has now come down, the way the UPC works is that if the patentee shows an imminent infringement in one UPC contracting member state, it is entitled to injunctive relief with respect to all UPC contracting member states where the patent is in force (unless there are special circumstances, none of which are present here).
Boehringer established competitive harm under the CoA’s decision that upheld a Syngenta injunction against Sumi Agro (item 1 of our March 8, 2025 UPC Roundup): going from a monopoly to a market in which two products compete leads to price erosion. Here, Boehringer argued that Zentiva’s generics would cost at least 30% less than the original product.
The request for information was denied:
There is no allegation of any completed infringement in this case. There is no indication that the requested information actually exists and, moreover, any explanation that the requested information is reasonably necessary for the purpose of advancing that party’s case is lacking. The Court of Appeal sees no reason in the present case to issue an order to communicate information as a result of an imminent infringement.
But that part was considered so unimportant in the greater scheme of things that Zentiva nonetheless has to bear 100% of the costs (the interim award amounts to €199K).
Court and counsel
Second panel: Presiding Judge Rian Kalden, Judge-rapporteur Ingeborg Simonsson and Judge Dr. Patricia Rombach, Technically Qualified Judge Andreas Gustafsson and Technically Qualified Judge Carola Wagner.
Counsel for Boehringer Ingelheim: Joana Piriquito Santos, Sara Nazaré and Beatriz Lima of NLP, which stands for Nazaré, Lima, Piriquito Santos & Associados).
Counsel for Zentiva: Antas da Cunha Ecija (lead: PatrĂcia Paias).