Be warned, Long post ahead!
The Court of Appeal (COA) of the Unified Patent Court (UPC) in Boehringer Ingelheim v. Zentiva (Boehringer Ingelheim) on 13th August 2025, issued an order addressing the pretty knotty question of when a preliminary injunction should be granted when an applicant (in this case, Boehringer) claims that infringement has not yet taken place but is imminent. This is somewhat similar to a Quia timet action under Indian law, where an interim injunction is sought because the plaintiff reasonably believes that infringement is imminent.
In this post, I will discuss in detail the order of the Lisbon Local Division (Lisbon Court), which had initially refused to grant the preliminary injunction. Then the subsequent order of the COA setting aside the order of the Lisbon Court for reasons we will discuss later in the post. Finally, I will discuss the some ancillary issues that come up with regard to Quia timet action in the Indian context.
Getting to the Facts:
Boehringer filed an application for a preliminary injunction against Zentiva (Defendant), claiming that there is a risk of imminent infringement since Zentiva had applied for and acquired two market authorisations (MAs) for generic medicines on 30th August 2024 containing the active pharmaceutical ingredient nintedanib (as esylate salt) in Portugal. Nintedanib is used to treat various kinds of lung diseases. Boehringer has a patent titled “Indolidone derivatives for the treatment or prevention of fibrotic diseases” (EP 1 224 170, Suit Patent) whose claims 1 and 2 cover nintedanib and nintedanib esylate (a salt form of nintedanib) and was selling the drug in its salt form with the market name Ofev. The Suit Patent is set to expire on 21st December 2025. Yet Zentiva did not stop with securing the MAs; it proceeded to acquire something called a Prior Evaluation Procedure (PEP) from a public administrative body, Infarmed. A PEP approval allows Zentiva to directly sell the generic medicine containing nintedanib to public hospitals in Portugal. This is relevant since, as per Portuguese law, nintedanib is restricted to hospital use, with the public hospitals being the primary market for nintedanib. On December 12 2024, a notice was issued by Infarmed, stating that the PEP approval for the generic version of nintedanib has been granted to Zentiva, paving the way for its procurement by public hospitals a good one year before the Suit Patent is to expire. This, in turn, led to Boehringer filing an application seeking a preliminary injunction before the Lisbon Court.
When does Infringement become “Imminent”?
Article 62 of the Unified Patent Court Agreement (UPCA) enables the Court of first instance (in our case, the Lisbon Court) and the COA to issue preliminary injunctions to “prevent any imminent infringement”. Article 62(4) clarifies that the burden of proof to establish imminent infringement is on the applicant seeking a preliminary injunction. Article 25 of UPCA meanwhile, specifies the exclusionary rights provided to the holder of a European Patent.
The Lisbon Court concluded that the mere grant of MAs and subsequent approval under PEP, thus enabling Zentiva to supply its generic medicines to public hospitals, is not a sufficient trigger to make a claim that infringement is imminent. The Lisbon Court’s decision was based on two grounds:
Firstly, it concluded that it was common industrial practice to secure both MAs and PEP before the patent expired. Secondly, it concluded that the claim for imminent infringement was not based on Zentiva’s own conduct but on the approval and notice issued by an administrative body (granting PEP to Zentiva by Infarmed and subsequent notice of the same). On these two grounds, it concluded that Boehinger had failed to show that infringement of the Suit Patent by Zentiva is imminent and hence the preliminary injunction was denied.
A Twist at the Appellate Stage:
COA in deciding the appeal, first clarified that imminent infringement arises when a certain set of fact situations exists that sets the stage for infringement to occur. It then further clarifies that, “in the context of marketing of generics, the mere application for a marketing authorisation by a generics company does not amount to an imminent infringement, nor does the grant of such an authorisation create one” [Para 47]. Then it states that completion of subsequent procedures at the national level like “health technology assessment, pricing and reimbursement for a generic medicine” can set the stage for imminent infringement, but will be based on fact situations and the surrounding circumstances at the national level [Para 48].
The primary test the COA came up with was to identify whether there are any additional administrative steps that Zentiva needs to fulfil before it can offer the generic medicines to public hospitals in Portugal. In other words, are there any further legal or administrative hurdles that prevented Zentiva from offering and then placing the generic product in the market? Here COA deviated from the Lisbon Court on the appreciation of the facts. It concluded that the only additional step Zentiva had to fulfil as per COA was to issue a pre-notification on Inframed’s website to trigger the offering of the generic medicines to public hospitals. This Boehinger contented, and COA agreed, was a mere formality which could be done at any time. Further, Boehinger will not be in a position to exactly ascertain when the generic medicines would be placed in the market by Zentiva if it chooses to do so. This in turn raises the possibility of price erosion and irreparable harm being caused to the Boehinger. Hence, COA concluded that if it was mere self-restraint that was holding back Zentiva and nothing else, then the claim of imminent infringement is valid. A preliminary injunction was granted ordering Zentiva to “refrain from making, offering, placing on the market or using, or importing or storing for those purposes, any product ” as claimed in the Suit Patent. This injunction was to last until the Suit Patent expires.
Some Critical Thoughts:
The injunctive relief granted by COA extended to all Contracting Member States (CMS) [Para 91]. This is based on Article 36 of UPCA, which states that decisions of the Court will cover all CMS where the European Patent has effect. Yet this sits uncomfortably with some other observations made by the COA. The COA had observed, as was discussed above, that the question of whether infringement is imminent must be answered with “due regard to the national regulatory and legislative context and considering the circumstances of the case”. In Para 62 it further notes how even if other member countries have a similar procedures in place to the one that exists in Portugal with regard to the pre-notification and other procedures post-grant of PEP, it is the specific aspect of the Portuguese system wherein the procurement system did not enable an originator company (Boehringer) to track when a generic company issues the notification and then places the generic drug on the market that swung the decision in favour of Boehringer. When the specific finding on the question of imminent infringement was based on the national regulatory and legislative context of Portugal, it seems a bit unreasonable to extend the preliminary injunction to all CMS, even though the same is mandated by UPCA.
Quia Timet Action, the Indian version of the Imminent Infringement standard?
Quia timet action is our own version of the imminent infringment test where the Plaintiff filing a Quia timet action reasonably believes that, absent any immediate intervention by the Court, the defendant would infringe away and cause irreparable harm to the plaintiff.
Yogesh and Tejaswini previously had discussed the specific standard to be applied in the context of Quia timet actions. Here, I wish to touch upon some additional ancillary issues. Firstly, the concept of Quia Timet action and its relation to the requirement of mandatory pre-institution meditation under Section 12A of the Commercial Courts Act (CCA). Secondly, the role of claim mapping in a Quia timet action. Finally, the difficulty in identifying the specific fact situations that can clearly establish that infringement is imminent.
Why mediate when you can contemplate
It has been argued previously that with the Supreme Court in Patil Automation v. Rakheja Engineers Private Limited making pre-institution mediation mandatory, Quia timet actions might not constitute urgent interim relief. The argument is threefold: Quia timet actions are filed even before the act of infringement has taken place. A patent is not presumed to be valid and hence the rights based on which the remedy is being sought itself is insecure. Hence, since the relief sought is based on apprehensions, it might not satisfy the requirement of urgency as required under Section 12A.
But I wish to disagree on this point, because Section 12A merely requires the plaint and the associated documents to “contemplate” urgent interim relief. Secondly, the question of whether the urgent relief is likely to be granted is not a relevant factor at the stage of admission of a plea seeking urgent interim relief.
The Supreme Court, in a more recent judgment of M/S Exclusive Capital v. Clover Media and others, considered a commercial court as a “sentinel at the door” checking the plaintiff’s “urgent” ticket. Thus requiring the commercial court to peruse the submissions of the plaintiff a bit more carefully to identify whether it “contemplates urgent interim relief”. Since “contemplating urgent interim relief” and getting the same urgent relief granted are distinct enquiries. Hence, one can be left with cases where mere apprehensions can cross the Section 12A threshold, while later failing to get the urgent relief on merits.
Claim mapping: Needed or not needed?
What is the role of claim mapping in establishing a prima facie case of possible infringement? If it is mandatory, then Quia timet action cannot survive since claim mapping is not possible without an alleged infringing product. Yet in another instance, a single bench of the Delhi High Court in Novartis v. Zydus, while deciding on the question of whether a plaint can be rejected for a lack of claim mapping, stated that the requirement of claim mapping in a Quia timet action is itself questionable, indicating that claim mapping is not mandatory in a Quia timet action. Yet this observation was in the context of maintainability of the suit, not in the context of an interim injunction application. E.R. Squibb v. Zydus (discussed here and here) accepted the indirect way of claim mapping performed by the plaintiff to establish a prima facie case of infringement. Thus, there are different and contradictory approaches with regard to claim mapping in a Quia timet action in recent times.
How imminent is the infringement?
Finally, as to how likely infringement is to occur in the future, one is confronted with the same questions the COA and the Lisbon Court were confronted with: what are the specific circumstances and fact situations that can give rise to a Quia timet action? Can I file for a Quia timet action if a generic is filing for a trademark application for selling a product that is covered by my Patent? Can I file a Quia timet action the moment the marketing approval for a generic or biosimilar drug is granted, combined with an investigation report that a generic entity is preparing for launch my patented product? What about anonymous emails being sent stating that a generic company might launch my patented product? All these indicate that infringement is probable, but is it imminent?
In conclusion, one is forced to throw up his hands and say, it’s facts, facts, facts all the way down…
Image from here
Thanks to Daanish Naithani for bringing the case to our notice and to Swaraj for his valuable input.