Under Development ≠ Imminent Infringement: Delhi HC Offers Welcome Clarification on the Scope of Qua Timet Injunctions
SpicyIP
In the recent refusal for a quia timet injunction by the DHC, Vikram Raj Nanda examines the reasons closely and writes on the contrasting jurisprudential development over ‘offer to sell’ under Section 48 of the Patents Act, 1970. Vikram Raj Nanda is a third year student at National Law School of India University, Bengaluru with a keen interest in IP law, Competition Law and Arbitration.
Under Development ≠ Imminent Infringement: Delhi HC Offers Welcome Clarification on the Scope of Qua Timet Injunctions
By Vikram Raj Nanda
On 26 September 2025, a single judge bench of the Delhi High Court (‘DHC’) declined to grant Helsin Healthcase SA a quia timet injunction against AET Laboratories and its parent company the Tiefenbacher Group, which were alleged to be developing a fixed-dose composition (FDC) tablet version of the Helsin’s patented oral dosage drug named AKYNZEO. The drug is used to treat nausea and vomiting induced by chemotherapy. This order gains relevance due to two reasons: first, it clarifies the scope of the phrase ‘offer for sale’ under Section 48 of the Patents Act, 1970 (prescribing the rights of a patentee) – an issue which has received little to no scholarly attention and second, it signals a clear shift from recent cases by drawing a firmer interpretation on what constitutes ‘imminent infringement’. In doing so, this post argues that this case may not be another instance of a routine quia timet injunction in the pharmaceutical sector, but also have broader implications on the scope of quia timet injunctions as a whole.
The Case in Brief and the Section 48 Dilemma
Helsin Healthcare, a Swiss pharmaceutical company, manufactures and markets a patented oral dosage drug, AKYNZEO. The facts leading up to the dispute arose after AET Laboratories had filed a post-grant opposition to Helsin’s patent. Thereafter, AET Laboratories’ parent company had engaged in commercial discussions with Helsin to jointly launch a fixed-dose composition (FDC) tablet of the same drug in the EU market. Helsin also found out that the parent company had publicly made presentations for launching this product at the Congress of Pharmaceutical Professions International (CPHI), a globally significant pharmaceutical event. Lastly, and perhaps most significantly, Helsin discovered that defendant’s website listed the impugned product in the ‘Under Development’ category and used AKYNZEO as a reference product.
However, despite these steps having been undertaken by the defendant, the Court refused the grant of an injunction. Relying on an earlier decision in Novartis v. Zydus Healthcare (2022), the Court reasoned that there was no ‘imminent’ threat of the defendant committing patent infringement (p.23). Prior to a commercial launch, the Court held that regulatory approvals and clinical trials need to be mandatorily conducted, which were admittedly not conducted by the defendants.
More importantly, on Section 48 of the Patents Act, the Court noted that the provision does not include ‘advertisements’ as being an instance of infringement of the patent holder’s rights – in contrast to Section 29 of the TM Act, 1999 (enumerating what constitutes trademark infringement), which includes ‘advertisements’. Accordingly, the Court noted that the ‘minimum threshold’ under Section 48 is an ‘offer for sale’ and mere listing on the website as ‘under development’ would not meet this threshold.
This observation raises a few interesting questions on Section 48. First, Section 48 is modelled on Article 28 of the TRIPS (enumerating the rights granted to a patent holder), where there has been a long-standing debate on whether the phrase ‘offers to sell’ encompasses advertisements (see here at pg. 352). From a contract law perspective, an advertisement is usually not considered as an offer. However, different considerations apply in cases of patents where the underlying rationale is to prevent a competitor from generating commercial interest in an infringing product to the detriment of the patent holder’s exclusive rights. Hence, some scholars advocate for an extension of this phrase to include advertisements (see here). However, the Court’s reasoning in this case appears to signal that advertisements require explicit legislative inclusion to qualify as infringing acts. This interpretation aligns with recent trends in U.S. jurisprudence, where courts have increasingly limited the meaning of ‘offer’ to its contract law understanding, thereby excluding advertisements. This has received some criticism as commercial advertisements of potentially infringing products can be prejudicial to the patent holder’s interests.
That said, on the specific facts of this case, the discussion around ‘advertisements’ itself seems somewhat misplaced. A listing describing a product as ‘under development’ cannot ordinarily be considered an advertisement, and it is unclear why the court relied on that terminology at all.
Ultimately, the decision may be defensible as there was no express evidence of a commercial launch. The evidence at hand clearly showed that the defendants’ products, though listed on their website, were not available for sale in Delhi (a point which also defeated Helsin’s claim that the DHC had territorial jurisdiction).
The Shifting Standards of Quia Timet Injunctions
The second important aspect of this case relates to the scope of quia timet injunctions. Such injunctions are usually filed by a patentee as a preventive measure, before an actual act of infringement takes place. In Novartis vs Zydus, the court laid down a three-fold test to decide upon the maintainability of a quia timet injunction: an express intention of the defendant to carry out infringement [I], the said activity being ‘imminent’ [II], and substantial/irreparable harm being likely to result in the absence of an injunction [III] (p. 50).
This test also formed the basis of the decision in the present case. As is evident from a bare perusal, the question of what constitutes an ‘imminent’ threat is essentially left to judicial discretion. As several blog posts earlier (see here, here and here) and Prof. Aparajita’s paper (see here) have highlighted, the test for granting quia timet injunctions is inherently subjective in nature. It grants the courts significant leeway in defining imminence, resulting in shifting standards and inconsistent outcomes across a line of precedents.
For instance, a good example can be found in one of the initial cases decided in the long Novartis saga (see here). In that case, the DHC had granted an injunction due to factors which included, inter alia, a statement advertising the biosimilar drug of the defendant being ‘under development’ and the defendants having filed a revocation petition for the patent. These facts are quite similar to the case at hand. While they had influenced the decision in favour of the plaintiffs in one case, in another, they remained inadequate to sway the Court. Such inconsistencies are often evident in patent injunction cases. For instance, the courts have granted injunctions in the past on often questionable bases, such as a lack of transparency in disclosures before the court (see here) or unverified claims over the defendant trying to launch the drug in the market (see here). While such inconsistent outcomes have formed the scope of several academic debates, I shall now proceed to discuss what the case at hand offers to these discussions.
A Course Correction in Quia Timet Jurisprudence?
I believe the Helsinn case may herald in a stricter approach towards quia timet injunctions in sharp contrast to these earlier cases. However, it becomes necessary to first mention a more procedural point. In earlier cases, courts typically dealt with applications under Order 7 Rule 11 CPC which pertains to the return or rejection of a plaint (see here and here). In such cases, the defendants would argue for the rejection of a quia timet application. Consequently, due to the operation of this provision, it was binding upon the courts to base their decision on the averments evident in the plaint itself, without delving into the counter-party’s pleadings. However, in Helsin, the patentees were the ones who had approached the court under Order 39 Rule 1 and 2. Consequently, due to no such limitation to restrict themselves to the plaint’s averments only, the DHC differentiated earlier cases and referred to the defendants’ pleadings as well. Perhaps this formed a significant swaying factor in the case, allowing the Court to analyse the counterclaims and rule against the plaintiffs.
In analysing such counterclaims, the court deviates from recent decisions that have arguably granted injunctions on lower thresholds. By positing a higher standard where even a public presentation of a purported launch and a pending challenge to the patent wasn’t adequate to amount to an imminent infringement, the court may be said to have corrected course to an extent. This is in line with recent international decisions. For instance, in Boehringer Ingelheim v. Zentiva, the Court of Appeal of the United Patent Court recognised that an assessment of imminent infringement must be made based on the national regulatory and legislative context, and whether the defendant is at a stage where an allegedly infringing product can be launched without significant regulatory hurdles. In the present case, the Court recognised that the defendants had admittedly not conducted any clinical trials or obtained any mandatory regulatory approvals which formed a major plank of its decision to refuse an injunction.
However, once again, this raises the question: can it not be said that a public announcement, coupled with discussions with the plaintiff themselves to launch a similar product and an attempt to oppose the patent itself amount to clear intention to commit infringement in the future or at the very least launch a similar product? In my opinion, it certainly may indicate a trajectory for such behaviour in the future. However, in the context of a quia timet injunction, I do not believe the court erred in its decision. Even from a viewpoint of the Novartis standard, ‘imminence’ must form the central plank of the court’s decision, and I do not believe an infringement was imminent to warrant an injunction. Furthermore, there are several public interest elements that must also be considered before granting such injunctions. For instance, a rise in granting such injunctions may lead to a rise in ‘sweetheart deals’ or ‘pay-for-delay’ measures, where the patentee may collude to pay a sum to the generic manufacturer to delay the launch of the generic drug (see earlier post here). The consumers would end up facing the brunt of such measures in the form of higher prices.
Seen in this light, I believe there may be some defence to the decision. While there was no specific discussion on public interest or on the broader inequities of quia timet injunctions, the case may form a basis for such discussions in the future. By refusing injunction in the development stage, the court has drawn a clearer line: a quia timet injunction is justified only where the infringing activity is highly imminent.