Court’s Decision
The Delhi High Court vacated an earlier ex parte interim injunction that restrained the defendants from commercially launching a pharmaceutical product allegedly infringing the plaintiff’s patent on Netupitant-Palonosetron formulations for chemotherapy-induced nausea and vomiting. The Court held that the plaintiff failed to establish (i) conditions necessary for a quia timet action, and (ii) the Court’s territorial jurisdiction. Stressing that “credible material indicating imminent threat is a prerequisite for quia timet relief”, the Court dismissed the plaintiff’s application under Order XXXIX Rules 1 and 2 CPC and allowed the defendants’ application under Order XXXIX Rule 4 CPC.
Facts
The plaintiff, a Swiss pharmaceutical company with expertise in oncology supportive care, owns Indian Patent IN 426553 covering an oral fixed-dose composition of Netupitant and Palonosetron. This formulation is marketed globally under the mark “Akynzeo” and in India through its licensee Glenmark Pharmaceuticals since 2018.
The defendants comprise a German healthcare company and its Indian subsidiary in Hyderabad engaged in developing generic formulations. In March 2024, the plaintiff became aware of the defendants’ post-grant opposition to its patent. Subsequently, in September 2024, the German parent initiated business discussions with the plaintiff regarding the fixed-dose combination for the EU market. In October 2024, the defendants presented the same product at the CPHI conference in Milan, showcasing it as “under development.”
The plaintiff alleged that the Indian subsidiary was manufacturing the impugned product in India for export to Europe and relied on product listings and patent applications of the defendants. On 23 December 2024, the Court granted an ex parte interim injunction restraining commercial launch in India without Court approval. The defendants appealed, but the Division Bench maintained the injunction with liberty to seek its vacation. The defendants then moved to vacate the injunction, leading to the present decision.
Issues
- Whether the plaintiff established a valid basis for a quia timet action in patent law by showing imminent threat of infringement in India.
- Whether the Delhi High Court had territorial jurisdiction when the defendants’ operations were based in Hyderabad and Germany.
- Whether listing the impugned product on a website accessible in Delhi constituted “offer for sale” sufficient to invoke jurisdiction.
Petitioner’s Arguments (Plaintiff)
The plaintiff argued that the defendants’ conduct demonstrated imminent intent to infringe. Filing of post-grant opposition, international promotion of the product at CPHI, and online product listings indicated that the defendants were preparing to commercially launch the infringing formulation, possibly from India. The plaintiff stressed that quia timet actions exist to prevent harm before it occurs, and waiting for actual infringement would defeat patent enforcement.
On jurisdiction, the plaintiff contended that since defendants’ other products were accessible on platforms like IndiaMart in Delhi, and because the defendants’ website was accessible from Delhi, the Court had jurisdiction. The plaintiff relied on precedents including Novartis v. Zydus Healthcare (2022), Shilpa Medicare v. Bristol Myers Squibb (2015), and Teva v. Natco Pharma (2014) to argue that apprehension of infringement is sufficient to sustain quia timet suits.
Respondent’s Arguments (Defendants)
The defendants contended that the plaintiff had distorted facts to create a false sense of urgency. The product was still at a nascent stage, pending clinical trials and regulatory approvals, and there was no plan to launch in India. Mere listing of the drug as “under development” with dossier status “Q3 2025” reflected internal development timelines for EU submissions, not imminent Indian commercialization.
They argued that Section 48 of the Patents Act protects against “offers for sale,” not mere advertisement, and unlike trademarks, listing in “under development” category does not constitute infringement.
On jurisdiction, the defendants pointed out that neither entity had an office in Delhi, and their products were not sold there. The IndiaMart listing related to POSATIF (an antifungal drug) manufactured only for export, briefly sold domestically during COVID-19. Mere accessibility of websites in Delhi did not amount to purposeful targeting of consumers there, as clarified in Banyan Tree v. A. Murali Krishna Reddy (2009).
Analysis of the Law
The Court examined the doctrine of quia timet actions, relying on Novartis v. Zydus Healthcare (2022) and Pfizer v. Rajesh Chopra (2006). A plaintiff must demonstrate: (i) deliberate intention to infringe, (ii) imminence of the infringing act, and (iii) irreparable prejudice if not restrained. The Court found these lacking—business discussions for EU launch, post-grant opposition, and listings of drugs “under development” did not establish imminent Indian infringement.
On jurisdiction, the Court relied on Banyan Tree (2009), holding that accessibility of a website in Delhi is insufficient unless it specifically targets Delhi customers. The plaintiff had no evidence of commercial transactions in Delhi. Reliance on Shilpa Medicare and Novartis was distinguished, since in those cases defendants had obtained manufacturing licenses in India, unlike here.
Precedent Analysis
- Novartis v. Zydus Healthcare (2022) – set standards for quia timet suits; distinguished here as imminent threat was absent.
- Shilpa Medicare v. Bristol Myers (2015) & Teva v. Natco (2014) – allowed quia timet actions where regulatory approvals were obtained; distinguished as no approvals existed here.
- Pfizer v. Rajesh Chopra (2006) – acknowledged threat perception for quia timet suits, but here the threat was speculative.
- Allied Blenders v. R.K. Distilleries (2017) – clarified different tests for Order VII Rule 11 (plaint demurrer) and Order XXXIX injunctions; applied to emphasize Court could assess defendant’s rebuttal.
- Banyan Tree v. A. Murali Krishna Reddy (2009) – held jurisdiction requires purposeful targeting of forum consumers; applied to deny Delhi jurisdiction.
- New Life Laboratories v. Dr. Ilyas (2023) – denial of injunction due to lack of evidence of sales in Delhi; applied directly here.
Court’s Reasoning
The Court emphasized that speculative apprehensions cannot sustain interim injunctions. Filing a post-grant opposition or presenting products at international conferences aimed at the EU market does not imply imminent Indian infringement. No evidence of clinical trials, regulatory approvals, or actual sales in India was provided.
On jurisdiction, the Court stressed that mere website accessibility in Delhi cannot create jurisdiction. There must be purposeful targeting and actual commercial activity, which the plaintiff failed to show. IndiaMart listings of unrelated drugs did not establish a territorial nexus.
Thus, the plaintiff failed on both parameters—no imminent threat and no territorial jurisdiction.
Conclusion
The Delhi High Court vacated the ex parte injunction granted in December 2024. The plaintiff’s application for interim injunction was dismissed, while the defendants’ application for vacation was allowed. The case will proceed before the Roster Bench, but without interim relief for the plaintiff.
Implications
This ruling underscores strict standards for quia timet patent suits in India. Plaintiffs must demonstrate concrete and imminent threat, not speculative fears. It also reaffirms that territorial jurisdiction cannot be claimed merely on the basis of accessible websites or speculative sales. The decision is significant for multinational pharmaceutical litigation, highlighting that Indian courts will carefully scrutinize jurisdiction and imminence before granting patent injunctions.
FAQs
Q1: What is a quia timet action in patent law?
It is a preventive action to restrain an anticipated infringement before it occurs, but requires proof of imminent threat, not speculation.
Q2: Can website accessibility in Delhi give jurisdiction to Delhi courts?
No. As held in Banyan Tree (2009), jurisdiction requires purposeful targeting of customers in Delhi, not mere accessibility.
Q3: Why was the injunction against the defendants vacated?
Because the plaintiff failed to show imminent Indian launch of the product or evidence of sales in Delhi, both of which are essential for interim injunctions.
