The Delhi High Court recently passed its judgement in the case of Helsinn Healthcare SA vs AET Laboratories Private Limited & Anr. [CS(COMM) 1188/2024], deciding two interlocutory applications: one filed by the Plaintiff seeking an interim injunction and another by the Defendants seeking vacation of the ex parte ad interim injunction granted earlier.

The suit was instituted by Helsinn Healthcare as a quia timet action to restrain the Defendants from infringing their patent IN 426553, titled “Compositions and Methods for Treating Centrally Mediated Nausea and Vomiting”, covering an oral dosage combination of Netupitant and Palonosetron hydrochloride, marketed as AKYNZEO.

The Defendant no. 1, AET Laboratories Pvt. Ltd., had filed a post-grant opposition against the suit patent. Subsequently, Defendant no. 2, AET GmbH, its German parent company, approached Helsinn for business discussions concerning a fixed-dose combination tablet comprising Netupitant and Palonosetron, which it was developing and intending to commercially launch in the European Union (EU) market. Around the same time, AET GmbH presented the formulation at the Congress of Pharmaceutical Professionals International (CPHI) in Milan and listed the formulation under the category of “Under Development” products on its website.

Claiming that these actions indicated an imminent threat of infringement, Helsinn approached the Delhi High Court seeking an injunction. On the first date of hearing, the Court granted an ex parte ad interim injunction against the Defendants.

The Defendants sought to vacate the injunction, contending that:

• The Plaintiff had distorted facts to create an impression of imminent threat. It was asserted that the impugned product was still at a nascent stage and clinical trials, regulatory clearances, and mandatory approvals were yet to be obtained. The dossier status marked “Q3 2025” (third quarter of 2025) merely referred to the expected completion of data compilation for submission to EU regulators, not a timeline for commercialization in India.

They also clarified that the post-grant opposition was filed not as an inventor of the impugned formulation but as a pharmaceutical company engaged in research. Furthermore, since Section 48 of the Patents Act does not include “advertising” or listing of a product under development as an infringing act, the mention of the impugned product on the Defendant’s website did not amount to an “offer for sale”.

• On territorial jurisdiction, the Defendants asserted that neither company had any presence within Delhi. AET Laboratories operated from Hyderabad, and AET GmbH was based in Germany. There was no evidence placed on record showing that their products were being sold or offered for sale in Delhi or that any part of the cause of action had arisen within the jurisdiction of this Court.

On the other hand, Helsinn maintained that:

• The Defendants’ conduct demonstrated clear commercial interest in the patented invention, sufficient to justify a quia timet action. It relied on the filing of the post-grant opposition, the ongoing business discussions, and the Defendants’ promotional activities at CPHI and on their website as indicators of intent to infringe.

Helsinn relied on earlier decisions of the Delhi High Court, including Shilpa Medicare v. Bristol Myers Squibb Company [2015 SCC OnLine Del 11164], Teva Pharmaceutical Industries v. Natco Pharma [2014 SCC OnLine Del 3373], and Novartis v. Zydus Healthcare [2022 SCC OnLine Del 4373], to assert that the instant suit qualified as a maintainable quia timet action.

• On jurisdiction, Helsinn contended that since AET Laboratories’ other pharmaceutical products were listed for sale on IndiaMART, including to customers in Delhi, the Defendants were carrying on business within the jurisdiction of this Court. The accessibility of the Defendants’ website from Delhi, it was argued, also created a territorial nexus.

The Court examined both the issues in detail:

• When Can a Quia Timet Action Be Entertained?

Applying the principles laid down in Novartis vs Zydus Healthcare, the Court found that Helsinn had failed to establish an imminent threat of infringement. The following findings were particularly emphasized:

• The mere filing of a post-grant opposition by the defendant could not, by itself, imply that the Defendants were poised to launch an infringing product in India.
• The admitted ongoing discussions between Helsinn and AET GmbH concerning development of the fixed-dose combination for the European market further negated any claim that the Defendants intended to manufacture or launch the impugned product in India.
• The presentation made at CPHI Milan was explicitly with reference to the EU market, not the Indian market.
• The Court noted that before any pharmaceutical product can be commercially launched in India, mandatory clinical trials and regulatory approvals must be obtained from the Central Drugs Standard Control Organization (CDSCO). The Defendants had not even initiated these steps.
• The Defendants’ product list described the impugned composition as “under development”, with “dossier status Q3 2025”, which the Defendants plausibly explained as the expected completion of data compilation for submission to European regulators. This, the Court observed, did not amount to any indication of commercial launch in India.
• The Court clarified that Section 48 of the Patents Act, 1970, which defines the rights of a patent holder, does not extend to “advertising” or listing a product as “under development”. Thus, mere mention of the impugned product on the Defendant’s website could not constitute an ‘offer for sale’.

Having examined these aspects, the Court concluded that Helsinn’s apprehension was speculative and unsupported by cogent evidence. It therefore did not meet the threshold of a legitimate quia timet action.

The Court also distinguished the decisions cited by Helsinn with the facts and stage of the case. It noted that the rulings in Shilpa Medicare, Teva Pharmaceutical Industries and Novartis were rendered in the context of applications under Order VII Rules 10 and 11 of CPC, where the Court only needs to consider the averments in the plaint on a demurrer. In contrast, the present proceedings arose under Order XXXIX Rules 1 and 2, where the Court can assess the pleadings as well as documents filed on behalf of the Defendantsto determine whether a prima facie case for interim injunction exists. Hence, while these precedents prevented summary rejection of quia timet suits at the threshold, they did not entitle the Plaintiff to an injunction.

Further, in the cited cases (Shilpa Medicare and Novartis), the Defendants had already obtained manufacturing approvals for the impugned products in India, which lent credibility to the apprehension of imminent infringement. No such factual foundation existed here. The Court therefore held that the reliance on these precedents was misplaced, and that the Plaintiff’s claim did not satisfy the evidentiary standard for entertaining a quia timet action.

• When Can Territorial Jurisdiction Be Invoked?

On the question of jurisdiction, the Court held that prima facie no part of the cause of action arose within Delhi. Both defendants were situated outside its jurisdiction, and the plaintiff failed to produce evidence showing that any of their products were being sold or offered for sale in Delhi.

The reliance on an IndiaMART listing for another drug was rejected, as said product was available only for delivery within Hyderabad. Moreover, mere accessibility of a website from Delhi does not establish jurisdiction.

Relying on the Division Bench ruling in Banyan Tree Holding vs A. Murali Krishna Reddy [2009 SCC OnLine Del 3780], the Court reiterated that jurisdiction is attracted only when the Defendant’s website is specifically targeted at customers in the forum state and leads to commercial transactions there. No such targeting was shown here.

In view of the foregoing discussion, the Court vacated the ad interim injunction granted in favour of the Plaintiff.