On July 9, 2024, the Delhi High Court issued an ad-interim order restraining the defendant (Zydus Lifesciences Ltd.) from marketing or selling its product ‘Sigrima’, a biosimilar version of the monoclonal antibody biologic ‘Pertuzumab’/ ‘Perjeta’ patented by plaintiffs (F- Hoffmann La Roche & Anr). Initially, the instant suit [CS(COMM) 159/2024] was filed as a quia timet action along with an interim application for injunction as the plaintiffs strongly apprehended that the threat of launch of the infringing biosimilar product by the defendant was imminent and would cause irreparable harm to the plaintiffs if not injuncted.
A quia timet (etymologically, means “since he fears”) action allows an innovator or patentee, in advance, to take preemptive measures against potential infringement. However, amidst the ongoing proceedings on the grant of an interim or quia timet injunction, the plaintiffs have brought certain facts to the Court’s attention that the defendant has obtained regulatory approvals, launched its product named ‘Sigrima’, and entered into a commercial licensing arrangement with a third party for co-marketing its product. The defendant has not disclosed this crucial information, which triggered the Court to pass the aforenoted order.
In its previous order of February 23, 2024, rather than granting any relief, the Court issued several directions to ensure a comprehensive adjudication of the interim application (in quia timet action), which included the submission of claim mappings by parties, process disclosure by the defendant, setting up of a confidentiality club, employing hot-tubbing, and appointing an independent scientific advisor. The absence of claim mapping between the plaintiffs’ and defendant’s patents substantially restricted the Court from fully assessing the infringement allegations.
During the hearings on the interlocutory application conducted on February 23 and subsequent dates, the plaintiffs had repeatedly stressed that there was a lack of transparency regarding the status of regulatory approvals for the defendant’s biosimilar and, therefore, explicitly requested the Court to direct the defendant not to launch their product in the market. In response to the plaintiffs’ expressed apprehensions, the Court had specifically inquired from the defendant about the status of their application for drug approvals. Despite specific inquiries in those hearings, the Court was not informed that regulatory approval was imminent.
Rather, in the hearing on July 9, the plaintiffs informed the Court that the defendant received approval from the regulatory authority (Central Drug Standard Control Organization) on April 4, 2024. The Court thus noted that, in the two hearings conducted after this regulatory approval, the defendant chose not to disclose this significant development to the Court. Moreover, permission to market the biosimilar drug in question was obtained on June 27, 2024, from the National Institute of Biologicals, which was apprised to the Court only in the hearing on July 9.
The Court believed that the defendant’s failure to communicate vital regulatory development transparently during the Court’s deliberations raised serious concerns about fairness in procedural conduct. The defendant’s recent conduct, including undisclosed regulatory approval and subsequent commercial launch of its biosimilar product, bolstered by its business venture with a third party, exemplified the potential to undermine the fair and equitable handling of the case.
The Court also noted that the timing of the biosimilar product’s launch suggested a strategic move by the defendant to establish a market presence before any potential judicial restrictions could be imposed. Allowing the defendant to continue the sale and distribution of the impugned product could alter the market situation, which would significantly disadvantage the plaintiffs, especially if the product is later found to infringe upon the plaintiff’s patents.
The defendant would merely be delayed from benefiting from a product whose legality was to be fully adjudicated. Thus, the balance of convenience was also titled in favour of the plaintiffs. By applying the principles of fairness, equity, and the balance of convenience, the Court restrained the defendant from marketing or selling its biosimilar product until the next date of hearing.
In conclusion, the defendant had a duty to disclose any pertinent information regarding the launch of the impugned product, particularly when the Court explicitly inquired about the timeframe for regulatory approvals during the hearings. The lack of such disclosure deprived the plaintiffs and the Court of timely and accurate information that could influence the Court’s decision and the plaintiff’s responses. Such transparency was crucial in a quia timet case of this significance.
The absence of a prima facie finding of infringement in the Court’s order is not unusual. The instant order neither grants a quia timet injunction on the previous interim application nor is it a decision on the recently filed interlocutory application; rather, it provides a mere ad-interim direction (also clarified in the subsequent order of July 15, 2024), which was largely prompted by the defendant’s conduct.
