By Jigyasa Pareek

The Delhi High Court in Novartis AG & Anr. vs Intas Pharmaceuticals Limited [CS(COMM) 433/2026] considered whether the material placed by the Plaintiffs, indicating that the Defendant was preparing to manufacture and commercialise the product containing the subject matter of the suit patent, was sufficient to sustain a quia timet action and warrant interim protection against infringement.

The suit patent, IN’275655, relates to Dabrafenib, which is a kinase inhibitor, its mesylate salt and pharmaceutical compositions comprising Dabrafenib and/or Dabrafenib Mesylate. The Plaintiffs instituted the suit as a quia timet action, relying on an RTI response from the Food and Drugs Control Administration, Gujarat, which stated that Intas had obtained approval for manufacturing Dabrafenib API and/or Dabrafenib tablets for export and/or the domestic market.

The Plaintiffs also relied upon an investigation report prepared by an independent agency, which indicated that Intas had obtained manufacturing approval/licence for Dabrafenib/Dabrafenib Mesylate API and/or tablets/capsules; had developed the API at its Gujarat facility; and was developing Dabrafenib tablets/capsules in 50 mg and 75 mg strengths. The report also recorded that Intas planned to commence commercial manufacture of the API and formulations for domestic and international markets.

The Court considered the requirements for interim relief and noted that the apprehension underlying the suit was not unfounded. It considered the RTI response together with the investigation report and held that, read harmoniously, the two documents provided a credible apprehension to the Plaintiffs to institute the quia timet action and seek an injunction against infringement of IN’655 and violation of their statutory rights under Section 48 of the Patents Act. At a prima facie level, the investigation report indicated that Intas had developed Dabrafenib/Dabrafenib Mesylate API and was developing the corresponding formulations with plans for commercial manufacture.

The Court further noted that the patent certificate demonstrated that IN 275655 was a valid and subsisting patent and that the Plaintiffs had placed the complete specification on record. It also took into consideration the previous suits instituted by the Plaintiffs for enforcement of the patent, in which favourable orders had been passed, as well as the sales turnover of the Plaintiffs’ Dabrafenib product. On these considerations, the Court held that the balance of convenience lay in favour of the Plaintiffs.

The Court also noted that Dabrafenib had been declared an International Non-proprietary Name (INN) by the World Health Organization. It consequently found that, in the absence of interim protection, the Plaintiffs were likely to suffer irreparable loss and injury which could not be adequately compensated in monetary terms.

Accordingly, the Court restrained Intas from manufacturing, stockpiling, importing, selling, offering for sale or supply, distributing, exporting or otherwise dealing in Dabrafenib API or pharmaceutical products or formulations containing Dabrafenib, including Dabrafenib Mesylate or other forms, where such activity may amount to infringement of IN’655. The Court, however, expressly clarified that Intas’ rights under Section 107A of the Patents Act, 1970 would remain protected, subject to compliance with the statutory requirements.