Summary
Incyte Holdings Corporation and its co-plaintiffs, who hold Indian Patent No. 269841 over the cancer drug compound ruxolitinib, sued Melody Healthcare Private Limited in the Delhi High Court. Melody had listed Ruxolitinib Phosphate API on its product list and on a third-party supplier platform, and held a manufacturing licence, but had not launched a finished product. The court granted an ex parte ad interim injunction, finding a prima facie case, a balance of convenience in the patentee's favour, and a risk of irreparable harm. The order matters because it shows how Indian courts treat pre-launch commercial signals in ruxolitinib patent infringement disputes, even when the patent has only weeks left to run.
Background
A ruxolitinib patent infringement suit over a cancer drug with barely eleven weeks of patent life left still drew an urgent injunction from the Delhi High Court, although the defendant had not sold a single finished tablet.
Incyte Holdings Corporation (“Incyte”) and its co-plaintiffs hold Indian Patent No. 269841 (“IN’841”), which protects the compound ruxolitinib, used to treat myelofibrosis, a cancer of the bone marrow. Incyte launched the drug in the United States in 2011 under the trademark JAKAFI, and a co-plaintiff launched it in India in 2013 as JAKAVI. The plaint pleaded that IN’841 is valid and subsisting, and that it expires on 12 December 2026. Melody Healthcare Private Limited (“Melody”) is a pharmaceutical company that supplies active pharmaceutical ingredients (“API”). In the first week of July 2026, Incyte found that Melody had listed “Ruxolitinib Phosphate” in its API product list, under the therapeutic category of atopic dermatitis, and appeared as a supplier of the ingredient on Pharmacompass, a third-party sourcing platform. An investigation report dated 9 September 2026 indicated that Melody held a manufacturing licence for the API from the Food and Drug Control Administration, Maharashtra, had developed a generic version in-house, and intended to begin commercial manufacturing or stockpiling. Incyte had already filed infringement suits on the same patent against other pharmaceutical companies. It then instituted a commercial suit before the Delhi High Court and sought an ex parte ad interim injunction. On 24 September 2026, a single judge granted that relief. No appearance was recorded for Melody.
Issues
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- Whether listing and advertising Ruxolitinib Phosphate API on a company product list and a third-party supplier platform amounts to an “offer for sale” under Section 48 of the Patents Act, 1970 (“Patents Act”).
- Whether a patentee can obtain an ex parte ad interim injunction against a defendant that holds a manufacturing licence and has declared a generic version, but has not yet launched a commercial product.
- Whether the prima facie case, balance of convenience, and irreparable harm tests were met for IN’841, a patent that expires on 12 December 2026.
Incyte’s Arguments
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- Melody advertised, listed, and offered to supply Ruxolitinib and Ruxolitinib Phosphate API on third-party platforms and accepted business enquiries, which Incyte said is an “offer for sale” under Section 48 of the Patents Act.
- Melody listed the API in its own product catalogue and appeared as a supplier on Pharmacompass, so the offer was commercial and visible to the trade.
- The investigation report of 9 September 2026 showed that Melody had obtained a manufacturing licence from the Maharashtra regulator, developed a generic version in-house, and planned commercial manufacturing or stockpiling.
- IN’841 is valid and subsisting, and Incyte had already enforced the patent through suits against other pharmaceutical companies.
- No finished drug product had been launched by Melody, so Incyte sought to stop the infringement at the stage of preparation and offer, before the harm became harder to undo.
Melody’s Position
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- No appearance was recorded for Melody at the ex parte hearing, so the court did not record any defence on merits.
Court’s Analysis
Pre-Launch Signals as Infringing Conduct
The court noted that the plaintiffs had placed on record the product listings, the Pharmacompass supplier entry, and the investigation report dated 9 September 2026. The court found that this material, taken together, made out a prima facie case of ruxolitinib patent infringement against Melody. The plaintiffs had framed the listings as an “offer for sale” under Section 48 of the Patents Act, which grants a patentee the exclusive right to prevent third parties from making, using, offering for sale, selling, or importing the patented product in India. The court observed that the plaintiffs had shown a patent that remains in force and conduct by Melody that went beyond mere regulatory preparation.
The Interim Injunction Tests on a Short Patent Clock
The court held that the balance of convenience favoured the plaintiffs. It reasoned that IN’841 is valid and subsisting, its term has not expired, and Melody had not commercially launched its product. The court further observed that an injunction would therefore cost Melody no existing sales, while the plaintiffs stood to lose control over a patented compound if the defendant moved from listing to supply. The court stated that the plaintiffs would suffer irreparable loss and injury if interim relief did not issue before the next hearing. This reasoning shows that, in ruxolitinib patent infringement proceedings, a defendant that has not launched can face a restraint where the patentee presents concrete evidence of licences, development, and commercial listings.
Reach of the Restraint and Case Management
The court found it appropriate to extend the restraint beyond Melody itself. The order covers its directors, group companies, associates, licensees, agents, distributors, and dealers, and it reaches manufacturing, stockpiling, importing, selling, offering for sale or supply, and exporting. The court limited the restraint to products containing ruxolitinib, alone or in combination, in a manner that infringes IN’841. The court also exempted the plaintiffs from pre-litigation mediation because of the urgency, and it issued notice on the plaintiffs’ application for interrogatories and production of documents. The court gave Melody four weeks to reply to the injunction application and listed the matter before the Joint Registrar on 17 November 2026 and before the court on 20 January 2027.
Findings
In view of the observations and the arguments presented by both the parties, the Delhi High Court held that:
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- The plaintiffs made out a prima facie case of infringement of IN’841 for an ex parte ad interim injunction.
- The balance of convenience favours the plaintiffs, as IN’841 is valid and subsisting and Melody has not commercially launched its product.
- The plaintiffs would suffer irreparable loss and injury if interim relief were not granted before the next hearing.
- Melody, its directors, group companies, associates, licensees, agents, distributors, and dealers are restrained until the next hearing from manufacturing, stockpiling, importing, selling, offering for sale or supply, exporting, or otherwise dealing in pharmaceutical products containing ruxolitinib that infringe IN’841.
- Melody may file its reply to the injunction application within four weeks, and the plaintiffs may file a rejoinder thereafter.
- The plaintiffs are exempted from pre-litigation mediation due to urgency, and the suit is listed before the Joint Registrar on 17 November 2026 and before the court on 20 January 2027.
Case Citation: Incyte Holdings Corporation & Ors. v. Melody Healthcare Private Limited, CS(COMM) 1054/2026, High Court of Delhi, decided on 24 September 2026. Copy of court order available here.
Authored by Gaurav Mishra, IP Attorney, BananaIP Counsels
