Misuse of Confidential Drug Dossiers for Losartan, Citalopram, Amlodipine: Noida Court Upholds Jubilant Generics’ Injunction Against Rivals

The plaintiff, Jubilant Generics Ltd, represented by its Authorized Representative, Sanjay Gupta, filed the suit against Medreich Limited (Defendant 1), V S International Private Limited (Defendant 2), Gracure Pharmaceuticals Ltd (Defendant 3), and Jamp India Pharmaceuticals Private Limited (Defendant 4) alleging that Jamp Pharma, a Canadian partner, violated a confidentiality agreement by sharing proprietary drug data, developed through years of research and investment, and was intended strictly for Canadian use, with Indian companies.

Jubilant submitted that it is the author of product dossier for three drugs namely Losartan, which is for the patients with the ailment hypertension and left ventricular hypertrophy; Amlodipine, which is a drug for antihypertensive antianginal agent for mild to moderte essential hypertension; and Citalopram, as antidepressant drug.

Jubilant alleged that it had entered into an agreement with Jamp Pharmaceuticals Corporation, a Canadian company, for the use, manufacture, and marketing of three pharmaceutical products—Losartan, Amlodipine, and Citalopram—as part of a product dossier. This dossier, developed after significant research and financial investment by the plaintiff, was protected under a mutual confidentiality and non-disclosure agreement between Jubilant Generics Ltd and Jamp Pharmaceuticals Corporation. The plaintiff further pointed out that an arbitration dispute was already ongoing between them and Jamp Canada in Canada.

The cause of action for the suit arose when Jamp India Pharmaceuticals Private Limited, the Indian subsidiary of Jamp Canada, allegedly breached the confidentiality of the product dossier and shared it with the other defendants.

The plaintiff sought a permanent injunction against the defendants, their promoters, shareholders, directors, officers, employees, and agents, preventing the unauthorized use of the protected dossier. The plaintiff also sought to restrain the defendants from manufacturing, distributing, and exporting the medicines based on the dossier and prayed for damages.

In response, the defendants argued that the formulas were for generic drugs and thus did not constitute proprietary intellectual property. They claimed that the data-sharing was limited to drug manufacturing under contract with Jamp Canada for exclusive distribution in Canada. They further argued that Indian jurisdiction was not applicable, citing an arbitration agreement governed by Canadian law, and contended that Indian law had no jurisdiction.

Defendants 1 to 3 filed separate affidavits, stating that they used the product dossier solely for the exclusive purpose of manufacturing the medicines for Jamp Pharmaceuticals for distribution in Canada. Specifically, Defendant No. 1 was manufacturing Citalopram (10 mg, 20 mg, and 40 mg), Defendant No. 2 was manufacturing Amlodipine (5 mg and 10 mg), and Defendant No. 3 was manufacturing Losartan (25 mg, 50 mg, and 100 mg) exclusively for export to Canada.

Defendant No. 4, however, filed written submissions challenging the suit on several grounds, including the claim that the court lacked territorial jurisdiction, as the matter was governed by the laws of Quebec, Canada, due to clauses in the agreement between the parties. It further argued that the Arbitration and Conciliation Act applied because the arbitration clause in the agreement required any disputes to be resolved in Canada, not India.

Defendant No. 4 also contended that the suit was not maintainable in India, as the issue of copyright over the product dossier was a triable issue, and the defendants did not engage in any wrongful transfer of the dossier for use in India except for the limited purpose of manufacturing drugs for export to Canada.

Defendant No. 4 additionally argued that the plaintiff had failed to establish a prima facie case, the balance of convenience was in favor of the defendants, and no irreparable loss would be suffered by the plaintiff, who had sought damages as compensation. Based on these arguments, Defendant No. 4 requested the court to vacate the ex-parte interim injunction.

After reviewing the submissions, the court determined that Jubilant had a valid prima facie case, with the balance of convenience favoring the plaintiff. The court ruled that sharing the dossier in India could potentially lead to irreparable harm to Jubilant’s intellectual property, which cannot be compensated solely by damages. It observed;

“This Court is of the view that the plaintiff has got prima facie case that he has right to protect his literary work being used without the knowledge of the plaintiff in India. The balance of convenience also lie in favour of the plaintiff because the plaintiff has shared his product dossier in respect to three lives saving drugs with Jamp Pharma, Canada and in view of comparative hardship the plaintiff shall suffered the drain of his literary work, against its agreement. The plaintiff shall also suffered irreparable loss and injury which shall not be compensated in terms of damages if the technical know how of all the product is substantially, shared with other companies."

Subsequently, the court granted the temporary injunction, restraining the defendants from manufacturing or sharing the dossier-related products in India until further proceedings. It held;

"Therefore, this Court is of the view that defendants shall be restraint from manufacturing the drugs as is mentioned in the product dossier, detailed in the plaint its marketing, selling or allied purposes and further restraint from sharing the product dossier available with them with any third party. ”

The case has been set for further hearings on January 6, 2025.

To view the original judgement, click on the link below: