Back
2026 Supreme(Online)(Del) 17874
IN THE HIGH COURT OF DELHI AT NEW DELHI
A. J. Bhambhani, J
Novartis AG – Appellant
Versus
BDR Pharmaceuticals International Private Limited – Respondent
CS(COMM) 293/2026
For the Appellants/Petitioners: Amit Sibal, Abhay Tandon, Hemant Singh, Mamta Jha, Kriti Chulet, Ritik G., Saksham Dhingra, Smriti Nair
For the Respondents: J. Sai Deepak, Meenakshi Ogra, Tarun Khurana, Samrat S. Kang, Vishnu Gambhir
In a quia timet action for patent infringement, if the defendant possesses a license only for testing and analysis, the court may mandate that the defendant seek prior judicial approval before commencing commercial manufacturing or launching the product.
Headnote:(A) Intellectual Property - Patents - Quia Timet Action - Apprehension of infringement - Where a defendant holds a license limited to the manufacture of a compound for examination, test, or analysis, and is not yet engaged in commercial production, the court may direct the defendant to seek prior judicial approval before proceeding to commercial manufacturing or launch. (Para 10)
(B) Civil Procedure - Return of Plaint - Order VII Rule 11 - Objections regarding the maintainability of the suit under Order VII Rule 11(a) & (d) are to be prioritized for consideration before other interim applications in the proceedings.
Issues: Whether the plaintiffs' apprehension of patent infringement justifies an interim injunction against the defendants who currently hold only a limited license for testing and analysis.
O R D E R
% 17.08.2026
The matter has been listed upon being released by the Predecessor Bench.
I.A.7599/2026(seekingleavetodeliverinterrogatoriesandproductionof document)
I.A.7600/2026(seekingleaveofthecourttoredactthenamesofthethird- parties in the RTI response)
Issue notice.
Learned counsel is present on behalf of the defendants; accepts notice; and seeks time to file replies.
Let replies to the applications be filed within 04 weeks; rejoinder(s) thereto, if any, be filed within 03 weeks thereafter; with copies to the opposing counsel.
List before the learned Joint Registrar for completion of pleadings on 17th November 2026.
List before court thereafter.
I.A. 12145/2026 (filed by defendants seeking return of plaint)
Issue notice.
Learned counsel is present on behalf of the plaintiffs; accepts notice; and seeks time to file replies.
Let replies to the application be filed within 04 weeks; rejoinder(s) thereto, if any, be filed within 03 weeks thereafter; with copies to the opposing counsel.
List before the learned Joint Registrar for completion of pleadings on 17th November 2026.
List before court thereafter.
Let the plaint be registered as a suit.
Issue summons in the suit.
Learned counsel is present on behalf of the defendants; accepts summons; and seeks time to file written statements.
Let the written statements to the plaint be filed within 30 days, alongwith affidavit of admission/denial of the documents filed by the plaintiffs. The plaintiffs may file replications to the written statements within 30daysthereafter,alongwith affidavit of admission/denial ofthe documents filed by defendants.
List before the learned Joint Registrar for completion of pleadings, for admission/denial of documents and marking of exhibits on 17th November 2026.
List before court thereafter.
I.A. 7597/2026 (interim injunction)
The matter is pending at the pre-notice stage since 23.03.2026.
Issue notice.
Learned counsel is present on behalf of the defendants; accepts notice; and seeks time to file reply.
As recorded in para 10 of order dated 23.03.2026, Mr. J. Sai Deepak, learned senior counsel appearing for the defendants had made the following submissions:
“10. Mr. J. Sai Deepak, learned senior counsel for defendants,aftersomearguments,underinstructionssubmitsthatthe three issues which should ordinarily allay the apprehension of the plaintiffs quathequiatimet actionareas under:
(i) The defendants do not have any commercial license to manufacture the compound/product in question fromanyauthority.
(ii)Healsosubmitsthatthelicense,whichaccording totheplaintiffshasgivenrisetotheapprehension,islimited in its purpose, in that, the scope of the license is only for manufacturing drugs for the purposes of examination, test oranalysis.Hefurtherclarifiesthatthesaidlicensealsohas proscribed its effect by specifically stating “Not for clinical trial unless or otherwise permitted by the licensing authority”.
(iii) He submits that at this stage, the protection granted under the provision of Section 107A of the Patents Act, 1999 , is fully in favour of the defendants and the defendantsareentitledtocontinuewiththeexamination,test andanalysisofthesaidcompoundtillanappropriatelicense is issuedinits favour.”
Ontheotherhand,Mr.Amit Sibal,learned senior counsel appearing for the plaintiffs submits that the plaintiffs’ apprehension, based on which they have filed the present suit, arises from an RTI response dated 17.10.2025 received by them from the Commissioner of Foods and Drugs Control Administration, Gandhinagar, Gujarat, which inter-alia stated the following:
[[IMG_1]]
[[IMG_2]]
Furthermore, Mr. Sibal points-out that in compliance of order dated 23.03.2026, the defendants have filed an affidavit dated 25.03.2026 stating inter-alia that defendants Nos.1 and 2 have obtained licence to manufacture the drug ‘DABRAFENIB’ strictly for the limited purpose of examination,testing and analysis and that the licensedoes not extend to or permit usage for clinical tr
