Novartis AG v Alembic Pharmaceuticals Limited (2026)

Summary

“By way of the present plaint, the plaintiffs inter-alia seek permanent injunction restraining the defendant from dealing in Active Pharmaceutical Ingredient (‘API’), pharmaceutical products or formulations containing ‘Dabrafenib’ or any other form or combination, whether in salt or crystalline or any other form, of the said API in any manner.” (para 4) Counsel for the plaintiffs submitted “that plaintiff No.1 holds a patent on the compound Dabrafenib vidé Indian Patent No. 275655” and that “other defendants who are similarly situate as the present defendant, have made statements admitting plaintiff No.1’s patent on the said compound and have given undertakings not to commercialise the patented compound, and to restrict their use only to research” (para 5). Counsel for the defendant “accepts notice; and submits that they are willing to give an undertaking in the same terms as the undertakings given by other similarly placed parties” (para 8), and “The submission made on behalf of the defendant is acceptable to the plaintiffs.” (para 10)

The Court ordered: “Accordingly, the present suit is disposed-of recording the statement and undertaking given on behalf of the defendant and with the directions and observations that follow” (para 11). The defendant was held bound, “It is made clear that the defendant shall not commercially manufacture, launch, import, export or deal in any API, pharmaceutical products or other formulation containing the patented compound ‘Dabrafenib’ during the validity of the suit patent. It is clarified however, that the rights of the defendant under section 107A of the Patents Act are protected, so long as the conditions required under the said provision are duly complied with by the defendant.” (para 11.2) “Pharmacompass is directed to remove the drug from their platform forthwith upon receipt of a communication to the above effect from the defendant.” (para 17) “Accordingly, the Registry is directed to draw-up the requisite certificate in favour of the plaintiffs for refund of the entire court fee affixed on the plaint within 04 weeks from today.” (para 21)

What the court decided

1. Procedure. Pre-litigation mediation. “By way of the present application filed under section 12A of Commercial Courts Act, 2015 read with section 151 of the Code of Civil Procedure 1908 (‘CPC’), the plaintiffs seek exemption from attempting pre-litigation mediation.” (para 1) “Having regard to the facts and circumstances of the present case, and in light of the judgment of the Supreme Court in Yamini Manohar vs. T.K.D. Keerthi and of a Division Bench of this court in Chandra Kishore Chaurasia vs. R A Perfumery Works (P) Ltd., the plaintiffs are exempted from attempting pre-litigation mediation.” (paras 1–2)
2. The undertaking recorded. Counsel for the defendant stated “that the defendant has not commercialised any product containing the patented product ‘Dabrafenib’ and does not intend to do so during the validity of the suit patent” (para 11.1). The Court held: “The statement made by Mr. Kumar is taken on record, holding the defendant bound by that statement. It is made clear that the defendant shall not commercially manufacture, launch, import, export or deal in any API” (“Active Pharmaceutical Ingredient”) “, pharmaceutical products or other formulation containing the patented compound ‘Dabrafenib’ during the validity of the suit patent.” (para 11.2) “The defendant shall be bound by the statement and undertaking given by their counsel as hereinabove recorded.” (paras 11.1, 11.2, 14)
3. Research use under section 107A. Counsel for the defendant requested “that the court protect the defendant’s rights under Section 107A of the Patents Act, 1970 to use the parented pharmaceutical product ‘Dabrafenib’ for purposes of research” (para 11.1). The Court held: “It is clarified however, that the rights of the defendant under section 107A of the Patents Act are protected, so long as the conditions required under the said provision are duly complied with by the defendant.” (paras 11.1, 11.2)
4. Listing on a third-party platform. Counsel for the plaintiffs “points-out that the defendant’s drug is also listed on Pharmacompass, which amounts to offering the drug for sale; and therefore to commercialisation of the suit patent” (para 15). Counsel for the defendant submitted “that Pharmacompass has listed the drug arising from the approval given by the Drug Controller and not at the defendant’s instance” (para 16). The Court directed: “In view of what has been stated on behalf of the defendant, Pharmacompass is directed to remove the drug from their platform forthwith upon receipt of a communication to the above effect from the defendant.” (paras 15–17)
5. Procedure. Refund of court fee. “This is the first listing of the suit.” (para 19) “In view of the Court Fees (Delhi Amendment) Act, 2026 which came into effect on 06.03.2026, section 16-A of the Court Fees Act, 1870 (as was applicable to Delhi) has been omitted. Accordingly, section 16 of the Court-fees Act, 1870 would be applicable, which allows for refund of the entire amount of court fee affixed on the plaint.” (para 20) “Accordingly, the Registry is directed to draw-up the requisite certificate in favour of the plaintiffs for refund of the entire court fee affixed on the plaint within 04 weeks from today.” (paras 19–21)

Subsequent treatment

No later judicial treatment and no further proceedings traced as of 16 September 2026.