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  • Setback to Novartis:...

Setback to Novartis: Delhi HC Rejects Cross-Examination Request in Post-Grant Patent Dispute

Susmita RoyWritten by Susmita Roy Published On 2025-09-26T17:18:20+05:30  |  Updated On 26 Sept 2025 5:18 PM IST
Setback to Novartis: Delhi HC Rejects Cross-Examination Request in Post-Grant Patent Dispute

Delhi High Court

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New Delhi: The Delhi High Court on Tuesday sharply criticised Novartis AG's belated attempt to cross-examine opponents' experts in a post-grant patent opposition, describing the company's petition as "complete hogwash" and a "dilatory tactic."

Justice Manmeet Pritam Singh Arora held that Novartis had consciously waived its right to cross-examination by not seeking it at the proper stage and dismissed all related writ petitions.

The matter arose from Patent IN’518, granted to Novartis on December 14, 2022, after dismissal of pre-grant oppositions. Subsequently, the Indian Pharmaceutical Alliance (IPA), Micro Labs, and IPCA Laboratories filed post-grant oppositions, challenging the patent’s validity on grounds including lack of inventive step and Section 3(d) of the Patents Act.

In March 2025, the Opposition Board recommended revocation of the patent. Novartis challenged this before the High Court, which allowed the company to file rebuttal evidence and directed a fresh consideration by a reconstituted Opposition Board. Novartis filed rebuttal evidence in June 2025, but the Board again recommended revocation on July 14, 2025. On the same day, Novartis filed a Rule 128 petition seeking cross-examination of the opponents’ experts.

Novartis contended that cross-examination was a matter of right under Section 79 of the Patents Act and Rule 62, and argued that denial of this opportunity violated principles of natural justice. The company claimed it had consulted its own experts and could not have filed the request earlier.

Also Read: Novartis Loses India Patent on Heart Failure Drug Vymada

The Court rejected these arguments, noting:

“The right of the party to seek cross-examination of the opposite party's expert has to be exercised diligently and at the earliest, after the cause of action has arisen. … In the considered opinion of this Court, this right to seek cross-examination has to be exercised not later than the stage when the evidence is admitted by the Controller. This right does not remain available to the party for all times to come until the issuance of notice of hearing, as sought to be contended by the Petitioner herein.”

The High Court also addressed Novartis’ plea of natural justice:

“The submission of the Petitioner that the non-grant of an opportunity to cross-examine the Respondent No. 2's Expert witnesses is in violation of principles of natural justice, and that the Petitioner is being denied of its substantive right, appears to this Court as complete hogwash.”

The Court highlighted Novartis’ conduct during the Controller’s hearings:

“This Court also finds that the Petitioner's conduct in abstaining from the hearing dated 20.08.2025 is impermissible and also disrespectful to the office of the Controller. A party who is aware of the scheduled hearing is not entitled to consciously abstain from the hearing. In case the party elects to abstain, it shall be precluded from alleging violation of principles of natural justice.”

Finally, the Court described the Rule 128 petition as:

“merely a dilatory tactic and ought to have been dismissed by the Controller on 19.08.2025 itself. … However, by consciously electing not to appear on 20.08.2025, the Petitioner is deemed to have abandoned the Rule 128 petition.”

Justice Arora concluded:

“In these facts, this Court finds no ground to interfere in the orders dated 19.08.2025 and 20.08.2025. The writ petitions are hereby dismissed.”

To view the order, click the link below:

https://medicaldialogues.in/pdf_upload/novartisagvscontrollerofpatentsanddesignsanron16september2025-1-302138.pdf
novartisdelhi high courtpatents actipamicro labsipca laboratories
Susmita Roy
Susmita Roy

    Mpharm (Pharmacology)

    Susmita Roy, B pharm, M pharm Pharmacology, graduated from Gurunanak Institute of Pharmaceutical Science and Technology with a bachelor's degree in Pharmacy. She is currently working as an assistant professor at Haldia Institute of Pharmacy in West Bengal. She has been part of Medical Dialogues since March 2021.

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