Summary
The Delhi High Court, in its order dated 16th September 2025, dismissed the writ petitions filed by Novartis challenging the Controller’s refusal to permit cross-examination of expert witnesses in the post-grant opposition proceedings concerning Indian Patent No. 4412/DELNP/2007. The Court found that Novartis had consciously waived its right to cross-examination by electing to file rebuttal evidence, and that there were no valid grounds to challenge the Controller’s order.
Background
Novartis filed Indian Patent Application No. 4412/DELNP/2007 on 8 June 2007, which was granted on 14 December 2022 following the dismissal of ten pre-grant oppositions. Subsequently, pharmaceutical companies, including PCA Laboratories, Indian Pharmaceutical Alliance, and Micro Labs (collectively referred to as “opponents”) filed post-grant oppositions, challenging the validity of the patent on grounds of lack of inventive step and violation of Section 3(d).
The opponents submitted additional expert affidavits under Rule 60 of the Patent Rules on 5 July 2024. Novartis objected to the admission of these affidavits and sought permission to file rebuttal evidence. The Controller admitted the opponents’ affidavits, but denied Novartis’s request for rebuttal, following which the Opposition Board recommended revocation on 17 March 2025.
Novartis challenged the Controller’s refusal before the Delhi High Court. Finding that the denial of rebuttal evidence violated principles of natural justice, the Court permitted Novartis to submit rebuttal material, directed constitution of a fresh Opposition Board, and prescribed strict timelines for the bound disposal of the post-grant opposition proceedings – eight weeks for filing rebuttal evidence and four weeks for the Board to issue a fresh recommendation. Novartis complied with these directions and filed its rebuttal evidence on 14 June 2025 in each opposition.
The new Opposition Board recommended revocation on 14 July 2025, which the Controller communicated to both parties the following day, along with a hearing notice which scheduled the matter for 19 August 2025.
Ahead of the scheduled hearing, Novartis filed a Rule 128 petition on 14 July 2025 seeking cross-examination of the opponents’ experts. At the hearing on 19 August 2025, the Controller directed that the opponents would argue first, followed by the patentee’s rebuttal, and left open the possibility of cross-examination for a later stage. However, when Novartis failed to appear on 20 August 2025, the Controller proceeded with the opponents’ arguments and concluded the hearing.
Aggrieved, Novartis again approached the Delhi High Court, alleging that denial of cross-examination opportunity violated principles of natural justice and Section 79 of the Patents Act.
Arguments by Parties
Novartis argued that its cross-examination request, made four weeks after filing the rebuttal evidence, was both timely and justified. It explained that the period was necessary to consult its experts on the opponents’ evidence. Relying on Section 79 of the Patents Act and the judgment of the Division Bench (DB) in Onyx Therapeutics v. Union of India, Novartis asserted that cross-examination is a statutory right and that denial of this right would cause irreparable harm, particularly at the late stage of the patent term. To mitigate delay, Novartis proposed a two-week schedule for cross-examination followed by a review by the Opposition Board, emphasizing that this would protect its rights without causing any prejudice to the opponents.
The opponents countered that Novartis’s request for cross-examination was a deliberate tactic to prolong the enforcement of the patent until expiry on 8 November 2026. They pointed out that Novartis had multiple prior opportunities to seek cross-examination but chose not to, and its prior writ petitions also did not request cross-examination.
The opponents further argued that Novartis’s reliance on Onyx Therapeutics was misplaced, as the patentee in that case had promptly sought cross-examination at the earliest stage without filing rebuttal evidence. They also objected to Novartis’s repeated demands for a change of Controller and maintained that belated cross-examination requests should not be entertained in writ proceedings, particularly where rebuttal evidence had already addressed the expert testimony of the opposing party.
Observations by the Court
The Court reviewed the facts of the Division Bench judgement in Onyx Therapeutics, relied upon by Novartis, and observed that in that case the patentee had sought cross-examination at the earliest opportunity along with its reply and did not file any rebuttal evidence. It noted that in the present case, Novartis received opponents’ expert affidavits on 8 July 2024. While it requested leave to file rebuttal evidence, it never sought cross-examination either before the Controller or the High Court. The Court was of the opinion that the right to cross-examine must be expressly sought at the earliest stage, immediately after service of evidence. By electing to rely solely on rebuttal evidence, Novartis delayed its request for cross-examination for over a year, which the Court deemed impermissible.
The Court reiterated that principles of natural justice are intended to ensure fairness and cannot be invoked to obstruct or delay proceedings. It observed that Novartis had been provided ample opportunity to respond through rebuttal evidence, satisfying the requirements of natural justice.
The Court highlighted that seeking cross-examination at a late stage, after the Opposition Board had already issued its fresh recommendation following strict timelines, would nullify the procedural process and undermine the expeditious disposal mandated by the High Court. The Court further noted that Novartis, as a large corporation with extensive experience in filing patent applications, was fully aware of the procedural requirements and had consciously elected not to request cross-examination, instead relying solely on its rebuttal evidence. The Court found no merit in the request to reset the process, observing that Novartis had disregarded the time and effort of the Opposition Board. The writ petitions were therefore deemed an abuse of process, aimed at derailing post-grant opposition proceedings.
The Court also noted that Novartis’s failure to appear at the hearing on 20 August 2025 precluded any claim of violation of natural justice. By failing to appear, Novartis was deemed to have abandoned its petition, and its allegation that the Controller had acted in a predetermined manner was rejected.
Conclusion
The Court concluded that there were no grounds to interfere with the Controller’s orders dated 19 and 20 August 2025. Accordingly, the writ petitions were dismissed.
Interestingly, on 12 September 2025, just days before the current judgment, the Controller revoked Novartis’ patent in the post-grant opposition proceedings, holding that the claimed ‘supramolecular complex’ did not demonstrate any clear therapeutic advantage over existing formulations.
Citation: Novartis Ag vs Controller Of Patents And Designs & Anr, W.P.(C)-IPD 50/2025 and connected matters, 16 September, 2025. Available at https://indiankanoon.org/doc/97274158/
Article Review: Vasundhara Paliwal
Accessibility Review: Rakesh Krishnan
