Novartis AG Vs. Controller of Patents -Manmeet Pritam Singh

Case Title: Novartis AG Vs. Controller of Patents and Designs & Ors.
Order Date: 16th September 2025
Case Number: W.P.(C)-IPD 50/2025, W.P.(C)-IPD 51/2025, W.P.(C)-IPD 52/2025
Neutral Citation: Not provided in the case document
Name of Court: High Court of Delhi
Name of Hon'ble Judge: Ms. Justice Manmeet Pritam Singh Arora

Fact

Novartis AG is the holder of Indian Patent No. 414518, which was granted after dismissal of several pre-grant oppositions. Post-grant, various pharmaceutical parties filed oppositions challenging the validity of the patent on the grounds of lack of inventive step and violation of Section 3(d) of the Patents Act, 1970. The patent grant was followed by procedural battles—opponents submitted further expert evidence through affidavits and Novartis responded with requests to file rebuttal evidence. This procedural exchange continued until a timeline was set by a prior High Court order to ensure expeditious proceedings in the post-grant opposition process.

Procedural Detail

Novartis filed its patent application in 2007 and received grant in December 2022. Following this, opponents filed post-grant oppositions under Section 25(2) of the Patents Act. Opponents submitted expert affidavits under Rule 60 of the Patent Rules, and Novartis objected, but the Controller admitted the evidence. Novartis sought an opportunity to file rebuttal evidence, which was initially rejected by the Controller. Novartis challenged this by filing writ petitions contesting the denial and the procedure followed. The High Court set aside earlier orders and allowed Novartis to file rebuttal evidence, ordered a new Controller for the matter and demanded that the process move forward under strict timelines. The parties complied with the directions—Novartis filed rebuttal evidence, the Opposition Board issued a fresh recommendation, and hearings were scheduled by the Controller. However, Novartis sought cross-examination of the opponents’ expert witnesses after having already filed rebuttal evidence and after the timeline for such applications had passed, leading to the present dispute over whether this belated request was maintainable.

Dispute

At the heart of the case is whether Novartis retained a right to seek cross-examination of expert witnesses after initially omitting to request it and electing instead to file rebuttal evidence. Novartis argued that the right to cross-examine arises as a matter of natural justice and does not get extinguished by not seeking it at the earliest stage. Respondents, including various pharmaceutical companies, opposed this position stating Novartis had multiple opportunities to make such a request and by not doing so had waived the right or was barred on grounds of delay and procedural abuse. They asserted that permitting the request at this stage would undermine the Court’s order for expeditious conclusion and render the previous proceedings futile.

Detailed Reasoning Including Judgements

Justice Manmeet Pritam Singh Arora systematically examined the sequence of events and arguments by both sides. The judgment discussed key procedural stages, including evidentiary filings, objections, hearings, and previous High Court interventions that set guidelines for timely and fair conduct. The Court considered if principles of natural justice demanded allowance of cross-examination at any stage, referencing several judgements such as Onyx Therapeutics v. Union of India (2019 SCC OnLine Del 7259, 11881) and Natco Pharma Ltd. v. Union of India (2019 SCC OnLine Cal 1609), which asserted cross-examination as a substantive right under Section 79 of the Patents Act. The Court, however, clarified that such a right must be exercised promptly, preferably at the time the expert evidence is admitted, to avoid unwarranted delay and disruption of proceedings.

The Court differentiated the facts of Onyx Therapeutics, where the patentee made immediate requests for cross-examination, from Novartis’s situation, where the request came much later after the right of rebuttal was specifically claimed and allowed, thereby satisfying natural justice. It is reasoned that failure to timely exercise the right, especially after a conscious election to file rebuttal evidence, not only constituted waiver but also operated as estoppel. The Court declared that the stage for seeking cross-examination ended when the Controller decided on the admissibility of evidence. Delay or tactical withholding of request cannot be used to reset the process or frustrate the timeline set by earlier judicial orders.

The Court addressed whether denial of cross-examination at a late stage constituted breach of natural justice and held it did not, as adequate opportunity for rebuttal was allowed and utilized. Judicial directions for expeditious disposal, and the procedural structure of patent oppositions—where evidence is first submitted and reviewed by an Opposition Board—were emphasized as safeguards for fairness and efficiency. The Court found that Novartis’s conduct in abstaining from hearings further reinforced procedural abandonment, and disallowed late assertions of rights which had already been considered and exhausted through the judicial process.

Decision

Justice Arora dismissed the writ petitions, upholding the Controller’s refusal to entertain the belated cross-examination request. The Court found that Novartis had waived its procedural right to cross-examination by electing to file rebuttal evidence and not seeking cross-examination at the time evidence was admitted. No procedural or substantive violation of natural justice had taken place. The efforts and timelines set by the Opposition Board and the earlier orders of the Court were protected against disruption through dilatory tactics. All pending applications were disposed of, confirming that parties must exercise their procedural rights in a timely and diligent manner, respecting guidelines laid down by judicial proceedings and statutory rules.

Disclaimer: The information shared here is intended to serve the public interest by offering insights and perspectives. However, readers are advised to exercise their own discretion when interpreting and applying this information. The content herein is subjective and may contain errors in perception, interpretation, and presentation.

Written By: Advocate Ajay Amitabh Suman, IP Adjutor [Patent and Trademark Attorney], High Court of Delhi

Suggested Titles for Publication

1. Timing and Waiver of Cross-Examination Rights in Patent Opposition: Lessons from Novartis AG v. Controller

2. Explaining Natural Justice in Patent Disputes: A Study of Novartis AG v. Controller

3. The Dilemma of Delayed Cross-Examination Demand: Delhi High Court’s Approach in Novartis AG

4. Patent Opposition Procedures: Judicial Insights from Novartis AG’s Case

5. Managing Procedural Rights: Understanding Waiver and Estoppel in Post-Grant Opposition