Strategic Delay Backfires: How Novartis Lost Its Cross-Examination Rights
SpicyIP
Strategic Delay Backfires: How Novartis Lost Its Cross-Examination Rights
By Anushka Kanabar
Timing may be core to the enforcement of procedural rights in patent disputes, a point driven home with unusual force in the Delhi High Court’s recent decision in Novartis v. the Controller of Patents, in which it dismissed what might otherwise have been a legitimate cross-examination request, after taking into account Novartis’ delay as well as conduct prior to the delay. The judgement was passed in the long ongoing Entresto (Valsartan/ Sacubitril) saga (previously discussed on the blog by Yogesh and Praharsh here and here). A few days before the Court passed the current order discussed in this post, the Controller passed a 200 plus page order (pdf) revoking Novartis’ patent (which will be covered in a different post).
Coming back to this judgement, it is a fascinating instance of how strategic litigation in the context of patents can backfire and be overridden by the need for expeditious dispute resolution. It is also yet another instance of courts being increasingly willing to scrutinize litigants’ strategies for signs of gamesmanship, particularly when significant judicial time has already been invested in the dispute. In this post, I’ll break down the reasoning in the Court’s judgement, rejecting Novartis’s writ petition after a detailed consideration of its arguments on its right to cross-examine the opponent’s experts.
A Year Long Silence
This writ petition was triggered by the post-grant oppositions faced by Novartis against its patent (IN’518) from several generic players, including the Indian Pharmaceutical Alliance. Novartis was served with the opponents’ expert evidence – which was to the effect that IN’518 lacked an inventive step and that the grant of the patent violated Section 3(d) of the Patents Act – in July 2024. At this stage, Novartis chose to file its own expert affidavits in rebuttal, instead of directly challenging the credibility of the evidence by cross-examining the opponent experts.
Pursuing this strategy all through 2024 and early 2025, Novartis consistently raised objections regarding the admissibility of the opponents’ evidence but limited itself to filing its own rebuttal evidence. Even at the stage it successfully challenged a procedural order before the Delhi High Court in April 2025, it only argued that it had been denied a fair chance to file rebuttal evidence (which was viewed favorably by the Court, which granted its plea while setting strict timelines).
The striking aspect here is that Novartis only filed an application seeking cross-examination of the opponent experts on 14 July 2025, the very day the Opposition Board was due to issue its fresh recommendations. A reading of the Controller’s order passed on 20 August 2025 shows that Novartis refused to attend the hearings until its cross-examination request was taken up despite repeated warnings from the Controller that he would proceed ex parte. This insistence on the cross-examination being conducted prior to the complete presentation of the opponent’s case finds no grounding in the Patents Act or even Rule 128, which does not prescribe a specific timeline for cross-examination. This absence and delay in filing, as we will see, would later prove to be fatal to its case.
Strategic Silences and Elections
Novartis advanced several arguments to justify this glaring delay. First, it argued that the necessity for cross-examination only arose after it had filed its rebuttal evidence on June 14, 2025. It contended that it was only after detailed consultation with its own experts that it discovered the inconsistencies in the opponent experts’ testimonies. This led it to conclude that the one-year delay – from receiving the evidence (July 2024) to filing the cross-examination request (July 2025) – was rather a “reasonable period” in the circumstances.
Second, Novartis relied heavily on the Delhi High Court’s judgement in Onyx Therapeutics v. Union of India to argue that cross-examination is a matter of right under Section 79 of the Patents Act, and once it was sought, the Controller was bound to grant it. Going by the text of Section 79 – which states that the Controller “may allow any party to be cross-examined” where he “thinks it right so to do” – this might already appear to be a stretch. In response to this, the Court first noted that the court in Onyx had explicitly stated that the right to cross-examine is not dependent on the patentee first filing its own rebuttal evidence (so the patentee always has an option to do both). Seeing that Novartis had extensively challenged the opponent experts’ evidence in its initial filings, it was evident that grounds for cross-examination existed from the very beginning and Novartis simply chose not to go that route.
The Court here also distinguished the case before it from Onyx, wherein the patentee had sought cross-examination at the earliest possible opportunity, i.e., along with its initial reply to the opposition, and consistently reiterated this request as new evidence was filed. This indicated its clear intent to test the evidence through cross-examination, as opposed to Novartis’s conduct in remaining silent on the matter for over a year. This way, the holding in Onyx was curtailed to protecting a right that the patentee actively asserts, a right, which as the case of Novartis shows, was not absolute, and could nonetheless be waived through conduct.
Novartis’s third broad argument was that even if the Court found its one year wait a “delay,” it was ultimately inconsequential and that the ends of justice would be met by allowing cross-examination now. It even proposed an expedited schedule to achieve this: two weeks for cross-examinations and another two for the Opposition Board to issue a third set of recommendations. The Court rejected this as setting at naught the entire process that had been meticulously followed pursuant to its own April 2025 order. It chastised Novartis for showing what it called a “nonchalant and dismissive outlook” towards the time and effort of the Opposition Board and refused to reward the very delay the Court’s previous order was supposed to prevent. While the Court attributed the delay to Novartis’s nonchalance, it is perhaps lucky for Novartis that the Court did not view this as a bad faith attempt to frame the benefit it derived from its own delay, (i.e., the subsistence of its patent rights until their expiry in November 2026), as a matter of natural justice.
Thus, even though nothing in the Court’s April 2025 order – allowing Novartis to file rebuttal evidence – explicitly restricted it from seeking cross-examination later, the Court refused to extend the same latitude towards it again. After having repeatedly sought recourse solely through rebuttal evidence, Novartis had made a conscious election and was now estopped from asserting its procedural rights to reset the process.
The Limits of Natural Justice
The Court’s reasoning largely proceeded on equitable principles, seeing that Novartis’s conduct was a textbook case of implied waiver. The strength of the language used in the judgement is telling – the Court termed Novartis’s delay in filing the petition and its decision to stonewall the final hearing before the Controller until its cross-examination request was fulfilled as an “impermissible and disrespectful” abuse of process, and labelled its claim of a natural justice violation as “complete hogwash.”
This may have been provoked by the Court’s own role in advancing the case along by granting Novartis a full opportunity to file detailed rebuttal evidence to counter the opponents’ experts, which it held sufficiently fulfilled the principle of natural justice. On this view, the principle does not require granting all procedural requests at every conceivable stage, especially when sought for tactical reasons, and must solely be relied on in good faith and within reasonable timeframes.
Novartis v. Controller of Patents therefore reinforces the objective of expeditious disposal that underlies opposition proceedings, and its emphasis on timing, consistency, and respect for administrative processes paves the way for closer scrutiny of patentees’ litigation strategies. By viewing Novartis’s request as a dilatory technique aimed at protracting the proceedings, the Court prevented the abuse of the opposition process and it straying away from its goals of testing patent validity. This ultimately serves as a warning that even the most sophisticated strategy must be deployed within the bounds of procedural propriety.