The Delhi High Court in Zydus v. Controller of Patents has reaffirmed a formal separation between patent examination and pre-grant opposition, characterising examination as a self-contained, non-adversarial process. While this approach emphasises procedural efficiency, it raises deeper questions about how natural justice operates once a pre-grant opposition is on record. Arshiya Gupta and Reyansh Khandelwal critically examine whether the Court’s insistence on formalism comes at the cost of substantive fairness in patent prosecution. Arshiya is a third-year law student at National Law University, Delhi, with a keen inclination towards PIL, IPR, and criminal law. Reyansh is a third-year law student at National Law University, Delhi, with interests in criminal law and public international law, and an active interest in mooting and ADR.
Natural Justice Without Participation? Patent Examination, Civil Consequences, and the Zydus Judgment
By Arshiya Gupta and Reyansh Khandelwal
The DHC’s recent judgment, passed on December 24, 2025, in Zydus Healthcare Ltd. v. Controller of Patents, held that the patent examination process is a self-contained, non-adversarial exercise in which a pre-grant opponent has no right to notice or participation. Holding so, the Court clarified that natural justice is satisfied so long as the statutory opportunity to oppose a patent application is preserved, irrespective of subsequent examination-stage hearings conducted exclusively with the applicant.
When read alongside the 2024 Division Bench ruling in Novartis AG v. Natco, the Zydus order reinforces a formal separation between patent examination and pre-grant opposition, holding them to be separate and parallel. The prevailing trend now is that examination is an autonomous, non-adversarial statutory exercise, while opposition is a limited participatory mechanism governed strictly by Section 25(1) of the Patents Act and Rule 55 of the Patent Rules.
This formalism, however, risks obscuring a reality that seems uncomfortable. Intuitively, once a PGO is filed, all decisions that pertain to examination, particularly those involving amendments and hearings under Section 14 (where the applicant is given an opportunity of being heard on an adverse report by the examiner), no longer operate in an administrative vacuum that is completely neutral or one-sided inquiry-based. Rather, the system is then supposed to shape the contours of a claim to exclusivity, particularly if implicating concerns of evergreening, which, if granted, may crystallise into a prospective monopoly and which can impose significant procedural and economic disadvantages on opponents. The Court’s refusal to acknowledge this narrows the scope of natural justice in patent prosecution, privileging procedural efficiency over substantive fairness. This blog post aims to try to restore the balance between the examination being a separate endeavour and ensuring the principles of natural justice aren’t ignored.
The Lis & Natural Justice Beyond Rights: Civil Consequences, the Missing Link
A central premise of the Court’s reasoning is that patent examination under the Patents Act is non-adversarial by design. As a matter of statutory structure, this is not contested because examination is framed as an issue between the applicant and the Controller, while adversarial participation is expressly contemplated only at the opposition stage. However, this formal separation obscures a deeper but established administrative law principle that a procedurally “non-adversarial” stage can nonetheless generate civil consequences for an identified third party. This is because natural justice in Indian administrative law is not triggered only by final adjudications or formally adversarial proceedings under a judicial or quasi-judicial authority. What also matters is the effect and not just the label. For instance, in a competitive examination evaluated on the cumulative scores of multiple tests, an applicant may be wrongly accused of malpractice in one component and assigned a zero score without being afforded a hearing. Even though no final declaration of disqualification is made, the procedural decision effectively determines the outcome of the selection process, and the civil consequence arises from the effect of the procedure on the applicant’s prospects.
There is also the concern of the Court’s insistence that natural justice is triggered only where a legal right is affected. This can be seen as it says that since a pre-grant opponent has no statutory right to participate in examination proceedings, exclusion from those proceedings is held not to violate fairness. This rights-centric conception of natural justice allows the Court to conclude that there can be no denial of a hearing where no right to be heard exists in the first place.
Yet administrative law in India has rarely been so constrained in both these aspects. Courts have consistently held that natural justice is attracted not merely by the deprivation of rights, such as can be seen in the case of DFO, South Kheri v. Ram Sanehi Singh (Supreme Court, 1970), or when the issue is non-adversarial, but by the infliction of civil consequences by that pure administrative action. These consequences, according to the case of Mohinder Singh Gill v Chief Election Commissioner (Supreme Court, 1977), are understood broadly to include infraction of not merely property or personal rights but of civil liberties, material deprivations, and non-pecuniary damages. Civil consequences, in this sense, flow not only from the final grant of rights but also from procedural developments that materially shape that outcome.
Viewed through this lens, the Single Judge’s anxiety in the Natco-Novartis litigation appears far less radical than the Division Bench suggested. Operating within a consolidated, adversarial conception of pre-grant opposition grounded in natural justice, the Single Judge was concerned with preventing opaque, unilateral examination-stage decisions from diluting an opponent’s statutorily conferred right to be heard. This was an approach the Division Bench rejected by re-casting opposition as merely facilitative within a parallel, efficiency-oriented examination process. The concern was not that pre-grant opponents possess a freestanding right to participate in every stage of examination. Rather, it was that once an opposition is pending, examination-stage decisions, particularly amendments, can restructure the very subject-matter of the opposition, often without affording the opponent any opportunity to respond. That restructuring itself constitutes a civil consequence.
Section 14 Hearings and the Privatization of Claim Redrafting
This tension is most visible in the Court’s treatment of hearings under Section 14. In Zydus, the Court held that a pre-grant opponent has no right to notice or participation in a Section 14 hearing conducted after the opposition hearing has concluded. The reasoning is straightforward that Section 14 hearings are part of the examination process, and the opponent’s statutory role is confined to Section 25(1).
What this reasoning underplays is the substantive function of Section 14 hearings in modern patent prosecution. These hearings often involve extensive claim amendments aimed at overcoming objections, many of which overlap substantially with grounds raised in opposition. When such amendments are discussed and accepted in a closed dialogue between the applicant and the Controller, the opponent’s challenge risks becoming procedurally obsolete, and the procedure itself restructures the contest, even before the formal decision is made.
To illustrate this using a simple example, let us consider that a patient group, fearing an increase in the price of a life-saving medicine due to a potential pharmaceutical monopoly, files a pre-grant opposition against a patent application. The opposition raises substantive objections, such as a lack of inventive steps or evergreening. After the opposition hearing concludes, the applicant is granted a Section 14 hearing, where the Controller suggests claim amendments. These amendments are framed in technical language that appears to narrow the claims but, in substance, merely mask the contentious features (such as what happened in the Nacto v. Novartis case itself, with respect to Valsartan-Sacubitril). Because the opponent is not heard at this stage, the Controller may conclude that the objections stand “neutralised” and later reject the opposition. The opponent never gets an opportunity to demonstrate how the amended claims continue to suffer from the same defects.
The exclusion of the opponent at this stage effectively allows applicants to recalibrate their claims in response to opposition arguments without engaging the opponent on the revised scope of protection. The pre-grant opposition, in such circumstances, is reduced to a static snapshot, while the patent application continues to evolve dynamically. The civil consequence here does not arise from the final grant alone. It arises earlier when claims are privately refined, objections are rendered ineffective, and the application is pushed closer to monopoly protection. For opponents, particularly in pharmaceutical cases, this exclusion has immediate commercial and public-interest implications. It affects market entry, drug pricing expectations, and litigation strategy. The availability of post-grant remedies does not undo this prejudice; delay in patent law is not neutral, and monopoly effects are often front-loaded.
The Single Judge’s concern, that opponents were being “kept in the dark” as discussed in detail here by Praharsh, was therefore not an attempt to judicially rewrite the statute. It was an effort to prevent the privatization of claim redrafting in a context where monopoly boundaries are actively contested.
Conclusion
The Zydus judgment and the Division Bench ruling in Novartis v. Natco clarify the law, but they also narrow the conceptual space for principles of natural justice in patent prosecution. By insisting on a rigid, rights-based conception of natural justice, the Court risks overlooking the functional reality that examination decisions resolve contested interests with irreversible effects. It also has the same concerns of delay and abuse of pre-grant opposition noted before by Yogesh, but it needs to be noted that procedural streamlining that excludes interested parties at critical stages redistributes power in favour of applicants and risks insulating examination decisions from meaningful scrutiny. Patent examination may be non-adversarial by design, but once opposition enters the picture, it is no longer consequence-neutral. Ignoring this may serve expedition, but it does so at the potential cost of patent quality and procedural legitimacy, costs that are especially difficult to justify in the context of pharmaceutical monopolies.
