The Delhi High Court’s order in Fresenius Kabi v. Controller may ultimately turn on a Section 14 violation, but the concerns it flags go well beyond procedure, extending to hindsight, prior-art mosaicking, and the treatment of technical evidence. Pranay Borupothu examines the decision and unpacks these procedural and substantive concerns in the Controller’s reasoning. Pranay is a 3rd-year LL.B.(Hons.) student at Rajiv Gandhi School of Intellectual Property Law, IIT Kharagpur, and has a keen interest in IP laws.
Section 14 is Not Section 25: Delhi High Court Revives Sugammadex Patent Bid
By Pranay Borupothu
The Delhi High Court’s recent decision in Fresenius Kabi v. Controller of Patents reads like a checklist of everything the Indian Patent Office has been repeatedly criticised for: denying mandatory hearings under Section 14, constructing prior-art mosaics without motivation, and dismissing technical evidence as irrelevant. Justice Jyoti Singh’s order, delivered on 31 August 2026, sets aside the refusal of a sugammadex process patent on the procedural ground alone, but uses the opportunity to flag substantive errors that should worry the Patent Office far more than the remand itself. This post covers the denial of mandatory hearing under Section 14, the Controller’s impermissible hindsight in mosaicking prior-art documents without motivation, and engages with the question of whether two separate hearings are procedural necessity or an avoidable redundancy.
Background
The dispute pertains to a provisional patent application (IN 201611009993) in respect of claimed invention ‘improved process for preparing sugammadex’ using an isolated salt of 3-mercaptopropionic acid (preferably the disodium salt). The applicant argued that using a pre-formed, isolated salt produces sugammadex of higher purity, with fewer impurities, in a shorter reaction time, and with better scalability for industrial manufacturing.
The Controller, on a pre-grant opposition, refused the patent application on grounds of lack of novelty under Section 25(1)(b), lack of inventive step under Section 25(1)(e), and non-patentability under Section 3(d) of the Patents Act, 1970. The appeal challenged the refusal on two broad fronts: procedural violation of Section 14, and substantive errors in the Controller’s obviousness and novelty analysis.
Section 14 and the Right to a Hearing
The first and foremost ground was that the Controller refused the application without granting the applicant a separate opportunity of hearing under Section 14 of the Patent Act, 1970. Section 14, read with Rule 129 of the Patent Rules, 2003, casts a mandatory obligation on the Controller to communicate the gist of objections to the applicant where the examiner’s report is adverse, and to give the applicant an opportunity of being heard before disposing of the application. The Court rejected the position of substituting the pre-grant opposition hearings with Section 14 hearings.
The Court relied on the Division Bench’s (DB) ruling of the Delhi High Court in Novartis AG v. Natco Pharma (2024), where the DB had held that the rejection of an opposition does not inevitably result in a patent being granted and the Controller remains independently bound to examine the application on its own merits (this dichotomy is explained in detail by Yogesh here). Further, the Court also relied on the Bombay High Court’s decision in AIC246 AG v. The Patent Office of India (2026), which set aside a Controller’s order for denial of a Section 14 hearing notwithstanding that hearings had been granted under Section 25(1). The Calcutta High Court’s decision in UPL Limited v. Union of India (2025) was cited to the same effect.
Manual of Patent Practice and Procedure, at paragraph 09.04(12), states unambiguously: No patent is refused without giving an opportunity of being heard under Section 14 of the Act. The new draft Manual of Patent Practice and Procedure (v4.0, 2026), at paragraph 09.04(16) carries this position forward unchanged, confirming that the Patent Office’s own internal guidance has remained consistent across iterations, even though the practice on the ground diverged from it. The Controller’s argument that the outcome would have been the same regardless was dismissed as a “post-order assertion” that cannot “legitimize or condone a clear breach of mandatory statutory safeguard.”
This decision clears the fog between the examination and opposition proceedings and confirms a growing judicial consensus across Delhi, Bombay, and Calcutta High Courts that the Patent Office cannot collapse the examination and opposition proceedings into a single hearing. The practical implication is clear: wherever a pre-grant opposition is filed, the Controller must still convene a separate Section 14 hearing before refusing the application, and must pass a speaking order under Section 15 that simultaneously decides both the application and the representation.
The fact that three High Courts have had to address this identical issue within roughly a year indicates that the conflation of Section 14 and Section 25(1) hearings is not an isolated lapse but a systemic practice across the Patent Office. The office appears to have adopted an internal convention of treating the opposition hearing as sufficient, which is difficult to reconcile with the statutory framework.
The draft manual itself states that it “does not constitute rule-making and, hence, does not have the force and effect of law.” This is relevant because it means the Manual’s guidance on Section 14 hearings is not legally binding in the way a statutory provision or a Rule would be. This judgment relies on paragraph 09.04(12) of the Manual, but the legal force of the holding comes from Section 14 and Rule 129 themselves, not from the Manual. The problem is not unclear guidance but non-compliance with existing guidance. A statutory amendment or a Rule clarification would carry the force of law, and would make it harder for the office to disregard.
The Section 14 hearing is between the applicant and the Controller, triggered by the Examiner’s report, and gives the applicant a chance to address objections and seek amendments. The Section 25(1) hearing is between the applicant, the opponent, and the Controller and is circumscribed by the grounds the opponent has raised. They are not two hearings on the same issue, but they are hearings on different sets of objections raised by different actors under different statutory provisions. The risk of endless serial hearings is real but manageable. Section 14 hearings do not restart the opposition clock, and Rule 55(5) requires the Controller to pass a speaking order under Section 15 within a defined timeframe after the opposition proceedings conclude. Strict timelines are a more effective way to address concerns about procedural delays than by collapsing two distinct statutory hearings into one.
Hindsight Bias and Impermissible Mosaicking
The Court’s reasoning for setting aside the Controller’s order was mostly focused on procedural aspects and expressly declined to rule on the merits. The most interesting concern the Court flagged but chose not to rule on was ‘Hindsight Bias.’ In patent law, Hindsight bias, or ex-post facto analysis, refers to the unconscious tendency of Examiners/Judges to view an invention as obvious simply because they already know how the invention works. In this dispute, the Controller constructed a mosaic of prior art (D1, D3, D4 and D7) without providing any reason “why a person skilled in the art would take D1 as starting point and combine teachings of D3, D4 and D7 with D1.” In doing so, the Controller adopted a hindsight approach, which is not allowed.
Farbewerke Hoechst AG v. Unichem Laboratories & Ors (1968), one of the earliest decisions where the Bombay Hight Court warned against the “common human failing of being wise after the event.” In Cipla v. F. Hoffmann-La Roche (2015), the Delhi High Court (DB) held that the “while conducting an inquiry into obviousness, hindsight is impermissible and the legal conclusion must be reached on the basis of facts gleaned from the prior art and should not include knowledge gleaned from patent disclosure.” The applicant in present dispute had relied on Avery Dennison Corporation v. Controller of Patents and Designs (2022), where the Delhi High Court had held that “a hindsight reconstruction by using the patent in question as a guide through the maze of prior art references so as to achieve the result of the claim in the suit, is to be avoided.” Therefore, the examiners cannot just stitch prior art together, they must establish teaching or motivation from prior art itself that would have led a skilled person to make the combination.
This is also why the failure to identify the closest prior art was flagged separately by the court: identifying the closest prior art is the first step in any structured obviousness analysis and is itself a safeguard against hindsight, because it anchors the inquiry in a single reference rather than allowing the examiner to cherry-pick elements across multiple documents.
The applicant also argued that the prior art teaches away from the claimed approach. The teaching away doctrine, recognised in jurisdictions such as the United States and increasingly referenced in Indian obviousness analysis, makes the hindsight problem even more acute. If the prior art points in the opposite direction, combining it to reach the invention is not just unmotivated but counter-motivated. The Controller’s order does not engage with this argument at all.
Other Gaps
The Section 3(d) question is more nuanced than the Controller’s order acknowledges. The provision excludes ‘the mere use of a known process unless it results in a new product or employs a new reactant.’ The applicant’s argument is that the product here is not identical to the prior-art product, it is free of specific impurities tied to sodium methoxide use in D1. Whether an impurity profile difference makes a product ‘new’ under Section 3(d) is a question the Controller simply did not engage with, stating only that the process does not involve any new reactant or result in a new product without addressing the evidence on impurities.
The Court noted this finding but did not rule on it, observing only that the Controller had not adequately addressed the applicant’s argument that the use of an isolated salt, a stable, characterizable chemical entity, is fundamentally different from using a transient in situ intermediate, and that this distinction has consequential effects on yield, purity, and scalability.
Likewise, the Court listed six specific questions pertaining to novelty and inventive step which the Controller had failed to answer. First, whether D1’s disclosure of the disodium salt was explicit or implicit, a distinction that matters because anticipation requires clear and unambiguous disclosure. Second, which of the four cited documents was the closest prior art, the anchor reference from which the obviousness analysis should begin. Third, whether the invention demonstrated any technical advancement or economic significance, factors that Section 2(1)(ja) expressly requires the Controller to evaluate. Fourth, why the step of isolating the salt before the reaction was not a new or distinctive step. Fifth, why the product, though free of specific impurities found in the prior-art product, was not considered a ‘new product’ under Section 3(d). And sixth, why the combined technical features of higher purity, reduced reaction time, and use of an isolated salt did not constitute novel or inventive features over the cited references.
What is striking is not that the Controller got these questions wrong, it is that the Controller never asked them. These are the basic procedures that the Patent Manual itself prescribes for novelty and inventive-step assessment. The Controller’s order jumped from citing prior art to a conclusion of obviousness without passing through any of this procedure. The Controller also overlooked the applicant’s submission that corresponding patents had been granted in the US, China, EU, Australia, and Hong Kong, a factor the Delhi High Court in Avery Dennison had held was relevant to consider, even if not binding on the Indian Patent Office.
Conclusion
The decision reinforces three principles that the Patent Office would do well to internalise. First, Section 14 hearings are not optional and cannot be substituted by Section 25(1) opposition hearings. Second, obviousness cannot be established by assembling a mosaic of prior-art documents without articulating a reason a skilled person would combine them. Third, the Controller must engage with the applicant’s technical evidence rather than dismissing it as outside the Patent Office’s concern. The Court’s order gives the Controller an opportunity to get it right the second time. Whether it does so will be closely watched.
I would like to thank Praharsh for his detailed and helpful comments, which made the post much better.