In a significant ruling on patent prosecution procedure, the Delhi High Court in Fresenius Kabi Ipsum S.R.L. v. The Assistant Controller of Patents and Designs & Anr.[1], [i]has once again reaffirmed that a hearing granted to an applicant during pre-grant opposition proceedings under Section 25(1) of the Patents Act, 1970 cannot substitute the applicant’s independent and mandatory right of hearing under Section 14 of the Act. The judgment, delivered by Hon’ble Justice Jyoti Singh, sets aside an order refusing a patent application and remands the matter for fresh consideration, underscoring that procedural fairness in patent examination is not a mere formality but goes to the root of the validity of the Controller’s decision.
Background of the Dispute
The appeal arose out of the refusal of Patent Application No. IN 201611009993, filed on 22 March 2016 by Fresenius Kabi Ipsum S.R.L., for an invention titled “An Improved Process for the Preparation of Sugammadex Which Involves the Use of a Salt of 3-Mercapto Propionic Acid, Preferably the Di Sodium Salt of 3-Mercapto Propionic Acid.” Sugammadex is a well-known pharmaceutical compound, and the application claimed an improved manufacturing process using an isolated di-alkali metal salt (preferably disodium salt) of 3-mercaptopropionic acid, as opposed to generating the salt in situ during the reaction. The Appellant argued that this modification improved the purity of the final product, reduced overall reaction time, avoided hazardous reagents such as sodium hydride, and eliminated the need for cumbersome purification techniques like chromatography or UV-based methods.
The application went through a long prosecution history: publication in January 2018, request for examination in mid-2019, a First Examination Report (FER) in March 2021 raising objections under Sections 2(1)(ja) (inventive step) and 3(d) (non-patentability) citing three prior art documents, and a reply in September 2021 with amended claims. Two separate pre-grant oppositions were filed i.e. the first in July 2020, and a second, more substantive one by Respondent No. 2 in October 2021 raising anticipation, lack of inventive step (based on seven prior art documents, D1 to D7), and non-patentability under Section 25(1)(f). After three rounds of oral hearings culminating in October 2024, the Assistant Controller refused the application on 21 November 2024 on grounds of lack of novelty, lack of inventive step, and non-patentability under Section 3(d), relying principally on prior art D1 (WO2014125501A1) along with D3, D4 and D7.
The Appellant’s Procedural Challenge
Before the High Court, the Appellant’s primary submission was procedural rather than substantive. It was argued that while hearings had indeed been conducted under Section 25(1) in connection with the pre-grant opposition, no separate hearing was ever granted under Section 14, even though the Controller was effectively about to refuse the application, a step that adversely affects the applicant and squarely attracts Section 14 read with Rule 129, Patent Rule 2003.
The Appellant drew a sharp statutory distinction between the two provisions. Section 14 is triggered by an adverse Examiner’s report and operates strictly between the Controller and the applicant; it is mandatory in character. Section 25(1), by contrast, is triggered by a third-party representation, is governed by Rule 55(5), and involves the Controller, the opponent, and the applicant. Thereafter the reliance was placed on the Division Bench ruling in Novartis AG v. Natco Pharma Limited[ii], which held that examination under Section 14 and opposition under Section 25(1), though structured to run in parallel, are independent processes that do not converge. Further reliance was placed on Zydus Healthcare Ltd. v. Assistant Controller of Patents and Designs[iii], the Bombay High Court’s decision in AIC246 AG & Co. KG v. The Patent Office of India[iv], and the earlier Delhi High Court ruling in Ferid Allani v. Union of India[v], all of which emphasised that denial of a Section 14 hearing , even where a Section 25(1) hearing has taken place , amounts to a breach of natural justice and a mandatory statutory safeguard.
On merits, the Appellant additionally argued that the impugned order was a non-speaking order that failed to address several critical questions.
The Respondents’ Defence
Appearing for the Patent Office, the respondent’s counsel defended the order as well-reasoned and speaking, pointing out that the Appellant had in fact been heard three times and had filed two rounds of written submissions and no law mandated a further hearing. It was argued that a separate Section 14 hearing would have made no difference to the outcome, since D1 disclosed the identical reactants and identical product, and the distinction between an isolated salt and an in-situ generated salt was a matter of routine workshop choice rather than invention. Counsel for Respondent No. 2, Mr. Durga Das Bhatla, went further into the chemistry, arguing that D1’s stoichiometric ratio of acid to base (1:2) inherently and implicitly disclosed formation of the disodium salt before the cyclodextrin reactant was introduced, relying on the European Board of Appeal’s test for implicit disclosure in T701/09 (refer page no. 75). It was also pointed out that the Appellant itself had admitted during prosecution that the salt is prepared in situ in the cited prior art.
The Court’s Reasoning
Justice Jyoti Singh undertook a detailed walk-through of the statutory scheme and relevant rules and section of Indian Patent Rules and Acts, from publication under Section 11(A), request for examination under Section 11(B), the Examiner’s enquiry under Sections 12 and 13, to the Controller’s power under Section 15 to grant, refuse, or require amendment. The Court held that Sections 12 to 15 together constitute the “examination process,” which is distinct from the “opposition process” under Section 25. Relying squarely on Novartis AG, the Court reiterated that a pre-grant opponent i.e. who may be any person, with or without a direct interest in the outcome, merely aids the Controller in conducting a comprehensive examination, and does not thereby acquire, nor confer upon the applicant, any substitute for the applicant’s independent right of hearing under Section 14.
The Court also relied heavily on the Bombay High Court’s reasoning in AIC246 AG, which held that permitting a Section 25(1) hearing to stand in for a Section 14 hearing would allow the Controller to bypass the mandatory provisions of Chapter IV and the Patent Office Manual, and to refuse an application without even passing a proper order under Section 15 which is the sole provision governing grant or refusal of a patent. Paragraphs 09.04(10), 09.04(12) and 09.06(10) of the Manual of Patent Office Practice and Procedure were extracted to demonstrate that no patent may be refused without a Section 14 hearing, and that after a Section 25(1) hearing the Controller must still pass a composite, speaking order under Section 15.
Applying this framework, the Court held that the Assistant Controller was under a clear statutory obligation to grant the Appellant a hearing under Section 14 before refusing the application, irrespective of the hearings already conducted under Section 25(1). The failure to do so was not a mere technical lapse but a violation of a substantive right, depriving the Appellant of the opportunity to respond to objections and, where necessary, amend its claims.
Outcome and Takeaway
The Court set aside the order dated 21 November 2024 and remanded the matter to the Assistant Controller for fresh consideration within six months, directing strict compliance with Sections 14, 15 and 25 of the 1970 Act and Rule 129 of the 2003 Rules, and mandating that the Appellant and Respondent No. 2 both be heard afresh, uninfluenced by the earlier order.
The ruling reinforces a straightforward but frequently contested proposition: examination and opposition are two distinct statutory tracks that run in parallel but never merge. A Section 25(1) hearing tests the opponent’s grounds; a Section 14 hearing protects the applicant’s independent right to meet the Controller’s own objections and seek amendment before an application is finally refused. Controllers cannot treat the two as interchangeable, and doing so renders the resulting refusal order vulnerable to being set aside, regardless of how the merits may ultimately play out. In patent prosecution, as this decision reaffirms, fairness in hearing is inseparable from the validity of the decision itself.
[i] C.A.(COMM.IPD-PAT) 7/2025,
[ii] (2024 SCC OnLine Del 152)
[iii] MANU/DE/5739/2025,
[iv] MANU/MH/2111/2026
[v] 2008 SCC OnLine Del 1756