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Introduction

In Fresenius Kabi Ipsum SRL v. The Assistant Controller of Patents and Designs & Anr. (C.A.(COMM.IPD-PAT) 7/2025), the Delhi High Court, on 31st August 2026, set aside an order refusing a patent for an improved process of preparing Sugammadex, a drug used to reverse the effects of certain anaesthetic agents. The application was rejected after a pre-grant opposition was allowed, but the Controller never gave the applicant a separate hearing under Section 14 of the Patents Act, 1970. The Court held this was not a technicality but a violation of a substantive right, and remanded the matter, reaffirming that examination and third-party opposition are separate legal tracks, each requiring its own hearing.

Facts of the Case

The applicant, Fresenius Kabi Ipsum SRL, filed a patent application on 22nd March 2016 for an improved process of preparing Sugammadex, using an isolated salt of 3-mercaptopropionic acid rather than generating the salt within the reaction itself. This was said to solve problems in earlier processes – poor purity, long reaction times unsuitable for large-scale manufacture, and hazardous reagents.

The application was published in January 2018 and examination requested in June 2019. In March 2021, the Controller issued a First Examination Report citing three prior publications and objecting on inventive step and patentability; the applicant amended its claims in reply. An earlier, unrelated pre-grant opposition filed in July 2020 played no further part in the case. The opposition central to this appeal was filed by the respondent in October 2021 under Section 25(1) of the Patents Act – open to any person – alleging lack of novelty, inventive step and patentability; the applicant replied in February 2022.

Oral hearings were held over three rounds, concluding in October 2024, followed by written submissions from both sides. On 21st November 2024, the Controller refused the application for lack of novelty, lack of inventive step, and non-patentability under Section 3(d) – barring a patent for mere use of a known process unless it yields a new product or reactant. The applicant had been heard only during the Section 25(1) opposition; no separate hearing was granted under Section 14, which requires the Controller to communicate the examiner’s objections and hear the applicant before deciding the application. This omission became the principal ground of the appeal under Section 117A(2).

Argument in Favour

The applicant argued that the refusal order was vitiated by a serious procedural defect. Section 14 requires the Controller to inform the applicant of adverse examination findings and give a hearing before disposal, and Rule 129 of the Patents Rules, 2003 separately obliges the Controller to give a hearing, ordinarily after ten days’ notice, before exercising discretion adverse to an applicant. The hearing granted in the pre-grant opposition, triggered by a third party’s objections, was said to be a distinct proceeding that could not substitute the hearing owed under Section 14.

The order was also said to be non-speaking, since it failed to explain which document was the closest prior art and why the claimed advantages did not amount to an inventive contribution. The applicant pointed out that corresponding patents had been granted for the same invention in several other jurisdictions, a fact the Controller had ignored.

On the merits, the applicant argued that an isolated, purified salt is fundamentally different from one generated in situ – stable and independently characterisable, not a transient intermediate – affecting purity and reaction time. A single distinguishing feature absent from the prior art was said to suffice for novelty, per the method in LAVA International Limited v. Telefonaktiebolaget LM Ericsson, 2024 SCC OnLine Del 2497; and the Controller was said to have improperly combined unrelated prior art through hindsight reasoning, contrary to Avery Dennison Corporation v. Controller of Patents and Designs, 2022 SCC OnLine Del 3659.

Argument Against

The Controller and the opponent defended the order: natural justice had been satisfied since the applicant took part in three rounds of oral hearings and filed written submissions, and a further hearing under Section 14 would have made no difference. On the merits, the essential reaction claimed was said to be identical to that already disclosed in the principal prior art document, regardless of whether the salt was isolated beforehand or generated in situ – a routine option for a skilled chemist, not an inventive step.

The respondents relied on the applicant’s own data to show the prior art achieved higher purity, and that once isolation and drying time was counted, the applicant’s process took longer. They also relied on the European Board of Appeal’s decision in T 701/09 – that prior art disclosure need not be explicit, and can include what a skilled reader would necessarily understand – to argue the isolated-salt step was implicit in the prior art.

Court’s Decision

The Court explained the statutory scheme. Sections 12 to 14 set out the examination process, under which an examiner reports to the Controller, who must inform the applicant of adverse findings and grant a hearing; Section 15 then empowers refusal or amendment on that basis. Section 25 separately governs opposition, open to any person, before grant.

Relying on Novartis AG v. Natco Pharma Limited and Another, 2024 SCC OnLine Del 152 – holding that examination under Chapter IV and opposition under Chapter V are independent, parallel processes – the Court held that a hearing in opposition cannot substitute the hearing owed under Section 14. This was reinforced by AIC246 AG & Co. KG v. The Patent Office of India and Ors., MANU/MH/2111/2026, which set aside a similar refusal despite a Section 25(1) hearing having been granted – itself relying on UPL Limited v. Union of India and Others, 2025 SCC OnLine Cal 7944, for the same separation.

On the mandatory nature of the hearing itself, the Court cited Ferid Allani v. Union of India and Others, 2008 SCC OnLine Del 1756, for holding that Rule 129 casts a statutory duty on the Controller to give a hearing before exercising adverse discretion, and rejected the argument that a separate hearing would have made no difference – a post-order assertion cannot excuse breach of a mandatory safeguard.

Although the technical merits were not finally decided, since the matter was being remanded on procedural grounds, the Court flagged concerns for reconsideration. It found it unsound to treat product purity as outside the Patent Office’s concern, and held that assessing obviousness through hindsight is impermissible, noting that the Controller had combined prior art documents without explaining why a skilled person would have arrived at that combination.

The Delhi High Court accordingly set aside the refusal order and remanded the application for fresh consideration, directing a new decision within six months, in compliance with Sections 14, 15 and 25 of the Patents Act and Rule 129 of the Patents Rules, after granting a proper hearing to both the applicant and the opponent.

Conclusion

This judgment reaffirms a principle that recurs in patent disputes – examination and third-party opposition are distinct statutory processes, and a hearing granted in one cannot satisfy the hearing required in the other. The right to be heard under Section 14 is a substantive safeguard, not a formality, letting an applicant respond to the examiner’s objections and, where necessary, amend the claims before refusal. The remand also reminds patent authorities that novelty and inventive-step findings must be reasoned, and that combining prior art requires explaining why a skilled person would have arrived at that combination. For applicants, the ruling is a reminder that procedural compliance matters as much as substantive merit.