Summary
Fresenius Kabi Ipsum Srl challenged the Assistant Controller of Patents and Designs' refusal of its sugammadex process patent application before the Delhi High Court, arguing that it had never been granted the mandatory Section 14 hearing despite being heard on a competitor's pre-grant opposition. The Delhi High Court held that examination proceedings under Section 14 and opposition proceedings under Section 25(1) are distinct statutory tracks that cannot substitute for one another, following its own Division Bench ruling in Novartis AG v. Natco Pharma and a comparable Bombay High Court decision. The court set aside the refusal and remanded the application for fresh consideration within six months, without expressing any view on whether the claimed process is ultimately patentable. The ruling reinforces that patent applicants retain an independent right to a Section 14 hearing regardless of how extensively a pre-grant opponent has already been heard.
Background
A single missed hearing can send a patent application back to square one, no matter how many rounds of arguments came before it. Nearly nine years after a pharmaceutical process invention was first filed, the Delhi High Court has ruled that a Section 14 hearing under the Patents Act, 1970 (“Patents Act”) cannot be substituted by a hearing granted during pre-grant opposition, however extensive that hearing may have been.
Fresenius Kabi Ipsum Srl (“Fresenius Kabi”), part of the global Fresenius Kabi group of generic drug manufacturers, filed Patent Application No. IN 201611009993 on 22 March 2016 for “An Improved Process for the Preparation of Sugammadex,” a chemical process for manufacturing the anaesthesia-reversal drug. The application drew scrutiny after the Assistant Controller of Patents and Designs (“Controller”) issued a First Examination Report on 30 March 2021 citing prior art references, and two pre-grant oppositions followed – one filed in July 2020 and a second in October 2021 by the eventual Respondent No. 2. Oral hearings on the opposition were held across three rounds between 2023 and 2024, and on 21 November 2024, the Controller refused the application solely on grounds raised in the pre-grant opposition proceeding under Section 25(1), citing lack of novelty, lack of inventive step, and non-patentability under Section 3(d). Fresenius Kabi appealed under Section 117A(2) of the Patents Act to the Delhi High Court.
Issues
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- Whether a hearing granted to an applicant during pre-grant opposition proceedings under Section 25(1) can substitute for the mandatory hearing required under Section 14 read with Rule 129 of the Patents Rules, 2003 (“2003 Rules”) before an examination-stage refusal.
- Whether the Controller’s order refusing the application for lack of novelty and inventive step, and non-patentability under Section 3(d), adequately addressed the technical distinctions raised by Fresenius Kabi between the claimed process and the cited prior art.
- Whether an order refusing a patent application must independently comply with the composite disposal requirements under Section 15 of the Patents Act.
Fresenius Kabi’s Arguments
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- The Controller was statutorily bound under Section 14 read with Rule 129 to communicate the gist of adverse findings and grant a hearing before disposing of the application, an obligation that exists independently of any hearing conducted under Section 25(1).
- Relying on Novartis AG v. Natco Pharma Limited and Another (2024 SCC OnLine Del 152), examination under Chapter IV and opposition under Chapter V of the Patents Act are separate statutory tracks that do not converge, so a hearing on the pre-grant opposition cannot discharge the Controller’s distinct duty under Section 14.
- The impugned order was a non-speaking order that failed to address why the claimed process, using an isolated salt of 3-mercaptopropionic acid rather than an in-situ generated salt, lacked novelty and inventive step over the cited prior art, or why corresponding patents had been granted in the United States, China, the European Union, Australia and Hong Kong.
- The refusal ignored comparative purity and reaction-time data and constructed a combination of four prior art documents without explaining why a person skilled in the art would combine them, amounting to impermissible hindsight reconstruction.
Patent Office’s Arguments
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- Rule 55 of the 2003 Rules provides a complete procedure for pre-grant opposition, and the bilateral hearing conducted on Section 25(1) grounds satisfied natural justice; granting a further Section 14 hearing would only duplicate proceedings.
- The claimed process was identical in substance to prior art D1, since both used the same reactants and yielded the same product, and the use of an isolated versus in-situ salt was an obvious workshop-level variation with no unexpected technical effect.
- The claimed invention was barred under Section 3(d) as the mere use of a known process without a new reactant or new product.
Court’s Analysis
Two Statutory Tracks That Cannot Merge
The court noted that Chapters IV and V of the Patents Act serve different purposes, and following the Division Bench’s reasoning in Novartis AG v. Natco Pharma Limited and Another (2024 SCC OnLine Del 152), examination and opposition are structured to run parallel to each other but were never intended to converge into a single hearing. The court observed that an opponent under Section 25(1) aids the Controller’s independent evaluation, but a Section 14 hearing remains a right that belongs exclusively to the applicant and cannot be discharged through a bilateral opposition hearing that also involves a third party.
Section 14 Is Mandatory, Not Optional
The court held that Section 14 read with Rule 129 of the 2003 Rules casts an unambiguous statutory duty on the Controller to communicate the gist of adverse findings and grant a hearing before disposing of an application adversely to the applicant. The court further observed that paragraph 09.04(12) of the Manual of Patent Office Practice and Procedure states that no patent shall be refused without an opportunity of being heard under Section 14, and that this requirement survives regardless of whether a hearing has already occurred under Section 25(1). Relying on the Bombay High Court’s decision in AIC246 AG & Co. KG v. The Patent Office of India and Ors. (MANU/MH/2111/2026), the court found the present facts squarely comparable: allowing a Section 25(1) hearing to substitute for the Section 14 hearing would let the Controller bypass Chapter IV altogether and act inconsistently with the statutory scheme.
Denial of Hearing Is a Substantive Defect
The court rejected the submission that a separate hearing would have made no difference to the outcome, reasoning that a post-order assertion of futility cannot cure a breach of a mandatory safeguard, and that the denial deprived Fresenius Kabi of a genuine opportunity to address objections and seek amendments. The court reasoned that this went to the root of the matter rather than being a mere irregularity.
Merits Left Open, But Gaps Flagged
Without expressing any opinion on the ultimate patentability of the claimed process, the court found that the Controller’s order left several questions unanswered, including which prior art document was the closest starting point for assessing inventive step, whether the disclosure in the principal cited reference was explicit or implicit, and why the comparative purity and reaction-time data furnished by Fresenius Kabi were disregarded. The court observed that constructing a combination of four prior art documents without explaining why a skilled person would combine them risked exactly the hindsight-driven reasoning that patent law seeks to avoid.
Findings
In view of the observations and the arguments presented by both the parties, the Delhi High Court held that:
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- A hearing under Section 14 of the Patents Act is a mandatory statutory right of the applicant that exists independently of any hearing conducted during pre-grant opposition proceedings under Section 25(1).
- The Controller’s failure to grant Fresenius Kabi a separate Section 14 hearing before refusing Patent Application No. IN 201611009993 vitiated the impugned order dated 21 November 2024.
- The impugned order was set aside without any finding on the merits of the novelty, inventive step, or Section 3(d) objections raised in the pre-grant opposition.
- The matter was remanded to the Controller for fresh consideration within six months, in compliance with Sections 14, 15 and 25 of the Patents Act and Rule 129 of the 2003 Rules, after affording a hearing to both Fresenius Kabi and the pre-grant opponent.
- No costs were awarded.
Case Citation: Fresenius Kabi Ipsum Srl v. The Assistant Controller of Patents and Designs & Anr., C.A.(COMM.IPD-PAT) 7/2025, High Court of Delhi, decided on 31 August 2026. Available at https://indiankanoon.org/doc/76514615/.
Authored by Gaurav Mishra, Patent Attorney, BananaIP Counsels
