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 (\u201cPatents Act\u201d) cannot be substituted by a hearing granted during pre-grant opposition, however extensive that hearing may have been.<\/p>\n
Fresenius Kabi Ipsum Srl (\u201cFresenius Kabi\u201d), part of the global Fresenius Kabi group of generic drug manufacturers, filed Patent Application No. IN 201611009993 on 22 March 2016 for \u201cAn Improved Process for the Preparation of Sugammadex,\u201d a chemical process for manufacturing the anaesthesia-reversal drug. The application drew scrutiny after the Assistant Controller of Patents and Designs (\u201cController\u201d) issued a First Examination Report on 30 March 2021 citing prior art references, and two pre-grant oppositions followed \u2013 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.<\/p>\n
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<\/em> (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.<\/p>\n 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.<\/em> (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.<\/p>\n 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.<\/p>\n 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.<\/p>\n In view of the observations and the arguments presented by both the parties, the Delhi High Court held that:<\/p>\nSection 14 Is Mandatory, Not Optional<\/h3>\n
Denial of Hearing Is a Substantive Defect<\/h3>\n
Merits Left Open, But Gaps Flagged<\/h3>\n
Findings<\/h2>\n
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