By Jigyasa Pareek

The Delhi High Court, in Fresenius Kabi Ipsum SRL vs Assistant Controller of Patents and Designs & Anr. [C.A.(COMM.IPD-PAT) 7/2025; decision dated August 31, 2026], set aside the order refusing patent application number IN 201611009993 relating to an improved process for the preparation of sugammadex using a salt of 3-mercaptopropionic acid, preferably the disodium salt. The Delhi High Court held that hearing granted to an Applicant during a pre-grant opposition proceeding under Section 25(1) of the Patents Act, 1970, cannot substitute the separate statutory hearing contemplated under Section 14 of the Act. The Court also noted that, in the instant case, the Controller had failed to adequately address several technical issues raised by the Applicant, including the distinction between an isolated salt and an in-situ generated salt and the basis for mosaicking multiple prior-art references to conclude lack of inventive step.

The claimed invention related to a process for preparing sugammadex by reacting an isolated salt of 3-mercaptopropionic acid with 6-per-deoxy-6-per-halo-y-cyclodextrin. The application stated that the use of an isolated di-alkali metal salt, particularly disodium 3-mercaptopropionate, improved the purity and/or reaction time of sugammadex. The claimed process was presented as addressing, inter alia, the unsatisfactory purity obtained through prior-art processes, lengthy reaction times and difficulties associated with the use of pyrophoric reagents and specialised purification techniques at industrial scale.

The application underwent examination, following which the First Examination Report (FER) raised objections on grounds of Sections 2(1)(ja) and 3(d), among other formal objections. The Applicant filed its response and amended the claims. Thereafter, pre-grant oppositions were filed, including one by Respondent No. 2, raising grounds of anticipation, lack of inventive step and non-patentability. Following the hearing afforded to the Applicant during the pre-grant opposition proceedings under Section 25(1), the Controller refused the application on grounds of lack of novelty, lack of inventive step and non-patentability under Section 3(d).

The Court examined the statutory scheme governing examination and opposition. It noted that Sections 11(A) and 11(B) deal with publication and request for examination, following which the application is referred to an Examiner under Section 12. Section 13 concerns examination with respect to anticipation, while Section 14 requires the Controller to communicate the gist of objections arising from the Examiner’s report and provide the Applicant an opportunity to respond where the report is adverse or requires amendment of the application. Section 15, in turn, empowers the Controller to refuse the application or require amendment. The Court described the process from Sections 12 to 14 as the examination process on the basis of which the Controller exercises power under Section 15.

Section 25, on the other hand, concerns opposition proceedings. A pre-grant opposition may be filed by “any person” on the grounds enumerated in Section 25(1), while a post-grant opposition is governed by Section 25(2). The Court emphasised that the two proceedings operate within distinct statutory frameworks.

In reaching this conclusion, the Court relied substantially on the Division Bench judgment in Novartis AG vs Natco Pharma Limited & Anr., which had held that the examination process under Chapter IV and the opposition process under Chapter V, although capable of proceeding in parallel, are independent and separate processes. Rejection of a pre-grant opposition does not automatically result in grant of the patent; the Controller remains independently required to examine the application on the basis of the FER and determine whether the patent is grantable. The purpose of pre-grant opposition is to assist/aid the Controller by bringing different perspectives and objections to the examination process, but it does not merge the opposition proceeding with the statutory examination.

The Court further noted that an Opponent participates in the opposition process and does not acquire a right of hearing in the examination process under Section 14. Thus, Sections 14 and 25(1) represent two distinct statutory pathways, and a hearing granted under Section 25(1) cannot displace the separate opportunity contemplated under Section 14.

The Court also referred to the Bombay High Court’s decision in AIC246 AG & Co. KG vs The Patent Office of India & Ors., where a refusal without a Section 14 hearing was found contrary to the statutory framework. The Bombay High Court had also relied upon the Patent Manual, which provides that no patent is to be refused without giving the Applicant an opportunity of being heard under Section 14 and that, after hearing the parties in opposition proceedings, the Controller is required to pass a speaking order under Section 15 and simultaneously decide the application and the representation in the pre-grant opposition.

Against this backdrop, the Delhi High Court held that there was merit in the Applicant’s contention that Section 14 and the Patent Rules had been violated. Rule 129 requires the Controller, before exercising a discretionary power likely to adversely affect an Applicant, to provide an opportunity of hearing, ordinarily upon giving ten days’ notice. Relying on Ferid Allani vs Union of India, the Court noted that this statutory requirement had previously been treated as sufficient, by itself, to warrant remand where the Applicant had been deprived of the opportunity of hearing.

Importantly, the Court characterised the denial of a Section 14 hearing as more than a mere procedural irregularity. According to the Court, the Applicant had thereby been deprived of an opportunity to respond to the objections and, if necessary, seek amendments to overcome them. The Court therefore regarded the omission as a violation of a substantive right which goes to the root of the matter. It expressly rejected the Respondents’ contention that the Section 25(1) hearing was sufficient or that a separate hearing under Section 14 would not have altered the outcome.

Although the finding on the Section 14 hearing was sufficient to dispose of the appeal, the Court also examined the impugned order to identify issues that would require consideration when the application was decided afresh.

The claimed process centred on the use of an isolated salt of 3-mercaptopropionic acid, whereas D1 disclosed formation of the salt in situ using sodium methoxide before reaction with halo-cyclodextrin. The Applicant had contended that an isolated salt was a distinct, purified and stable chemical entity capable of independent characterisation and that its use had technical consequences in terms of reaction reproducibility, yield, purity and scalability. It had also relied upon experimental data showing differences in impurities and product purity.

The High Court observed that the Controller appeared to have treated the difference between the isolated and in situ salt as merely cosmetic and as an obvious modification. However, the Court found that the Controller had not addressed the Applicant’s case that the two approaches constituted technically different chemical processes and that the difference had a consequential effect on yield, purity and scalability. The Court reiterated that anticipation requires disclosure of every element of the claimed invention in a clear and unambiguous manner and that even a single distinguishing technical feature, if absent from the prior art, can be material to novelty.

The Court was also critical of the treatment of the experimental data. The Controller had apparently observed that the issue of percentage purity in prior-art processes did not fall within the concern of the Patent Office. The High Court considered this approach fallacious, observing that such an approach could foreclose consideration of technical distinctions in several inventions. The Court noted that the evidence concerning the absence of impurities due to non-use of sodium methoxide had not been given due consideration.

The Court noted several specific questions which had not been addressed in the refusal order. These included whether disclosure of D1 was explicit or implicit while assessing novelty; what constituted the closest prior art for assessing inventive step; whether the claimed invention demonstrated technical advancement or economic significance; why isolation of the salt was not a new step; why the product obtained, which was asserted to be substantially free of impurities, was not a new product; and why the asserted purity, reduced reaction time and use of an isolated salt did not constitute novel or inventive features.

The Court also found substance in the Applicant’s contention that the Controller had constructed a mosaic of D1, D3, D4 and D7 in concluding that the claimed process lacked inventive step, without explaining the basis for doing so. The Court observed that there was no reasoning in the impugned order explaining why a person skilled in the art (PSITA) would select D1 as the starting point and combine the teachings of D3, D4 and D7 with D1, or how such a combination would render the claimed invention obvious. The Court noted that the use of multiple references without such reasoning amounted to a hindsight approach, which had been repeatedly cautioned against in patent jurisprudence.

In view of the foregoing, the Court set aside the order and remanded the application to the Patent Office for fresh consideration.