Patent prosecution and pre-grant opposition may concern the same patent application, and some of the objections raised in the two processes may overlap. Procedurally, however, they do not become one proceeding merely because they run alongside each other.
The Delhi High Court has reinforced this distinction in Fresenius Kabi Ipsum SRL v. The Assistant Controller of Patents and Designs & Anr., C.A.(COMM.IPD-PAT) 7/2025, decided on 31 August 2026. The Court set aside the refusal of Indian Patent Application No. IN 201611009993 after finding that the applicant had not been afforded the hearing contemplated under Section 14 of the Patents Act, 1970. A hearing conducted in the pre-grant opposition under Section 25(1), the Court held, could not substitute that opportunity.
The decision is significant for applicants and patent practitioners because it deals with more than the mechanics of scheduling a hearing. It concerns the statutory separation between examination of a patent application and opposition to its grant, and the procedural rights available to an applicant before an application is refused.
The dispute before the Delhi High Court
The application concerned an improved process for preparing sugammadex, involving the use of an isolated salt of 3-mercaptopropionic acid, preferably its disodium salt. The application had been filed on 22 March 2016.
During examination, the First Examination Report raised objections including inventive step under Section 2(1)(ja) and patentability under Section 3(d). The applicant responded and amended its claims. A pre-grant opposition was subsequently pursued under Section 25(1), raising objections that included anticipation, lack of inventive step and non-patentability. The Assistant Controller ultimately refused the application on 21 November 2024.
The applicant challenged that refusal before the Delhi High Court.
An important procedural issue arose in the appeal. The applicant had participated in the Section 25(1) proceedings, but it had not received a separate opportunity of hearing under Section 14 before the application was refused.
The Controller’s position was, in substance, that a hearing had already taken place in the opposition proceedings and that another hearing would not have changed the outcome.
The High Court did not accept that approach.
Section 14 and Section 25(1) serve different purposes
This distinction is central to the judgment.
Section 14 operates within the examination framework. Where the Examiner’s report is adverse to the applicant, or requires amendment of the application, specification or other documents to secure compliance with the Act and Rules, the Controller is required to communicate the gist of the objections and, where the applicant so requires within the prescribed period, provide an opportunity of being heard before disposing of the application.
Section 25(1), by contrast, concerns a pre-grant opposition. It permits a representation opposing grant to be made on the statutory grounds specified in that provision.
The fact that both processes can affect whether a patent is ultimately granted does not make them interchangeable.
Drawing upon the earlier Division Bench decision in Novartis AG v. Natco Pharma Limited, the Court reiterated that examination under Chapter IV and opposition under Chapter V are independent and separate statutory processes, even though they may proceed in parallel. The Court described Sections 14 and 25(1) as distinct statutory pathways that do not merge.
This has an important procedural consequence: an applicant’s participation in a pre-grant opposition hearing does not, by itself, exhaust the applicant’s right to be heard in relation to examination objections under Section 14.
Why the distinction matters in actual patent prosecution
At first sight, requiring separate hearings may appear repetitive where similar novelty, inventive-step or patentability objections arise during examination and opposition.
That view overlooks the function of the two proceedings.
In examination, the Controller considers the application against the statutory requirements for grant. The process originates from examination of the application and the objections identified through that process.
A pre-grant opposition originates differently. It is initiated through a representation by a third party and is directed to the grounds on which that party seeks to oppose the grant.
This distinction can have practical consequences for an applicant’s response strategy. During a Section 14 hearing, an applicant may need to address the Controller’s examination objections, explain the technical significance of particular claim features or, where legally and procedurally permissible, propose amendments directed to overcoming outstanding objections.
The Delhi High Court expressly recognized the importance of that opportunity. It observed that the absence of the Section 14 hearing deprived the applicant of an important right to respond to the objections and, if necessary, carry out amendments to overcome them. The Court treated this not merely as a procedural irregularity, but as a violation going to the root of the matter.
Rule 129 of the Patents Rules, 2003 also formed part of the Court’s consideration. The Rule addresses an opportunity of hearing before the Controller exercises discretionary power likely to adversely affect a patent applicant.
The technical merits were not finally decided
This part of the judgment deserves particular attention.
The High Court did not hold that Fresenius Kabi’s claimed process was novel, inventive or patentable under Section 3(d). Nor did setting aside the refusal result in grant of the patent.
The Court found the absence of the Section 14 hearing sufficient to require reconsideration. It consequently refrained from finally deciding the competing arguments on the merits so as not to prejudice either party when the matter returned to the Controller.
The refusal order dated 21 November 2024 was set aside, and the application was remanded for fresh consideration. The Controller was directed to take a fresh decision within six months, following the procedures under Sections 14 and 15 as well as Section 25 and Rule 129, and after providing an opportunity to the applicant and the pre-grant opponent.
That distinction is important when reading patent appeal decisions. Setting aside a refusal on procedural grounds should not be reported as a judicial determination that the claimed invention is patentable.
The Court also flagged concerns with the substantive analysis
Although the procedural defect was sufficient for remand, the judgment did not ignore the applicant’s concerns regarding the Controller’s treatment of the technical issues.
One issue concerned the distinction asserted by the applicant between using a pre-formed isolated salt of 3-mercaptopropionic acid and prior-art processes in which the salt was generated in situ. The applicant had relied on alleged technical advantages including purity, reaction time and suitability for industrial-scale manufacture.
Questions were also raised about the manner in which multiple prior-art references had been considered for inventive step. The Court flagged the need for the Controller, on reconsideration, to address issues raised by the applicant that had not been adequately dealt with in the refusal order. It nevertheless deliberately stopped short of expressing a final opinion on the merits.
This aspect has broader relevance to patent prosecution. An inventive-step analysis involving more than one prior-art reference cannot be reduced to identifying individual claim elements across different documents after the invention is already known. The reasoning must address why the relevant skilled person, viewed from the appropriate priority-date perspective, would have been led to the claimed combination or modification.
Technical evidence submitted by an applicant can likewise be material to that inquiry and should be considered in the context in which it is offered.
A developing line of authority on separate examination and opposition proceedings
The Fresenius Kabi decision does not stand alone.
The judgment considered the Delhi High Court’s earlier decision in Novartis AG v. Natco Pharma Limited, as well as the Bombay High Court’s 2026 decision in AIC246 AG & Co. KG v. The Patent Office of India. In the latter case too, the absence of a Section 14 hearing was held significant notwithstanding proceedings under Section 25(1). The Delhi High Court also referred to the Calcutta High Court’s decision in UPL Limited v. Union of India, which treated opposition and examination as distinct statutory processes.
The direction emerging from these decisions is relevant to prosecution practice: procedural overlap should not be assumed to erase the statutory identity of examination and pre-grant opposition.
What patent applicants should take from the decision
For applicants facing a pre-grant opposition in India, prosecution strategy should continue to account separately for the examination record and the opposition record.
Responses filed against an FER, amendments made during prosecution, technical affidavits or experimental material, submissions responding to an opponent, and arguments advanced before the Controller may interact with one another. They nevertheless arise within a statutory framework in which examination and opposition retain different functions.
Applicants and their patent counsel should therefore monitor whether outstanding examination objections have been properly addressed and whether the procedural opportunity contemplated by Section 14 has been afforded before an adverse disposal of the application.
Equally, the decision should not be understood as creating a procedural device for obtaining repetitive hearings on identical issues. Its significance lies in preserving the statutory process that Parliament has provided for examination and opposition rather than permitting one to be treated administratively as a substitute for the other.
A procedural safeguard with substantive importance
The Delhi High Court’s ruling in Fresenius Kabi is a useful reminder that patent prosecution is not concerned only with the ultimate conclusion on novelty, inventive step or patentability. The route by which that conclusion is reached also matters.
Where the statute provides an applicant with an opportunity to answer examination objections before refusal, participation in a separate pre-grant opposition cannot simply be treated as having satisfied that requirement.
For patent applicants, the practical lesson is equally clear: Section 14 examination proceedings and Section 25(1) pre-grant opposition proceedings must be approached as related, but legally distinct, components of Indian patent prosecution.
That distinction may appear procedural. As this case demonstrates, it can determine whether a refusal order survives judicial review.
This article is intended for general information on Indian patent law and should not be treated as legal advice for any particular patent application or opposition proceeding.
Also Read: 5 Essential Investor Tips to Help Women Entrepreneurs Secure Funding