Justice Jyoti Singh of the Delhi High Court has set aside the Patent Office's refusal of Fresenius Kabi Ipsum Srl's process patent application for sugammadex, a drug used to reverse muscle relaxation during anaesthesia, on a purely procedural ground — holding that examination hearings under Section 14 of the Patents Act, 1970 and pre-grant opposition hearings under Section 25(1) are distinct, parallel processes that do not converge into one another.
The application, originally filed in 2016, had been refused after a hearing conducted in the context of a pre-grant opposition proceeding under Section 25(1). The Patent Office treated that opposition hearing as having also disposed of the applicant's separate right to be heard on the examination report under Section 14. Fresenius Kabi challenged the refusal, arguing it had never actually been granted a distinct Section 14 hearing on the objections raised during examination, even though such a hearing is a specific procedural entitlement built into the examination process independent of any opposition that may be pending.
The Court agreed, holding that Section 14 and Section 25(1) serve different statutory purposes and involve different considerations — the former is the applicant's opportunity to be heard on the Controller's own objections to patentability arising from examination, while the latter is a contested proceeding triggered by a third party's opposition. Treating participation in one as satisfying the requirement of the other, the Court held, deprives the applicant of a statutorily guaranteed opportunity. Because the refusal order rested entirely on this procedural defect, the Court set it aside without going into whether the invention was in fact patentable, remitting the matter for the applicant to be given its distinct Section 14 hearing.
The ruling addresses what the Court and commentators have flagged as a recurring gap in Patent Office practice, where applicants facing simultaneous pre-grant opposition and unresolved examination objections have sometimes found their Section 14 rights effectively subsumed into the opposition hearing without a clear, separate opportunity to address the examiner's own objections.