The case revolved around an international patent application filed by Arcturus Therapeutics Inc., a biopharmaceutical company specialising in RNA therapeutics, concerning an invention titled “Ionizable Cationic Lipid For RNA Delivery.” The application had been refused by the Assistant Controller of Patents on technical grounds, without a substantive evaluation of the invention’s merit, prompting the appellant to seek judicial intervention.
The origins of the dispute trace back to November 18, 2013, when Arcturus filed a priority application in the United States, followed by a PCT (Patent Cooperation Treaty) application a year later. The Indian national phase of this PCT application was filed on June 2, 2016, and was assigned Application No. 201617019205. As is customary, a First Examination Report (FER) was issued on February 15, 2019, wherein the Indian Patent Office raised objections primarily on three grounds: lack of inventive step under Section 2(1)(ja) of the Patents Act, and non-patentability under Sections 3(d) and 3(h).
The appellant filed its response to the FER in August 2019 and participated in a first hearing scheduled in March 2022. Following the hearing, Arcturus submitted written arguments in May 2022. In January 2023, the Patent Office granted a second hearing, emphasising the need for comparative empirical data to assess the invention. Arcturus attended the second hearing on May 2, 2023, and requested a one-month extension to submit the requested data and additional written arguments. Although the extension was granted until June 17, 2023, the company filed its final submissions only on July 25, 2023, by which time the Assistant Controller had already passed the impugned order rejecting the application, citing failure to submit within the stipulated timeline.
Crucially, the impugned order, issued under Sections 15 and 43 of the Patents Act, did not address the substantive issues raised in the FER. Instead, it summarily rejected the patent application for procedural delay. The Assistant Controller’s reasoning was terse: although multiple opportunities had been provided and an extension granted, the applicant failed to submit the necessary documents within the allowed period, and thus the objections stood unresolved, justifying a rejection.
The appellant challenged the order under Section 117A of the Patents Act before the Delhi High Court. The principal contention was that the rejection was procedurally excessive and materially unjust, as the patent office failed to consider the merits of the case, including the submissions already made, oral arguments presented during two hearings, and extensive data filed—albeit belatedly.
The Court critically examined the sequence of events and noted that patent rights are valuable rights with significant commercial and scientific implications. The mere procedural delay, especially when caused by the time-consuming nature of conducting scientific studies, should not become a ground to extinguish such rights without a fair adjudication on merit. The Court emphasised that natural justice requires the decision-making authority to consider all materials submitted and to engage with the substance of objections raised, particularly in technical matters where the consequences of refusal are profound and often irreversible.
The Court observed that the Assistant Controller, instead of mechanically refusing the application for a delay of a few weeks, ought to have considered the earlier submissions, the oral arguments from both hearings, and the final written submissions, even if late. Importantly, the delay had not been intentional but arose due to the complex scientific analyses required for the comparative empirical data requested by the patent office itself.
In a firm rebuke to the purely procedural approach taken by the patent authority, the Court held that the Assistant Controller had erred by failing to apply his mind to the substantive content of the application. It noted that the impugned order lacked any discussion of the objections under Sections 2(1)(ja), 3(d), or 3(h), nor did it evaluate whether the invention truly lacked inventive step or was otherwise non-patentable.
Accordingly, the Court set aside the impugned order and remanded the matter to the Assistant Controller for a fresh decision, explicitly directing that the application be assessed on its merits. A fresh hearing was ordered, and the Assistant Controller was requested to decide the matter expeditiously, preferably within three months. The Court clarified that the appellant did not intend to submit any further material and that the pending decision should be based solely on the already submitted records, including the belated but crucial July 25 submissions.
In closing, the judgment underlined that its directions were based on the peculiar facts of this case and should not be treated as precedent. Nevertheless, the decision sends a strong signal to patent offices across jurisdictions that procedural formalities should not override the need for reasoned and fair evaluations, particularly in the domain of scientific innovation.
